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 Dr. Robert Califf said in an agency news release on the warning. "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 (kravenic.com) and have 1 milligram (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 non-tobacco nicotine, including synthetic nicotine. The new law was a response to an increase in the use of non-tobacco nicotine products, including e-cigarettes, among youths. No non-tobacco nicotine product has been granted a marketing order from the FDA.
"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 wake-up call for manufacturers of these illegal products that the FDA is actively working to identify violations and to swiftly seek corrective actions."
In a statement about the warning, the FDA cited a recent study published in the journal Pediatrics in which researchers found that flavored non-tobacco 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.
Nicotine is both highly addictive and dangerous for kids. It can harm the developing brain during adolescence, and can cause nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. Ingesting even small quantities can be severely toxic to a child younger than 6, the FDA said.
In its warning letter, the FDA tells the company that it must tell the agency how it plans to address any violations and bring products into compliance with the Federal Food, Drug, and Cosmetic Act. The company could face fines, seizure or injunction if it does correct violations within 15 days, the agency said.
The FDA provides both regulatory oversight of tobacco products, mass media tobacco prevention campaigns aimed at kids and collaborates with the U.S. Centers for Disease Control and Prevention on the National Youth Tobacco Survey,
The American Lung Association has more on nicotine sickness.
SOURCE: U.S. Food and Drug Administration, news release, Aug. 18, 2022