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. 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.
While these actions permit 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. Those who do not use tobacco products shouldn’t start.
FDA also issued marketing denial orders to Logic for multiple other ENDS products. Any of those products currently on the market must be removed or FDA may take enforcement action. Retailers should contact Logic with any questions about products in their inventory. Applications for Logic’s additional products remain under FDA review.
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.
The agency 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 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.