The Food and Drug Administration (FDA) sent a warning letter to the manufacturer of nicotine-flavored gummy products because it does not have authorization to manufacture, sell or distribute the products in the U.S.
The FDA cited public concern because the gummies resemble “kid-friendly food or candy products” and have the potential to cause severe nicotine toxicity or death among young children. This is the first time the FDA has issued a warning letter for this type of product.
The letter was sent Thursday to VPR Brands, LP (doing business as Krave Nic), which markets gummies in three flavors — blueraz, cherry bomb and pineapple. The packaging says the products contain tobacco-free nicotine.
Nicotine is highly addictive, and exposure during adolescence can harm the developing brain.
“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 M. Califf, M.D., said in a statement. “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 manufacturer states each gummy contains 1 milligram (mg) of nicotine with 12 gummies per package. Research indicates ingesting 1-4 mg of nicotine could be toxic to a child under 6 years, depending on the child’s body weight. Nicotine toxicity among youths of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and death.
A study recently published in Pediatrics found flavored nontobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco product among youths in southern California — second only to e-cigarettes.
“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,” Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products, said in a statement.
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. Failure to correct violations could result in further action, such as civil penalties, seizure and/or injunction.