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FDA Releases Compliance Proposal; Flavor Premarket Application Date Moved Up to 2021

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Since soon-to-be-former Food and Drug Administration Commissioner Scott Gottlieb’s resignation announcement, the organization has had a busy couple of weeks. The most recent announcement came mid-March, when the FDA released its proposal: Modifications to Compliance Policy for Certain Deemed Tobacco Products. The main points of the proposal are that anyone under 18 is banned from brick-and-mortar shops or the shop owners must keep vaping devices and e-liquids in separate rooms not accessible to those under 18. Online sellers must use pre-approved age-verification steps. The proposal is not outright banning flavors — yet. The draft would require manufacturers of flavored e-liquids (mint, tobacco and menthol would be exempt) to submit their premarket applications by Aug. 8, 2021. This is a year earlier than the previous deeming regulation date. (See below for Gottlieb’s latest crusade against flavors.) Axios.com predicts that convenience stores will be the first to challenge the FDA’s legal authority in this space.

The FDA told CNBC that the premarket change “would likely remove some flavored e-cigarettes and cigars from stores.” The organization is also seeking to limit sales of flavored nicotine pods online and within vape shops.

Axios.com broke down Gottlieb’s proposal to senior White House staff to ban sale of flavored e-cigarettes in convenience stores. Earlier in March right after his resignation announcement, he met personality with officials from the Domestic Policy Council, the White House counsel's office and the National Economic Council. Gottlieb’s proposal states:

  • If a store wants to sell flavored e-cigarettes (tobacco, mint, menthol excluded), it has to ask people for the ID cards before they enter the store. So, as stated above, convenience stores like gas stations would have to find a separate room to sell vaping products and have a door person to card.

The White House is the final say before this policy could pass. This is, of course, a proposal, so the public now has 30 days to make comment on the draft released March 14.