Tag: nontobacco nicotine

  • FDA Warns Nic Nac ‘Nicotine Mints’

    FDA Warns Nic Nac ‘Nicotine Mints’

    Image: FDA

    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.

  • FDA Updates Nicotine Definition in Docs

    FDA Updates Nicotine Definition in Docs

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has updated its definition of “tobacco products” to include nontobacco nicotine products.

    In response to the increase of nontobacco nicotine in popular tobacco products, Congress passed a federal law that went into effect on April 14, 2022, granting the FDA authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. This new law extended the tobacco product requirements in the Federal Food, Drug and Cosmetic Act to manufacturers, importers, retailers and distributors of nontobacco nicotine products. Previously, the FDA’s tobacco product authority only extended to tobacco products that contain nicotine made or derived from tobacco.

    Under this legislation, the definition of “tobacco product” in the FDA’s regulations and guidances has been considered to be amended since April 14, 2022. The FDA has now issued two notices in the Federal Register updating the definition of “tobacco product” in its existing regulations and guidances.

    In addition, the agency has also posted the following nine revised guidances to the FDA’s website: Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers (Revised); Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order (Revised); Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products (Revised); Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug and Cosmetic Act Requirements to Vape Shops (Revised); Listing of Ingredients in Tobacco Products (Revised); Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (Revised); The Prohibition of Distributing Free Samples of Tobacco Products (Revised); FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised); and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3).