FDA WARNING_LETTER - Golden Leaf, LLC d/b/a Golden Leaf Shop - November 09, 2023

On November 8, 2023, the FDA issued a Warning Letter to Cesar Perez and Daniel Branca regarding electronic nicotine delivery system (ENDS) products sold on goldenleafshop.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements.

The letter highlights that the definition of "tobacco product" was expanded on March 15, 2022, to include products with nicotine from any source. Generally, "new tobacco products" require premarket authorization. The FDA found that products like "Elf Bar BC5000 Disposable – Honeydew Pineapple Orange" and "Elf Bar BC5000 Disposable – Strawberry Watermelon" are new tobacco products, not commercially marketed before February 15, 2007, and lack the required FDA marketing authorization.

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 stated that all new tobacco products without premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and injunction. The firm must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance.