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tag:blogger.com,1999:blog-112348622016-07-25T07:22:08.070-04:00The Rest of the Story: Tobacco News Analysis and Commentary...Providing the whole story behind tobacco news.Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-48163832997609245642016-07-25T06:45:00.000-04:002016-07-25T07:22:08.091-04:00FDA's Convoluted Response to a Simple Question Shows How Arbitrary, Capricious, and Inane the Deeming Regulations AreSomeone shared with me the actual reply they received from the FDA in response to a very simple question:

"Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?"

This seems like a simple and straightforward question that could and should be able to be answered with a simple "yes" or "no." After all, if e-cigarettes do not contain nicotine then there is no basis for the FDA to assert jurisdiction over them as tobacco products. Therefore, these nicotine-free e-liquids would not be subject to the pre-market approval requirements.

A simple answer of "no" would have and should have sufficed.

The Rest of the Story

Instead, here is the FDA's actual response:

Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, "Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act" (Deeming rule). The information contained in this message is what is provided to vape shops to assist them with any questions about compliance. We hope that you find this helpful.

FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business. We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.

It may be useful for you to know that the Deeming rule published in the Federal Register on May 10, 2016, and takes effect on August 8, 2016. While FDA continues to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products, the Deeming rule extends FDA's authority to "newly deemed" tobacco products such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts, but not the accessories of newly deemed products. The Deeming rule also includes additional restrictions for "covered tobacco products." A "covered tobacco product" is any newly deemed tobacco product, but excludes any component or part that is not made or derived from tobacco.

The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer.

The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated since 2009.

These requirements include:

Register domestic manufacturing establishment(s) and submit product listings to FDA by December 31, 2016;

Reporting ingredients, and harmful and potentially harmful constituents;

Requiring premarket review and authorization of new tobacco products by the FDA;

Placing health warnings on product packages and advertisements; and

Not selling modified risk tobacco products (including those described as "light," "low," or "mild") unless authorized by the FDA.

Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

For products that were not on the market as of the effective date, a premarket authorization is required prior to marketing those products. For products on the market as of the effective date, under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.

FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the links provided below for more information.

As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation. These products will be evaluated on a case-by-case basis. This applies to closed and open system devices that contain zero-nicotine.

As a tobacco product, your product will automatically be subject to all of the requirements in Chapter IX of the Federal Food, Drug, and Cosmetics Act and its implementing regulations relating to tobacco products when the deeming rule becomes effective on August 8, 2016. However, for many provisions FDA is providing a compliance period with additional time during which FDA does not intend to enforce compliance with the requirements, as stated in the final rulemaking document.

In addition, if you're solely a supplier and your zero-nicotine product is sold only to another company for further manufacture into a finished tobacco product, at this time, FDA does not intend to enforce certain automatic provisions of the law with respect to your product. Therefore, for example, FDA does not intend to enforce the requirement that you register your manufacturing establishment and list your products, submit premarket applications, or submit ingredient listings or health documents.

There are additional requirements in the rule, such as minimum age, identification, and vending machine restrictions and health warning requirements that apply only to "covered tobacco products," which does not include a component or part that is not made or derived from tobacco. Accordingly, if your product is not made or derived from tobacco, it is not subject to such requirements. Even if your product is not a covered tobacco product, however, FDA regulations prohibit you from distributing free samples of your newly-regulated product, including its components and parts, to anyone.

Regarding your fourth question, if the product does not contain nicotine and you have submitted a statement to FDA certifying so, according to the regulatory requirement, then you would not have to include the mandatory warning regarding the contents of nicotine in the product.

For More Information

To assist the newly-regulated tobacco industry in complying with the requirements, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA's current thinking on issues specific to the newly-regulated products.

Final Rule and Accompanying Documents

Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements

Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); Draft Guidance for Industry

Tobacco Product Master Files; Guidance for Industry

Resources for Additional Information

FDA continues to update its Deeming webpageto provide information designed to help industry understand the Deeming rule. We anticipate that many of your questions will be addressed by the resources available on this website. We plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA plans to post Tobacco Compliance Webinars, including one specifically addressing requirements for vape shops, to our website and updates will be provided as additional webinars are available.

We also encourage you to subscribe to FDA's "This Week in CTP." By subscribing, you'll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.

Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:

Email:

firstname.lastname@example.com

Phone:

1-877-287-1373

Mail:

Food and Drug Administration

Center for Tobacco Products

10903 New Hampshire Avenue

Silver Spring, MD 20993

____________________

Center for Tobacco Products

Food and Drug Administration

CTP Call Center: 1-877-CTP-1373

www.fda.gov/tobaccoproducts

What Does This All Mean?

Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations, I have no clue what the heck the FDA is talking about. I can't even imagine a scenario where a nicotine-free e-liquid would be incorporated into a "tobacco product," but if it were, it would only be a tobacco product if it was mixed with nicotine-containing e-liquid, in which case the manufacturer or retailer is not selling a nicotine-free e-liquid. Of course that would be considered a tobacco product.

The question here was much simpler. If I produce a finished e-liquid that is nicotine-free, is my product regulated and if so, do I have to submit a pre-market application? The answer appears to be no. But the FDA hides this answer in such a stream of incomprehensible jibberish that the poor small business owner (or even the large business owner) is more confused after having asked the question than they were before.

The time and resources necessary to even understand what is regulated and what is not regulated are prohibiting for most small business owners in the vaping market. And that's before even getting to the issue of what would be required in a pre-market application if the product is regulated.

This is quite obviously a nonsensical and non-workable regulatory approach and for that reason alone, it is not going to protect the public's health. Quite the opposite, it will harm the public's health by decimating the e-cigarette market, forcing thousands of owners of small entities out of business, and protecting real cigarettes from competition, thus increasing smoking-related disease and death.

In my opinion, this response from the FDA could be used by the plaintiffs in litigation against the agency in order to demonstrate the arbitrariness and capriciousness of the regulations, as well as their undue complexity and burden on small business owners.

So in response to the FDA's expressed hope to the inquiring business owner that "We hope that you find this helpful," I say: "Yes. Very helpful indeed."Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-7563949516533298702016-07-22T14:44:00.001-04:002016-07-22T14:44:22.826-04:00Great Article on VapingThis is one of the best articles on vaping that I've read. It makes a difference to have a young person's perspective because they are in the best position to have insight into the nature of smoking and vaping behavior among their peers.Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-51901083414040064102016-07-21T08:39:00.001-04:002016-07-21T09:41:24.519-04:00CDC Bemoans Failure to Decrease Overall Alcohol Product Use among Teens, Despite Large Decline in Current DrinkingAccording to data from the Centers for Disease Control and Prevention (CDC), the prevalence of current drinking among high school students has declined dramatically in the past decade and a half, dropping from 50.0% in 1999 to 34.9% in 2013. One would think that would be cause for celebration. However, the CDC is telling the public that despite this decline in drinking among youth, overall use of alcohol products has stayed the same.

The Office on Alcohol and Health issued a statement yesterday, arguing that the recent declines in youth drinking have been undermined and offset by an increase in the use of new and emerging types of alcohol product use. These products, which look just like traditional alcohol drinks and are consumed in a similar way, threaten the public's health according to CDC because they look like traditional alcohol drinks and are therefore re-normalizing drinking and serving as a gateway to traditional alcohol use.

However, an investigation by The Rest of the Story has revealed that the drinks which CDC is now classifying as "alcohol products" do not actually contain alcohol. In fact, our investigation revealed that these products were created with the specific intention of providing youth with beverages that look like alcohol products and are consumed the same way, but which are much safer because they don't actually contain alcohol.

By submitting a Freedom of Information Act (FOIA) request, we were able to determine that the CDC has rigged the numbers for the past five years by starting to classify alcohol-free beverages as "alcohol products." For example, the CDC now considers Shirley Temples to be alcohol products. Other beverages that the CDC now classifies as alcohol products include alcohol-free spritzers, alcohol-free Sangria, sparkling (non-alcoholic) limeade, and non-alcoholic watermelon/strawberry coolers.

Anti-alcohol groups throughout the U.S. have uniformly condemned Shirley Temples. In fact, one group released a report just yesterday entitled "Shirley Temples are Destroying America's Youth."

The Rest of the Story conducted an exclusive interview with the CDC about their new classification system. Here are excerpts from the interview:

Rest of the Story: Aren't you pleased with the recent declines in youth drinking? Wouldn't you say that is a public health accomplishment?

CDC: Unfortunately, the dramatic decline in youth drinking of traditional alcoholic beverages has been offset by an increase in youth use of novel alcohol products, such as Shirley Temples and non-alcohol spritzers. Drinking among high school students dropped to the lowest levels since the National Youth Risk Behavior Survey (YRBS) began in 1991, but the use of other alcohol products, including Shirley Temples, among students poses new challenges.

Rest of the Story: But I don't understand. How can you classify Shirley Temples and other non-alcoholic beverages as "alcohol products" when they don't actually contain alcohol? Isn't that being dishonest, or at least, disingenuous?

CDC: Current drinking is at an all-time low, which is great news. However, it's troubling to see that students are engaging in new risk behaviors, such as drinking Shirley Temples and alcohol-free sangria. We must continue to invest in programs that help reduce all forms of alcohol use, including Shirley Temples, among youth.

Rest of the Story: But what is the problem with youth drinking alcohol-free beverages? In fact, wouldn't we rather that youth drink alcohol-free beverages than drinks that actually contain alcohol?

CDC: There are concerns that Shirley Temples contribute to normalizing drinking as a social norm and may be a gateway to youth drinking.

Rest of the Story: But isn't the goal to prevent youth drinking of alcohol?

CDC: During 2011–2015, there was no change in current use of any alcohol product among middle and high school students, and in 2015, an estimated 4.7 million U.S. middle and high school students currently used any alcohol product. As in 2014, Shirley Temples were the most used alcohol product among U.S. middle and high school students in 2015. During 2011–2015, substantial increases in Shirley Temple use among middle and high school students were reported, resulting in an estimated total of 3.0 million middle school and high school Shirley Temple users in 2015. Although youth drinking declined during 2011–2015, there was no change in use of alcohol products during this time period. Because of increases in the use of Shirley Temples, no decline occurred in alcohol use overall during 2011–2015.

Rest of the Story: Isn't there evidence that drinking Shirley Temples is much safer than drinking alcohol-containing beverages?

CDC: Youth use of alcohol in any form is unsafe. For this reason, comprehensive and sustained strategies are needed to prevent and reduce the use of all alcohol products among youths in the United States.

Rest of the Story: Is there actual clinical evidence that drinking Shirley Temples is unsafe?

CDC: Despite what many people believe, Shirley Temples are not just pure water. Furthermore, youth consumption of Shirley Temples will re-normalize drinking behavior. Policies to denormalize alcohol use in society and historic reductions in alcohol consumption may be undermined by this new 'gateway' product.

Rest of the Story: But how can consumption of alcohol-free beverages normalize the drinking of alcohol? Wouldn't that in fact de-normalize alcohol consumption?

CDC: Youth should not use any alcohol product. Moreover, there are other problems with Shirley Temple use. For example, these products may cause former drinkers to relapse to alcohol use. They also may delay the achievement of sobriety among current drinkers. It would be devastating if alcoholics were to substitute Shirley Temples for their drinking instead of quitting alcohol use entirely.

Rest of the Story: Is there anything else you would like to emphasize to the public?

CDC: Yes. Shirley Temples are not just harmless water, as the alcohol industry has been advertising.

Rest of the Story: Thank you for your time.

Recently, the Food and Drug Administration (FDA) promulgated regulations which "deem" alcohol-free beverages like Shirley Temples to be "alcohol products." Restaurants which serve Shirley Temples will now be considered alcohol manufacturers. In addition, other component parts of these beverages will also be regulated as alcohol products, including the glasses they are served in. After consultation with multiple legal experts, The Rest of the Story has confirmed that the cherries that are served with Shirley Temples are also regulated under these alcohol product rules.

We asked the FDA whether this means that companies which sell cherries must submit pre-market alcohol applications (PMAAs) to the agency before they market their cherries. We were referred to the FDA draft guidance, which indicates that cherries will only be regulated if they are part of a "finished alcohol product." This means that companies which sell cherries to restaurants and bars will not have to submit PMAAs. However, if a restaurant incorporates those cherries into a finished alcohol product (e.g., a Shirley Temple), then the restaurant is considered an alcohol manufacturer and will have to comply with the regulations, including the requirement to submit a PMAA.

Despite the concerns of highball glass manufacturers throughout the country, we have confirmed that these companies will not have to submit PMAAs unless they are selling finished alcohol products, meaning a complete Shirley Temple. However, restaurants that prepare their own Shirley Temples will have to conduct safety testing on their highball glasses. In addition, companies that sell pre-made Shirley Temples will be regulated as alcohol manufacturers. Restaurants and bars that sell pre-made Shirley Temple cocktails will not have to comply with the regulations, but those which self-mix the Shirley Temples themselves will have to comply.

Making the PMAA even more burdensome is the FDA's requirement that any variation in the contents of a Shirley Temple require a separate application. This means that restaurants and bars will need separate FDA approval for every different ratio of 7-Up to grenadine that they use in their drinks. Moreover, a separate application will be required for every combination of 7-Up/grenadine ratio and type of glass. Different varieties of cherries will also require separate applications and a separate determination that the Shirley Temple with that particular cherry variety is beneficial for the public's health. That determination must take into account not only the impact of Shirley Temples on individuals who already drink alcohol, but on non-alcohol users who might start drinking Shirley Temples.

One restaurant has filed suit against FDA, arguing that the agency grossly underestimated the number of PMAA submissions that will be required under the regulations. While the FDA estimates there will be only 750 applications, the owner of this restaurant told us that he alone will have to submit 96 separate applications, as they use four different ratios of 7-Up to grenadine, three different types of glasses, four varieties of cherries, and two types of toothpicks.

According to many restaurant owners, the most troubling aspect of the FDA deeming regulations is that they will not be allowed to inform patrons that Shirley Temples are free of alcohol, are safer than real alcoholic beverages, or to even use the term "alcohol-free." For example, restaurants can no longer list Shirley Temples under a menu category of "non-alcoholic beverages." Instead, Shirley Temples will now be lumped in under a general category of "alcoholic beverages," so this menu item will be mixed in with each restaurant's selection of bourbon, fine scotch, rum cocktails, and schnapps.Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-82128595547691158522016-07-19T21:11:00.000-04:002016-07-19T21:11:38.980-04:00Groundbreaking Research Finds that Products which are Cool and New Appeal to YouthsAnti-Vaping Advocate Says this Finding Adds to Evidence that E-Cigs are a Gateway to Youth Use of Tobacco Products

A groundbreaking study published yesterday in the Canadian Medical Association Journal presents the shocking finding that youth are drawn to products that are new and cool and that this is why they find electronic cigarettes appealing.

The study, which involved a survey asking Ontario youth why they find e-cigarettes appealing, reported the startling finding that a major reason for youth e-cigarette experimentation is that they like "engaging in seemingly exciting new behaviours." The paper's final conclusion was that: "Adolescents in this population appear to be motivated by the appeal of trying something new."

In an accompanying editorial, Dr. Matthew Stanbrook argues that this study adds to evidence that e-cigarettes are a "gateway" to youth tobacco product use, stating that the findings "add to mounting evidence associating use of e-cigarettes with tobacco use." He also cited a recent study involving US youth which "found that never-smokers in grades 11–12 who used e-cigarettes had sixfold higher odds of becoming cigarette smokers a year and a half later when they reached the legal age to purchase tobacco."

The Rest of the Story

The international reaction to these remarkable and shocking new findings has been intense. Marketers throughout the world have expressed their surprise at these findings and are already looking to change their tactics to take advantage of this new knowledge.

For example, Apple CEO Tim Cook told The Rest of the Story that: "This is truly a game changer. We had no idea that cool, exciting, new products would appeal to youth. We've been hammering away at young people for years with the same old Apple 1's, thinking that they are totally into old-fashioned, traditional products. Cook said that the findings of the study instantly gave him the idea of launching a series of what he called "i" products, such as multi-functional cell phones, with new versions coming out each year to attract young people to innovative, new, and exciting features.

Sony CEO Kazuo Hirai was also surprised by the study findings. "No wonder our Betamax video recorders haven't been selling well among the young people. It never occurred to us that to attract youth, you have to come up with something new and exciting. This is going to change the way we do business."

The Rest of the Story also interviewed Nintendo CEO Tatsumi Kimishima, who told us that the findings of this study sparked a novel idea: "Instead of just providing kids with the old, kind of boring video games where you catch Pokemon while sitting on your couch, we're going to integrate the Pokemon game with high-tech GPS and state-of-the-art mapping technology. This will create the novelty of young people having to get off their couches and venture into the real world to catch Pokemon in real-life settings. According to this new research, the novelty and excitement of this activity should really catch on quickly." While Kimishima has not officially decided on a name for the product, he told us that he was preliminarily calling it "Pokemon on the Go."

The Rest of the Story also interviewed several tobacco control experts, asking them what aspect of the new study shed light on the gateway hypothesis. One researcher kept us on hold for four hours, while frantically searching the paper in a seemingly hopeless attempt to find anything in the study which was relevant to the question of whether e-cigarettes are a gateway to youth use of tobacco products.

Another researcher told us that he couldn't find anything, but was having the article translated into three other languages to see if perhaps he was missing something.

A third researcher declined our request for comment, explaining that it would take him six hours to download the article on his Apple 1. When asked why he is still using such an antiquated computer, he told us that he "doesn't like new, cool things. That's why I still write my papers with an Olivetti Lettera 32 manual typewriter, watch my favorite programs on a GE 17-inch TV set, and listen to music on my Victrola 3-speed turntable."

 Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-30930130462877913092016-07-19T06:24:00.000-04:002016-07-19T08:06:30.264-04:00Physician Recommends Against Quitting Smoking for Smokers Who Do Not Want to Use NRT or Cessation Drugs; Hides Conflict of InterestAn article in the Annals of Family Medicine argues that smokers who do not wish to use nicotine replacement therapy (NRT), varenicline, or other drugs should be counseled by their physicians not to quit smoking. Specifically, these patients should not be encouraged to try to quit using e-cigarettes. Moreover, the article scares physicians into thinking that if they do encourage smoking cessation via e-cigarettes, they are putting themselves into legal danger.

According to the lead author - Dr. Adam Goldstein of the University of North Carolina - e-cigarettes are dangerous and have not shown to be helpful in smoking cessation and should therefore not be recommended to patients. If they are recommended, he argues, physicians face legal risks:

"the ethical duty of medicine is to do no harm. Jumping from the 10th floor of a burning building rather than the 15th floor offers no real benefit. If a clinician recommends penicillin for a resistant infection in the face of more effective therapy, they would face an uncertain defense in front of their colleagues or courts. For clinicians that do recommend ENDS, do they document such in the medical record? Given the rise in medical lawsuits related to ENDS side effects or injuries, until such time that medical evidence supports ENDS safety and effectiveness, and robust regulatory frameworks exist, clinicians who recommend ENDS to patients in favor of more effective and safe products may face medico-legal risks."

The authors also argue that e-cigarettes should not be recommended to subgroups of smokers: "Some clinicians may be tempted to recommend ENDS for certain subgroups of smokers, but this approach is problematic."

They specifically advise physicians to recommend that asthmatic smokers keep on smoking rather than attempt to quit using e-cigarettes: "It is problematic to recommend ENDS for asthmatic tobacco users, as immediate reduction in lung function is observed when using ENDS."

The Rest of the Story

By advising physicians not to recommend e-cigarettes for smoking cessation, this article is actually advising them to recommend that smokers who don't want to quit using FDA-approved methods should continue smoking, rather than trying to quit by switching to vaping.

This is a dangerous and misguided recommendation that is completely non-evidence-based and which is destructive to the health of patients by discouraging them from quitting smoking unless the quit using a particular method favored by the physician.

I cannot emphasize strongly enough that if a patient is not interested in quitting using NRT or another drug, he or she should be advised to find some other method of quitting, including e-cigarettes. That patient should not be thrown under the bus, as is being recommended in this article. Better that the patient attempt to quit using e-cigarettes than not try to quit at all. Moreover, if the patient expresses particular interest in e-cigarettes and a disdain for or previous failure with FDA-approved therapies, he or she should be strongly advised to go for it. Millions of ex-smokers have successfully quit using vaping products and there is no justification for promoting continued smoking over a quit attempt with e-cigarettes.

Not only is the medical recommendation in the article misguided and damaging, but the evidence presented to support it is highly biased and incomplete. The paper cites research which identified potential risks of vaping but fails to cite any of the many articles which have documented the significant benefits associated with switching to e-cigarettes.

For example, the paper cites two articles which found sub-clinical increases in airways resistance among e-cigarette users, but failed to cite two other articles which documented significant improvement in lung function among asthmatic smokers. The recommendation against asthmatic smokers trying to quit using e-cigarettes ignores solid evidence that asthmatic smokers experience dramatic improvement in their respiratory symptoms and clinical lung function if they are able to switch to e-cigarettes.

The paper also fails to cite the most important study of all: the one and only clinical trial conducted on e-cigarettes, which happened to find that these products are just as effective as the nicotine patch for smoking cessation.

Unfortunately, the bias apparent in the paper has the appearance of being related to an unreported conflict of interest. Specifically, the lead author - Dr. Goldstein - failed to disclose that he has received funding from Big Pharma; in particular, funding from a company that makes Chantix, for which e-cigarettes are a major market competitor. It is imperative that a physician who publishes a medical recommendation like this disclose any relevant conflicts of interest, especially prior funding from a company that stands to benefit tremendously from the recommendation being made.

By his own acknowledgment, Dr. Goldstein has received research funding from Pfizer, the maker of Chantix. Pfizer certainly stands to gain financially from the recommendation that physicians discourage patients from using e-cigarettes to quit. So this conflict should have been disclosed. It appears that Dr. Goldstein received a $500,000 grant from Pfizer from 2010-2012. I think that a half million dollar grant from a corporation which stands to gain financially from the medical recommendation made in the article is something that readers deserve being made aware of.

Elsewhere, Dr. Goldstein acknowledges that he has served on advisory boards for Pfizer and for Boehringer Pharmaceuticals. In addition, the UNC Nicotine Dependence Program, of which Dr. Goldstein is listed as a member, has received funding from Pfizer. Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-31183756162969656602016-07-18T06:24:00.000-04:002016-07-18T08:55:44.625-04:00Altria Urges Changes in FDA E-Cigarette Regulations that Would Decrease Its Share of Vaping Market and Help Save Many Smaller ManufacturersIn a move that casts serious doubt on anti-tobacco groups' maligning of the motives of the tobacco companies in marketing vaping products, Altria Client Services, on behalf of Nu Mark (the maker of Mark Ten e-cigarettes), has submitted comments to the FDA that blast its pre-market tobacco application (PMTA) requirements for e-cigarettes, arguing that these requirements are unduly burdensome, unnecessary, and beyond the scope of the agency's jurisdiction under the Tobacco Control Act.

In the comments, Altria Client Services expresses particular concern that the burdensome PMTA requirements will force many manufacturers out of business, undermining the Tobacco Control Act's public health goals.

Altria writes: "The Draft Guidance is not aligned to the FSPTCA's goal of promoting public health because the complexity of information recommended for the application process and the short compliance period for FDA to complete PMTA reviews may result in some existing ENDS products being forced off the market."

Altria also notes that FDA itself acknowledged that a large number of e-cigarette companies would go out of business, yet failed to account for this in its regulatory impact analysis.

To remedy the situation, Altria suggests an approach similar to what I have been advocating: the agency should "establish baseline performance standards for ENDS products that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory PMTA requirements."

Two of Altria's main goals, as stated in the comments, are to:

 1) "support manufacturers' efforts to develop and bring to market innovative products that may advance the public health."

2) "allow industry participants to engage and compete in a dynamic market."

The Rest of the Story

For tobacco control advocates and groups which continue to argue that the tobacco companies have failed to change their behavior, they need to check their calendars and realize that we're now in 2016, not in the pre-Engle time period. Things have changed substantially, and nowhere is this seen more noticeably than with the tobacco industry's embrace of true harm reduction products, especially e-cigarettes and vaping products.

Many of my colleagues continue to argue that Altria and Reynolds American are insincere in wanting to promote vaping, that they are merely trying to promote smoking by encouraging vaping as a mechanism to avoid smoking cessation, and that their main purpose is to try to recruit new smoking customers by getting youth addicted to e-cigarettes and then encouraging them to proceed on to tobacco cigarette smoking. Many of the anti-tobacco groups continue to accuse Altria and Reynolds American of marketing their products to youth and using slick advertising and youth-oriented flavorings like gummy bear and cotton candy to appeal to kids.

The truth is that these are not your father's cigarettes. What Altria and Reynolds American are doing with vaping products is nothing like what they used to do with the marketing of tobacco cigarettes.

In fact, Altria and Reynolds American are not offering youth-friendly flavors like bubble gum, cotton candy, and gummy bear. Their marketing is not targeted at youth, either in its advertising placement or content. Their sales practices for Vuse and Mark Ten are not directed at facilitating the youth purchase of these products.

VUSE
Candy and fruit flavors: None prior to 2015. Only tobacco and menthol. Last year, introduced four new flavors: Mint, Chai, Berry, and Crema.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

MARK TEN
Candy and fruit flavors: None before last year. Only tobacco and menthol. Last year, introduced two new flavors: Fusion and Mint.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

If these companies were truly going after kids, why would they be actively avoiding youth-friendly flavorings? Why would they refrain from selling disposable products, which are much less expensive and are most likely the type that youth purchase?

To be sure, there are a small number of "bad actors" in the e-cigarette industry. But Altria and Reynolds American are not among them.

Please note that I am not arguing here that companies which are selling e-cigarettes via the internet, marketing disposable products, or selling multiple flavors are targeting kids or that they have any desire for youth to use their products. Quite the opposite: these aspects of the market are essential to reach adult smokers and curtailing any of them would decimate the market, leading tens of thousands of ex-smokers to return to smoking and discouraging smokers from switching to vaping products in the future. I am simply pointing out that Altria and Reynolds American are clearly not targeting youth and using these points to demonstrate how inaccurate the anti-tobacco groups are in characterizing the behavior of these companies.

If there were any remaining doubt about the sincerity of the two major domestic cigarette companies in marketing vaping products, it should disappear after reviewing Altria's comments to the FDA. (First of all, recognize that these comments are not a publicity ploy because the company is not publicizing them -- I was unable to even find them online.) In these comments, Altria supports policy changes that are not in its best financial interests in the sense that the current burdensome regulations are in Altria's favor and without changes to make them less burdensome, these regulations would essentially hand the entire vaping market to Altria and Reynolds American. Virtually no other companies have the financial resources to develop the required PMTAs. So Altria could easily just sit by quietly and then enjoy an oligopoly in the vaping market.

But this is not what Altria is doing. The company is actually trying to save at least some vitality in the e-cigarette and vaping market by urging the FDA to weaken the burdensome requirements so that many more manufacturers have an opportunity to stay on the market. And these two tobacco companies are also strongly behind the Bishop-Cole amendment which would grandfather existing vaping products, thus preventing the decimation of the e-cigarette market and the creation of a Big Tobacco oligopoly.

Anti-tobacco advocates are going to have to come to terms with the apparently threatening reality that our long-term mantra is no longer valid. Their entry into the vaping market is not merely a ploy to get youth hooked on nicotine so that they can get new smoking customers. They are legitimately interested in creating a new and robust market for harm reduction products.

Now I am not arguing that financial incentives do not play a role. Of course they do. The companies see an eventual decline in the use of combustible tobacco products in the United States, and they want to be able to derive some economic benefit even as smokers move away from these combustibles. By entering the vaping product market, the companies have an alternative source of revenues to help sustain them. And they can use price increases with their traditional cigarettes to help lessen the financial blow, by protecting revenue even as sales decline. And while their market share will not be nearly as high in a robust, thriving vaping market, the overall market will likely be much greater if there are a large variety of alternative choices for smokers who want to quit but do not feel able to do so without the aid of a vaping device.

But instead of denying that this could possibly be happening, we need to open our eyes and see that this is one example where there is a confluence of public health goals and economic incentives for the vaping industry. Profits from the sale of vaping products increase as the sale of traditional cigarettes fall.

At some point, we need to figure out what our goal is. Is the goal to save lives and improve the public's health by decreasing the tremendous burden of smoking-related morbidity and mortality. Or is the goal simply to continue an unrelenting attack on the cigarette companies, which creates nice publicity for our organizations' membership and helps to attract larger donations?Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-53775447458943069092016-07-14T07:07:00.003-04:002016-07-14T07:07:29.769-04:00Op-Ed Explains Why FDA Deeming Regulations are NonsensicalMy op-ed, published yesterday in BU Today, explains why the FDA e-cigarette deeming regulations are nonsensical.Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-51866109166792485512016-07-13T10:24:00.000-04:002016-07-13T10:24:03.469-04:00FDA Botched Cost-Benefit Analysis of Its E-Cigarette Deeming RegulationsAfter reviewing the declaration of Nicopure Labs' CEO Jeff Stamler in its lawsuit against the FDA, I have concluded that the FDA completely botched its cost-benefit analysis of the e-cigarette deeming regulations, drastically underestimating the costs of the regulations and without even attempting to quantify the benefits.

As such, this represents a violation of the Administrative Procedures Act, providing strong grounds for the D.C. District Court to overturn the regulations.

In its declaration, Nicopure reveals that it has 2,400 stock keeping units (SKUs), including e-liquids, vaporizers, and component parts. This means that in order to keep its products on the market, Nicopure will have two years to complete 2,400 pre-market tobacco applications (PMTAs), each of which is estimated by the FDA itself to cost approximately $300,000 and to require 1,500 hours to complete.

Nicopure estimates the actual cost of each PMTA to be between $3 million and $5 million. But even if we use FDA's more conservative estimate, it would cost Nicopure $720,000,000 ($720 million) to keep its products on the market. The company estimates that at very best, it could complete PMTAs for 12 of its products. Thus, the regulations - if not overturned - will decimate the overwhelming majority of Nicopure's offerings to vapers.

The Rest of the Story

The FDA estimated that it would receive only 750 PMTAs. So one of two things must have occurred:

1. The FDA grossly underestimated the number of regulated products on the market.

While the FDA apparently thought there were only 750 products, we now know that one company alone manufactures 2,400 different products. With hundreds of companies out there, it seems clear that the agency didn't even come close to providing an accurate estimate of the number of PMTAs that would be required under its regulations.

2. The FDA assumed that most companies would go out of business and therefore not submit any PMTAs.

A second possibility is that the FDA did have an accurate idea of the number of companies and products on the market, but assumed that the overwhelming majority of these companies would not bother to submit PMTAs because of the prohibitive expense and would therefore go out of business.

In both cases, the FDA would have botched its cost-benefit analysis.

In case #1, the agency grossly underestimated the costs of the regulations because it failed to even come close to an accurate estimate of the number of affected companies and products.

In case #2, the agency grossly underestimated the costs of the regulations because it failed to account for the economic costs associated with hundreds of small companies going out of business.

Either way, it seems clear that the FDA failed to conduct a proper cost-benefit analysis and therefore violated the Administrative Procedure Act, providing strong grounds for the D.C. District Court to overturn the deeming regulations.

Note that this is only one of many grounds upon which the deeming regulations have been challenged. I outlined some of the other grounds elsewhere.

Making the violation even worse is the fact that by its own admission, the FDA failed to quantify the expected benefits of the regulations. The agency could not document that e-cigarettes are currently causing substantial health harm that would be negated by its promulgation of these regulations.

After speaking with many vape shop owners and e-cigarette and e-liquid manufacturers in the weeks since the deeming regulations were released, it seems clear to me that the overwhelming majority of e-cigarette businesses are unable to afford the expense of completing any PMTAs. It is simply too expensive and these small businesses do not have the kind of capital on hand that would be required. As a result, many of these companies are resolved to do business for another two years and then drop out of the market. Others are deciding to drop the majority of their products and just focus on perhaps one or two flavorings.

There is no question that the combined effect of the regulations will be to decimate the vaping product market, both by forcing hundreds of small and medium companies out of business and by removing the overwhelming majority of vaping products and flavorings from the market.

The impact will be not only the severe economic losses to small and medium businesses, but also the damage done to the public's health by helping cigarettes restrain what otherwise would have been serious competition from safer alternative products. The deeming regulations are therefore a godsend to the tobacco cigarette market. It is brutally ironic that an agency entrusted with protecting the public's health has taken an action that will promote cigarette sales and protect cigarette profits.Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-72605308665052305732016-07-12T08:02:00.004-04:002016-07-13T10:54:34.078-04:00Eating Corn Flakes is Half as Dangerous as Smoking, According to Reasoning of Anti-Vaping ResearchersBased on evidence that chemicals often found in e-cigarette aerosol produce endothelial dysfunction and decreased arterial compliance, Dr. Aruni Bhatnagar of the University of Louisville has concluded that e-cigarettes are no safer than real cigarettes, and Dr. Stan Glantz has argued that vaping is up to half as dangerous as smoking. Both of these anti-vaping researchers reasoned that since the dose-response relationship between smoking and cardiovascular disease is non-linear and risk saturates at rather low levels of exposure, and since e-cigarettes contain chemicals that can cause acute cardiovascular injury, vaping is therefore not much safer than (Glantz) or no safer than (Bhatnagar) smoking.

Bhatnagar concludes that: "The dose-response relationship between smoking and cardiovascular mortality is non-linear, suggesting that reduction in HPHC concentrations in e-cigarette aerosols may not result in proportional harm reduction and decreased HPHC exposure may be offset by increased use by individuals who believe that e-cigarettes are safer than conventional cigarettes. Thus, taken together, current evidence does not entirely support the notion that e-cigarettes are reduced harm products... ."

Glantz concludes that: "Given the evidence that effects on the cardiovascular system and lungs account for more than half the smoking-induced deaths and that at least some of the short-term effects of e-cigarette use on these systems are comparable to cigarettes, agencies concerned about public health should consider them at least 1/3 as bad as cigarettes and maybe as high as half as bad (or higher)."

The Rest of the Story

A study published in the Journal of the American College of Cardiology found that the hyperglycemic state associated with eating Corn Flakes results in measurable decrements in endothelial dysfunction, as assessed by endothelium-dependent flow-mediated dilation, among obese and overweight non-diabetic adults (see: Lavi T, et al. The acute effect of various glycemic index dietary carbohydrates on endothelial function in nondiabetic overweight and obese subjects. Journal of the American College of Cardiology 2009; 53:2283-2287).

The study found that: "Baseline FMD [flow-mediated dilation], not significantly different in the 3 carbohydrate-based meals, was reduced 2 h post-prandially in all groups, showing statistical significance in only high-glycemic index meals: glucose (15 ± 9% vs. 10 ± 8%, p < 0.01), cornflakes (13 ± 7% vs. 9 ± 7%, p < 0.01)."

Cigarette smoking has been shown to have similar effects on the endothelium.

So based on the above reasoning:

Given the evidence that effects on the cardiovascular system and lungs account for more than half the smoking-induced deaths and that at least some of the short-term effects of Corn Flakes ingestion on these systems are comparable to cigarettes, agencies concerned about public health should consider them at least 1/3 as bad as cigarettes and maybe as high as half as bad (or higher).

Using this reasoning, the cigarette companies would be justified in taking out advertisements that say: "Smoking is only twice as bad as eating Corn Flakes."

Bhatnagar and Glantz are making wild extrapolations that are simply not justified based on the nature of the existing data. And Bhatnagar's paper admits as such:

"CVD [cardiovascular disease] is a result of pathological changes in several processes (blood pressure regulation, cholesterol metabolism, insulin signaling, and endothelial function), and, therefore, the cardiovascular effects of inhaled toxins cannot be adequately simulated by simple in vitro assays but must be studied in animal models and humans... . Unfortunately, such data are not available for e-cigarettes... ."

So if the data needed to understand the effects of e-cigarettes on cardiovascular risk are not available, how are these researchers able to quantify the cardiovascular risk associated with vaping and to conclude that vaping is half as harmful or equally harmful to smoking?

The answer appears to be that they have drawn a pre-determined conclusion and are simply manipulating the existing data to support these conclusions.

If a cigarette company were to take out an ad saying: "Cigarette smoking is only half as bad as vaping," it would be attacked for making fraudulent statements and undermining the public's appreciation of the severe hazards of smoking. But the truth is that Altria could take out an ad today which truthfully informed smokers that: "Tobacco researchers have concluded that smoking is no more hazardous than, or only twice as hazardous as vaping. So if you're thinking of quitting smoking using e-cigarettes to improve your health, don't bother."

Sadly, this is precisely the message that these anti-vaping researchers are sending to smokers throughout the world. Don't quit because your Marlboros, Camels, and Newports are little worse than using tobacco-free e-cigarettes. And if you already have quit by switching to vaping, you might as well go back to smoking. These are dangerous statements that clearly undermine the public's appreciation of the hazards of smoking and which do actual public health damage by deterring many smokers from quitting and encouraging many ex-smokers to return to smoking.

I'm surprised that Altria doesn't take out ads saying: "Marlboro: 100 times the pleasure of an e-cigarette, but with only half the risk." Or that Reynolds American doesn't take out an ad saying: "Camel cigarettes: The same level of safety that you expect with a tobacco-free e-cigarette, but 100 times the pleasure."

Meanwhile, while anti-vaping researchers like Glantz and Bhatnagar are busy making wild extrapolations, some researchers are actually conducting clinical studies that measure the demonstrated effects of smoking compared to vaping in humans. And these studies are showing that vaping dramatically reduces health risks. Multiple studies, for example, have documented that asthmatic smokers who switch to vaping experience an improvement in their respiratory symptoms as well as in their lung function, as measured by spirometry.

And just today, a new study published in the journal Toxicology Mechanisms and Methods reports that smokers who quit by switching to electronic cigarettes experience a reduction in exposure to harmful and potentially harmful constituents which is equivalent to that experienced by smokers who quit completely (without the use of e-cigarettes).

Specifically, exposure to chemicals such as tobacco-specific nitrosamines and volatile organic compounds including acrolein, benzene, and acrylonitrile was reduced by the same amount among smokers who quit using e-cigarettes and those who quit without e-cigarettes. Furthermore, blood levels of carboxyhemoglobin were reduced by the identical amount in smokers who quit using vs. not using e-cigarettes.

The study was funded by Fontem Ventures, which is a subsidiary of Imperial Brands (a tobacco company which is also marketing e-cigarettes). While this needs to be considered in evaluating the validity of the findings, I do not see any scientific issues in the methodology or reporting of the results that lead me to question the validity of the basic finding that biomarkers of exposure to the above chemicals decreased by the same amount in smokers who switched to vaping as in smokers who quit completely without the aid of e-cigarettes.

That Glantz and Bhatnagar do not even mention these studies demonstrates an apparent bias. Strangely, there are extrapolating from data that does not directly measure e-cigarette risks among humans and ignoring data that directly measures the effects of e-cigarettes in the clinical setting.

To be clear, I am not arguing that vaping is risk-free or that exposure to chemicals such as formaldehyde and acrolein is not a problem. In fact, I have advocated directly addressing these risks by forcing the FDA to set standards for these chemicals, either directly or by regulating maximum coil temperatures or voltage/resistance combinations. This is an approach that, ironically, anti-tobacco groups have not supported. Instead, they want to virtually wipe out the vaping industry, which would likely cause tens of thousands of ex-smokers to return to cigarette smoking.

It should also be noted that both Glantz and Bhatnagar are claiming that vaping causes chronic obstructive lung disease. This claim is based solely on evidence of acute irritation of the airways associated with vaping. But it ignores research showing that vaping has no effect on clinical lung function, as measured by spirometry (which is in sharp contrast with cigarette smoking). It also ignores research showing that smokers who switch to vaping experience dramatic improvement in their lung function. To be clear to readers, there simply is not any existing evidence that vaping causes chronic obstructive lung disease. But this is precisely the assumption that goes into Dr. Glantz's estimate that vaping is half as harmful as smoking.

The information that we tell the public regarding the relative safety of smoking vs. vaping is critical and it truly has life or death implications. The public is relying on this information to make important decisions such as whether to try to quit smoking with e-cigarettes or to stay on tobacco cigarettes, or whether to continue vaping or to return to smoking. The statements of anti-vaping researchers like Glantz and Bhatnagar are instructing smokers not to try to quit smoking with e-cigarettes and are undoubtedly causing many former smokers to return to smoking.

The tragedy, and the rest of the story, is that these recommendations are based on extremely weak science, involve wild and unsupportable extrapolations, ignore actual clinical studies of the effects of vaping vs. smoking, and show evidence of severe bias.Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-45677708622092676152016-07-11T06:52:00.000-04:002016-07-11T06:52:00.823-04:00Findings from New Pediatrics Study are Not Relevant to Overall U.S.A new study published today in the journal Pediatrics concludes that overall nicotine product use among youth is increasing and that many youth who would not otherwise have used a nicotine product are doing so because of e-cigarettes.

(See: Barrington-Trimis JL, et al. E-cigarettes, cigarettes, and the prevalence of adolescent tobacco use. Pediatrics 2016; 138(2):e2015983.)

The study reports the prevalence of current cigarette smoking and e-cigarette use among a cohort of youth reaching 11th and 12th grade, after having been followed for a period of two to 12 years. The youth sample was drawn from schools in 12 southern California communities. Based on the finding that the combined use of cigarettes and/or e-cigarettes increased from 2004 to 2014, the authors conclude that overall nicotine use among youth is increasing due to e-cigarettes, meaning that many youth who would not have smoked cigarettes are becoming vapers.

Specifically, cigarette smoking among high school seniors at these schools dropped from 9.0% in 2004 to 7.8% in 2014, e-cigarette use increased from 0% in 2004 to 9.8% in 2014, and the combined use of cigarettes and e-cigarettes rose from 9.0% in 2004 to 13.7% in 2014.

The Rest of the Story

The most important thing for readers to understand is that this study pertains to 12 specific schools in southern California, so the results cannot be generalized to the overall United States. In fact, comparable data from the national Monitoring the Future survey refute the findings in this paper. On a national level, there was a HUGE decline in current smoking among high school seniors from 2004-2014, which was accompanied by a large increase in e-cigarette use, such that the overall use of nicotine products among these youth did not change much. Nationally, overall nicotine use has remained about the same, but the profile of that use has changed, with a shift from combustible tobacco products (tobacco cigarettes) to electronic (non-tobacco cigarettes).

Further, the data from California is not comparable to the overall U.S. because the youth smoking trends in California are vastly different than in the rest of the nation. For example, while the reported smoking prevalence for high school seniors in this article for 2004 is just 9%, the Monitoring the Future study for 2004 reports current smoking prevalence for high school seniors nationally of 25%. This is a drastic difference. While youth smoking prevalence in the overall U.S. declined markedly in the past decade, this paper found very little decrease (from 9% to 8%). Clearly, what happened in California is atypical so it is important not to draw generalized conclusions from this study for the national situation.

It is also important to point out that the survey in this study did NOT ask youth whether or not they were actually using e-cigarettes with nicotine. The Monitoring the Future study reported that about 60% of youth vapers use e-cigarettes without nicotine (they only contain flavorings). Therefore, it is still possible that overall nicotine use among these California youth did not go up (since the majority of the youth e-cigarette users may not have been using nicotine-containing e-cigarettes).

It is also important to recognize that this study is defining "current" e-cigarette use as any use within the past 30 days. This should not be equated with "regular" e-cigarette use, or with a youth being a "vaper." It is very possible that many of these youth are using e-cigarettes in an experimental fashion, at parties, on an occasional basis, but that they are not becoming addicted to nicotine or using the product frequently enough to experience any adverse health effects.

Finally, even if it is true that among this specific population, the overall use of nicotine has increased, that is not necessarily a bad thing for the overall public health. We do not know whether e-cigarette use among youth has any significant adverse health impact, so it is possible that the benefits from the observed decline in cigarette smoking far outweigh minor risks associated with the use of non-tobacco vaping products.

Taken as a whole, this study does not change my overall assessment that nationally, the benefits from the huge observed decline in cigarette smoking among youth far outweigh the minor risks associated with youth vaping. Moreover, it does not change the important fact that nationally, the drastic increase in youth use of e-cigarettes has been associated with a dramatic decline in cigarette smoking, which argues against the hypothesis that e-cigarettes are a gateway to smoking and strongly suggests that these products may actually be deterring youth from smoking by serving as a more popular alternative to smoking. Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-79681252915357184392016-06-28T07:31:00.005-04:002016-06-28T19:19:48.487-04:00Detroit Wayne County Mental Health Authority Issues Fraudulent Public Statements on Risks of Cigarette SmokingIn an action reminiscent of the tobacco industry of the 1970's, the Detroit Wayne County Mental Health Authority (DWMHA) has issued one of the most fraudulent claims about the risks of cigarette smoking as I have ever seen.

The DWMHA created a billboard in which it told the public that smoking is no more dangerous than vaping. "E-qually dangerous," the billboard asserts.

The Rest of the Story

There is abundant scientific evidence that vaping, which has caused no documented chronic disease or death in any identified individual, is safer than smoking, which kills more than 400,000 people each year, causes chronic lung disease, cardiovascular disease, and cancer, and contains more than 10,000 chemicals, of which more than 60 are proven human carcinogens.

There is no debate in the tobacco control community about this point. Even Dr. Stan Glantz - a fierce opponent of vaping - acknowledges that smoking is more hazardous than vaping.

Ironically, while the Detroit Wayne County Mental Health Authority is lying to the public, the tobacco companies are telling the truth. Each of the major tobacco companies has acknowledged that smoking its cigarettes is far more dangerous than vaping.

By informing the public that smoking is no more hazardous than using a product which contains no tobacco and merely creates an aerosol by heating propylene glycol, glycerin, nicotine, and flavorings, the DWMHA is dangerously undermining the public's appreciation of the severe consequences of cigarette smoking.

The misinformation that the Detroit Wayne County Mental Health Authority is disseminating is damaging to the public's health. First, it may discourage people from quitting smoking - people who otherwise would have greatly improved their health by quitting smoking completely with the help of e-cigarettes. Second, it may convince ex-smokers who have quit using electronic cigarettes that they are just as well off returning to smoking than remaining ex-smokers by virtue of those electronic cigarettes.

A study just published in the journal Addiction reported that at least 6.1 million people in the EU have quit smoking using e-cigarettes and another 9.2 million have substantially reduced the amount they smoke. This amazing public health accomplishment would obviously not have occurred had public health authorities in Europe conducted a fraudulent campaign to convince EU citizens that vaping is equally hazardous as smoking.

That this fraudulent statement is being made by a mental health services agency is particularly egregious because persons with mental health and substance abuse disorders have disproportionately high rates of smoking and are especially resistant to traditional methods of smoking cessation. These are people who could benefit the most from the availability of e-cigarettes for smoking cessation. But the DWMHA is actively discouraging them from trying to quit smoking. In fact, the message being sent is that you are better off (or equally well off) continuing to smoke than quitting smoking using e-cigarettes.

It's been close to two decades since we've seen a tobacco industry campaign to severely undermine the public's appreciation of the health hazards of smoking. That campaign is now back. It's just a shame that it is now being orchestrated by health agencies, while the cigarette companies are the ones providing accurate information to the public about the real hazards of smoking. Who ever thought it would come to this?Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-82545923737630550172016-06-27T06:37:00.000-04:002016-06-27T06:37:02.805-04:00Four More Lawsuits Filed Against FDA to Block its E-Cigarette Deeming RegulationsLast month, I reported that Nicopure Labs, a maker of e-liquids and vaping devices, filed a lawsuit against the FDA challenging its deeming regulations, claiming that they are in violation of the Administrative Procedures Act (APA) and the First Amendment. Today, I report that four more lawsuits have been filed against the agency; all seek an injunction against enforcement of various aspects of the regulations or seek to overturn the regulations in their entirety.

1. Lost Art Liquids, LLC has filed a challenge to the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, and the Fifth Amendment.

As the company explains:

"Lost Art Liquids' Complaint alleges that FDA's regulation of vapor products is illegal in that it exceeds the very limited and specific scope of authority Congress granted FDA to regulate "tobacco products" under the Tobacco Control Act in 2009. "Vapor products are technology products, not tobacco products," said Ryan Thomas, Lost Art Liquids' Co-Founder and COO. "The legislative history and factual findings that serve as the predicate to the Tobacco Control Act make clear that Congress never intended to give FDA authority to regulate vapor products when it enacted the Tobacco Control Act in 2009. It was created to regulate products like cigarettes and smokeless tobacco, not vapor," he continued. "FDA has introduced one of the most burdensome, misguided and harmful regulations in its history without adequately sound science, or adhering to required, lawful procedures. These regulations will harm Lost Art Liquids' business and customers by eliminating vapor products from the market, forcing consumers to resort to more harmful products like cigarettes and cigars," added Thomas."

2. Larry Faircloth, a delegate in the West Virginia House of Representatives, has filed a lawsuit against the FDA, challenging the deeming regulations under the APA, the First Amendment, and the Tenth Amendment.

First, the complaint alleges that FDA's application of the Tobacco Act to all vaping devices and their components goes far beyond the Act's definition of "tobacco products" and is therefore a violation of the APA. For example, "programmable software," "batteries," and "glasses and vials" are deemed to be tobacco products even though they clearly do not meet the Act's definition of a tobacco product (i.e., a product made of tobacco or containing a tobacco-derived component [nicotine]).

Second, the complaint alleges that the FDA's ban on new product introductions after August 8, 2016 is arbitrary and capricious and without a rational basis. The effect of this aspect of the regulation is to prevent the introduction of any new products and the improvement of any existing products, thus harming the public's health both by forcing many vapers to return to smoking and by precluding necessary safety improvements.

Third, the complaint alleges that the FDA failed to conduct a proper cost-benefit analysis, as it failed to quantify the benefits of the regulation and grossly underestimated the costs. For example, the agency estimated that only 750 pre-market tobacco applications would be required, while the truth is that there are single companies that would have to file that many applications alone.

Fourth, the complaint alleges that the regulations violate the First Amendment because they prohibit companies from making truthful and non-misleading statements about their products (such as that e-cigarettes contain no tobacco and produce no smoke or that they contain lower levels of various constituents compared to tobacco cigarettes).

3. A coalition of vaping-related associations, including the Right to Be Smoke-Free Coalition, the American E-Liquid Manufacturing Standards Association, and the American Vaping Association, has challenged the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, the Fifth Amendment, and the Fourteenth Amendment.

Many of the complaints in this lawsuit are similar to those mentioned above, including the allegations that the FDA exceeded its authority, violated the intent of Congress, lacks a rational basis for the regulatory scheme (especially since it treats e-cigarettes more harshly than cigarettes), fails to conduct a proper cost-benefit analysis, and infringes upon the free speech rights of companies by prohibiting them from making truthful, non-misleading claims about their products without any legitimate government interest in doing so. The suit challenges the grandfather date, the entire pre-market authorization process, the ban on allowing customers to try e-liquid flavors in vape shops that are restricted to adults, the application of the "tobacco product" definition to component parts of vaping devices that do not meet that definition, and the entire modified risk provision section.

4. Altria has filed a lawsuit which challenges the deeming regulations' prohibition on the use of the brand name "Black and Mild," which has been the trade name for one of its premium cigar brands for more than four decades.

This suit claims that the ban on the use of the term "mild" in the brand name violates the First Amendment because it restricts free speech without any legitimate government interest and violates the Fifth Amendment because it represents a taking of private property without compensation. Unlike the term "mild" as used in many cigarette brands and ads - which were documented to have been intended to falsely convey a sense of safety - the "Black and Mild" brand name has been around for more than 40 years and conveys information about the taste and body of the product, rather than its safety.

The Rest of the Story

All five of the lawsuits that have been filed so far present strong and solid legal challenges against the deeming regulations. I have been arguing for months that applying the modified risk provisions of the Tobacco Act to e-cigarettes would violate the First Amendment because there is no legitimate government interest in preventing commercial speech that is both truthful and non-misleading. In addition, I pointed out in my comments to OMB/OIRA that the FDA failed to conduct a proper cost-benefit analysis.
Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-33987230078655538172016-06-20T06:01:00.000-04:002016-06-20T14:18:26.994-04:00Pediatrics "Gateway" Article Author Hiding Conflicts of Interest with Big Pharma; Drug Companies Have Gotten More than their Money's WorthLast week, I discussed an article published in Pediatrics which is going to deal a devastating blow to the vaping industry because it wrongly concludes that e-cigarettes are a gateway to smoking among youth. Evidence like this is the death knell to vaping, as perhaps it should be if it were true.

The problem, however, is that as I explained, the Pediatrics study cannot conclude that e-cigarettes are a gateway to smoking because it measured only e-cigarette experimentation at baseline and was unable to document that a single nonsmoking vaper actually became addicted to vaping. Nor was the study able to document that a single nonsmoking vaper actually used a product that contained nicotine. Since the Monitoring the Future study suggested that a solid majority of youth e-cigarette users do not use nicotine products, this is a major study limitation.

In fact, the overwhelming evidence suggests that e-cigarettes are actually contributing towards the denormalization of smoking. The magnitude of the gateway "risk" identified in the Pediatrics paper is mathematically impossible given the recent data showing that while e-cigarette experimentation has skyrocketed among youth, smoking rates among those same youths has plummeted. Furthermore, there is now direct evidence - this time from qualitative interviews with youth - that e-cigarettes may actually be a roadblock to smoking.

Today, I reveal that what makes the Pediatrics paper even more problematic than simply its unsupported conclusions is the fact that these conclusions have the appearance of being influenced by financial conflicts of interest among one of the study authors -- conflicts that the author hid from the public.

The Rest of the Story

Clearly, there is a strong financial interest in e-cigarette research among pharmaceutical companies that manufacture smoking cessation drugs. E-cigarettes and vaping products represent enormous potential competition to the sales of cessation drugs if they prove to be effective and of reasonable risk, which would lead to more lenient regulation.

One of these companies with a financial interest in e-cigarette research is GlaxoSmithKline, maker of the following cessation drugs: nicotine gum, nicotine lozenges, nicotine patches, Wellbutrin, and Zyban. Therefore, any of the Pediatrics study authors who has received money or research funding from GlaxoSmithKline has a significant financial conflict of interest that must be disclosed in the article.

Another company with a financial interest in e-cigarette research is Pfizer, which manufactures Chantix (varenicline), a very popular and lucrative smoking cessation drug. Therefore, any of the Pediatrics study authors who has received money or research funding from Pfizer has a significant financial conflict of interest that must be disclosed in the article.

However, all of the authors have signed a disclosure indicating that none of them have any financial conflict of interest: the disclosure statement reads "The authors have indicated they have no financial relationships relevant to this article to disclose."

Therefore, I would take this as meaning that none of the authors have had any financial relationships, such as receiving grant funding or consultant fees, from GlaxoSmithKline, Pfizer, or any other pharmaceutical companies that market smoking cessation medications.

Hiding a Conflict of Interest - the Rest of the Story

Unfortunately, this is not the case.

One of the study authors - Dr. Jonathan Samet - was actually named in a 2011 conflict of interest lawsuit filed by Lorillard and R.J. Reynolds against the FDA, which argued that: "During the last decade, Dr. Samet has received grant support for research and writing from GSK on at least six occasions, including in 2010. In addition, he formerly led the Institute for Global Tobacco Control, which is funded by GSK and Pfizer. Moreover, until 2009, Dr. Samet received regular honoraria from Pfizer for his service on the Pfizer Global Tobacco Advisory Board."

Dr. Samet has in fact acknowledged having received grant funding from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - was funded by GlaxoSmithKline and Pfizer. Furthermore, Dr. Samet agreed "to serve on Pfizer's global tobacco control advisory board and will be compensated." Dr. Samet acknowledged serving on Pfizer's tobacco control advisory board from 2004-2009.

The journal Pediatrics adheres to ICJME policies, and under those policies, authors are required to disclose all "relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work." This requirement does not specify that the relationships or activities must be current or within the past 3 years. There is no time frame given, so the clear intent here is to make sure that authors disclose any prior history of funding from corporations that could give the appearance of a potential conflict.

To remind readers, a conflict of interest does not represent wrongdoing, and it is actually in the authors' best interest to err on the side of being most inclusive. After all, conflict of interest procedures are largely in place to protect the author and the institution, not just the journal and the readers. Conflict of interest disclosures are not some sort of punitive procedure, forcing authors to pay penance for past wrongdoing. There is no wrongdoing. The sole purpose is to make sure that any financial relationships (no matter when they occurred) that could be perceived as potentially representing a conflict are disclosed.

In large part, the reason why virtually all scientific journals have conflict of interest policies now is this past history of failed disclosures of scientists' ties to the tobacco companies.

It is for this reason that it becomes so imperative for us, as scientists in the tobacco control movement, to disclose our own conflicts of interest. It would seem highly hypocritical for us to demand that past relationships with tobacco companies need to be disclosed but that past relationships with pharmaceutical companies can remain hidden. No one is suggesting that the public health implications are the same; however, the principle is.

Ultimately, if we want the public to take seriously our efforts to protect the integrity of science from influence by corporations which have a vested interest in influencing the public's opinion about the safety of their products, then it becomes critical that we set the example by being transparent about our own conflicts of interest. Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-24464573570447482882016-06-15T21:10:00.001-04:002016-06-15T21:45:57.262-04:00Why Must the American Cancer Society Continue to Lie to the Public? This Time, They Do So in Coordinated FashionIn a letter to the editor published last week in the Bradenton Herald, an individual identified as being with the American Cancer Society Cancer Action Network tells the public that the Bishop-Cole amendment would "strip FDA's authority to review new products, ones becoming increasingly popular with youth, like e-cigarettes, cigars and hookah." She goes on to urge Florida's Senator Nelson not to "fall for the industry's latest trick to avoid critical FDA oversight of these addictive and potentially lethal products."

The Rest of the Story

There's just one problem with this letter. It's not telling the truth. The rest of the story is that in contrast to what the American Cancer Society-affiliated author states, the Bishop-Cole amendment would not strip FDA's authority to review new products. In fact, under the Bishop-Cole amendment, any new product placed on the market from the effective date of the deeming regulations on would need to obtain pre-market approval from the FDA before being sold. And that would involve a burdensome and expensive process, costing millions of dollars, and would virtually ensure that very few new vaping products reach the market.

This would damage the public's health because the newer vaping products are generally safer and more effective than the older ones. Moreover, it's only by allowing new products and improved products onto the market that we can improve the safety of e-cigarettes and definitively address problems such as exploding batteries, high levels of carbonyl compounds in some products, and other manufacturing and quality control problems.

So the problem is exactly the opposite of what the American Cancer Society is suggesting. The problem is not that the Bishop-Cole amendment takes away FDA's authority to review new products before they enter the market; the problem is that the amendment retains authority to require these ridiculous pre-market approval applications which stifle innovation and freeze existing defective products on the market so that they cannot make safety improvements.

Regardless of anyone's opinion about the way the FDA should regulate e-cigarettes, it is inappropriate to mislead the public by lying about the legislation that Congress is considering. The amendment being debated would absolutely not strip the FDA's authority to review new products. It would merely allow existing products to remain on the market. New products would still be subject to FDA review and pre-approval.

To be sure, I do not blame the author for this factual error. I'm sure she is getting her information from the American Cancer Society and they are the source of this lie.

In fact, we know that this is the case.

How?

Because with a little research, I uncovered the fact that this letter to the editor is part of a broader letter-writing campaign orchestrated by the American Cancer Society in which they told their volunteers exactly what to say, even though it was false information.

Consider this letter in the Tallahassee Democrat, also published last week, from another individual with the American Cancer Society Cancer Action Network. The letter is nearly identical in structure to the Bradenton letter, with just minor wording changes, suggesting that these ACS volunteers received a template that they were instructed to follow. The Tallahassee letter contains nearly the exact same lie, claiming that the Bishop-Cole amendment: "would strip FDA's authority to review new products, many – like e-cigarettes – that are popular with kids."

But it doesn't stop there.

A nearly identical letter from another American Cancer Society volunteer from Avon Park, Florida appeared last week in the Highlands Today/Tampa Bay Times. And the letter contains the same lie that the ACS wants to spread far and wide: "The tobacco industry and its allies in Congress are working to attach amendments to the agriculture appropriations bill that would fund the FDA — that would strip FDA's authority to review new products, ones becoming increasingly popular with youth like e-cigarettes, cigars and hookah."

In fact, this letter is almost identical to that in the Bradenton Herald, with just some minor word changes here and there.

This coordinated campaign of deception is not restricted to Florida. A nearly identical letter to the editor also appeared last week in the St. Louis Post-Dispatch. The letter is the same, word-for-word, as the Bradenton letter, except that it substitutes the number of tobacco-related deaths in Missouri for the number of deaths in Florida. It also claims that the Bishop-Cole amendment would: "strip FDA's authority to review new products, ones becoming increasingly popular with youth like e-cigarettes, cigars and hookahs."

Hopefully, the newspapers will not become aware of the fraud behind these letters because it is clear that the letters were not authentic. They were not written by the individuals who claimed to write them, but instead, were plagiarized from text that was presumably provided by the American Cancer Society Cancer Action Network.

While a pre-formatted letter is not inappropriate for a letter-writing campaign directed at individual policy makers, when you write a letter to the editor of a newspaper it is published with the understanding that the individual who signed the letter wrote the letter. So not only did the American Cancer Society err by orchestrating this campaign of deception, but it used its own volunteers as pawns to carry out the dissemination of the lie, and it put these volunteers in the unfortunate position of essentially being guilty of plagiarism, since they did not write the letters that are published under their names.

I also doubt that the American Cancer Society explained the truth to these individuals: that the Bishop-Cole amendment preserves the FDA's authority to review all new tobacco products, including e-cigarettes. This is a highly shady activity: essentially a conspiracy to de-fraud these newspapers and the public by making it look like tons of individuals independently came to the same conclusions about the Bishop-Cole amendment and wrote similar letters. The truth is that the letters were plagiarized and not in fact written by the authors to whom they are attributed. Shame on the American Cancer Society for using these volunteers in this way.

I guess I should answer my own question. Why must the American Cancer Society lie to the public? Because if they tell the truth, the public won't support their position. There would be no need to resort to lying if the ACS' argument stood on solid ground. The only reason to lie is if you can't win the argument by telling the truth. It's one thing for the American Cancer Society to take responsibility for its own lies. But to drag innocent volunteers into this and have them do the dirty work is unethical and unfair.

These volunteers working for the American Cancer Society are true heroes. They are dedicating their lives to this vital cause and volunteering their precious time to try to find ways to prevent and better treat cancer and to support cancer patients and cancer survivors. This is no way for them to be treated. Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-8476843210707627712016-06-13T06:00:00.000-04:002016-06-13T11:51:50.026-04:00New Pediatrics Study Provides Absolutely No Evidence that E-Cigarettes are a Gateway to SmokingA new study published online today in the journal Pediatrics purports to show that electronic cigarettes are a gateway to smoking among youth. The study followed a sample of approximately 150 never-users of e-cigarettes and 150 ever users of e-cigarettes for one year. Both groups consisted entirely of never smokers. At one-year follow-up, the initiation of smoking was compared between the two groups. E-cigarette users were found to be six times more likely to have initiated smoking. Based on these findings, the paper concludes that e-cigarette use among youth increases the risk of progression to smoking: "These findings suggest that e-cigarette use may promote smoking during the transition to adulthood ... ."

(See: Barrington-Trimis JL, et al. E-cigarettes and future cigarette use. Pediatrics 2016; 138(1): e20160379. Published online ahead of print on June 13, 2016.)

The Rest of the Story

This study is virtually meaningless in terms of its evaluation of the "gateway" hypothesis.

Baseline e-cigarette use was defined as ever having taken even one puff of an e-cigarette. And smoking initiation was similarly defined as ever having taken even one puff of a cigarette. So the study did not document that even one subject in the study was ever a regular vaper. It is entirely possible (and in fact likely) that the majority of these kids had experimented with e-cigarettes, failed to become vapers, and then turned to regular cigarettes. In fact, it's entirely possible that had these kids been able to stick with vaping, they would never have become smokers.

In addition, the study counted anyone who had even puffed a cigarette as being a smoker. So theoretically, a subject could have had a single puff of an e-cigarette and hated it, and then had a single puff of a cigarette and hated it, and they would be considered someone who initiated smoking because of first becoming addicted to vaping.

What the study does show, quite convincingly, is that kids who have a personality type that lends itself to experimenting with e-cigarettes are also more likely to experiment with regular cigarettes. There is no surprise here and had the researchers found anything different, one would have to question the validity of the study findings. Frankly, the study doesn't really add any knowledge that we didn't have already. It simply confirms what we already knew: kids who are more likely to experiment with e-cigarettes are more likely to experiment with tobacco cigarettes.

In fact, what this study is basically documenting is that having ever tried an e-cigarette is a better indicator of susceptibility to smoking than the traditional measures of smoking susceptibility. That's really all one can conclude from the study. The key point is that the e-cigarette group consisted of youth who had ever puffed on an e-cigarette, not youth who reported being regular vapers. In order for the gateway hypothesis to be true, kids would have to become regular vapers – addicted to nicotine – and then move on to smoking. The paper provides no evidence that this is the case.

The rest of the story is that despite the way the results are being interpreted, the truth is that the study provides absolutely no evidence that electronic cigarettes are a gateway to smoking or that the use of vaping products increases rates of smoking initiation among youth. What the study demonstrates is merely that youth who experiment with e-cigarettes are more likely to experiment with cigarettes as well.

It is important to recognize that an equally plausible (and I think more likely) explanation of the results is that the ever e-cigarette using youth who progressed to smoking did so because they failed to take up vaping, rather than because they experimented with e-cigarettes. Had they become regular vapers, it is much less likely that they would have progressed to real smoking because after getting used to the sweet and tasty flavors of e-cigarettes, it is implausible that they would then become attracted to the harsh taste of real tobacco smoke.

Either way, the findings from this study do not provide any evidence to support the gateway hypothesis.

However, population-based data on trends in youth vaping and smoking released last week do provide evidence that relates to the gateway hypothesis. But those data suggest that e-cigarettes are a gateway away from smoking. In other words, as vaping has become more popular among youth, it has displaced cigarette smoking and contributed towards the de-normalization of cigarette smoking.

In fact, the strongest argument against the paper's interpretation of its findings is their inconsistency with the population-based data. If youth who experiment with e-cigarettes really were six times more likely to initiate smoking, then given the high level of experimentation, the observed rate of youth smoking would certainly be substantially higher than revealed by the Youth Risk Behavior Survey. Youth smoking rates would not have experienced a 41% decline concomitant with a 24-times increase in e-cigarette experimentation if e-cigarette use were really a substantial promoter of smoking initiation.Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-86431760903724691892016-06-09T20:23:00.001-04:002016-06-09T20:23:45.751-04:00CDC Data Reveal Drastic Decline in Youth Smoking, Blowing E-Cigarette Gateway Hypothesis Out of the WaterThe Centers for Disease Control and Prevention (CDC) yesterday released new data from the Youth Risk Behavior Survey (YRBS) revealing that despite a striking increase in youth e-cigarette use in the past two years, the prevalence of current smoking among high school students nationally declined by a whopping 31% from 2013 to 2015, falling from 15.7% to 10.8%. This represents a historic low and a 41% decline since 2011. Frequent smoking also fell to a historic low, dropping from 5.6% to 3.4%, a 39% decline. Daily smoking dropped by 42%, from 4.0% to 2.3%, and overall tobacco use declined by 23%, falling from 24.0% to 18.5%.

The 41% drop in youth smoking from 2011 to 2015 occurred at the same time as a 24-fold increase in youth e-cigarette use, which rose from just 1% to 24%.

In response to these data, and in spite of the data, anti-smoking advocates and groups claimed that this shows e-cigarettes are leading kids to smoking.

For example, according to a Health Day article: "Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said, 'While cigarette smoking in high school students is at an all-time low, the rise of e-cigarette use poses a risk that teenagers will transition from 'e' to 'real' cigarettes.'"

The Campaign for Tobacco-Free Kids claimed that: "this survey also raises fresh concerns that other tobacco products, especially electronic cigarettes and cigars, are undermining overall efforts to reduce youth tobacco use and could be luring a new generation of kids into nicotine addiction."

The Rest of the Story

For the first time in a long time, I have to admit that the anti-smoking groups are correct about electronic cigarettes: these products are indeed a gateway.

They are a gateway away from smoking.

It is increasingly becoming clear that the advent of vaping has contributed to the most marked decline in youth smoking in recent history. In contrast to what the anti-smoking groups are saying, overall tobacco use is falling, not staying the same, and the use of e-cigarettes is not undermining progress in reducing youth smoking but contributing to it.

There are simply too many youth using e-cigarettes to argue that vaping is not to some extent replacing smoking as a behavior in the youth population.

Moreover, it is now abundantly clear that e-cigarettes are not serving as a gateway to smoking and tobacco use. In contrast, vaping appears to be acting as a deterrent, or more accurately, as a diversion away from smoking. In other words, it appears that as an alternative to smoking, electronic cigarettes are diverting kids from smoking to vaping.

Obviously, reducing smoking by diverting youth to an alternate form of nicotine use is not an ideal solution to the problem of youth tobacco use and smoking addiction. It would be preferable to reduce smoking without having youth turn to any other behavior that carries some risk. Nevertheless, the rest of the story is that e-cigarettes are not undermining efforts to reduce youth smoking and/or youth tobacco use. They are actually contributing to those efforts.

To be clear, this does not mean that we should be encouraging vaping among youth. However, it does mean that the widespread concern that e-cigarettes will be a gateway to smoking is just not panning out. Vaping is clearly not resulting in the re-normalization of smoking. It is quite the opposite. Vaping is helping to further de-normalize smoking. Vaping is becoming increasingly cool among youth and helping to make smoking ever more unpopular and uncool. What is playing out is exactly the opposite of what anti-smoking groups claim.

There is no question that the FDA's recent ban on sale of e-cigarettes to minors is warranted, as are restrictions on marketing of e-cigarettes to youth and educational campaigns to help youth understand the health risks of both smoking and vaping. But we also need to be careful. The last thing we want to do at this stage of the game is to create an increased demand for real cigarettes by removing the competition. Banning e-cigarette flavors would do just that, as would allowing the predicate date in the current e-cigarette regulations to remain.

What this story also reveals is that anti-smoking groups have a pre-scripted message and that they automatically twist their interpretation of scientific data to facilitate that message, rather than allowing the science to inform their communications and their agenda. This is a striking example because the data are so inconsistent with the anti-smoking groups' conclusions that it is almost comical to see.

Indeed, as youth e-cigarette use increased from 1% to 24% concurrently with a massive 41% decline in youth smoking, anti-smoking groups are concluding that vaping is re-normalizing smoking. If that's the case, then I guess we should strive to re-normalize smoking as much as we can. Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-14480545127215279162016-06-05T12:32:00.004-04:002016-06-05T12:32:57.067-04:00The Last Straw: Anti-Tobacco Groups are Actively Promoting SmokingReaders of the Rest of the Story may have noticed that I have not posted for a few days. This is not for lack of material. Lots is happening that deserves comment, and in the days to follow I will catch readers up on some important developments, including two more lawsuits filed against the FDA in an attempt to overturn its electronic cigarette deeming regulations.

I have not been able to write because I have been too distraught. I have come to the realization that the anti-smoking movement - which I have been a part of for the past 31 years, is essentially dead. And even worse, the anti-smoking movement is now actively promoting smoking. This is extremely difficult for me to understand and to reconcile. And it is especially difficult to stomach given the irony that while the anti-smoking movement is promoting smoking, hundreds of for-profit companies are the ones who are actually fighting to make smoking obsolete. In contrast, anti-smoking groups are fighting to preserve smoking and make sure that it does not become obsolete.

The last straw - the straw that broke the camel's back - is the anti-smoking movement's support of a complete ban on flavored e-liquids for use in vaping products, which follows its earlier vigorous opposition to a complete ban on flavors in toxic tobacco cigarettes.

To be clear, the major anti-smoking groups - including the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association - opposed a complete ban on flavored tobacco cigarettes, but are now supporting a complete ban on flavored tobacco-free cigarettes. In other words, these groups have lobbied to retain the tobacco companies' ability to attract kids to smoking using a tasty, smooth, and attractive flavoring, while lobbying to remove non-tobacco companies' ability to attract smokers away from cigarettes and toward a much safer tobacco-free, smoke-free alternative.

Last week, it was revealed that the Office of Management and Budget (OMB) had made one critical change in the deeming regulations sent to it for review by the FDA. Specifically, the OMB removed from the regulations a ban on the use of all flavors except tobacco in e-liquids. This action is in accordance with the recommendation that I made to OMB in my meeting with OIRA staff last year.

After this revelation, the major anti-smoking groups and advocates criticized OMB, indicating that these groups support a complete ban on flavored e-cigarettes. For example, the American Lung Association stated: "We are deeply troubled that these important safeguards were stripped in this way when FDA repeatedly demonstrated that the science shows flavored products appeal to youth and young adults."

The Campaign for Tobacco-Free Kids stated: "It is deeply disappointing that the White House missed this opportunity to protect our nation's children by deleting this provision to remove candy- and fruit-flavored e-cigarettes and cigars from the market."

Dr. Stan Glantz argued that the FDA should issue a rule that bans all flavored e-cigarettes immediately.

The Rest of the Story

There is no greater action that the FDA could take to promote cigarette smoking than to ban the use of flavors in e-cigarettes. And by supporting such a ban, the anti-smoking groups are essentially promoting cigarette smoking in the population.

Flavored e-cigarettes have helped literally hundreds of thousands of smokers to quit smoking and millions more to cut down substantially on the amount that they smoke. A ban on flavored e-cigarettes would have resulted in countless former smokers being forced to return to smoking and countless current smokers being unable to quit smoking due to their lack of interest in switching to a non-flavored or tobacco-flavored alternative product.

Without question, the most critical feature that makes electronic cigarettes attractive to adult smokers and allows them to compete with deadly tobacco cigarettes is that they offer a broad array of flavors, providing ample choice so that every smoker can find a flavor that is particularly attractive. Without flavors in e-liquids, vaping would lose most of its appeal for most of its users and would largely wither away. Jacob Sullum has pointed out that 77% of vapers prefer flavored products. To be sure, a ban on flavored e-cigarettes would have amounted to a de facto ban on all e-cigarettes and would have caused tens of thousands of former smokers to return to cigarette smoking.

That supposedly anti-smoking groups are supporting a policy that is the single most effective step that the FDA could take to promote cigarette smoking in the United States is unfortunate, sad, and disillusioning. Clearly, the anti-smoking groups care more about kids (most of whom are already tobacco users) experimenting with flavored vaping products than with smokers dying of cancer, lung disease, heart disease, stroke, and peripheral vascular disease.

After pain-staking analysis, I have come to several conclusions about why anti-smoking groups are now ironically promoting smoking:

1. Electronic cigarettes represent a huge threat to their ideology. There is simply no room for a nicotine-containing product that could actually help improve people's health.

2. E-cigarettes are also a threat because it destroys the anti-smoking ideology to think that a person might actually derive some enjoyment from nicotine without it killing them.

3. It is unacceptable for people to be using a nicotine product that does not kill them because it doesn't allow for punishment of what is seen as this bad moral choice. In contrast, continued high levels of smoking are tolerable because these nicotine addicts are being punished for their poor behavior.

4. The "save the smoker" argument does not bring in donations, while the "save our children" appeal allows anti-smoking groups to continue to produce effective financial appeals to their constituents.

5. E-cigarettes not only threaten to make smoking obsolete, but to greatly reduce the use of pharmaceutical products, harming companies with which numerous anti-smoking groups have significant financial relationships.

6. Actually making smoking obsolete would essentially put anti-smoking groups out of business. Ensuring that vaping remains at the margins of society helps ensure that anti-smoking professionals continue to have jobs. Vaping products would actually make a cigarette "end-game" possible because they provide an alternative to smokers, easing concerns about the development of a cigarette black market. Thus, vaping actually does pose a threat to a continued high availability of jobs in tobacco control.

Fortunately, the OMB listened to my advice (and similar advice from thousands of vapers, harm reduction scientists and advocates, e-cigarette distributors, retailers, manufacturers, and consumer advocacy groups, and even the tobacco companies) and decided that promoting cigarette smoking is not an appropriate action for a public health agency like the FDA to take.

The former anti-smoking groups will continue to push for a ban on flavored e-cigarettes, and I will continue to everything in my power to oppose and prevent such a regulation from being promulgated and approved.Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-40589696769837047632016-05-26T09:24:00.002-04:002016-05-26T09:25:07.045-04:00IN MY VIEW: American Lung Association Would Rather Smokers Die than Save their Lives "the Wrong Way"Re-defining the meaning of paternalism, the American Lung Association on Tuesday boldly and unashamedly told smokers that if they quit smoking the wrong way, it doesn't count, essentially condemning the nearly 7 million Americans who are vaping instead of smoking.

In a Reuters article, the American Lung Association told the nation's smokers that: "We think there are certainly more and better ways to quit. When you're going to e-cigarettes, you're not quitting, you're switching."

The Rest of the Story

This is perverse paternalism. It is an attempt to so strongly control the lives of smokers that the American Lung Association is literally lying to smokers in trying to control their behavior.

What the American Lung Association is telling smokers is not merely that they should quit, but that they must quit in the way that the ALA tells them to or they might as well continue smoking. Thus, this message insinuates that the ALA would rather these smokers die than quit the wrong way.

Let me set the record straight and try to undo some of the damage that the American Lung Association is causing. There is no right or wrong way to quit smoking. What matters for your health is that you quit. The body doesn't know how you quit; what it knows is that you are no longer inhaling tobacco smoke with its tens of thousands of chemicals and more than 60 known human carcinogens. Whether you quit using a nicotine patch, a pill, hypnosis, vaping, acupuncture, or natural magick, you have successfully quit smoking, are no longer inhaling toxic tobacco smoke, have essentially saved your life, and I congratulate you for having accomplished the single most important - and most difficult - thing you can do to protect your health.

In contrast, the American Lung Association only congratulates you if you quit in the ways that it approves. If you quit by switching to vaping, you are not going to be congratulated by the ALA. In fact, they don't even consider you to be an ex-smoker, apparently. The ALA would redefine the clearly established definition of "former smoker" that has been used by the CDC for decades in order to avoid having to call a single-use vaper an ex-smoker.

This, of course, is lying to the American public. It simply is not true that if you switch from smoking to vaping, that you are still a smoker. You are a successful quitter, not merely a "switcher."

The public health damage being done by the American Lung Association and other anti-vaping groups with similar messages is immense. In the past year, the proportion of U.S. adults who incorrectly believe that smoking is no more hazardous than vaping rose from 38% to 47%. Thanks to the messages being disseminated by the American Lung Association and similar groups, nearly half of all adults fail to recognize that smoking is any more dangerous than vaping. This is outrageous and sinful. The health groups are doing as much to undermine the public's appreciation of the severe hazards of smoking as the tobacco companies used to do (and which led to Big Tobacco companies being recognized as adjudicated racketeers).

The natural question that arises is why is the American Lung Association going to this extreme of lying to the public in order to support a position which is clearly in direct conflict with its own avowed mission?

The answer, I have concluded, is that like so many organizations these days, the American Lung Association has lost sight of its true public health mission and is being diverted by ulterior motives, such as preserving an underlying ideology that justifies its schema with which it views the world, appeals to potential donors, and protects the organization from what it perceives as threats to its world view.

Put simply, I believe that groups like the American Lung Association are threatened by the idea that someone could possibly derive any pleasure from nicotine and that a form of nicotine use could be associated with an actual improvement in their health. This concept is simply too foreign to their world view, which cannot accommodate this notion. So rather than altering its world view, the organization has to change the facts, misrepresent the science, and re-define basic definitions in order to force what this phenomenon to fit into its world view.

Ironically, it is precisely the fact that vaping is so much safer than smoking that I think truly threatens these groups. They are comfortable with the status quo and their long-time perspective: people who smoke cigarettes and become addicted are punished because smoking is so toxic that they develop disease or die. Addiction is a human flaw and it is punished appropriately. The idea that someone could be a "nicotine addict" but be worthy of praise is just not coherent with the world view of groups like the American Lung Association. Without the natural consequences of these "addicts" dying of cancer or lung disease, the ALA must concoct its own punishment and castigation for these people.

The rest of the story, however, is that these people number in the millions. And they are people who should be congratulated for having finally succeeded in quitting smoking - something that they were unable or unwilling to do using the methods that the American Lung Association recommends.

Furthermore, the public health miracle of 2016 - an unprecedented drop in adult smoking rates (the largest year-to-year drop ever observed) - would likely not have occurred if smokers actually followed the American Lung Association's advice. Instead of having probably about 5 million adults crossed out from the current smoker category and placed into the former smokers who are vaping, we would most likely have had several million adults remain in the current smoker column.

But apparently, the American Lung Association would rather see these millions of people smoking rather than vaping because the idea that literally millions of people might be benefiting from the use of a product that contains nicotine is simply too hard to bear. It doesn't fit nicely into the organization's world view, so it must be dismantled.Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-14759319827481262332016-05-24T06:54:00.000-04:002016-05-24T06:54:06.514-04:00Why Anecdotal Evidence Proves that Electronic Cigarettes ARE Helpful for Smoking CessationOne of the widest scientific misconceptions about evaluating the effectiveness of electronic cigarettes for smoking cessation - and one promulgated by anti-vaping groups and health agencies like the CDC and FDA - is that anecdotal evidence is insufficient to demonstrate that electronic cigarettes can be effective in helping smokers to quit smoking. In fact, this is a widespread fallacy. The truth is that the abundant anecdotal evidence of e-cigarettes helping many smokers quit is actually sufficient evidence to conclude that e-cigarettes are helping many smokers quit.

How can this be the case? Haven't we all been taught that anecdotal evidence is not sufficient? Aren't more rigorous research designs necessary to draw a conclusion that e-cigarettes can help some smokers quit? Since anecdotal evidence that a drug helps improve a medical condition among some patients cannot be used to conclude that the drug is an effective treatment, how can anecdotal evidence that many smokers have quit using e-cigarettes be used to conclude that e-cigarettes are effective for smoking cessation for many smokers?

The Rest of the Story

To understand this, we need to consider exactly why it is that anecdotal evidence is not sufficient to conclude that a drug is effective. Suppose a person with high blood pressure takes a medication for a week and her diastolic blood pressure is lower by 5 after one week (say it drops from 130/95 to 130/90). There are basically three possibilities that could explain the drop in blood pressure:

1. It would have dropped anyway, for reasons not related to her taking the drug.
2. The drop was caused by a placebo effect. It would have dropped had she taken a pill that just had sugar in it and not the medication.
3. The drop was caused by the medication.

So to conclude that the explanation for the drop in blood pressure is #3 above, we need to eliminate #1 and #2 as alternative explanations.

How do we eliminate #1? The way we eliminate #1 is to employ a control group: that is, a group of people with high blood pressure who are followed for one week without taking the medication to see whether their blood pressure drops anyway.

How do we eliminate #2? The way we eliminate #2 is to give a control group a placebo instead of the actual medication. If this group also experiences a decline in blood pressure, then it may be a placebo effect rather than a true drug effect.

In practice, conducting a placebo-controlled trial will address both #1 and #2 in one study because if either explanation #1 or #2 is true, then the blood pressure will drop in the control group and there will be no significant difference in blood pressure at follow-up between the treatment and the control group.

Now let's consider a behavioral outcome instead of a clinical (disease) outcome. Suppose a smoker uses a nicotine patch and at six month follow-up has stopped smoking. There are again three possible explanations:

1. The smoker would have quit anyway because by virtue of taking the nicotine patch, it is clear that he was motivated to quit and trying to quit. So it is quite plausible that the smoker would have quit even without the nicotine patch. The act of trying the patch indicated a desire to quit and a certain level of motivation to do so, above and beyond the motivation of other smokers.

2. The nicotine patch had a placebo effect. Simply by putting a patch on, it helped the person to quit due to placebo effect, not due to the actual nicotine.

3. The nicotine patch was effective in helping the smoker to quit.

To eliminate possible explanations 1 and 2, we again conduct a placebo-controlled trial, comparing the quit rate among a treatment group with the quit rate among a control group that receives a placebo patch. If either explanation 1 or 2 is correct, then there will be no difference in the cessation rate between the treatment and control groups.

Now, let's apply to same reasoning to a smoker who decides to try electronic cigarettes and is able to quit smoking. There are again three possible explanations:

1. The person may have quit smoking anyway, even had she not tried e-cigarettes. The act of trying e-cigarettes for smoking cessation could indicate a heightened level of motivation to quit smoking.

But there's a major problem with this explanation. It's not consistent with the available scientific data. The available data demonstrate that as a group, smokers who try electronic cigarettes are less motivated to quit and have much less confidence in their ability to quit. In fact, the very reason that smokers turn to e-cigarettes in the first place is that they have been unable to quit using other methods and have no self-efficacy regarding their ability to quit smoking otherwise. The data also show that smokers who try e-cigarettes tend to have higher levels of nicotine dependence and are thus much less likely to quit. In other words, the evidence supports the contention that the alternative to not trying e-cigarettes for most vapers is not quitting, but continuing to smoke. This alternative explanation therefore does not appear to hold water in most cases.

2. The person may have quit smoking due to a placebo effect. The act of using the e-cigarette (which simulates smoking) may be the reason for the successful cessation.

But there's a major problem with this explanation as well. The placebo effect is precisely the "mechanism of action" of vaping. It is a huge part of the reason why vaping could potentially be effective for cessation. The whole point of vaping products is to substitute for smoking by simulating the smoking experience. So in arguing that the observed association between vaping and smoking cessation is a placebo effect, one is actually arguing that the smoking cessation was a consequence of the e-cigarette use, since it works through a placebo effect. Therefore, this alternative explanation does not refute the third explanation: that the smoking cessation was attributable to the use of the e-cigarette.

The rest of the story is that the abundant anecdotal evidence of smokers quitting successfully using e-cigarettes is strong evidence that e-cigarettes are - for these smokers - effective in helping them quit. The FDA's view on this issue is misguided because it doesn't understand the basic scientific reasoning behind this relationship. The agency is used to evaluating drug studies, which must include placebo-controlled trials rather than rely on anecdotal evidence.

Please note: I am not arguing that clinical trials of smoking cessation with e-cigarettes compared to other approaches are not needed. I've made it very clear that conducting such trials should be a research priority. Neither am I arguing that anecdotal evidence that e-cigarettes can help smokers quit provides any estimate of the magnitude of the effect: we cannot, from the anecdotal evidence, determine what proportion of smokers who attempt to quit using e-cigarettes will succeed.

However, the argument that we do not have evidence to conclude that e-cigarettes can help smokers to quit is fallacious. The abundant anecdotal evidence available provides substantial evidence that e-cigarettes can and do help many smokers to quit.

Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-70973151914885120272016-05-19T06:42:00.000-04:002016-05-19T06:42:00.192-04:00Why is the American Cancer Society Lying to Its Members About the E-Cigarette Regulations?In an urgent action alert, the American Cancer Society (through its Cancer Action Network) is encouraging its members to write their federal legislators and demand that Congress not strip the FDA of its authority to regulate electronic cigarettes.

The "suggested" letter which the ACS pre-populates for its members states: "Congress should not strip FDA of its oversight authority when electronic cigarette use by high school students has jumped to 16 percent in a very short time... ."

This action alert seems to be clearly informing ACS members that Congress is considering stripping the FDA of its authority to oversee the regulation of electronic cigarettes.

The Rest of the Story

Now why is it necessary for the American Cancer Society to lie about the pending Congressional legislation, which absolutely does not strip the FDA of its authority to regulate electronic cigarettes. The legislation would merely change the predicate date for new products, meaning that it would allow vaping products now on the market to continue to compete against cigarettes for a share of the nicotine market, but in a much safer, tobacco-free form. The FDA would still have the authority to regulate vaping products and in fact, the Cole-Bishop amendment would force the agency to be more aggressive in its regulations by requiring it to set uniform safety standards for vaping products.

I don't see the inherent value in the American Cancer Society lying to its members. Does it think its membership is too stupid to be able to handle a more subtle and nuanced message? Does it even care about the truth, or is it just using its members as pawns on a chessboard to manipulate them to do its work for it? Does the ACS not see the damage it could be causing to itself, its reputation, and its relationship with its membership if members find out that they were being lied to? What is wrong with being candid, frank, and transparent? I know that we don't expect that from our politicians, but we should it expect it from the non-profit public health advocacy groups.

I had to change the pre-populated text of my message in order to exculpate the lie and replace it with the truth. I told my Congressmembers that in contrast to what the ACS told me to tell them, the Cole-Bishop amendment would not strip the FDA of its regulatory authority over e-cigarettes, but instead would strengthen it by forcing the agency to promulgate uniform safety standards as well as to regulate e-cigarette marketing, something it failed to do in its deeming regulations. The Cole-Bishop amendment would not strip the FDA of its regulatory authority. Quite the opposite. It would strengthen the FDA's regulatory authority by forcing it to actually do something to protect the health of the American people, rather than to simply create a gigantic bureaucracy that accomplishes little else than to shield toxic tobacco cigarettes from competition from a much safer, tobacco-free alternative.Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-23805886095817932002016-05-17T20:06:00.006-04:002016-05-17T20:10:18.464-04:00American Lung Association Disseminates Negligent Medical Advice About VapingThe president of the American Lung Association yesterday disseminated negligent medical advice regarding vaping through a tweet that included advice from six physicians.

Each of these six physicians provides negligent medical advice regarding smoking cessation using electronic cigarettes.

1. Chicago: This advice is negligent because it misrepresents the benefit-risk profile of electronic cigarette use for the individual patient. The physician is telling all smokers that the risks of trying e-cigarettes outweighs the potential benefits. But this is not at all consistent with the science. The science unequivocally demonstrates that there are tremendous medical benefits to patients who are able to quit or cut down substantially using e-cigarettes. And there are essentially no harms because smokers who use e-cigarettes are precisely those who believe they are unable to quit using other methods. This is a complete distortion of the risk-benefit ratio for the individual patient, and it therefore constitutes negligent medical advice.

2. Germany: This advice is negligent because the physician is telling patients that vaping is the same as smoking. This is categorically false. Vaping involves no tobacco whatsoever, and it involves no combustion. E-cigarette aerosol eliminates tens of thousands of the chemicals present in tobacco smoke, including more than 60 known human carcinogens. Switching from smoking to vaping results in dramatic and immediate improvement in respiratory symptoms and lung function. This physician is spreading false information, and it therefore constitutes negligent medical advice.

3. Texas: Like the physician from Germany, this physician is telling patients that e-cigarette health risks are analogous to those for real cigarettes. This is false information, and the medical advice is therefore negligent.

4. Colorado: This physician is telling patients that e-cigarettes are likely no safer than tobacco cigarettes. This is categorically false. Vaping involves no tobacco whatsoever, and it involves no combustion. E-cigarette aerosol eliminates tens of thousands of the chemicals present in tobacco smoke, including more than 60 known human carcinogens. Switching from smoking to vaping results in dramatic and immediate improvement in respiratory symptoms and lung function. This physician is spreading false information, and it therefore constitutes negligent medical advice.

5. Baltimore: This physician is telling patients that vaping harms their lungs. However, there is no clinically meaningful evidence to back this up. While e-cigarette aerosol is a mild respiratory irritant, it has not been shown to affect lung function as measured by spirometry. And it certainly is going to do a lot less harm than continuing to smoke. This stops just short of being negligent medical advice.

6. Minnesota: This physician is telling patients that using e-cigarettes is not a way to quit smoking. Well, it certainly has been a way to quit smoking for hundreds of thousands of Americans who quit smoking by switching to vaping. It is irresponsible for this physician to essentially lie to her patients about the fact that e-cigarettes have helped so many tens of thousands of people to quit smoking. It may not be the way that she wants them to quit, but it is a legitimate way to quit. For putting her own concerns over the best interests of the patient, this is negligent medical advice.

The Rest of the Story

It is difficult to understand what the American Lung Association's objective is here. The effect of this communication is certainly going to be to discourage quit attempts among thousands of smokers who might otherwise have been able to achieve smoking cessation using e-cigarettes. And it might also dissuade thousands of ex-smokers from continuing to vape and instead, cause them to return to smoking. Either way, I don't see how this is in any way helping to improve lung health in this country.

It is, however, public health malpractice, which I define as advice which when given to an individual patient would constitute medical malpractice, but which is instead being disseminated to the general public.

For example, if I tell my patient that vaping is just as hazardous as smoking and therefore I advise my patient not to quit using e-cigarettes, I would consider that negligent medical advice because it is false information and it had the effect of causing the patient to assume an increased risk that he otherwise might not have assumed. Thus, disseminating the same information and advice to the general public is an example of public health malpractice, or negligent public health advice.

The difference is not in the harm that is caused by the two; it is simply in that one comes with liability and the other does not.Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-89867467027611602592016-05-16T19:28:00.001-04:002016-05-16T19:28:24.633-04:00American Lung Association and CVS Health Campaign Downplays the Importance of Smoking in Preventing Lung Cancer Ad Looks Like Big Tobacco Ad from the 20th Century

The American Lung Association (ALA), with primary financial support from CVS Health (CVS), has initiated a campaign called "Lung Force." The campaign features a video ad with the theme of "Anyone Can Get Lung Cancer." Although the ad cites the fact that lung cancer incidence among women has increased over the past decades and mentions radon and air pollution as causes, nowhere in the ad is smoking even mentioned.

I went to the Lung Force fact sheet on lung cancer and found that the #1 most important fact is as follows:

"1. Anyone can get lung cancer."

If you click on the link to get more information, it brings you to the video ad with the theme of "Anyone Can Get Lung Cancer" which doesn't mention smoking.

In a detailed sheet which summarizes the campaign, there is not a single mention of the importance of smoking as a cause of the increasing incidence of lung cancer among women, even though the sheet emphasizes how important it is to get out all the facts and educate women about the "basics" and even though the sheet mentions air pollution, radon, family history, and secondhand smoke as risk factors.

And in a detailed summary of the Lung Force campaign, it again fails to mention smoking. Instead, it de-emphasizes smoking by hiding the fact that smoking is overwhelming the chief cause of lung cancer among women. In fact, it appears that the main objective of the campaign is to downplay the role of smoking in causing lung cancer among women:

"We aim to change people's minds about what it means to have lung cancer—so that everyone understands that anyone can get lung cancer."

In a long video about lung cancer featuring numerous lung cancer survivors, smoking is not mentioned a single time, other than in an attempt to suggest that smoking is not as important a risk factor for lung cancer as previously thought.

In fact, the campaign actively suppresses the sharing of the fact that smoking is overwhelmingly the leading cause of lung cancer. For example, in presenting Kellie Pickler's involvement in the campaign, sparked by the death of her grandmother from lung cancer, it fails to mention the important fact that her grandmother was a long-term smoker.

The Rest of the Story

I'm not sure that I can overstate my level of condemnation of this campaign. It is disturbing, and it is damaging. It undermines decades of education about the severe health hazards of smoking and about the role of smoking as the overwhelming most predominant cause of lung cancer. About 90% of the suffering that the campaign highlights could be prevented if we made smoking history. But instead, the campaign talks about air pollution, which only causes about 1% (at the most) of lung cancer.

The campaign's theme, and the video ad, look like a Big Tobacco campaign from the 20th century, downplaying the role of smoking in lung cancer by emphasizing that "anyone" can get lung cancer. I'm not sure the tobacco industry itself could have done a better job of downplaying the role of its products in the devastating lung cancer epidemic.

Moreover, not only does the campaign fail to mention smoking as a leading cause of lung cancer and not only does it downplay the role of smoking, but it actively tries to confuse women about the role of smoking. By emphasizing that most lung cancer is diagnosed in nonsmokers and omitting the important fact that most of these women are former smokers, it appears to be intentionally trying to get women to think that smoking is not the predominant cause of lung cancer. Furthermore, it does not once mention the role that the tobacco industry played in the epidemic of lung cancer among women.

The tobacco industry should really send a thank-you note to the Lung Force campaign for running a public awareness campaign that downplays the role of smoking in a way that even Big Tobacco would not do, and is not doing, in the 21st century.Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-42211562287166787262016-05-15T20:00:00.000-04:002016-05-15T20:00:14.020-04:00FDA is Defending Deeming Regulations from Well-Placed Criticism By ... ... LyingLast week on The Source, a Texas Public Radio news show, a spokesperson for the FDA's Center for Tobacco Products (CTP) was confronted with a very solid and well-placed criticism of the agency's e-cigarette deeming regulations. The host asked her how she could defend these regulations in the face of uniform statements by vaping companies that "this is so onerous that this is going to drive them out of the business."

In response, the CTP spokesperson defended the regulations by stating: "It's important to remember that we're talking about products that kill people."

The Rest of the Story

Let's get the facts straight. Yes, it is true that we're talking about products that kill people. But those products are not called e-cigarettes; they're called real tobacco cigarettes.

That the FDA is forced to resort to lying in order to defend its regulations suggests that it realizes it doesn't have a leg to stand on. If there were a legitimate public health reason for putting an onerous, expensive burden on vaping businesses that is going to drive most of them out of business, I'm sure that the FDA would immediately be able to tell us what it is. Destroying thousands of small businesses is not something that we in public health take lightly.

But the rest of the story is that the FDA cannot tell us what the reason is. The only thing they can resort to in defending their onerous regulations is lying. The regulations are needed because we're talking about products that kill people.

Well, let's get one thing straight. The products that are killing people are real cigarettes. And the FDA has chosen to give these cigarettes a completely free ride by putting every possible economic burden in front of much safer smoke-free, tobacco-free cigarettes so that they have little hope of being able to compete with the killer products.
Michael Siegelhttp://email@example.com:blogger.com,1999:blog-11234862.post-9293226706281595902016-05-11T14:09:00.001-04:002016-05-11T14:14:26.090-04:00First Lawsuit Filed Challenging FDA Deeming RegulationsYesterday, the first lawsuit was filed which challenges the legality of the FDA's electronic cigarette deeming regulations. The suit was filed in the D.C. District Court by Nicopure Labs, a maker of vaping devices and e-liquids. The complaint alleges that the FDA deeming regulations are in violation of the Administrative Procedure Act (APA) and the First Amendment.

There are three claims under the APA:

1. The FDA has interpreted the term "tobacco products" way too broadly and in a way which is inconsistent with the Tobacco Act.

Nicopure points out that the FDA has construed the term "tobacco product" so broadly that it includes not only e-liquids which actually do contain nicotine, but also batteries, wicks, electronic displays, and glass vials, which do not contain nicotine and are not derived from tobacco or any constituent of tobacco.

Comment: This seems like a good point. If I am a manufacturer of batteries for electric toothbrushes and people start using my batteries in their vaping devices, and I then put a note on my web site stating that these batteries may be used in vaping devices, I am now a tobacco product manufacturer under the regulations and must comply with all provisions. This means I must label my product as a tobacco product (falsely stating that it contains tobacco) and furthermore, that I cannot make any changes to my batteries after August 8, 2016, even if those changes are critical safety improvements, unless I receive pre-market authorization approval from the agency. If I am a manufacturer of glass vials and I am reasonably aware that many consumers are using these vials to store e-liquids, I could possibly be deemed to be a tobacco product manufacturer. If I advertise that these glass vials would make good containers for e-liquids, then I am most definitely considered a tobacco product manufacturer.

 2. The FDA regulations are arbitrary and capricious and impose a huge burden on businesses but without any rational connection to the protection of the public's health.

Comment: The best example of this is the setting of August 8, 2016 as a date beyond which manufacturers cannot make any changes, including safety improvements, to their products. That date is arbitrary, as is the treating of products on the market on August 8th systematically different from products on the market as of August 7th. Moreover, there is no rational basis for imposing huge burdens on businesses through the pre-market tobacco application requirements because these requirements do not directly advance any public health objective. In fact, the FDA has failed to show that there is any substantial threat to the public's health posed by vaping products or that its regulations will mitigate that threat. There is certainly no rational basis for preventing companies from making safety improvements to their products after August 8th.

3. The FDA's cost-benefit analysis grossly underestimates the costs while exaggerating, and failing to even quantify the benefits of the regulations.

Comment: This is also a valid point. The deeming rule estimates that there will be 750 PMTAs submitted each year. However, one company alone will submit more than 750 PMTAs. A single company that sells 190 flavors of e-liquid, each in four nicotine strengths, will have to submit 760 PMTAs. That's just a single company. It seems clear that an accurate cost-benefit analysis would have revealed that the costs of imposing these regulations are astronomical. Moreover, the FDA did not even quantify the benefits of the regulations. The agency pointed to no evidence that vaping products are causing public health harm. Nor did it quantify any of the supposed harms. It is difficult to see how the hypothetical benefits of regulation, which couldn't even be quantified, justify the imposition of literally billions of dollars in capital costs on the vaping industry, including thousands of small business owners.

 4. The regulations violate the free speech rights of the company under the First Amendment by prohibiting it from making truthful and non-misleading statements about its products, and without any legitimate government interest.

Comment: I believe this is the strongest of the legal arguments. Without question, by subjecting vaping products to the modified risk provisions in section 911 of the Tobacco Act, the FDA has prohibited companies from claiming, truthfully, that their products are safer than real cigarettes, contain no tobacco, produce no smoke, or produce aerosol that contains levels of certain chemicals that are much lower than in tobacco smoke. These are all accurate and non-misleading claims that are in fact essential for consumers to understand, and these are the primary benefits of the product that companies need to be able to convey.

Moreover, the prohibition of these truthful claims advances no substantial government interest. In fact, it doesn't advance any government interest. What government interest is there in banning companies from informing consumers that these products do not contain tobacco? How does that threaten the public's health? The truth is that notinforming consumers that these products do not contain tobacco is what will threaten the public's health. It will hide from the public critical information necessary for people to make rational, informed decisions in choosing between smoking real, tobacco cigarettes and vaping fake, non-tobacco ones.

Because the FDA is prohibiting truthful claims that are in no way misleading, the test of whether these restrictions will survive First Amendment scrutiny will certainly be under strict scrutiny, or under the Central Hudson criteria. The government will have to show that these restrictions are based on a substantial government interest and that they will effectively advance that interest.

But I can think of no government interest in precluding a company which makes a much safer product than cigarettes from informing its consumers that its product is safer. I see no government interest in forcing companies to hide from their consumers the basic fact that their products do not contain tobacco. There is certainly a justification for forcing ingredient disclosure, but I cannot think of a legitimate interest that is served by forcing ingredient non-disclosure. I think it will be quite clear to the court that companies have a right to voluntarily disclose their ingredients and that the government has no interest in prohibiting that unless such disclosure would somehow be misleading. In this case, not disclosing that these products do not contain tobacco and do not produce smoke is what would be misleading.

The Rest of the Story

This is the first of what I imagine will be many lawsuits challenging the deeming regulations. The First Amendment challenge I think is extremely strong. There is a high likelihood of success on legal grounds, and enforcing the modified risk provisions would clearly cause severe and irreparable harm to the vaping companies. Thus, I think there is a solid chance that the court will grant injunctive relief and enjoin the FDA from enforcing this aspect of the regulations while the full case is heard. Because of the severability of the regulation provisions, only the modified risk provisions would be subject to injunctive relief under this aspect of the complaint.

It is more difficult to predict what the court will do with the APA claims. Of those, I believe the flawed cost-benefit analysis is the strongest claim because it will be easy to show that the FDA greatly underestimated the costs it is imposing on businesses. Essentially, the FDA underestimated the cost by at least two if not three orders of magnitude. The FDA estimated that there would be 750 PMTA's per year. But the FDA itself acknowledged that there are 4,600 vape shops that mix their own liquids. Assuming, conservatively, that each vape shop sells only 10 e-liquid flavors, this amounts to 46,000 applications. And this is just from small businesses. It doesn't include the large e-liquid manufacturers. Given the high likelihood of success of this argument and the severe and irreparable harm that enforcing it would produce, I think there is at least a solid chance that the court could provide injunctive relief on this claim, which would temporarily enjoin the FDA from enforcing the PMTA requirements.

The other two claims are compelling, but courts generally give federal agencies a huge amount of discretion when using the "rational basis" test.

The rest of the story is that Nicopure's complaint outlines several compelling arguments which demonstrate that the FDA has exceeded its authority in its deeming rule in violation of the APA and in a way that cannot stand scrutiny under the First Amendment. I'm certain that this is only the first of many more lawsuits to come. This is not unexpected when a federal agency puts onerous and financially prohibitive burdens on an industry that result in a de facto elimination of the bulk of that industry.
Michael Siegelhttp://firstname.lastname@example.com:blogger.com,1999:blog-11234862.post-78279783443703043232016-05-10T11:39:00.001-04:002016-05-10T13:05:31.417-04:00FDA Regulations Present an Imminent Threat to the Safety of the Public: Urgent Changes are NeededWhile I have already argued that the FDA deeming regulations pose a long-term threat to the public's health because they will result in the removal of most vaping products from the market (so cigarette sales will continue uncontested), today I explain why these regulations pose a substantial immediate threat to the public's health.

As of August 8, 2016, no new vaping products will be allowed on the market. Because the FDA considers virtually any change in a product to constitute a new product, this means that the deeming regulations will essentially "freeze" the vaping market as it exists on August 8. From that date forward, not only will companies not be able to introduce new products but they will also be unable to make changes in their existing products. Such changes would require a substantial equivalence (SE) determination (which is unlikely because few, if any products are similar to a predicate product on the market in 2007), an SE exemption (which is unlikely because the company cannot show that the product is essentially the same as a predicate product on the market in 2007), or a new product application (which will be prohibitively expensive for most companies). Moreover, these regulations will discourage companies from undertaking any revisions to their products. Several companies have already decided to freeze their inventory and discontinue their innovation research and development.

To be clear, even small changes in products will not be allowed. For example, changes to the battery will not be allowed. If a company wanted to change to a new type of battery in a rechargeable model they produce, this will not be allowed because it would represent the introduction of a new tobacco product into the market for interstate commerce. Similarly, if a company wanted to change their propylene glycol supplier and use a different grade of propylene glycol, this would not be allowed.

The Rest of the Story

The FDA deeming regulations present an imminent threat to public safety. Why? Because after August 8, companies will not be able to make changes to their products to improve product safety.

Suppose company X finds out on August 7 that one its e-cigarettes exploded. The company does an investigation and finds that the batteries they are using do not contain the proper safety features to prevent explosion. The company wants to change batteries in their products to protect the public from an immediate and severe safety hazard. In the absence of the deeming regulations, the company could replace the batteries the next day. But the deeming regulations actually prevent the company from making such a change to its product. You can easily see how these regulations impose an imminent threat to public safety.

Suppose that a company finds a way to prevent potential safety hazards by introducing a new battery overcharge protection system. After August 8, the company cannot do that.

Suppose a company wants to change from a low-grade propylene glycol to a much purer, USP propylene glycol. That would not be allowed because it would represent the introduction of a new tobacco product into the marketplace.

Suppose the company determined that the voltage setting on its battery was too high and resulted in the formation of formaldehyde. Is that company allowed to lower the voltage setting to avoid this problem? Once again, the answer is no because it would represent the unlawful introduction of a new tobacco product into the marketplace.

The regulations will have a chilling effect on product innovation, including safety improvements. This is obviously not in the interests of protecting the public's health. And to the contrary, it actually introduces safety concerns that would not otherwise have been present if companies were permitted to make improvements in their products without pre-authorization.

I can't see how these regulations are going to hold up in court because there needs to be a public health rationale behind them. There is no public health rationale behind the prohibition of product safety improvements.

Remember that in banning the introduction of new products, the FDA is not only preventing the potential introduction of new products that could represent an increased threat to public safety, but it is also preventing the introduction of much safer products.

The rest of the story is that the FDA is essentially freezing any defective products that are on the market as of August 8th, producing a substantial safety hazard.

If defective batteries are on the market as of August 8th, those batteries will continue to explode and cause damage, even if the manufacturers recognize the danger and want to eliminate the hazard.

It should have been clear to the FDA that the requirement for pre-market approval of new cigarettes does not fit the regulation of vaping products. The only reason for the prohibition of new cigarette products in the 2009 Tobacco Act is that there was a history of tobacco industry product changes that resulted in harm to the public's health. For example, companies added ammonia to their products to make them more addictive, introduced light cigarettes to deceive consumers into thinking these products were safer, etc. That is the reason for the pre-market approval for cigarettes.

But it makes no sense to apply that framework to electronic cigarettes because there is no evidence and no reason to believe that companies are manipulating their products in a ways that make them more hazardous to consumers. In fact, it is quite the opposite. For the most part, the innovations that have taken place are improving the safety profile of vaping products. For example, it appears that the diethylene glycol problem has essentially been resolved, we now have many brands on the market which have been shown not to produce detectable levels of any hazardous volatile organic compounds, and the prevalence of unsoldered joints and other manufacturing defects appears to be decreasing.

Since the FDA seems determined to continue to try to force a round peg into a square hole, it is now incumbent upon Congress to intervene and create a new statutory regulatory framework for vaping products. That framework should eliminate any requirements for pre-market approval of vaping products and instead, should require the FDA to simply promulgate a set of uniform safety standards, including batteries that do not explode.Michael Siegelhttp://firstname.lastname@example.com