This month, Brownson • Norby, PLLC’s Regulatory Practice Group submitted two comments relative to FDA’s regulation Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 21 CFR Parts 1100, 1140, 1143 (“Deeming Rule”).
The first comment, submitted on December 7, 2017, concerned the efficacy of the Deeming Rule in light of Executive Orders 13771 and 13777, which related to the administration’s regulatory reform agenda. Highlighting the compliance challenges presented to the industry, which resulted in significant inefficiencies, we outlined a proposed course of action to revise the Deeming Rule to better serve the public health goals. For example, several challenges stem from Deeming Rule definitions like “tobacco products,” a term which encompasses products that contain no tobacco. As a result of this definitional scheme, under the Deeming Rule, products containing no tobacco or nicotine must still bear a warning label stating the product either contains tobacco or nicotine. In addition, the Deeming Rule requires ingredient listings for all “tobacco products”, which includes the components and parts of such products. Consequently, under the Deeming Rule, manufacturers must submit “ingredient” breakdowns for bottle stoppers, electrode rings, silicone caps, etc. The result of this one definitional issue is significant inefficiencies and expense, without a benefit to public health. We are hopeful that this comment will encourage FDA to revise the Deeming Rule to more accurately reflect the novelty of electronic nicotine delivery systems (“ENDS”). A copy of the December 7, 2017 Comment (FDA-2017-N-5095-0015) is available here: 12-7-2017 Comment to FDA.
The second comment, submitted on December 21, 2017, was in response to FDA’s request for comments on proposed good manufacturing practices (“GMPs”) to account for ENDS products set forth in a June 7, 2017 letter from the Global Vapor Standards Association. Briefly, the June 7, 2017 proposed supplements and revisions to proposed standards submitted by the traditional tobacco community in 2012. Our comment supports the general position of the June 7, 2017 proposal that “tobacco product” GMPs must be broad enough to apply to the diverse spectrum of “tobacco products” but must also reflect the distinction between ENDS products and traditional tobacco products. In addition, we further recommended FDA engage further with ENDS manufacturing associations like the Global Vapor Standards Association, and the American E-Liquid Manufacturing Standards Association, to better inform the rule and standards-making process. A copy of the December 21, 2017 Comment is available here: 12-21-2017 Comment to FDA.
We are encouraged by FDA’s continued involvement of the industry in the rule and standard-making process and look forward to further discourse to develop well-suited rules and regulations for the ENDS industry.