# FDA WARNING_LETTER - Pure Smoke LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/pure-smoke-llc/959653d5-deaa-4b01-ab6a-fc06a64ecffb

> FDA WARNING_LETTER for Pure Smoke LLC on Unknown Date. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pure Smoke LLC
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products reviewed puresmokeonline.com and determined that PureSmoke 5 Cartomizers Cool Mint ENDS product, a tobacco product under section 201(rr) of the FD&C Act, was sold to a person younger than 18 years of age. This constitutes a misbranding violation under section 903(a)(7)(B) of the FD&C Act, as it violates 21 C.F.R. § 1140.14(b) which prohibits the sale of covered tobacco products to minors. The FDA's investigation confirmed a purchase by a minor.

The company is required to immediately correct this violation and similar issues across all sales and advertising platforms to ensure compliance 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 of violative sales/advertising and a compliance plan, must be submitted within 15 working days to the FDA Center for Tobacco Products.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.globalkeysolutions.net/companies/pure-smoke-llc/dce8823e-45ad-4d19-8174-ef1c5ceb4e08

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