FDA’s Approach to Evaluating Nicotine Replacement Therapies; Public Hearing; Request for Comments
CTP 2017-1029 Nicotine Replacement Therapies
2018-02-13 2018-02-13 2018-02-13 2018-02-13 2018-01-26 2018-02-15 2018-01-02 2017-12-05 2018-01-26 2017-12-19
FDA-2017-N-6529-0015 FDA-2017-N-6529-0019 FDA-2017-N-6529-0021 FDA-2017-N-6529-0022 FDA-2017-N-6529-0014 FDA-2017-N-6529-0040 FDA-2017-N-6529-0009 FDA-2017-N-6529-0006 FDA-2017-N-6529-0013 FDA-2017-N-6529-0007
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https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0015 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0019 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0021 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0022 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0014 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0040 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0009 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0006 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0013 https://api.regulations.gov/v4/comments/FDA-2017-N-6529-0007
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Comments on IQOS. Existing Cigarettes Cause Death and Cancer. IQOS has a lot less risk than normal cigarettes.It is Nicotine! I am for the Philip Morris IQOS.  It doesnt have all the nasty cigarette stuff in it.  Also if you think you are going to lower nicotine amounts incigarettes good luck, when that happens the Mexican Sinaloa Drug Cartel will smuggle in Nicotine in the USA just as theydo Meth, Cocaine, Ecstasy, and Marijuana and other Drugs. The Culiacn  Mexican Drug cartel will smuggle it in the USAwhen you lower the amount of nicotine in cigarettes you will create a black market.  Did you know the Sinaloa Drug cartel gets 25% of their profits from Marijuana that they smuggle into the USA???  Interesting huh.  I learned all of this on Netflix check it out sometime.I dont think the government wants to enrich the Mexican Drug with the ban or lowering the level of Nicotine in Cigarettes.If you do lower it, its not rocket science you will create a black market and the Sinaloa Drug Cartel will bring in the nicotine.Well see what happens.....By the way...I dont do any drugs never have and never will...I am just smarter than the average person in America! After reading a small portion (plus a synopsis) of the 590 page study released last week from the National Academies on Public Health Consequences of E-Cigarettes [ http://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes ] I am convinced the Royal College of Physicians was correct and our CDC was not thinking in the best interest of all Americans. Yes the report suggests there may be some potential risks associated with e-cigarettes, but they found sufficient research to suggest that, compared with combustible tobacco cigarettes, e-cigarettes contain fewer toxicants; can deliver nicotine in a manner similar to combustible tobacco cigarettes; show significantly less biological activity in a number of in vitro, animal, and human systems; and might be useful as a cessation aid in smokers who use e-cigarettes exclusively. I think the potential risks from flavorings with any diacetyl, acetoin or acetyl propiony components need further evaluation. Is 0.05% mortally harmful or 5.0%? What are the acceptable ppm that we might inhale here and explain it in comparison to walking down a crowded street in New York City where I live. I dont want to only hear about the AWFUL DANGERS, I WANT TO KNOW HOW THAT COMPARES IN RELATIONSHIP TO THE MANY OTHER RISKS WHICH ARE NOT SCRUTINIZED TO THIS LEVEL.  Should the vaping industry only offer, as some companies who focus on ejuice flavorings never include these trace elements (Purilum, Flavor Revolution are two, Loranns does not. Within The Flavor Apprentice, a person must look at each product to find out, or simply look at the FLAVOR BLACKLIST on DIY EJUICE RECIPE WEBSITES )  I do believe that vapers can live without the potential risk of a cinnamon, as it is made as a flavoring today, just to give you one example. But should you restrict such simple flavors as Flavorahs Apricot, Banana or Brie Cheese? NO. Which also makes me remind you that potassium supplements bout OTC and not evaluated by the FDA are not Bananas, yet the 3% (?) of the tobacco leaf that is Nicotine is Tobacco????  The true addition of cigarettes stems from a multitude of ingredients, one addictive portion, adding another layer to the next. If Nicotine is the 3%, what is that next component called with is know as the 4th  5th % which many people trying to quit add to ejuice because they need that chemical too? WTDs or something like that. I believe that is a more addictive component both physically and psychologically. Nic Salts are another consideration. Regardless, Vaping is not smoking as the CLEAN INDOOR AIRr ACT OF NYS HAS NOT DELINEATED. I personally started my journey as a vaper using the Juul device a friend thought I would benefit and it truly did work... but a year into it, I noticed I needed 1 more box of 4 pods a month. I switched to a simple Innokin mod and Naked100s Amazing Mango at 6mg. Today, I might vape anywhere from ZERO to 6 mg/ml strength ejuice and never more than 90ML a week. Im at the point 30 months into vaping, I could stop... I dont chose to and my physician of 26 years, an Assoc Prof at NYU is pleased with my decision. I do not believe we should restrict the flavors for any other reason until they have independently documented and confirmed by a second un-related source harm. VAPING IS MORE SUCCESSFUL THAN ANY NRT AVAILABLE TODAY AT GETTING CURRENT SMOKERS TO STOP LIGHTING UP AND REMAIN COMBUSTION FREE BEYOND 6 MONTHS, BEYOND 1 YEAR... None of the approved NRTs have a success rate that is significantly higher than a persons choice to go Cold Turkey. One reason vaping has been so successful, is the variety of choice to match each individuals personal taste bud. If you return to the range of Regular Tobacco Flavors or depth of Menthol as a flavoring thinking, you will be opening the door for a new Cartel as opposed to the many Small Businesses, the back-bone of American inspiration and dedication, who keep this marketplace competitive. I WAS VERY PLEASED TO FINALLY HEAR AN AMERICAN VOICE, BESIDES HARVARDS TOBACCO HARM REDUCTION SUPPORTERS, SAY THIS:Thus, among adult populations, the Report states, to the extent that e-cigarette use promotes either reduction or complete abstinence from combustible tobacco smoking, e-cigarettes may help to reduce health risks. E-cigarettes could similarly reduce risks to youth who take up e-cigarettes instead of combustible tobacco cigarettes.So, in summary, please back off the vaping industry with all your stigmatized prejudice and start taking action to save more lives. Furthermore, giving individual buproprion with the nicotine patch is a good idea because the nicotine patch alone abstinence rate is 32%; whereas, wellbutrin combined with a nicotine patch increases abstinence rates to 50%. However, since wellbutrin is only prescribed by physicians including physicians in the FDA new NRT policy is essential. As a mental health provider, I have seen first hand the harrowing effects of nicotine on health as well as anxiety and mood.  Most of my patients desire to quit, they just dont know how or need NRT to assist them in being successful. I have seen great benefit from the patch combined with lozenges and gum on smoking cessation.  Unfortunately, many insurance companies will not cover the cost of these modalities and in the underserved and marginalized population that I serve, they  simply cannot financially manage the cost of NRT out of pocket.  This is a community health concern, and the negative effects of smoking are utilizing  significant tax dollars in managing the medical co-morbidities that come as an after effect of nicotine use.   Has the FDA been in talks with 22nd Century Group, Inc. about their very low nicotine combustible cigarettes? Would the FDA sponsor these products in effort to promote smokers the ability to quit? Representing ATTUDs comments on Nicotine Replacement Therapies It seems that there is continuing research that shows that switching smokers to cigarettes with very low nicotine levels may be the most effective way of alleviating the addiction to cigarettes.  Can you share the results of the FDAs study into Very Low Nicotine cigarettes and give us an update on the status of regulating nicotine levels in cigarettes to non-addictive levels?  Also, will you be regulating the nicotine levels in smokeless tobacco as well, as this is a market with an addiction problem as well.  I thank you for your time.   Good Evening,I want to applaud your efforts, time and resources to allow a low nicotine cigarettes to become available to everyone who are trying to quit but still have the need to have a cigarette in their hand. My grandma used a patch and tried the gum and it was unsuccessful for her. She enjoyed having that cigarette  in her hand and I know if she was alive today I truly think the spectrum cigarette would have been a successful path for her quitting smoking for good but unfortunately she passed from cancer due to her past habit:(22nd century has what society needs and that is the lowest nicotine cigarette. The science has proven this is capable its in your hands to make it become available to the people that want and need to stop.Thank you Kami Provide a clear statement of whether you support or oppose the proposed rule or guidance.LEAVE OUR CIGARETTE TOBACCO ALONE......STOP WASTING TAXPAYERS MONEY ON DESTROYING AMERICANS FREEDOM OF CHOICE.......THE ALTERNATIVES ARE .....NOT.....WHAT....WE.....WANT......Include any of the following that support your position:    data= ANY TIME THE GOVT IS INVOLVED IN OUR FREEDOM OF CHOICE, PER THE CONSTITUTION.....THERE IS ALWAYS A SEVERE PROBLEM.........    research......OUR CHOICE, NOT YOURS........    analysis....SUPPOSED HELPING THE CHILDREN......GREAT COMMUNIST TALKING POINTS......THE MORE YOU STIR THE POT, THE MORE IT STINKS........HUMAN NATURE, WHEN YOU MAKE A BIG DEAL OUT OF SOMETHING, CHILDREN WILL .....ALWAYS.....MIGRATE TOWARDS IT.   IF YOU (GOVERNMENT) WOULD GET OUT OF THE AMERICAN PEOPLES PERSONAL BUSINESS, THERE WOULD BE NO NEED FOR PROGRAMS SUCH AS: WAR ON DRUGS, AND 1,000 OTHER GOVT WASTEFUL PROGRAMS........ To have an addiction to smoking is an issue that is very common and an issue that is rapidly growing and affecting younger ages. Statistics even show that the average age for a new smoker is 13 (Illinois Dept. of Public Health). Millions are affected by smoking, more and 16 million Americans alone are suffering from diseases caused by smoking (CDC, 2017). Taking the initiative to reach out to the public to bring an idea together to tackle this issue is a great idea. As said, the first plan of action by the FDA is to look into reducing nicotine levels in cigarettes to a minimal and non-addictive amount. This is a great start and I believe that the first action should be a major one in order to actually make an impact on the publics health and those who need this change. The plan to increase access to replacements for nicotine and access to therapy is also a major step that will help in the process to impact the public in a positive and major way. Much of the public is not exposed to opportunities to reach out for therapy, and its possible much of the public is not educated on what replacements there are in order to help. But most importantly, there are communities that arent even aware of how important it is to seek a replacement and/or therapy. Many people are ignorant to the consequences of smoking and this is something that should be emphasized when advertising any therapy programs