The U.S. Food and Drug Administration (FDA) has issued a warning letter for marketing flavoured nicotine gummies that are especially attractive to youths, according to an FDA press release.
The warning letter was the first for this type of product and underlines the FDA’s commitment to protecting youths by enforcing laws against illegal products such as flavoured nicotine gummies. The FDA states that products such as nicotine gummies are of “particular public concern” because they look like child-friendly candy products but have the potential to cause serious nicotine toxicity that could result in death of young children.
The company that has received the warning letter is VPR Brands LP known under the name “Krave Nic”. It produces and markets gummies in three fruity flavours that contain 1mg of nicotine each and according to packaging contain tobacco-free nicotine. According to the FDA, the company 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 US.
“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.”
VPR Brands LP is now required to respond to the warning letter in written form. Failure to do so can result in further action such as civil money penalties, seizure, and/or injunction, according to the FDA press release. The company must also stop selling and distributing products and submit a PMTA to receive marketing authorization from FDA before resuming selling or distributing the product in the US.