FDA WARNING_LETTER - Smart Toothpicks, LLC - September 11, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Smart Toothpicks LLC on September 11, 2025, following an inspection that revealed regulatory violations concerning their nicotine toothpick products. The inspection determined that Smart Toothpicks LLC manufactures and distributes nicotine toothpick products, which are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products include the SMART TOOTHPICKS Cinnamon Nicotine Toothpick 3 mg and SMART TOOTHPICKS Peppermint Ice Nicotine Toothpick 3 mg.

Under the FD&C Act, tobacco products containing nicotine from any source must comply with FDA regulations, including obtaining a premarket authorization order. The FDA found that Smart Toothpicks LLC"s products lack the necessary marketing authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA requires Smart Toothpicks LLC to take immediate corrective actions to address these violations. The company must submit a written response within 15 working days detailing their actions to comply with the FD&C Act, including cessation of violative sales and a compliance plan. Failure to comply may result in enforcement actions such as civil penalties, product seizure, or injunction.

Smart Toothpicks LLC is advised to ensure all products and related marketing comply with FDA regulations. The company is directed to address the violations and submit their response to the FDA"s Office of Compliance and Enforcement.