Bugatti Vape, LLC – FDA Warning Letter, Sep 12, 2024

The FDA issued a Warning Letter on September 12, 2024, to Gal Ohayon, David Saig, Shlomi Biton, and Moshe Man, following a review of the website https://vapebugatti.com. The FDA determined that electronic nicotine delivery system (ENDS) products, specifically "Bugatti Vape - Strawberry Banana" and "Bugatti Vape - Blue Razz," are manufactured and offered for sale or distribution in the United States without required marketing authorization.

These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. 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 requires prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. A written response detailing corrective actions, including dates of discontinuation and a plan for maintaining compliance, must be submitted within 15 working days of receipt of the letter. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.