Bryan Haynes of the Troutman Sanders Tobacco Team will be at the Food and Drug Law Institute Enforcement Conference on December 12-13, 2018 in Washington, DC. Of note, both FDA Commissioner Scott Gottlieb and FDA Center for Tobacco Products Director of the Office of Compliance and Enforcement Ann Simoneau will be presenting at the conference. Perhaps the FDA will elaborate on its recently-announced policy changes with the stated intention of deterring youth access to flavored tobacco products.
These policy changes reflect a multi-faceted approach on flavored products, and include the Agency's stated intention to issue proposed rules banning sales of menthol cigarettes and flavored cigars, while also restricting access to flavored electronic nicotine delivery systems (ENDS) in certain locations. With its revised policy, the Agency stopped short of a ban on flavored e-cigarettes by stating that it would make flavored ENDS subject to a revised Premarket Tobacco Product Application (PMTA) deadline. In other words, the FDA indicated that it intends to change the PMTA deadline earlier than the current August 8, 2022 deadline for ENDS products on the market as of August 8, 2016. Under the FDA's revised policy, all flavored ENDS products (other than tobacco, mint, and menthol flavors or non-flavored products) must be sold at retail in age-restricted venues, and, if sold online, under heightened practices for age verification. The FDA states it will be working to identify these tighter measures for age verification to prevent youth access via online sales, and that the Agency plans to issue "best practices" for industry soon, likely in the form of draft guidance. The result is that flavored ENDS products would not be available in retail locations where people under the age of 18 are permitted (with the exception of tobacco, mint and menthol flavored ENDS).
As for the restriction of minors at retail locations, the FDA has not yet provided detailed guidance on what age verification activities must be undertaken at the physical location to adequately prevent minors from entering. This also raises other issues that would need to be addressed down the road. For instance, if a minor provides a false ID and illegally enters the store to purchase a flavored ENDS, who is liable? Would FDA pursue enforcement action against both the retailer and the tobacco product manufacturer?
The FDA also plans to advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, presumably including cigarettes, cigars and traditional pipe tobacco, as would be informed by the comments on the FDA's Advanced Notice of Proposed Rulemaking (ANPRM). The FDA is also apparently going to propose a rule to ban flavors in cigars. It is not clear whether the policy would ban only "characterizing flavors" (as is the case with cigarettes) or whether it would ban all flavor additives in cigars. Finally, the FDA states that it will continue to aggressively pursue enforcement action against ENDS products that are asserted to be marketed or appealing to children. The FDA states that it intends to issue guidance shortly that provides additional details, including what the agency might consider an “age-restricted” location, what it might consider “heightened” age-verification online, and timelines for when FDA intends to implement these policies and to issue proposed rules.
We will report back on any new developments or announcements from the conference.
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