The Food and Drug Administration on Wednesday warned eight retailers for selling unauthorized tobacco products, including nicotine pouches and dissolvable tobacco products. The FDA said the products cited in the warning letters are advertised as having a variety of designs and functions that cause the products to imitate candy, breath strips and cough drops.
“No tobacco product should look like candy—it’s a blatant ploy to target children and mask the true nature of these products,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP). “FDA and its partners are committed to implementing an aggressive enforcement strategy to stop illegal products like these from ending up on shelves or in the hands of kids.”
The agency said the tobacco products lack FDA authorization and are in violation of the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products, including cigarettes, electronic cigarettes, cigars and hookah tobacco. The designs of the unauthorized products appeal to youth because they may help conceal the nature of the products as tobacco products from parents, teachers or other adults, the agency said.
The retailers were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law, the FDA said.
Failure to do so could result in additional FDA action such as injunctions, seizure or civil money penalties.
To date, the FDA has issued more than 800 warning letters to companies for manufacturing or distributing unauthorized new tobacco products. It has also issued more than 1,000 warning letters to retailers for the sale of unauthorized tobacco products.
On May 8, the FDA issued a new guidance document that outlines the agency’s current approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products that do not have premarket authorization.
The agency said enforcement would apply to products with certain presumptively underage-appealing elements such as depicting a cartoon-like fictional character; disguising its nature as a vaping product; or resembling a children’s toy, phone or gaming platform.
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