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On January 15, 2021, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S. The firms did not submit a Premarket Tobacco Product Application (PMTA) by the Sept. 9, 2020 deadline.
This is the first set of warning letters being issued to firms who have not submitted PMTAs to the FDA and are continuing to sell or distribute unauthorized ENDS.
(Have you received a Warning Letter? Read our article "Responding to a Warning Letter in 5 Steps here)
Applications for premarket review of certain deemed new tobacco products that were on the market in the United States as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review. The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.
The director of FDA's Center for Tobacco Products, Mitch Zeller, J.D., stated, “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law.”
While each warning letter issued cites specific products as examples, collectively these companies have listed a combined total of over 100,000 products with the FDA. Companies must ensure all of their products comply with federal rules and regulations—including the premarket review requirement.
The FDA’s review of the companies’ websites revealed that each firm is manufacturing and selling or distributing unauthorized new tobacco products. Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated and misbranded and may not be marketed without FDA authorization as per the agency’s stated enforcement priorities.
The FDA has requested responses from each firm within 15 working days of receiving the letter detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to address any violations may lead to regulatory action such as a civil money penalty complaint, seizure and/or injunction. In addition, products that appear to be misbranded or adulterated that are offered for import into the U.S. may be detained or refused admission.
Premarket applications for tobacco products must demonstrate the products meet the applicable statutory criteria for receiving marketing authorization, such as whether marketing the product is appropriate for the protection of the public health. In such cases, the FDA may assess, among other things, how particular e-cigarettes or other ENDS may have the potential to help addicted adult smokers seeking to transition away from cigarettes, while also weighing the concerning use of these products by young people.
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