The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which 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, according to the FDA.
“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 the FDA’s Center for Tobacco Products (CTP). “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 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.
One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. 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. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.
“Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the 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.”
The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.