Re: Docket No FDA-2014-N-0189, Request for Extension of Comment Period
Dear Mr. Zeller:
On April 25, 2014 the Food and Drug Administration (FDA) announced the Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the Proposed Rule) and subsequent 75 day comment period. I am writing as an individual to request that the comment period be extended for an additional 105 days, from its current 75-day period, to 180 days.
I am not writing as a consumer of any product affected by the Proposed Rule. I have never used any tobacco product and do not use electronic cigarettes. However, I am a stakeholder as a member of the society that will bear the public health ramifications of the final rulemaking.
As a mother and a concerned citizen, it is very important to me that Tobacco Harm Reduction (THR) products, such as electronic cigarettes, are not excessively restricted while combustible cigarettes remain widely available. Regulating electronic cigarettes is important, but that regulation must be done based on science and reason. There are simply too many unanswered questions in the Proposed Rule to move forward without allowing adequate time for information gathering from those with real world experience of the potential benefits of THR. If the Proposed Rule is finalized as it is now it will remove over 99% of current electronic cigarette products from the market and be catastrophic for public health.
The Agency asks for comment on over 90 questions in the Proposed Rule pertaining to non-combustible products. It is very important to me to respond to each of these but the time provided does not allow me to provide adequate and substantive comments. I have already spent many hours researching and dissecting these issues, but creating responsible regulation for these novel products under the Tobacco Control Act (TCA) is challenging. Electronic Cigarettes are unlike any product currently regulated by the TCA, in that they are a rapidly evolving technology product. Additionally, unlike the products that the tobacco regulatory framework was designed for, electronic cigarettes have the potential to seriously mitigate smoking related death and disease.
Considering that FDA spent several years drafting the Proposed Rule, I do not believe that it is at all unreasonable to allow the public a mere six months to comment on it. While tobacco companies, pharmaceutical companies, large electronic cigarette manufacturers and tobacco control groups have had opportunities to meet with the Agency, this comment period is the only opportunity for consumers and concerned citizens such as myself to be involved in the process.
Despite their characterization in the media, electronic cigarettes are not an innovation of the tobacco industry designed to circumvent regulations. Consumers that are so thrilled to have finally been able to successfully quit smoking combustible cigarettes have driven the explosive growth of the electronic cigarette industry. As an agency that works to reduce smoking rates, it is imperative that FDA takes adequate time to hear from and understand the concerns of the most important stakeholders, those that have been able to quit smoking because of electronic cigarettes.
I am very passionate about electronic cigarettes and believe that they have the potential to save millions of lives. I wish to provide you with information on how electronic cigarettes have impacted my life as a non-user as well as science- and evidence-based responses to your questions. FDA has the authority under 21 CFR 10.40 to extend the comment period and has exercised this authority on numerous occasions in the past. I would therefore ask that you do so in this instance, so that all stakeholders have the opportunity to provide their comments. Because the Proposed Rule has the potential to negatively impact public health it is imperative that all relevant information be included in the final decision making process.
I would implore you, as a member of the society you seek to protect, please do not allow pressure from the media and public health groups to rush this process. As the Proposed Rule states, FDA must base its decisions on scientific evidence. Lack of evidence, ideology, media fear mongering and hypothetical scenarios are not appropriate reasons to hastily finalize a set of regulations with largely unknown consequences.
Thank you for your consideration of my request. I would be happy to provide additional information or discuss this issue further.