On August 11, 2023, FDA issued a warning letter to Amarillo Snuff Co. for manufacturing, selling, and/or distributing unauthorized smokeless nicotine products, including products that are made with corn husks instead of tobacco leaves. The unauthorized products contain non-tobacco nicotine and thus fall under FDA's authority to regulate all tobacco products containing nicotine from any source.
“Last year, Congress clarified FDA’s authority to regulate tobacco products containing nicotine from any source, which closed a loophole that several companies were using to try to evade regulation,” said Brian King, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “Our authority over these products is clear, and FDA is committed to holding those responsible for illegal products accountable for their actions.”
The products cited in the warning letter lack marketing authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic Act in order to legally market a new tobacco product. To date, FDA has not authorized any non-tobacco nicotine products. Therefore, all non-tobacco nicotine products on the market are marketed unlawfully.
FDA generally sends warning letters the first time an investigation or inspection reveals a violation. To achieve voluntary compliance, warning letter recipients have 15 working days to respond with the steps they will take to correct and prevent future violations. However, failure to promptly correct the violations can result in additional FDA actions, such as an injunction, seizure, and/or civil money penalties.
“A majority of firms that receive warning letters correct their violations, but if they fail to do so, the products are subject to enforcement,” said Ann Simoneau, Director of CTP’s Office of Compliance and Enforcement. “FDA continues to bring enforcement actions, including injunctions and civil money penalties, as appropriate.”
Today’s warning letter is the latest in FDA’s crackdown to curb the marketing of unauthorized non-tobacco nicotine products across the tobacco product supply chain. As of July 28, 2023, FDA has issued nearly 600 warning letters to manufacturers of unauthorized tobacco products, with more than 100 of these warning letters being for unauthorized non-tobacco nicotine products. Among retailers, as of June 30, 2023, FDA has issued more than 2,800 warning letters and 825 civil money penalties for sales of e-cigarette products to underage purchasers, including more than 1,000 warning letters and more than 140 civil money penalties for violations in relation to their sale of non-tobacco nicotine products to underage purchasers.