WASHINGTON, D.C. — The U.S. Food and Drug Administration issued warning letters to eight retailers accused of selling unauthorized nicotine pouches and dissolvable tobacco products designed to resemble candy, cough drops, and breath strips, escalating federal enforcement against tobacco products regulators say could appeal to children.
The agency said the products lacked required FDA authorization and violated the Federal Food, Drug, and Cosmetic Act.
According to the FDA, regulators are increasingly focused on tobacco and nicotine products that mimic common consumer items because of concerns they could both attract minors and increase the risk of accidental ingestion by young children.
“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.
The warning letters direct the retailers to address both the cited violations and any similar compliance issues involving unauthorized tobacco products. The FDA said companies that fail to correct violations could face seizures, injunctions, or civil monetary penalties.
The enforcement action follows recent FDA guidance outlining priorities for unauthorized electronic nicotine delivery systems and nicotine pouch products that have not completed federal premarket review.
Federal regulators argue such products undermine the agency’s tobacco oversight framework because they may contain ingredients or chemical compositions that have not undergone scientific evaluation.
The latest action forms part of a broader FDA crackdown on unauthorized nicotine and tobacco products marketed in ways regulators believe could appeal to younger consumers.
The agency said it has issued more than 800 warning letters to manufacturers, distributors, and sellers of unauthorized tobacco products, along with more than 1,000 warning letters to retailers accused of selling unauthorized nicotine products.
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