WASHINGTON— Two convenience- and gasoline-retailing associations defended operators against proposals in the U.S. Food and Drug Administration’s (FDA) draft guidance document that could significantly curtail sales of flavored tobacco products within that retail segment, the two groups said in a joint press release.
NACS and SIGMA in early May jointly submitted formal comments on the FDA’s draft guidance regarding the sale of flavored (other than mint, menthol and tobacco) electronic cigarettes. They did so along with what they said were “hundreds of retailers” who also submitted remarks as that formal comment period closed last month.
In a letter addressed to Norman Sharpless, acting commissioner of the FDA, NACS and SIGMA said they share the FDA’s concern over the increased use of e-cigarettes by underage consumers; however, the groups pointed out that the draft guidance doesn’t address that concern but instead favors some retail outlets over others “in a way that is not consistent with the reality of the marketplace.”
In its draft guidance, the FDA proposed to focus its enforcement efforts in stores that allow minors to enter, essentially banning c-stores from selling most flavored e-cigarettes. Simultaneously, the FDA intends to allow stores that are adult-only (such as vape shops and tobacco shops) to continue selling the products.
The groups claim that the FDA has not provided data that supports making a distinction between adult-only and stores where minors can enter. In fact the two groups say that the draft guidance itself cites data showing that more teens acquire e-cigarettes from vape shops (14.8%) than from convenience stores (8.4%).
While the Tobacco Control Act gives the FDA the authority to regulate tobacco products, it also imposes limits on that authority, NACS and SIGMA officials said. For example, the Tobacco Control Acts states that the FDA cannot “prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets.”
The associations also said the FDA is circumventing the normal rulemaking processes required by law, and that the industry would need more time to comply with any final guidance if that document became formalized in the coming months.