FDA WARNING_LETTER - Safa Goods LLC - October 05, 2023

On October 5, 2023, the FDA issued a Warning Letter to Safa Goods, LLC, following a review of inspection records. The FDA determined that Safa Goods, LLC distributes Electronic Nicotine Delivery Systems (ENDS) products, specifically citing "EB Design BC5000 Blue Razz Ice," for commercial distribution in the United States.

These ENDS products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include products containing nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "EB Design BC5000 Blue Razz Ice" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, this product is 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 notice or information.

The introduction or delivery into interstate commerce of adulterated or misbranded tobacco products, or the failure to provide required reports, constitutes prohibited acts under sections 301(a) and 301(p) of the FD&C Act.

Safa