FDA WARNING_LETTER - greenrushsmokeshop.com - March 11, 2025

On March 7, 2025, the FDA issued a Warning Letter to Green Rush Smoke Shop, located at 8620 San Ysidro Ave, Ste 112, Gilroy, CA 95020-3627, following a review of their website, https://www.greenrushsmokeshop.com. The FDA determined that the company is offering for sale or distribution in the United States electronic nicotine delivery system (ENDS) products that are considered "new tobacco products" and lack the required premarket authorization.

Specifically, the products identified as lacking marketing authorization are "Lost Mary Space Edition OS5000 Puffs, Black Mint" and "Lost Mary Space Edition OS5000 Puffs, Pineapple Mango." These products are deemed new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization orders or exemptions.

Consequently, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the absence of required premarket authorization and failure to