FDA WARNING_LETTER - The Pipe Nook, LLC - April 30, 2019

The FDA Center for Tobacco Products issued a Warning Letter to James E. Gray regarding the website https://www.thepipenook.com, which offers pipe tobacco products for sale in the U.S. The review determined that Sir Walter Raleigh Aromatic pipe tobacco sold on the website is a "covered tobacco product" subject to FDA jurisdiction under section 901(b) of the FD&C Act.

The primary violation identified was the sale of Sir Walter Raleigh Aromatic pipe tobacco to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to individuals under 18.

The FDA requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations for all tobacco products, labeling, and advertising across all platforms. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinuation of violative sales and a plan for maintaining compliance, is required within 15 working days.