FDA WARNING_LETTER - Geetanjali Inc., d/b/a Tobacco World

The FDA's Center for Tobacco Products issued a Warning Letter to Tobacco World (Geetanjali, Inc.) after reviewing its website, tobaccoworldohio.com. The FDA determined that the company is offering for sale cigarette tobacco and roll-your-own (RYO) tobacco products, such as "Criss Cross Green (Mint)" and "Smokers Palace Mint," which are presented as "pipe tobacco" but promoted and sold as RYO tobacco. These products are subject to FDA jurisdiction under the FD&C Act.

The primary violations concern flavored tobacco products. The FDA found that these products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) because they contain an artificial or natural characterizing flavor (other than tobacco or menthol), which is prohibited for cigarettes, cigarette tobacco, and RYO tobacco under section 907(a)(1)(A) (21 U.S.C. § 387g(a)(1)(A)). Alternatively, if the products do not actually contain a characterizing flavor but are advertised as such, they are misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) or § 387c(a)(7)(A)) due to false or misleading labeling/advertising.

Tobacco World is required to immediately correct these violations and discontinue the violative promotion, advertising, sale, and distribution of these products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply could result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.