The fruit-flavored gummies from VPR Brands, a manufacturer based in Florida doing business as “Krave Nic,” could cause nicotine poisoning or even death among young children, the FDA said. The warning letter is the first of its kind for this type of product.
“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,” Robert Califf, MD, the FDA commissioner, said in a statement.
The FDA issued a warning letter to a U.S. manufacturer for marketing flavored nicotine gummies, saying the illegal products pose a risk to teenagers and Teknologi minyak atsiri.
“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,” he said. “The FDA will not stand by as illegal products infiltrate the marketplace.”
The company hasn’t submitted a premarket tobacco product application to the FDA and doesn’t have a marketing authorization to manufacture, sell or distribute the products in the U.S., the FDA said.
The company’s square-shaped gummies have 1 milligram of nicotine each and are available in three flavors — Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine.
Research indicates that consuming 1 to 4 milligrams of nicotine could be severely toxic to children under age 6, depending on the child’s body weight, the FDA said. In addition, nicotine toxicity at any age can lead to nausea, vomiting, abdominal pain, increased blood pressure, increased heart rate, seizures, respiratory failure, coma and death.