The Food and Drug Administration warned Amarillo Snuff Co. for selling unauthorized smokeless nicotine products, including products made with corn husks instead of tobacco leaves.
The unauthorized products contain non-tobacco nicotine and fall under the FDA’s authority to regulate all tobacco products containing nicotine from any source, the agency said Friday.
The FDA said in its letter to the Amarillo, Texas-based company that unauthorized smokeless nicotine products on Amarillo Snuff Co.’s website included Lemon Zest, Wintergreen and Vanilla. The company sells tobacco-free snuff and nicotine pouches, according to its website.
“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 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.”
In March 2022, President Joe Biden granted the FDA authority over tobacco products containing synthetic nicotine.
Manufacturers of these products needed to submit a premarket tobacco product application (PMTA) to remain on the market, pending FDA authorization. The agency said in July it was processing more than 1 million applications for non-tobacco nicotine products submitted by the deadline, but as of yet, it has not granted any authorization. Therefore, all non-tobacco nicotine products on the market are illegal, the agency said.
Warning letter recipients have 15 working days to respond with the 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, the FDA said.
As of July 28, the FDA has issued nearly 600 warning letters to manufacturers of unauthorized tobacco products, with more than 100 of those being for non-tobacco nicotine products. It has issued more than 2,800 warning letters and 825 civil money penalties among retailers for sales of e-cigarette products to underage purchasers.
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