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FDA issues warning against manufacturer of 'nicotine gummies'

Agency says gummies pose risk of severe illness, death to children.

Published: August 19, 2022 4:38pm

Updated: August 19, 2022 4:49pm

The U.S. Food and Drug Administration this week issued a stark warning against a U.S. manufacturer of nicotine-infused gummy candies, claiming that the products pose a significant health risk to children who may consume them. 

The FDA told Florida-based Krave Nic in a warning letter that it had determined the company was "manufactur[ing] and offer[ing] for sale or distribution to customers in the United States nicotine gummy products without a marketing authorization order," specifically the nicotine gummies.

"[T]hese products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and are intended for human consumption," the FDA said in a press release

The FDA told Krave Nic that a failure to address the allegations "may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction."

Krave Nic says on its website that it seeks through its products to "empower adult smokers with the tools to use nicotine on their own terms."

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