AVA Request to FDA for Extension of Deeming Regulations Public Comment Period
To: U.S. Food & Drug Administration – Center for Tobacco Products
From: Gregory J. Conley, JD, MBA (President, American Vaping Association)
10 July 2014
VIA REGULATIONS.GOV
Dear Mr. Zeller,
I am writing on behalf of the American Vaping Association (AVA) to request a second extension of the open comment period with regard to 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. The AVA is a nonprofit organization that advocates for the rapidly growing vaping and electronic cigarette industry. We are dedicated to educating the public and government officials about the growing evidence that vapor products reduce help and effectively help smokers quit.
In order to ensure that the FDA acts on the best available science, we are requesting that the comment period on the proposed deeming regulation be extended to 180 days. Although the FDA previously extended the original 75-day comment period by 30 days, the present 105-day period is still inadequate in light of the vast number of questions posed by the agency with regard to the regulation of vapor products.
As noted in a pair of comments filed by Dr. Carl Phillips, Scientific Director of the Consumer Advocates for Smoke-free Alternatives Association (CASAA), the proposed deeming regulation solicits comments on approximately 100 separate questions that relate to e-cigarettes and others smoke-free nicotine products. The proposed regulations, which total in the hundreds of pages, took approximately 3 years to be developed, vetted and released to the public. Groups like CASAA and others are in a prime position to offer useful data on vapor product users, but cannot be expected to do so within such a narrow timeframe.
Moreover, the AVA believes it is in a position to provide data on the economic impact that the deeming regulation would have on small- and medium-sized businesses across this country. However, we will be unable to provide such information before the current deadline. In light of the FDA’s admittance in its Preliminary Regulatory Impact Analysis that the agency only expects, at most, 20 to 80 e-cigarette products to still be legally available on the market once the regulation is in full effect, it is critical that the agency has access to accurate and complete information about the effect of forcing the exit of so many companies and products from the market. [1]
If the FDA is unable to grant this extension for the general public, we request that the AVA be granted an extension of the same length requested above so that we have the opportunity to provide much-needed economic data to the agency.
We understand that the FDA is under a great deal of pressure to move forward with new e-cigarette regulations. Nonetheless, unless the FDA wishes to hand over the e-cigarette market to large cigarette companies, it must take additional time to receive and consider information with great relevance to public health and the economy.
Sincerely,
Gregory J. Conley, JD, MBA
President – American Vaping Association
[1] A recent study estimated that as of January 2014, 466 e-cigarette brands and more than 7,700 e-cigarette flavors were available for purchase online. See Zhu S-H, et al. Four hundred sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco Control. Published online ahead of print on June 17, 2014.
For regulatory purposes, each flavor in each individual nicotine concentration, bottle size, vegetable glycerin – propylene glycol ratio, etc. is considered a separate product (and therefore would require a separate premarket tobacco application). Therefore, the actual number of e-cigarette products that the FDA is assuming it will remove from the market is actually in the tens of thousands.
