SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has authorized several tobacco-flavored electronic nicotine delivery system (ENDS) products from Logic Technology Development LLC, Pompano Beach, Fla., under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
After a review of the product applications, the FDA concluded 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 the FDA’s action permits these specific products to be sold in the United States, it does not mean these products are safe or that they are “FDA approved,” the agency said.
The agency also issued marketing denial orders to Logic for other ENDS products. Any of those products currently on the market must be removed or the FDA may take enforcement action. Applications for Logic’s additional products, including menthol, remain under review, said the agency.
Under the premarket tobacco product application (PMTA) pathway, manufacturers or importers must demonstrate to the FDA, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the agency to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely effect of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
The FDA’s review of Logic’s applications for the products it has currently authorized determined that the marketing of the tobacco-flavored products and associated components is appropriate for the protection of the public health. The FDA authorized these tobacco-flavored ENDS products because, among several key considerations, the data submitted by the company and the available evidence show that marketing these products may help addicted adult smokers transition away from combusted cigarettes and reduce their risk of exposure to harmful and potentially harmful toxins compared to combusted cigarettes. At the same time, the data showed there was low risk for non-users, including youth, to use the products. The risk was also low for non-users, including youth, to progress to regular use of the products.
Specifically, available data showed that current tobacco users who used these tobacco-flavored products were more likely to significantly decrease their use of combusted cigarettes and that those who don’t smoke are unlikely to start using these products. Most study subjects decreased the number of combusted cigarettes they smoked each day by greater than 80%, from an average of 13-16 cigarettes per day at screening to 1-2 by day 59. The data also showed that the products produce fewer or lower levels of some toxins, like carbon monoxide, than combustible cigarettes and the products’ abuse liability or their ability to encourage continued tobacco use, addiction or dependence was lower than combusted cigarettes.
Additionally, the current authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA will closely monitor how Logic markets these ENDS products and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, the agency said. The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons, including if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
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, it said.
The agency said it 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,” said the FDA.
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