FDA Warns Texas Company Over Illegal Sale of Nontobacco Nicotine Products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued a warning to Amarillo Snuff Co. for selling a nontobacco nicotine products without its authorization.

The agency sent a letter to the Amarillo, Texas-based company on Aug. 11 calling out the sale of smokeless nicotine products, including products that are made with corn husks instead of tobacco leaves, without marketing authorization from the FDA, which is required under the Federal Food, Drug, and Cosmetic Act.

"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 (CTP). "Our authority over these products is clear, and FDA is committed to holding those responsible for illegal products accountable for their actions." 

[Read more: FDA's Regulatory Scope Expands to Include Synthetic Nicotine]

According to the FDA, the agency generally sends warning letters the first time an investigation or inspection reveals a violation. Amarillo Snuff Co. has 15 working days to respond with the steps it will take to correct and prevent future violations.

Failure to promptly correct the violations can result in additional FDA actions, such as an injunction, seizure, and/or civil money penalties, the agency added.

"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."  

This is just the latest move in the FDA's crackdown on the sale of unauthorized nontobacco nicotine products. As of July 28, the agency has issued nearly 600 warning letters to manufacturers of unauthorized tobacco products, with more than 100 of these warning letters being for unauthorized nontobacco nicotine products. Among retailers, as of June 30, the FDA has issued more than 2,800 warning letters and 825 civil money penalties for sales of electronic 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 nontobacco nicotine products to underage purchasers.