FDA Issues Decisions on Electronic Cigarette Products
This week, the U.S. Food and Drug Administration took a series of actions as part of its work to ensure any electronic nicotine delivery system (ENDS) products available on the market have demonstrated that marketing of the products is appropriate for the protection of public health.
The FDA authorized several tobacco-flavored ENDS products from Logic Technology Development, LLC, after concluding that the likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs risk to youth, provided that the company follows post-marketing requirements to reduce youth access and exposure to marketing. The FDA also issued marketing denial orders to Logic for multiple other ENDS products. Denied products currently on the market must be removed or the FDA may take enforcement action.
The FDA has taken action on approximately 99 percent of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than one million ENDS products. Of additional note, the FDA is close to making additional decisions on applications for popular ENDS products that account for a large part of the market. The continued marketing of these products, according to the FDA, has the potential to have a substantial public health impact, either positively or negatively, as they hold an overall large market share and are used by a significant amount of people.
Additional information from the FDA is available here.