# FDA WARNING_LETTER - Smoke-Free Planet, LLC d/b/a Smoke Free Nation - April 27, 2022

Source: https://www.keypedia.com/records/warning_letter/smoke-free-planet-llc-dba-smoke-free-nation/4e1ed986-be66-4a61-b642-34e39e4e8d53

> FDA WARNING_LETTER for Smoke-Free Planet, LLC d/b/a Smoke Free Nation on April 27, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Smoke-Free Planet, LLC d/b/a Smoke Free Nation
- Inspection Date: 2022-04-27
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On April 27, 2022, the FDA issued a Warning Letter to Smoke-Free Planet, LLC d/b/a Smoke Free Nation, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that the company's "Smoke Free Nation Meteor Menthol 3mg 120 ml e-liquid product" is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product is deemed adulterated under section 902(6)(A) of the FD&C Act because it lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i). Additionally, it is misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA emphasized that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 150 listed products, must ensure all products comply with the

## Related Officers

- [Gerald Reed](https://www.keypedia.com/people/gerald-reed/048020b2-beb5-4e30-a6c9-15072795a8cc)
- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/smoke-free-planet-llc-dba-smoke-free-nation/d4572b96-5989-4162-8bdb-52e604462147

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