Once again, the FDA has given free publicity to an obscure nicotine product while loudly ordering it removed from the market. Today the agency issued a press release and multiple social media posts to trumpet a warning letter sent to a virtually unknown manufacturer of nicotine lozenges.
Nic Nac Naturals, based in Spokane, Washington, sells lozenges it describes as “nicotine mints” in both 3 and 6 milligram strengths and several flavors. The product appears to have entered the market early this year, based on a February story in the Spokane Journal.
According to the Journal, co-founder and owner Nicco Magnotto launched the small venture with $650,000 borrowed from family and friends. He said he hoped the company would begin turning a profit by the end of this year. That won’t happen, thanks to the FDA.
Warning letter recipients are expected to remove the cited products from the market. They are given 15 working days to reply to the warning letter, describing what corrective actions they’ve taken or disputing the agency’s allegations. Those who don’t reply or comply with the warning may face additional FDA sanctions.
The warning letter is entirely based on the company not receiving premarket authorization before selling the products, but the FDA felt the need to issue a press release claiming the products “are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children.”
“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 FDA Center for Tobacco Products (CTP) Director Brian King in a statement. “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”
The Nic Nac products are sold in cans similar to those used by manufacturers of nicotine pouches, FDA-authorized snus, and other nicotine lozenges on the market. But the FDA chose to include photos in its press release comparing the Nic Nac package with a package of Ice Breakers candies.
FDA-approved nicotine gum and lozenges, sold over the counter as nicotine replacement therapy (NRT), can contain as much nicotine as Nic Nac’s lozenges, and are sold in larger quantities per package. They’re also made in a variety of flavors, and can be just as easily mistaken for candy.
The Nic Nac products, according to the company’s website, are made with “non-tobacco” (synthetic) nicotine, which fell under the CTP authority last year. According to the agency, synthetic nicotine products that had not received premarket authorization by July 14, 2022, are illegal to market in the United States. Products coming to market after that date must have prior FDA authorization.
The FDA action was long overdue. It has been over a year since the agency issued a warning letter to the manufacturer of Krave nicotine gummies—a product almost no one had heard of before the FDA swung into action.
In its press release promoting that action, Brian King was quoted saying, “We remain unwavering in our use of compliance and enforcement resources to curb all unlawful marketing of tobacco products, especially those that youth could easily confuse with something that they consume regularly—like candy.”
Apparently that quote was so impressive the CTP decided to recycle it for use a year later.
In today’s press release, Ann Simoneau, director of the CTP Office of Compliance and Enforcement, is quoted as saying, “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.”
Image courtesy Nic Nac Naturals