The U.S. Food and Drug Administration recently 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 nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks.  FDA’s warning letter focused on the following, specific violations: (1) selling a tobacco product to a minor through the company’s website;  (2) selling unauthorized modified risk tobacco products; and (3) failing to include required nicotine addiction warning statements on both packaging and advertising. In making the illegal sales finding, FDA cited the fact that a person younger than 18 years of age was able to purchase Peppermint Ice Nicotine Toothpicks from the company’s website. The company’s website also contained some advertising claims that came under scrutiny as modified risk claims because they represented that the product presents a lower risk of tobacco-related disease or is less harmful than other commercially marketed tobacco products (such as its website claims, “Nicotine Satisfaction without smoke damage to your lungs” and “Smart Toothpicks – A catalyst to promote a healthier way of life… in a flavorful way!”). The products were also found to be misbranded because both the website and the product packaging were missing the required nicotine addiction warning statement.

This action provides an illustration of the Agency’s interpretation of “tobacco product,” which FDA defines broadly as any product made or derived from tobacco that is intended for human consumption. The Agency takes the position that this definition includes novel, non-tobacco products that contain nicotine derived from tobacco, such as nicotine-infused toothpicks. Referring to the nicotine-infused toothpicks as “dissolvable tobacco products,” the Agency concluded that the products are “covered tobacco products” under 21 C.F.R. § 1140.3, and thus subject to the same FDA requirements as other deemed products, including sales restrictions to minors and marketing authorization requirements.

This action also signifies the extensive reach of FDA’s regulatory authority, and highlights to others in the growing novel nicotine products industry that FDA remains focused on holding retailers and manufacturers accountable for marketing and sales practices that can lead to increased youth appeal of tobacco products.  In fact, FDA has gone on record to state that it is increasingly focused on “novel nicotine-containing products” as one such way to facilitate youth access and nicotine addiction. Accordingly, others in the industry would be prudent to heed this warning and ensure full compliance with FDA regulations, including heightened age verification for online sales and reviewing product advertising and any use of non-tobacco flavors appealing to minors.