# FDA WARNING_LETTER - James Audi d/b/a The Broke Smoker - October 22, 2019

Source: https://www.keypedia.com/records/warning_letter/james-audi-dba-the-broke-smoker/cb65b617-6d8f-406a-9f07-f0496aa02ad5

> FDA WARNING_LETTER for James Audi d/b/a The Broke Smoker on October 22, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: James Audi d/b/a The Broke Smoker
- Inspection Date: 2019-10-22
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to James Audi, operating as The Broke Smoker, on September 27, 2019, following a review of the website https://www.thebrokesmoker.com. The FDA determined that e-liquid products sold on the website are tobacco products subject to FDA jurisdiction.

The letter identifies three primary violations:
1.  **Sales to Minors:** BrokeSmoker Hawaiian Juice, BrokeSmoker Doublemint, and BrokeSmoker Sweet Tart e-liquid products were sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the products misbranded under section 903(a)(7)(B) of the FD&C Act.
2.  **Failure to Include Nicotine Warning on Product Packages:** Packages for BrokeSmoker Hawaiian Juice, BrokeSmoker Doublemint, and BrokeSmoker Sweet Tart e-liquid products lacked the required nicotine warning statement ("Warning: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(a). This also misbrands the products under section 903(a)(7)(B) of the FD&C Act.
3.  **Failure to Include Nic

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Joseph Robertson](https://www.keypedia.com/people/joseph-robertson/b20c8326-bc11-4afa-9a68-15a954f7ec28)

Company: https://www.keypedia.com/companies/james-audi-dba-the-broke-smoker/ba94c21b-6448-46c1-803e-ed041304d65a

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