# FDA WARNING_LETTER - Shisha Pen Shop - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/shisha-pen-shop/767f813f-13ff-41d3-a723-e17bde68217d

> FDA WARNING_LETTER for Shisha Pen Shop on Unknown Date. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shisha Pen Shop
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to Shishapendirect.com after reviewing their website and determining that e-liquid products were offered for sale to U.S. customers. The FDA classified these e-liquids as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Hangsen Red Energy e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors. The investigation revealed that a minor ordered "Hangsen RedBull e-liquid" but received "Hangsen Red Energy e-liquid."

The letter mandates immediate correction of this violation and similar issues to ensure compliance 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. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Mr.](https://www.globalkeysolutions.net/people/i-seal/47caeef4-6b0a-4edc-94fb-598936ffb5ed)

Company: https://www.globalkeysolutions.net/companies/shisha-pen-shop/3be32529-ad94-4927-a913-fdd724737367

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