FDA WARNING_LETTER - eCig Distributors, Inc. d/b/a eJuices.com - October 30, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Paul Davey and William Wilson regarding electronic nicotine delivery system (ENDS) products sold on ejuices.com. The FDA determined that the website offers ENDS products for sale or distribution in the U.S. that are considered "tobacco products" under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. Specifically, the products "North South Connect 35K Puffs Phone Disposable Vape – Mexico Mango" and "Craftbox V-Touch 30,000 Puffs Phone Call Vape Disposable – Gummy Licious" were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern that the product labeling and advertising for these ENDS products imitate smartphones or other smart technology, potentially appealing to youth and aiding in concealment from adults.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinu