The U.S. Food and Drug Administration sent a warning letter to Amarillo Snuff Co. on Aug. 11, 2023, for manufacturing, selling and/or distributing unauthorized smokeless nicotine products, including products that are made with corn husks instead of tobacco leaves, according to an FDA release.
The unauthorized products contain nontobacco nicotine, which falls under the FDA’s regulation authority.
“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, director of the FDA’s Center for Tobacco Products (CTP). “Our authority over these products is clear, and FDA is committed to holding those responsible for illegal products accountable for their actions.”
The cited products lack FDA marketing authorization. To date, the FDA has not authorized any nontobacco nicotine products.
After receiving a warning letter, recipients have 15 working days to respond with steps they will take to correct and prevent future violations; failure to promptly correct violations can result in additional FDA actions such as 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 the CTP’s Office of Compliance and Enforcement. “FDA continues to bring enforcement actions, including injunctions and civil money penalties, as appropriate.”
As of July 28, 2023, the FDA has issued about 600 warning letters to manufacturers of unauthorized tobacco products, with 100 of the letters being for unauthorized nontobacco nicotine products. As of June 30, 2023, the FDA has issued more than 2,800 warning letters and 825 civil money penalties for sales of e-cigarettes to underage purchasers, with over 1,000 warning letters and more than 140 civil money penalties relating to sales violations of nontobacco nicotine products to underage consumers.