

Comment Info: =================

General Comment:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
RE: Docket No. FDA- 2014-N-0189

RE: “Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act,” Docket No. FDA- 2014-N-0189 request for extended comment period.

Dear Director Zeller:


I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration’s (“FDA”) 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”) published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days. I wish to provide you with my personal story, as well as science and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past.

I appreciate the opportunity to respond to the Food and Drug Administration’s (FDA or the Agency) request for comments on the proposed rule for “Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act,” Docket No. FDA- 2014-N-0189.  I am in the process of preparing detailed comments in response to the FDA’s numerous requests in the proposed rule, but am very concerned that I will not be able to adequately respond to those requests in the 75-day comment period (i.e., by July 9, 2014).  There are many requests for comments in the proposed rule that I am considering responding to on behalf of consumers of e-cigarette /refillable e-liquid products, many of which require obtaining, summarizing and providing supporting scientific research and other evidence.  The 75-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to many of the questions raised in the proposed rule.  Accordingly, I respectfully urge the Agency extend the current comment period by, at the very least, an additional 105-days (so that comments would be due by October 22, 2014), to provide ample time for stakeholders to provide constructive and valuable feedback on the issues raised in the proposed rule.  I do not believe that such an extension would significantly delay any potential regulatory action on these important issues, and can only aid in providing the FDA with the information that it needs to regulate the growing refillable e-liquid industry in a responsible manner.

If you have any questions or concerns, please do not hesitate to contact me.  I thank FDA for the opportunity to provide my views on the proposed rule.


Sincerely,
Terry Shoulders
