FDA issues warning letter to emerging tobacco company over production and sale of synthetic nicotine

On August 11, 2023, the FDA issued a warning letter to emerging tobacco product manufacturer Amarillo Snuff Company for manufacturing, selling, and distributing unauthorized non-tobacco (synthetic nicotine) products, including products made with corn husks instead of tobacco leaves. These products contain non-tobacco nicotine and therefore fall under the FDA’s regulatory authority.

Brian King, Ph.D., Director of the FDA’s Center for Tobacco Products, said: “Last year, Congress clarified the FDA’s authority to regulate tobacco products containing nicotine from any source, closing a loophole some companies tried to use to evade regulation. Our authority over these products is clear, and the FDA is committed to holding those responsible for illegal products accountable.”

According to the FDA press release, the snuff products mentioned in the warning letter lack FDA marketing authorization, which is required under the Federal Food, Drug, and Cosmetic Act for the lawful sale of new tobacco products. To date, the FDA has not authorized any non-tobacco nicotine products. Therefore, all non-tobacco nicotine products currently on the market are being sold illegally.

The FDA typically sends a warning letter when violations are first identified during an investigation or inspection. To encourage voluntary compliance, recipients of warning letters have 15 working days to respond with the steps they will take to correct the violations and prevent future ones. Failure to promptly correct violations may result in additional FDA action, such as injunctions, seizures, and/or civil money penalties.

“Most companies that receive warning letters correct their violations, but if they do not, these products will face enforcement action,” said Anne Simoncini, Director of the CTP Office of Compliance and Enforcement. “The FDA will continue to take enforcement action as appropriate, including injunctions and civil money penalties.”

It is understood that as of July 28, 2023, the FDA had issued nearly 600 warning letters to manufacturers of unauthorized tobacco products, including more than 100 warning letters related to unauthorized non-tobacco nicotine products. On the retail side, as of June 30, 2023, the FDA had issued more than 2,800 warning letters and 825 civil money penalties to retailers for selling vaping devices to minors.