SILVER SPRING, Md. — The U.S. Food and Drug Administration warned VPR Brands LP, doing business as Krave Nic, for marketing illegal flavored nicotine gummies. This is the first warning letter for this type of product, the agency said.
Krave Nic markets gummies with 1 milligram of nicotine each, available in flavors like Blueraz, Cherry Bomb and Pineapple. The packaging claims the products contain tobacco-free nicotine, but the firm has not submitted a premarket tobacco product application (PMTA) to the FDA and does not have authorization to sell these in the United States, the agency said.
“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,” said FDA Commissioner Robert Califf. “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 FDA will not stand by as illegal products infiltrate the marketplace.”
Ingesting 1 to 4 milligrams of nicotine could be severely toxic to a child under 6 years old, the FDA said, and nicotine toxicity among youth of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizers and more, including death. Nicotine is also highly addictive and exposure during adolescence can harm the developing brain, the agency said.
The warning letter requests a written response from the manufacturer describing how it intends to address any violations and bring its products into compliance with the Federal Food, Drug and Cosmetic Act.
In response to the increase of non-tobacco nicotine in tobacco products, Congress passed a federal law that took effect on April 14, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source.
“We remain unwavering in our use of compliance and enforcement resources 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’s Center for Tobacco Products. “Today’s action should be a wakeup call for manufacturers of these illegal products that the FDA is actively working to identify violations and to swiftly seek corrective actions.”
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