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Nicotine gummies could be toxic and even deadly if consumed by kids under 6, warn federal regulators, who call the fruit-flavored candies a “public health crisis just waiting to happen” among American youth as a new school year begins.

The Food and Drug Administration on Thursday issued a first-of-a-kind warning to one maker of nicotine gummies, calling the products particularly troublesome because they resemble kid-friendly food or candy and could potentially “cause severe nicotine toxicity or even death among young children.”

An FDA-funded study recently found nicotine candies to be the second-most popular tobacco product among high school students in Southern California, with e-cigarettes placing first. 

“Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” FDA Commissioner Robert Califf, M.D., stated. “We want parents to be aware of these products and the potential for health consequences for children of all ages – including toxicity to young children and appeal of these addictive products to our youth.”


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The agency won’t stand by as the “illegal products infiltrate the marketplace,” the commissioner added. 

The FDA’s warning letter was addressed to Fort Lauderdale, Florida-based VPR Brands, which had marketed its square-shaped gummies as made with “tobacco-free nicotine.” The vaping company and others in recent years have made the claim in reference to synthetic nicotine. 

The company had not received FDA authorization to market a tobacco product as legally required, the FDA said. 

Reached by telephone, a company employee declined to comment. However, the website devoted to its Krave nicotine gummies brand on Friday marked the product as discontinued. 

The company advertised its gummies as each containing 1 milligram of nicotine, or 12 milligrams for each tin. Ingesting 1 to 4 milligrams of nicotine is enough to be toxic for a child under 6, depending on weight, the FDA said. Further, nicotine is highly addictive and exposure to it during adolescence can harm the developing brain, the agency noted. 

The FDA in July unveiled plans to ban Juul e-cigarettes, but its order was postponed after the popular vaping company took the agency to court.

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