The FDA sent a warning letter to a U.S. manufacturer marketing flavored nicotine gummies, who ignored the ban on them, calling them an unsafe temptation for children.
Among young children, the fruit-flavored gummies from VPR Brands, a manufacturer based in Florida doing business as Krave Nic, could cause nicotine poisoning or even death, the FDA warned. This warning letter is the first of its kind in regard to this type of product.
Nicotine gummies are a public health crisis waiting to happen among our nation’s youth, especially as we begin a new school year, said Robert Califf, MD, the FDA commissioner.
“We want parents to be aware of the health consequences for children of all ages and the appeal of these addictive products to our youth, he said.” “The FDA won’t stand by while illegal products enter the market.”
According to the FDA, the company does not have an application for a premarket tobacco product submitted to the FDA nor a marketing authorization to sell or distribute such products in the U.S.
This company produces 1 milligram square-shaped gummies and has three flavors – Blueraz, Cherry Bomb, and Pineapple. The products’ packaging states that they contain tobacco-free nicotine.
A study found that children under the age of six could be severely harmed by consuming 1 to 4 milligrams of nicotine depending on their weight, according to the FDA. At any age, nicotine toxicity can result in nausea, vomiting, abdominal pain, elevated blood pressure, elevated heart rate, seizures, respiratory failure, coma, and death.
Additionally, the FDA cited recent research showing that nicotine gums, gummies, lozenges, and similar products are becoming increasingly popular with teenagers, second only to e-cigarettes.
According to The Associated Press, this past year Congress passed a law granting the FDA control over nicotine no matter what plant it stems from or if it is manufactured in a lab. The law closed a loophole in the FDA’s regulations which previously did not take into account nicotine derived from tobacco plants.
A warning letter from the FDA gives the company 15 days to respond and address any violations or remove products from the market. A representative of VPR Brands told the AP, We have no comment on Thursday.
In the absence of a response, FDA could take further action including court proceedings, financial penalties, seizure and injunction.
I remain unwavering in my dedication to the appropriate regulation of all advertisements for tobacco products, which, of course, have a troubling tendency to appeal to minors, FDA Center for Tobacco Products director Brian King said in the statement.
“Today’s action should serve as a warning to manufacturers of these illegal products that the FDA is actively looking for violations and swiftly seeking corrections,” he said.