The U.S. Food and Drug Administration (FDA) has issued warning letters to nine firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids. The move comes as they did not submit a premarket tobacco product application (PMTA) by the September 9, 2020 deadline.
Following a court order, the selling of these products, which lack premarket authorization, is considered illegal, and therefore they cannot be sold or distributed in the U.S.
The firms that received warning letters are The Mad Alchemist LLC, Austin Vapor, BloVape, Bombay Vapor LLC, Chief Vapor, American Legends E-Liquid, LLLP, Average Joes Juice LLC, Cloud Chasers Apothecary LLC, and Carolina Vapor Mill, LLC. These firms were selling the products through their websites.
They have collectively listed a combined total of over 100,000 products with the FDA. However, the warning letter cites specific products as examples.
The PMTA process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA, including the harms associated with tobacco use, especially for kids.
The agency now plans to post a list of products for which it has already received applications. For such firms or products, FDA generally intends to continue to defer enforcement for up to one year pending FDA review.
The FDA said it will continue to prioritize enforcement against companies that market ENDS, including e-cigarettes, without the required authorization or submission of PMTA.
The FDA states that 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.
The agency 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 and its plans for maintaining compliance.
The FDA warned that failure to address any violations may lead to regulatory action such as a civil money penalty complaint, seizure and/or injunction. The can also detain or refuse import of such products.
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