FDA WARNING_LETTER - Love Your Potion - September 14, 2023

On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to the operator of yourlovepotion.com after reviewing their website and identifying electronic nicotine delivery system (ENDS) products offered for sale or distribution in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the "Bang XL Disposable – Watermelon Lemonade" ENDS product was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires the firm to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the violative products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter also advises the firm to ensure all tobacco products and related advertising on all platforms comply with the