The Agency remains committed to protecting young people by combating illegal products
SILVER SPRING, MD., August 18, 2022 / Prnewswire/ – Today, the Food and Drug Administration of the United States has published a warning letter for the illegal marketing of flavored nicotine gums – the first warning letter for this type of product. These types of gums are particularly worrying for the public because of their resemblance to foods or candies adapted to children and the potential to cause serious toxicity of nicotine or even death in young children.
The manufacturer, VPR Brands LP (doing business as “Krave Nic”), markets gummies that contain 1 milligram (mg) of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain nicotine without tobacco. This company has not submitted a tobacco product marketing authorization application (PMTA) to the FDA and does not have a marketing authorization order to manufacture, sell, or distribute these products in the United States.
“Nicotine gum is a public health crisis just waiting to happen among our nation’s youth, especially as a new school year approaches.“, said the commissioner of the FDA Robert M. CaliffMD “We want parents to be aware of these products and potential consequences for the health of children of all ages – including toxicity for young children and the attraction of these addictive products for our young people. The FDA will not remain arms crossed as illegal products seep into the market.”
The manufacturer declares that each eraser contains 1 milligram of nicotine with 12 gums (12 mg) per box. Research indicates that ingesting 1 to 4 milligrams of nicotine could be seriously toxic to a child under 6 depending on the child’s body weight. However, nicotine toxicity in young people of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma, and even death. Nicotine also creates high dependence and exposure during adolescence can affect the development of the brain.
In a recent study published in the journal PediatricsResearchers discovered that oral nicotine products other than tobacco, including gelled candies and pastilles, were among the most commonly used tobacco products in young people in the south of the country. California – just behind electronic cigarettes. Use was particularly high among certain racial or ethnic, sexual or gender minority groups, and among people with a history of nicotine use. These tobacco-free flavored oral nicotine products pose an increased risk to young people due to their resemblance to child-friendly foods or candies, such as gummies or gummies, the availability of flavors appealing to young people, and the potential for teenagers to conceal the use of adults.
The warning letter issued today requests a written response from the manufacturer outlining how the company intends to remedy any violations and bring its products into compliance with the federal Food, Drug, and Cosmetic Act ( FD&C Act). Failure to promptly correct violations may result in further action such as monetary civil penalties, seizure and/or injunction. In addition, the company must not sell or distribute non-conforming products. The company must submit a PMTA and receive marketing clearance from the FDA before selling or distributing the product in the United States.
In response to the increase in nicotine not linked to tobacco in tobacco products, including in some of the most popular electronic cigarette brands with young people, Congress has adopted a federal law that has entered into force April 14, 2022, clarifying the authority of the FDA to regulate tobacco products containing nicotine from any source. This law gives the FDA Authority on products manufactured with tobacco -free nicotine, including synthetic nicotine, and imposes requirements under the FD & C law to manufacturers, importers, retailers and distributors of products based on tobacco without tobacco . To date, no nicotine product other than tobacco has been authorized for marketing.
“We remain steadfast in our use of compliance and enforcement resources to combat any illegal marketing of tobacco products, especially those that young people could easily mistake for something they consume regularly – like candy,” said declared Brian King, Ph.D., MPH, director of the FDA’s Center for Tobacco Products. “Today’s action should be a wake-up call to manufacturers of these illegal products that the FDA is actively working to identify violations and seek prompt corrective action.”
Efforts like these support the FDA’s commitment to using a science-based approach to protect young people from tobacco use initiation. In addition to the regulatory surveillance of the FDA, the agency recognizes the critical need for targeted effort to prevention of smoking in young people designed to protect American children, including media campaigns such as “The Real Cost”. The FDA is also collaborating with the Centers for Disease Control and Prevention on the National Youth Smoking Survey, the only nationally representative survey of middle and high school students that focuses exclusively on the use of tobacco products.
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The FDA, an agency of the American Department of Health and Social Services, protects public health by guaranteeing the safety, efficiency and safety of drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security and security of food supply, cosmetics, food supplements, products issuing electronic radiation and the regulation of tobacco products.
SOURCE US Food and Drug Administration