FDA WARNING_LETTER - Rudra Ventures Pvt. Ltd.

The FDA's Center for Tobacco Products issued a Warning Letter to Rudra Ventures after reviewing their website, http://www.rudraventures.com, which offered "Royal Black (clove)" cigarettes for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that Royal Black cigarettes purport to contain a natural or artificial characterizing flavor (clove), which is prohibited for cigarettes under section 907(a)(1)(A) of the FD&C Act. This makes the product adulterated under section 902(5) of the FD&C Act. Alternatively, if the product does not contain a characterizing flavor, its labeling or advertising is false or misleading, rendering it misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act.

Rudra Ventures is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products are also subject to detention and refusal of admission if imported.

A written response detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance,