A warning letter has been issued by the Food and Drug Administration (FDA) to the manufacturer, VPR Brands LP, for marketing illegal flavored nicotine gummies.

The warning letter states that the manufacturer was in violation of the Federal Food, Drug, and Cosmetic (FD&C Act), as they have not submitted a premarket tobacco product application (PMTA) and do not have a marketing authorization order to manufacture, sell, or distribute these products. 

According to the manufacturer, each gummy contains 1mg of nicotine with 12 gummies (12mg) per tin and are available in 3 flavors: Krave Nic Blueraz, Krave Nic Cherry Bomb and Krave Nic Pineapple. While the packaging claims that these products contain tobacco-free nicotine, the amended FD&C Act has extended the FDA’s jurisdiction to products “containing nicotine from any source,” not just nicotine derived from tobacco.

In a study published in the journal Pediatrics, researchers have found that these flavored non-tobacco oral nicotine products, including gummies and lozenges, were the most commonly used tobacco products among adolescents. An ingestion of 1 to 4mg of nicotine carries a risk of severe toxicity in children under 6 years of age, whereas nicotine toxicity among adolescents of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death.

The FDA has requested a written response from the manufacturer within 15 working days, and failure to correct the violations outlined in the letters may result in legal action, including product seizure and/or injunction. The manufacturer will also be required to submit a PMTA and receive marketing authorization from the FDA.

“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 M. Califf, MD. “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.”

Reference

US Food and Drug Administration. FDA warns manufacturer for marketing illegal flavored nicotine gummies. Accessed August 18, 2022. https://www.fda.gov/news-events/press-announcements/fda-warns-manufacturer-marketing-illegal-flavored-nicotine-gummies