FDA Finalizes Enforcement Policy on Flavored Cartridge-Based E-Cigs

FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-Based E-Cigarettes

The U.S. Food and Drug Administration (FDA) is kicking off the new year much as it did in the previous year–setting its agenda that puts e-cigarettes in its crosshairs. The FDA has issued a policy prioritizing its enforcement against certain unauthorized flavored e-cigarette products that it believes appeals to kids, including fruit and mint flavors. Under the new policy, companies that don’t stop manufacturing or distributing these unauthorized flavored cartridge-based e0cigarettes within 30 days will face the risk of FDA enforcement actions.

In a press release, HHS Secretary Alex Azar used the same terminology as former FDA commissioner Scott Gottlieb to describe the rise of e-cigarettes and vaping among teens, referring to it as an “epidemic.” Azar want on to say that the HHS is taking a comprehensive, aggressive approach to enforcing the law that was passed by Congress which states that due to the Deeming Rule, no e-cigarette that is currently on the market is being marketed and distributed legally. The agency is prioritizing the enforcement against e-cigarettes due to their popular among children and teens but will allow for some e-cigarette products–menthol and tobacco flavored–to remain on the market for adults seeking an alternative to traditional combustible tobacco products. The agency will continue to monitor the situation and is prepared to take further actions as necessary, Azar adds.

“Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery,” adds Stephen M. Hahn, M.D., FDA Commissioner. “While we expect that responsible members of industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”

Beginning 30 days from the publication of this notice, which was issued on Jan. 2, 2020, the FDA intends to prioritize the enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:

Any flavored, cartridge-based ENDS product (other than tobacco- or menthol-flavored ENDS product
All other ENDS products for which the manufacturer has failed to take (or is tailing to take) adequate measures to prevent minors’ access; and
Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors

Due to the low numbers youth using both menthol- and tobacco-flavored, cartridge-based ENDS products, the FDA opted not to include these in its enforcement priorities. However, the FDA has said that it will take additional actions against these products should youth be found to begin using these products in higher numbers. The FDA will also be prioritizing enforcement with respect to any ENDS products that are targeted to youth or likely to promote use of ENDS by youth, including products marketed with labeling and/or advertising that resemble kid-friendly foods and drinks such as juice boxes or kid-friendly cereal. Also, the FDA will be enforcing its policies against ENDS products that are marketed directly to minors by promoting ease of concealing the product or disguising it as another product and products that are marketed with characters designed to appeal to youth.

The FDA is quick to point out that its FDA’s enforcement is nota ban on flavored or cartridge-based ENDS. The FDA is currently reviewing several premarket applications for flavored ENDS products including flavored e-cigarettes and e-liquids. If a company that demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including how its marketing may affect youth initiation and use, the FDA could authorize the product for sale. After May 12, 2020, the FDA will also prioritize enforcement against any ENDS products that continue to be sold without the manufacturer having submitted a premarket application. If a premarket application is submitted by May 12, 2020, the FDA intended to continue to exercise enforcement discretion for up to one year pending FDA review of applications, unless there is a negative action by the FDA on such application or the product is authorized to be marketed by the FDA. The May 12, 2020 Substantial Equivalence (SE) process applies to all covered tobacco products, including premium cigars, pipe tobacco, hookah and e-cigarette and vapor products.

You can read the FDA’s full press release here. For all the latest legislation and FDA news impacting the tobacco industry, click here.