| Section | Link to Section |
|---|---|
| About The Children | It is Always About The Children—Even When It Isn't. |
| FDA Took Action | The FDA Took Action When Tobacco Regulators Plagiarized Each Other |
Once again, the FDA has given free attention to an obscure nicotine product while emphatically demanding its removal from the market. Today, the agency published a news release and many social media posts to highlight a warning letter received from a completely unknown maker of nicotine lozenges.
Nic Nac Naturals, located in Spokane, Washington, sells lozenges marketed as "nicotine mints" in 3 and 6-milligram doses and a variety of flavors. According to a February piece in the Spokane Journal, the product appeared on the market early this year.
According to the Journal, Nicco Magnotto, co-founder and owner, established the modest business with a $650,000 loan from family and friends. He expressed hope that the firm will begin producing a profit by the end of this year. This will not happen, owing to the FDA.
The receivers of warning letters are expected to withdraw the mentioned items from the market. They have 15 working days to respond to the warning letter, detailing any corrective efforts they have made or challenging the agency's findings. Those who do not respond or comply with the notice may face additional FDA consequences.
It is Always About The Children—Even When It Isn't.
The warning letter is entirely based on the company's failure to obtain premarket approval before selling the products, but the FDA felt compelled to issue a press release claiming the products "are of particular concern because they resemble 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 crack down on companies selling unlawful products, particularly those that can appeal to youth," said FDA Center for Tobacco Goods (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."
Nic Nac products are packaged in cans identical to those used by makers of nicotine pouches, FDA-approved snus, and other nicotine lozenges on the market. However, the FDA opted to publish photographs in its news statement comparing the Nic Nac box to a package of Ice Breakers candy.
FDA-approved nicotine gum and lozenges, offered over the counter as nicotine replacement therapy (NRT), can contain as much nicotine as Nic Nac's lozenges and come in bigger packages. They come in a variety of tastes and are often mistaken for candy.
According to the company's website, Nic Nac products include "non-tobacco" (synthetic) nicotine, which was regulated by the CTP last year. According to the EPA, synthetic nicotine products that do not have premarket authorization by July 14, 2022 are prohibited to market in the United States. Products introduced after that date require prior FDA approval.
The FDA Took Action When Tobacco Regulators Plagiarized Each Other
The FDA took action when tobacco regulators plagiarized each other, which was long overdue. It has been more than a year since the FDA issued a warning letter to the producer of Krave nicotine gummies, a product nearly no one had heard of before the FDA stepped in.
Brian King was quoted in a press release promoting the action as 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 they consume regularly—like candy."
That phrase was so impressive that the CTP chose to recycle it for use a year later.
Ann Simoneau, director of the CTP Office of Compliance and Enforcement, is quoted in today's press release 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 they consume regularly—like candy.
