FDA WARNING_LETTER - Pipe World Inc

The FDA Center for Tobacco Products reviewed Pipeworld.com and determined that smokeless tobacco products, including Longhorn Loose-Leaf, Oliver Twist, and Swedish Snus, are offered for sale in the U.S. These products are subject to FDA jurisdiction as tobacco products.

The FDA found that Pipeworld.com's webpage for these smokeless tobacco products fails to include any required health warning label statements, rendering them misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings for smokeless tobacco advertisements, such as "WARNING: This product can cause mouth cancer." The absence of these warnings makes the advertising false or misleading by failing to reveal material facts about product use consequences.

Additionally, the letter notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA-approved plan.

Pipe World Inc. is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising on their website and other media comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates for violative activities and a compliance plan