The Food and Drug Administration sent a warning letter to Nic Nac Naturals LLC for selling dissolvable nicotine pouches, which the company describes as “nicotine mints.”
The FDA said the product resembles a pack of mints and are of particular concern because of its resemblance to popular candies like Ice Breakers mints. This could cause severe nicotine toxicity or even death if accidentally ingested by young children, the agency said.
“FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of FDA’s Center for Tobacco Products. “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”
Nic Nac markets the tobacco products in a variety of mint and fruit flavors, which come in two nicotine strengths of 3 and 6 milligrams, the FDA said. The packaging state the products contain non-tobacco nicotine.
The company does not have a marketing authorization order from the FDA to sell or distribute these products in the United States, therefore, the sale of these products is illegal, the FDA said.
Ingesting 1 to 4 milligrams of nicotine could be toxic to a child under 6 years old, depending on their body weight, the FDA said. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and death, the agency said. Nicotine is also highly addictive.
“Today’s action is another example of our ongoing efforts against illegal non-tobacco nicotine products,” said Ann Simoneau, director of CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”
Warning letter recipients have 15 working days to respond with the steps they will take to correct and prevent future violations. Failure to do so might result in additional FDA action.
The FDA has issued 600 warning letters to firms marketing unauthorized tobacco products, with more than 100 of those being issued for unauthorized non-tobacco nicotine products. Synthetic nicotine products have been regulated by the FDA since April 2022. The agency received premarket tobacco product applications (PMTAs) for about 1 million non-tobacco nicotine products submitted by more than 200 manufacturers by May 14 2022.
The agency has also issued complaints for civil money penalties against 42 brick-and-mortar retailers for the illegal sale of Elf Bar/EB Design e-cigarettes.
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