FDA Issues Rulings on E-Cigarette Products

The U.S. Food and Drug Administration (FDA) has issued an announcement regarding another batch of electronic nicotine delivery systems (ENDS), also known as e-cigarettes. The results of this batch were announced March 24 and authorized several tobacco-flavored e-cigarette products manufactured by Logic Technology Development, LLC. These approvals include products that are a part of the Logic Vapeleaf, Logic Power and Logic Pro brands, and include flavors and devices.

These products were authorized by the FDA for sale in the U.S. after reviewing the company’s product applications. The audit of the application concluded several points:

  • These products are likely to assist adult smokers looking to reduce or eliminate their combustible cigarette use.
  • The likely benefit for adult smokers who significantly reduce their cigarette use outweighs the risk of youth addiction.
  • Sale of this product, along with compliance with FDA marketing requirements, is not likely to increase youth nicotine addiction.

Along with their approval, the FDA provided Logic with a number of postmarketing requirements that the company must follow in order to reduce the access and exposure of young people to the company’s marketing.

The FDA also did not universally approve Logic’s e-cigarette products. The agency issued multiple marketing denial orders to Logic for a number of e-cigarette products. Logic must now remove all of those e-cigarette products from the market or the FDA may take enforcement action against them.

FDA Commissioner Robert M. Califf, M.D. spoke on the FDA’s continued efforts to move through the backlog of e-cigarette applications, stating, “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.”

Along with the commissioner’s words, the FDA noted that while their authorization allows these e-cigarettes to be sold in U.S. markets, “it does not mean these products are safe nor are they ‘FDA approved.’” The agency noted that any tobacco product is harmful and addictive, and people who don’t use tobacco products should not start.

The FDA’s final point on new smokers clarified the agency’s stance on e-cigarette approval. Commissioner Califf spoke about the balance between authorizing smoking cessation devices and risking new users by stating, “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. The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products.”

Applications for additional Logic products, including menthol flavorings, remain under FDA review. Flavored e-cigarettes have been a frequently-cited area of concern as a potential in-road for new e-cigarette users, particularly underage users.

The FDA noted in its announcement that it has taken action on approximately 99% of the nearly 6.7 million ENDS product applications submitted for premarket authorization. These actions have included denying over one million e-cigarette products.

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