FDA WARNING_LETTER - Cosmos Indian Store - March 19, 2019

The FDA issued a Warning Letter to Cosmos Indian Store LLC, specifically addressing their website http://www.indianonlinegrocery.com, for violations related to the sale and advertising of smokeless tobacco products. The FDA determined that the company sold BABA 120 Premium Tobacco smokeless tobacco to a person under 18 years of age, which misbrands the product under section 903(a)(7)(B) of the FD&C Act and violates 21 C.F.R. § 1140.14(a).

Additionally, several smokeless tobacco products offered on the website, including IPCO Creamy Snuff, Sopariwala Must Khaini, Baba 160 Saffron Blended Luxury Tobacco, and Rajnigandha Pan Masala, were found to lack required health warning statements. This constitutes misbranding under section 903(a)(1) and/or section 903(a)(7)(A) of the FD&C Act, as per the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402). The letter also noted the requirement for quarterly rotation of warning labels.

Cosmos Indian Store LLC is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including