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

Source: https://www.keypedia.com/records/warning_letter/the-pipe-nook-llc/a4ae1fb0-e3a9-4d64-b308-f671fae8d36b

> FDA WARNING_LETTER for The Pipe Nook, LLC on April 30, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Pipe Nook, LLC
- Inspection Date: 2019-04-30
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [James E. Gray](https://www.keypedia.com/people/james-e-gray/157e2f2c-fe4d-4610-a1a2-57a3475f51ee)

Company: https://www.keypedia.com/companies/the-pipe-nook-llc/2da67be5-d0f4-4e60-be7d-7b6156e7be6d

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374