Smart Toothpicks, LLC – FDA Warning Letter, Jan 31, 2020

The FDA issued a Warning Letter to Smart Toothpicks, LLC, following a review of their website, smarttoothpicks.com, which revealed violations related to the sale and marketing of dissolvable tobacco products, specifically nicotine-infused toothpicks.

The company's "Peppermint Ice Nicotine Toothpicks" were found to be misbranded under 21 U.S.C. § 387c(a)(7)(B) because they were sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b).

Additionally, several nicotine-infused toothpicks were deemed adulterated under 21 U.S.C. § 387b(8) because they are considered "modified risk tobacco products" under 21 U.S.C. § 387k(b)(2)(A)(i) and were sold without a required FDA order. The website's advertising implicitly or explicitly represented these products as presenting a lower risk or being less harmful than other tobacco products, or being free of certain substances.

Furthermore, the "Peppermint Ice Nicotine Toothpicks" product package and the website advertising for several dissolvable tobacco products (e.g., Peppermint Ice, Cinnamon, and Wintergreen Nicotine Toothpicks) were found to be misbranded under 21 U.S.C. § 3