FDA Finalizes Enforcement Guidance on ENDS

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The FDA has finalized its enforcement guidance for the policy regarding flavored e-cigarettes and other electronic nicotine delivery systems (ENDS).

Following months of consideration by the Trump Administration, the FDA has released final guidance on its enforcement policy regarding flavored e-cigarettes and other electronic nicotine delivery systems (ENDS).

Previously: FDA Finds Flavored E-Cigs in Poor Taste

Rather than imposing a “ban” on flavors in ENDS products, the FDA will target enforcement against manufacturers of flavored cartridge-based ENDS products, except tobacco- and menthol-flavored ENDS, if they haven’t received FDA approval to market/sell those products.

Manufacturers wishing to market ENDS products, including all e-cigarettes and e-liquids, are required by law to submit a premarket application and demonstrate that the product meets applicable statutory standards for marketing authorization.

The FDA's updated enforcement policy also addresses the agency's intention to continue prioritizing enforcement against ENDS product manufacturers that fail to take adequate measures to prevent access to minors, as well as against manufacturers whose ENDS products are targeted to minors/whose marketing is likely to promote use by minors.

FEMA recently updated its publicly available statement, Safety Assessment and Regulatory Authority to Use Flavors: Focus on Vaping Products, which was first published in 2013. The company will work to update the statement to reflect FDA's most recent regulatory action.

FDA's guidance states that:

Within 30 days of publication of the final guidance release date (1 February 2020), flavored cartridge-based e-cigarette and ENDS products, except for tobacco- or menthol-flavored products, will be subject to prioritized enforcement. Importantly, FDA is limiting the prioritized enforcement to cartridge-based products, which are those enclosed units sold as cartridges or pods and designed to fit within or operate as a part of an electronic nicotine delivery system and not to open tank-based ENDS products which are typically larger systems sold at retail vape shops and may be customized by consumers.

Manufacturers of all ENDS products must submit premarket applications to FDA by May 12, 2020. The agency intends to prioritize enforcement actions against manufacturers of any ENDS product that is offered for sale after May 12, 2020 for which the agency has not received a premarket application.