FDA Plans to Move Up Approval Enforcement Dates for Flavored e-Cigarettes, Cigars
The Food and Drug Administration intends to move up enforcement dates for new rules on e-cigarettes and flavored cigars in response to concerns about their use among minors, FDA said in a draft guidance issued March 13. Under the proposed policy, FDA would begin requiring pre-marketing approvals for certain e-cigarettes and flavored cigars before they are sold in the U.S., it said. The policy would take effect 30 days after the agency’s guidance is finalized. Comments on the policy are due April 15.
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FDA had been holding off enforcement of new product approval and annual registration requirements under its 2016 “deeming rule,” which brought cigars, electronic cigarettes, pipe tobacco and other tobacco products under the regulatory scheme that applies to cigarettes (see 1605050011). Under that rule, products that were not commercially marketed in the U.S. as of Feb. 15, 2007, are treated as new tobacco products that require pre-market approval.
But after extending those compliance dates multiple times, until 2022 for some requirements, FDA is now reversing course. For flavored electronic nicotine delivery systems (i.e., e-cigarettes) and flavored cigars, in particular, new data has “suggested an alarming increase in the use of ENDS products by middle and high school students,” FDA said in the draft guidance.
In response, FDA is now proposing to consider flavored ENDS (other than tobacco, mint or menthol-flavored) and flavored cigars to be new tobacco products if they were not marketed prior to Feb. 15, 2007, effective on Aug. 8, 2016, which was the original effective date of the deeming rule. “New tobacco products require premarket authorization before they can be legally marketed,” and “are legally required to be subject to an order authorizing their marketing,” FDA said.
FDA would not enforce the new requirements equally, however. Flavored ENDS products that are offered for sale in ways that pose a greater risk for minors to access them would be subject to enforcement immediately after the new policy takes effect. That includes products sold in places that minors can enter at any time, and products sold through retail establishments and online retailers that have sold to minors, FDA said.
Flavored ENDS products that don’t pose a particular risk for minors would become subject to FDA enforcement if they are unapproved and sold after Aug. 8, 2021, FDA said. FDA would lastly prioritize enforcement of “all ENDS products that are targeted to minors or likely to promote use of ENDS by minors.”
For flavored cigars, beginning 30 days after this guidance is finalized, FDA would prioritize enforcement for products on the market on Aug. 8, 2016, and that began to be sold after Feb. 15, 2007, FDA said. The enforcement policy would apply to all flavored cigars, including mint and menthol flavors.
FDA also considered moving up enforcement dates for waterpipe tobacco and mint and menthol flavored ENDS, but is not proposing to do so because of decreased risks for minors and, in the case of the ENDS, potential use by adults to quit smoking regular cigarettes, it said. “Other deemed products, such as pipe tobacco and dissolvables, do not appear to have wide-spread, significant youth use at this time, so FDA is not currently revisiting the compliance policy with respect to such products,” FDA said.
(Federal Register 03/14/19)