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: