On Nov. 7, 2023, FDA issued a warning letter to Nic Nac Naturals, LLC for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and resemble a pack of mints. These 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 Brian King, Ph.D., M.P.H., 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.”
The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 milligrams and 6 milligrams). The packaging states the products contain non-tobacco nicotine. FDA regulates tobacco products containing nicotine from any source, including non-tobacco nicotine. The firm does not have a marketing authorization order from the agency to sell or distribute these products in the U.S. and the manufacture and sale of these products is illegal.
One container of this product containing 15-nicotine “mints” can have as much as 90 milligrams (mg) of total nicotine (6 mg/nicotine per “mint”). Research indicates that ingesting 1 to 4 milligrams of nicotine could be toxic or severely toxic to a child under 6 years of age depending on the child’s body weight. Thus, ingesting one or more of these mints could be severely toxic to a child under 6 years of age depending on the child’s body weight and number of mints consumed. Moreover, 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 even death. Nicotine is also highly addictive and exposure during adolescence can harm the developing brain.
“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.”
FDA generally sends warning letters the first time an investigation or inspection reveals a violation. To achieve voluntary compliance, warning letter recipients have 15 working days to respond with the steps they will take to correct and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, such as an injunction, seizure, and/or civil money penalties (CMPs).
Today’s warning letter marks another step in FDA’s continued efforts across the supply chain to remove illegally marketed tobacco products from the market. As of Sept. 19, 2023, the agency has issued more than 600 warning letters to firms marketing unauthorized tobacco products, with more than 100 of these warning letters being issued to firms for unauthorized non-tobacco nicotine products. Further, since September 2023, FDA issued complaints for CMPs against 42 brick and mortar retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, which contain non-tobacco nicotine and are the most commonly used e-cigarette brand among U.S. youth.