In what is the first of its kind a warningthe agency said it considers the gums particularly troubling because they resemble candy and can cause severe nicotine toxicity or death if eaten by young children.
“Nicotine gum is a public health crisis waiting to happen among our nation’s youth, especially as we approach the new school year,” said FDA Commissioner Dr. Robert Califf at the agency. news release on warning. “We want parents to be aware of these products and the potential health effects for children of all ages, including the toxicity to young children and the addictive appeal of these products to our youth.”
The gums in question are manufactured by VPR Brands LP (kravenic.com) and have 1 milligram (mg) of nicotine in each gum. They are sold in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine, but the company is not authorized to sell or distribute such a product in the United States, according to the FDA. As of Friday morning, the company’s website said the candies had been discontinued.
New federal law which went into effect in April, gave the FDA authority over non-tobacco nicotine products, including synthetic nicotine. The new law was a response to the increase in youth use of non-tobacco nicotine products, including electronic cigarettes. No non-tobacco nicotine product has been given a marketing authorization by the FDA.
“We continue to deploy compliance and enforcement resources to stop all illegal marketing of tobacco products, especially those that youth can easily confuse with something they use regularly, such as candy,” said Brian King, Director FDA Center for Tobacco Products. “Today’s action should send a wake-up call to the manufacturers of these illegal products that the FDA is actively working to identify violations and quickly seek corrective action.”
In the warning statement, the FDA cited a recent study published in the journal Pediatrics in which researchers found that flavored non-tobacco oral nicotine products were among the most commonly used tobacco products among youth. The products are considered a risk because they can be easily hidden by teenagers from adults and have a taste that appeals to young people.
Nicotine is highly addictive and dangerous for children. It can damage the developing brain during adolescence and can cause nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. Swallowing even small amounts can be very toxic to a child under the age of 6, according to the FDA.
In its warning letter, the FDA tells the company that it must tell the agency how it plans to remedy any violations and bring the products into compliance with Federal Food, Drug and Cosmetic Act. The company could face fines, confiscation or a ban if it corrects the violations within 15 days, the agency said.
The FDA provides both regulatory oversight of tobacco products and tobacco prevention campaigns in media aimed at children, and collaborates with the US Centers for Disease Control and Prevention on the National Youth Tobacco Survey.
The American Lung Association has more information nicotine disease.
SOURCE: US Food and Drug Administration, Press Release, August 18, 2022