July 19, 2018
Via Electronic Submission (http://www.regulations.gov)
Division of Dockets Management (HFA-305) Food and Drug Administration
5630 Fishers Lane, RM. 1061
Rockville, Maryland 20852
Re: FDA Docket No. FDA-2017-N-6565; Regulation of Flavors in Tobacco Products; Joint Comment by the Smoke-Free Alternatives Trade Association and the American E-Liquid Manufacturing Standards Association
The Smoke-Free Alternatives Trade Association (SFATA) and the American E-Liquid Manufacturing Standards Association (AEMSA) appreciate this opportunity to respond to the Food and Drug Administration (FDA or Agency) request for comments on the Advanced Notice of Proposed Rulemaking (ANPRM) on the Regulation of Flavors in Tobacco Products (FDA Docket No. FDA-2017-N-6565).
Both SFATA and AEMSA support responsible, science-based and appropriately tailored regulations for Electronic Nicotine Delivery Systems (ENDS) based on the “continuum of risk” of nicotine products. As described herein, ENDS including e-liquids – all of which are flavored – are appropriate for the protection of the public health, as they are critical to reducing harm from combustible tobacco by helping cigarette smokers who are otherwise unwilling or unable to quit smoking transition permanently to less harmful sources of nicotine, such as non-combustible ENDS. The SFATA and AEMSA members, which include hundreds of small and large businesses across the United States, rely heavily on the sale of flavored e-liquids and ENDS products to adults; any ban or restriction of such products would likely result in these companies going out of business, and be severely detrimental to public health. We discuss our reasoning…
To read the full comment submission, please download the PDF available here:
AEMSA and SFATA Joint Comment – FDA-2017-N-6565