Tyler Wholesale Supply LLC d/b/a BBW Supply – FDA Warning Letter, Nov 16, 2023

On November 16, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to BBWSUPPLY.COM after reviewing their website, which offered Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are classified as tobacco products under the FD&C Act, specifically section 201(rr), due to containing nicotine from any source.

The FDA identified that the "Snowwolf Ease 8000 Puffs" products (Lemon Mint, Icy Mint, Blueberry Kiwi Lemon) were being marketed without the required premarket authorization order. These are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. 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 Snowwolf Ease products imitate beverage containers and their design helps conceal their nature as tobacco products, potentially promoting youth use.

BBWSUPPLY.COM is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,