# FDA WARNING_LETTER - Be Smokeless LLC d/b/a Southwest Smokeless - October 05, 2023

Source: https://www.keypedia.com/records/warning_letter/be-smokeless-llc-dba-southwest-smokeless/4a90c82f-08f6-4fb9-991d-f234301593a5

> FDA WARNING_LETTER for Be Smokeless LLC d/b/a Southwest Smokeless on October 05, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Be Smokeless LLC d/b/a Southwest Smokeless
- Inspection Date: 2023-10-05
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: This FDA Warning Letter, dated October 5, 2023, was issued to Be Smokeless LLC d/b/a Southwest Smokeless for manufacturing and distributing e-liquid products, specifically "Appletini," without the required premarket authorization. The Center for Tobacco Products determined that these e-liquid products, containing nicotine from any source, are "tobacco products" under the FD&C Act and require FDA marketing authorization. The "Appletini" e-liquid is considered a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks the necessary FDA marketing authorization order or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notices or information. Furthermore, the marketing of adulterated/misbranded products in interstate commerce (section 301(k)) and the failure to provide required reports (section 301(p)) constitute prohibited acts. The FDA requires the firm to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.

## Related Officers

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

Company: https://www.keypedia.com/companies/be-smokeless-llc-dba-southwest-smokeless/9800389d-a96c-4ecf-bed0-8d358e944224

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