FDA Issues Warning to Maker of Illegal Nicotine Gummies

FRIDAY, Aug. 19, 2022 (HealthDay News) — The U.S. Food and Drug Administration on Thursday warned a maker of nicotine gummies to stop marketing what is an illegal product.

In what is a first-of-its-kind warning, the agency said it considers these gummies particularly concerning because they resemble candy and can cause severe nicotine toxicity or death if young children eat 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,” FDA Commissioner Robert Califf, M.D., said in an agency news release. “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.”

The gummies in question are made by VPR Brands LP and have 1 mg of nicotine in each gummy. They have been sold in three flavors — Blueraz, Cherry Bomb, and Pineapple. The packaging claims the products contain tobacco-free nicotine, but the company does not have a marketing authorization order to sell or distribute such a product in the United States, the FDA said. As of Friday morning, the company’s website said the gummies have been discontinued.

A new federal law that went into effect in April gave the FDA authority over products with nontobacco nicotine, including synthetic nicotine. The new law was a response to an increase in the use of nontobacco nicotine products, including electronic cigarettes, among youths. No nontobacco nicotine product has been granted a marketing order from the FDA.

In a statement about the warning, the FDA cited a recent study published in the journal Pediatrics in which researchers found that flavored nontobacco oral nicotine products were among the most commonly used tobacco-type product for youth. The products are considered a risk because they can be easily concealed by teens from adults and have flavors that appeal to youth.