The U.S. Food and Drug Administration (FDA) has issued a warning letter to a company that is marketing flavored gummy candies infused with nicotine. The August 18 announcement detailed how VPR Brands LP and their brand name “Krave Nic” have created a product that could potentially create a health crisis among children.
In the warning letter to Krave Nic, which marks the first time that the FDA has taken action against nicotine gummies, the FDA cited a legislative amendment to the Federal Food, Drug, and Cosmetic Act to allow the agency to regulate products “containing nicotine from any source.”
The FDA took issue with the resemblance of Krave Nic’s gummy products to candy and food products marketed to children. This resemblance, the FDA argued, could lead to children developing severe nicotine toxicity or death if they confused Krave Nic’s gummies for actual candy.
The products that the FDA is targeting are the one-milligram nicotine gummies with flavors of “Blueraz, Cherry Bomb and Pineapple.” According to VPR Brands LP packaging, the products are advertised as containing tobacco-free nicotine. The company has not submitted a premarket tobacco product application to the FDA and subsequently has not received any approval for these products, nor does it have a marketing authorization order to manufacture, sell or distribute the named products in the United States.
The FDA stated that ingesting one to four milligrams of nicotine can be severely toxic to children under the age of six. Additionally, nicotine toxicity can cause a number of negative symptoms even, in adults, including:
- Abdominal pain
- Elevated heart rate
- Increased blood pressure
- Respiratory failure
In addition to increasing the risk of complications, these nicotine gummies can cause harm to children’s mental development. Additionally, nicotine is a highly addictive substance that can lead to a transition to other nicotine-rich products like cigarettes, e-cigarettes, or cigars.
Supporting this theory is a 2022 study in the American Academy of Pediatrics which found that flavored non-tobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco product among youth in Southern California with particularly high rates of usage among minorities.
FDA Commissioner, Dr. Robert M. Califf M.D., stated, “Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth.”
Dr. Califf took note of the potential toxicity of these products, the need for parental awareness, and the FDA’s commitment to combat illegal nicotine products in the marketplace.