Vapesstores.com – FDA Warning Letter, Aug 23, 2023

The FDA issued a Warning Letter to Vapesstores.com on August 23, 2023, following a review of their website, which revealed the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products in the United States. These products are considered "tobacco products" under the FD&C Act, including those containing nicotine from any source, as per the Consolidated Appropriations Act, 2022.

The identified violations include the marketing of "new tobacco products" without the required premarket authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Specific unauthorized products listed are KERG-BBK Strawberry Bear Disposable 8000 Puffs – Peach, PURE Explosion Minions Disposable 6000 Puffs – Lemon Ice, JODK Bottle Disposable 9000 Puffs – Blueberry Ice, FOUNS Tiger Disposable 6000 Puffs – Blueberry, and ELF BAR Disposable BC 5000 Puffs – Blue Razz Ice.

The FDA expressed particular concern that the product labeling and advertising imitate children's toys, movie characters, and sports water bottles, potentially promoting youth use and concealing the products' nature as tobacco products.

Vapesstores.com must submit a written response within 15 working days detailing actions taken to address the violations,