FDA In Brief: FDA Warns Maker of Nicotine-Containing Toothpicks of Several Violations, Including Illegal Sales
January 31, 2020
The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D:
“The FDA has made it clear, we will not tolerate violations of federal tobacco regulations designed to protect the American public – especially underage tobacco sales to youth. In this case, the FDA was prompted to take action because Smart Toothpicks LLC ignored the laws.
“The FDA has been holding retailers and manufacturers accountable for marketing and sales practices that have led to increased youth accessibility and appeal of tobacco products. We’re especially concerned about novel nicotine-containing products, such as these nicotine-containing toothpicks, being sold and marketed to youth. Evidence shows that youth exposure to nicotine can adversely affect the developing adolescent brain and put youth at risk for nicotine addiction.
“The enforcement tools we used in this case are the same tools we will continue to employ to address the access and appeal of all tobacco products, especially e-cigarettes, to young people. We remain committed to using all available regulatory tools to ensure that no tobacco product is marketed or sold as reduced risk without FDA authorization or without the required nicotine warning statements – especially to kids.”
- Today, the U.S. Food and Drug Administration issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells dissolvable tobacco products, including Peppermint Ice Nicotine Toothpicks.
- The FDA sent a warning letter to the manufacturer for three specific violations: selling a tobacco product to a minor through the company’s website; selling unauthorized modified risk tobacco products; and failing to include required nicotine warning statements on both packaging and advertising.
- The FDA has requested that Smart Toothpicks provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the FD&C Act, including its plan to prevent the same or similar violations. Failure to ensure compliance with the FD&C Act may result in the FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.
- As part of the agency’s Youth Tobacco Prevention Plan, the FDA continues work on all fronts to prevent and reduce youth tobacco use through all available regulatory tools. This includes taking action against manufacturers and retailers who market or sell these products to minors, educating youth about the dangers of tobacco, and implementing the policies necessary to keep them out of the hands of America’s kids. .
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.