WASHINGTON — The U.S. Food and Drug Administration (FDA) has issued a warning letter to Smart Toothpicks LLC over alleged website sales practices that may allow minors access to its products, plus other issues related to packaging and advertising, the agency said.
The FDA cited several alleged violations of the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, against the Tempe, Ariz.-based seller of dissolvable tobacco products, which include Peppermint Ice Nicotine Toothpicks.
In a warning letter sent at the end of last month, the agency cited 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.
“We immediately corrected the few images on our website that were in question and will be changing over to a much better age-verification system,” Kirk Hansen, a spokesperson for Smart Toothpicks, told CSP Daily News. “As far as selling unauthorized tobacco products, the registration deadline has been moved to May 12, 2020, and we will be completely and legally registered for the FDA before the deadline.”
Hansen is referring to the deadline for submitting new-product applications for FDA authorization to market tobacco products in the United States. The process involves a premarket tobacco application (PMTA), which is due May 12.
In a Jan. 31 statement, the FDA said it requested that Smart Toothpicks provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the federal statues, including its plan to prevent the same or similar violations. Failure to ensure compliance may result in the FDA initiating further action, including monetary penalties, seizure of products and injunctions on distribution and sales.
As part of the agency’s Youth Tobacco Prevention Plan, the FDA said it continues to work 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 tobacco products out of the hands of minors.
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