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Food and Drug Administration and Compliance Issues
Agency Remains Committed to Protecting Youth by Enforcing Against Illegal Products
Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. These types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.
The manufacturer, VPR Brands LP (doing business as, “Krave Nic”), markets gummies that have 1 milligram (mg) of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine. This firm has not submitted a premarket tobacco product application (PMTA) to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.
“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, M.D. “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.”
The manufacturer states that each gummy contains 1 milligram of nicotine with 12 gummies (12 mg) per tin. Research indicates that ingesting 1 to 4 milligrams of nicotine could be severely toxic to a child under 6 years of age depending on the child’s body weight. However, nicotine toxicity among youth of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. Nicotine is also highly addictive and exposure during adolescence can harm the developing brain.
In a recent study published in the journal PediatricsExternal Link Disclaimer, researchers 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 – second only to e-cigarettes. Use was particularly high among certain racial or ethnic, sexual or gender minority groups, and those with a history of nicotine use. These flavored non-tobacco oral nicotine products present an increased risk to youth due to their resemblance to kid-friendly food or candy products, such as gummies or gum, the availability in youth-appealing flavors, and the ability for teenagers to conceal use from adults.
The warning letter issued today requests a written response from the manufacturer describing how the firm intends to address any violations and bring their products into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Failure to promptly correct violations can result in further action such as civil money penalties, seizure, and/or injunction. Additionally, the firm must not sell or distribute violative products. The firm must submit a PMTA and receive marketing authorization from FDA before selling or distributing the product in the U.S.
In response to the increase of non-tobacco nicotine in tobacco products, including in some of the e-cigarette brands that are most popular with youth, Congress passed a federal law that went into effect on April 14, 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source. This law gives the FDA authority over products made with non-tobacco nicotine, including synthetic nicotine, and imposes requirements under the FD&C Act for manufacturers, importers, retailers and distributors of non-tobacco nicotine products. To date, no non-tobacco nicotine product has received a marketing granted order.
“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, Ph.D., M.P.H., 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.”
Efforts such as these support the FDA’s commitment to using a science-based approach to protect youth from initiating tobacco use. In addition to the FDA’s regulatory oversight, the agency recognizes the critical need for targeted youth tobacco prevention efforts designed to protect America’s kids, including mass media campaigns such as “The Real Cost.” The FDA also collaborates with the Centers for Disease Control and Prevention on the National Youth Tobacco Survey, the only nationally representative survey of middle and high school students that focuses exclusively on tobacco product use.