That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. Under the Premarket Tobacco Product Application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.” The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine. “As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M.

The continued marketing of these products 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 lot of people. The agency is close to making additional decisions on applications for popular ENDS products that account for a large part of the market.The FDA has taken action on approximately 99% of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products.Applications for Logic’s additional products, including menthol, remain under FDA review. Retailers should contact Logic with any questions about products in their inventory. Any of those products currently on the market must be removed or FDA may take enforcement action. The agency also issued marketing denial orders to Logic for multiple other ENDS products.Those who do not use tobacco products shouldn’t start.

While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they “FDA approved.” All tobacco products are harmful and potentially addictive.

These products were authorized after the agency’s review of the product applications concluded, among other things, that the likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.

The FDA authorized several tobacco-flavored ENDS products from Logic Technology Development LLC (Logic) under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.

Food and Drug Administration took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.

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