BitByBitCrypto Inc. d/b/a Vape Crypto – FDA Warning Letter, Sep 30, 2019

The FDA issued a Warning Letter to Robert Pisack concerning e-liquid products sold on vapecrypto.com, specifically the VaporFi Bites Vanilla Caramel Swirl e-liquid. The FDA determined this product is a tobacco product under section 201(rr) of the FD&C Act and is misbranded under sections 903(a)(1) and/or 903(a)(7)(A). The misbranding arises from false or misleading labeling and/or advertising that causes the e-liquid to imitate food products, particularly those appealing to children. Examples cited include cylindrical, tapered packaging with ice cream swirl images, the word “Bites,” and a sweet scent, visually similar to products like Edy’s Dibs. This poses a significant public health risk, as children are susceptible to ingesting such products, leading to potential acute nicotine toxicity, seizures, coma, or death, given the product's high nicotine content (up to 12 mg/mL). The FDA requires immediate correction of this violation and similar issues across all tobacco products, labeling, and advertising. A written response detailing corrective actions, including discontinuation dates and a compliance plan, must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, criminal prosecution, seizure, and injunction.