# FDA WARNING_LETTER - Smoke Brake Vapes, LLC - July 16, 2019

Source: https://www.keypedia.com/records/warning_letter/smoke-brake-vapes-llc/1b186c1e-40cc-4378-b966-7e78801692a7

> FDA WARNING_LETTER for Smoke Brake Vapes, LLC on July 16, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Smoke Brake Vapes, LLC
- Inspection Date: 2019-07-16
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Smoke Brake Vapes, LLC on May 18, 2019, following a review of their website, https://www.smokebrakevapes.com. The FDA determined that the e-liquid products sold are tobacco products under the FD&C Act.

The company was cited for two primary violations:
1.  **Sales to Minors:** An investigation revealed that a person younger than 18 years of age purchased "Blue Raspberry" e-liquid from the website, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act.
2.  **Failure to Include Required Nicotine Warning Statement:** The labeling and/or advertising for several e-liquid products, including "Blue Raspberry," "Pineapple Xpress," and "Silly Rabbit," among others, failed to include the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or (b), making the products misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Tracy Riffel](https://www.keypedia.com/people/tracy-riffel/733d0874-49d4-4e82-b136-28701696be3e)
- [Joseph Wright III](https://www.keypedia.com/people/joseph-wright-iii/88d95fcb-c3b7-4520-9971-2c78618355b8)

Company: https://www.keypedia.com/companies/smoke-brake-vapes-llc/8e9d340a-df7d-434b-997b-df67ad8699eb

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