Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems
2015-381 Colleen Maschal CTP
2018-03-23 2016-06-15 2016-06-15 2016-07-07 2016-07-22 2016-07-22 2016-07-22 2016-07-22 2016-07-22 2016-07-22
FDA-2015-D-2496-0048 FDA-2015-D-2496-0012 FDA-2015-D-2496-0005 FDA-2015-D-2496-0021 FDA-2015-D-2496-0025 FDA-2015-D-2496-0037 FDA-2015-D-2496-0028 FDA-2015-D-2496-0038 FDA-2015-D-2496-0024 FDA-2015-D-2496-0031
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https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0048 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0012 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0005 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0021 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0025 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0037 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0028 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0038 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0024 https://api.regulations.gov/v4/comments/FDA-2015-D-2496-0031
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Do not take away flavors that is the only thing making it so I can vape and quit smoking and Im former cancer patient so this is saving my life it has made me stop coughing up stuff every day every time I cough amd everything  Currently the FDA allows for 510k clearance for devices, additives, equipment, and packaging of transfusion approved biologics, such as packed red blood cells, plasma, platelets, etc.The process, application, and regulation of these products allows for substantial equivalency to be awarded based on products already approved for use regardless of their initial premarket evaluation and approved application. For example, a material used in the creation of bags approved for packed red blood cells can be deemed substantially equivalent in function and safety if used to hold cryoprecipitate or used as tubing in the transport of biologics from one container to another.  This process is also applied many times in other regulated categories such as pharmaceuticals, medical equipment, food additives, preservatives, and processing techniques for dairy and meat. When it comes to the application process for END liquid/juice production the FDA should justify the requirement of separate PMTP applications for base compounds that are produced in the same facility, with the same ingredients following cGMP as outlined by the FDA, and bottled, marketed, and sold by the same company due to greater or lesser contents of nicotine.Nicotine amount in varying concentrations (mg/mL or %vol.) cannot, under any reasonable or scientifically founded circumstances, be considered unequivocal  to itself. That is to say that any standardized solution with varying concentration cannot be promulgated as substantially unequivocal without unwinding decades of regulated solutions and concentrations sold for consumption being approved without premarket evaluation costs. As such, guidance released by the FDA for the PMTP application process should include a clearly defined route with which varying nicotine levels can be established as substantially equivalent after a flag or initial product is submitted and approved via the PMTP application process. An example of this would be artificial sweeteners with varying levels of their active ingredient below the limiting threshold established by the FDA and the ADI as calculated by the FDA.For clarity, a limit for the highest concentration of nicotine allowed in these products is not at question and is a reasonable variable in the production of e-liquid/juice to regulate. However, any concentration below that upper limit should be considered the same product and waived from additional applications and approval by the very concrete and undeniable rules of physics and chemistry.Additionally the use of flavorings in the creation of these e-liquid/juices that are currently considered GRAS or unregulated for use in perfumes, deodorants, candles, air fresheners, or any other inhaled product not currently under scrutiny for adverse health effects, must have a reasonable or scientifically justifiable premise for submission as a PMTP.As such if a common use of these chemicals is in fact inhalation, the requirement that they be regulated by the FDA via PMTP applications rather than a substantial equivalence raises deep concerns about the FDAs scope of regulation versus the FDAs mandate by law. Guidance in the PMTP application process should in fact include a multitude of options for meeting the regulatory threshold without compromising the value of the FDA as a consumer health and regulation agency rather than a private laboratory or corporation. I file a dissent to the new rule governing e-cigarette sale and manufacture.1. I personally smoked cigarettes for over 30 years and quit with the help of e-cigarettes and with no ill effects.2. A U.K. medical study cites this nicotine delivery system is up to 95% safer than cigarettes.3. Theres no proof they are a gateway to smoking cigarettes by the young.  Theyre having the opposite effect for current smokers.4. Theres no solid proof e-cigs are harmful.5. The cost of compliance will put many companies out of business and employees out of work.6. Only big tobacco can afford the price of admission.  The fact that R.J. Reynolds was even involved with the process is suspect. This gives the appearance of their powerful lobby getting to the right people in government, to get this regulation pushed through.  Their traditional sales have plummeted and its well known they wish to gain access to this new lucrative industry. Its also well known, while we condemn smoking, the government has subsidized tobacco growers. As an American adult, I choose to enjoy premium tobacco products. Many of those products have been introduced in recent years. I oppose setting an arbitrary date after which those products would be required to undergo lengthy and costly testing. Some, if not all of the items I currently enjoy would disappear or become ridiculously expensive, even though theyve been sold for a number of years. Please allow adults to make decisions for themselves.   Stop killing business adults support.   I dont need a nanny.  I need you to enforce the laws requiring people be 18 or 21 to purchase tobacco or nicotine delivery devices.   Enough is enough.  If you want i would be happy to bring someone from your office to a real vape store and show you that these are adults purchasing these products and they are a positive social situation.   Not kids doing inappropriate things for their age.  Punish people doing wrong, like selling to underage poeple.   Not arbitrarily punish business and people doing something new or different.   Kids in my area can find stores to buy actual tobacco products, but vape stores keep them out completely.  Or is this the goal?  Keep getting kids to use cigarettes so taxes keep rolling in?  Thanks for listening to my rant....   :) Dear FDA, as a former smoker of 20 years and current vaper of over 3 years I am ashamed to live in a country where corrupt, selfish, bureaucrats like yourselves can take peoples freedoms and spit upon them just to stuff more cash in their pockets. Your deeming regulations are unconstitutional and you deserve to be imprisoned for your corrupt methods of business. I will not comply and the fact that you want to implement a process that only tobacco companies can comply with and consider a product to be tobacco when it is not made from nor contain any tobacco just because it contains nicotine yet do not consider the same for other products that do, such as NRT products shows that you have a particular agenda to carry out for vested interests. What you are trying to do is wrong, poses extreme risks to public health and will be fought everywhere. As a small eliquid manufacturing company and long time advocate for vaping, I can assure you that this will effectively stifle and could even shut down many small business owners in this community. Thousands of jobs will be lost. Millions of people will convert back to smoking because they will not be able to get eliquid. All due to the draconian regulations being introduced.  For me electronic cigarettes were a God send. My doctor told me 6 years ago (when I started using them) that for the first time in all the years hes treated me my lungs and bronchial tubes were clear. They have remained clear and Ive gotten healthier.However it looks like thats all coming to an end. With the FDAs new rules Ill be forced back to smoking as they have left us with no options.Most other leading countries are legalizing them because their medical institutions have proven the benefits in using electronic cigarettes. But their contrives value their citizens more than money.Its pretty plain that money, or the loss of is whats causing our governments agencies to make such an idiotic rule. It gives control for the electronic cigarette industry to big tobacco as they are the only ones with enough money to compete in the industryLastly it locks out all the devices that deliver enough vapor to satisfy a nicotine consumers needs.I would like to thank the FDA for sending me back to smoking and the unhealthy life it carries. But really I dont think they care as Im just a US citizen and not a US dollar. The FDA has overstepped their boundaries as I and others cannot get straight answers to our questions about the unfounded assault on the pipe and pipe tobacco industry. If the powers that be truly did their research into said industry, they would realize that it is the cigarette tobacco companies that take floor sweepings and package them in bags and label them as pipe tobaccos to skirt taxes and rules they should be going after. Pipe tobacco has none of the additives and carcinogens that are in cigarettes. As a study by the U.S. Surgeon General (No. 1103 page 112 and 92) found that the death rates for pipe smokers were little if at all higher than nonsmokers. In the same report, it also came to the conclusion that pipe smokers on whole lived three years longer than nonsmokers.As the vast majorities of pipe smokers do not inhale, the dangers that cigarette smokers face are not present. As our country is rebuilding our economy, with miles to go, there is no logical reasoning for this attack on small artisan pipe makers, retailers and pipe tobacco blenders. It was the commerce from tobacco that help establish and fund our country in the first place. Lets not turn our backs on history. Ecigs and juice have NO TOBACCO in them, so how can they be considered a tobacco product?  The FDA is pissed because big tobacco is losing billions of dollars every year because people are vaping instead of smoking.  I hope you get sued and go bankrupt!  We as vapers are united and will NOT conform to your greed!