Health

FDA issues first-ever warning for flavored nicotine gummies



The Food and Drug Administration has issued an official warning against a company that makes and sells flavored nicotine gummies without proper authorization, saying it’s potentially harmful for children.

In the warning letter, the FDA told VPR Brands, doing business as Krave Nic, that “you manufacture and offer for sale or distribution to customers in the United States nicotine gummy products without a marketing authorization order.”

The FDA was particularly concerned about how flavored gummies, not dissimilar to fruit candies, could sell nicotine to children. The gummies come in pineapple, cherry, and blue raspberry flavors.

The company’s website now says the gummies are discontinued, while another site used for the company’s vape pens, kraveit.com, shows the gummies on the front page but has no product pages for them.

“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. We want parents to be aware of … toxicity to young children and the appeal of these addictive products to our youth,” FDA Commissioner Robert Califf said in an agency press release.

Tobacco products introduced to the U.S. market after Feb. 15, 2007, must receive an authorization from the FDA to market their products.

On March 15, President Biden signed legislation expanding the definition of tobacco products to include synthetic nicotine, which is used to make nicotine gummies.

Each tin contains 12 gummies, and each gummy contains approximately 12 milligrams of nicotine. Krave Nic sold the gummy tins in increments of 6, 12, 18, and 24.

“FDA has not received an application from your firm requesting marketing authorization for the products listed in this Warning Letter.  These products… are adulterated and misbranded and are subject to enforcement action at FDA’s discretion,” the agency wrote further in its warning letter.

The FDA aims to “curb all unlawful marketing of tobacco products, especially those that youth could easily confuse with something that they consume regularly – like candy,” said Brian King, Director of the FDA Center for Tobacco Products, in the press release.

Advocates for smoking alternatives, which can include synthetic nicotine products like vapes and gummies, decried the FDA move and pointed out the higher potency of approved products like Nicorette.





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