FDA WARNING_LETTER - Vape4Style, Inc - May 31, 2023

The FDA issued a Warning Letter to Vlady Rubin, operating as Vape4Style, following a review of their website, vape4style.com. The FDA determined that the company offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products, specifically "Puff Bar Disposables – Lush Ice" and "Puff Bar Disposables – Lychee Ice," which are considered tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These ENDS products are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices or information under section 905(j).

The Warning Letter mandates that Vape4Style address these violations and bring all tobacco products offered for sale or distribution into compliance with the FD&C Act. Failure to comply may result in regulatory or legal actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15