# FDA WARNING_LETTER - Big Ds Vape House - June 11, 2019

Source: https://www.keypedia.com/records/warning_letter/big-ds-vape-house/d3fb7c5e-edd7-4e40-9c5c-8f6467933c40

> FDA WARNING_LETTER for Big Ds Vape House on June 11, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Big Ds Vape House
- Inspection Date: 2019-06-11
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On May 17, 2019, the FDA issued a Warning Letter to Dennis Carman of Big D's Vape House, LLC, following a review of their website, bigdsvapehouse.com. The FDA determined that e-liquid products, specifically Banana Nut Bread e-liquid, were manufactured and offered for sale or distribution in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act.

The letter cited two primary violations:
1.  **Sales to Minors:** The Banana Nut Bread e-liquid was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
2.  **Misleading FDA Approval Claims:** A statement on the website's search engine description, "Big D's Vape House Sells FDA approved handcrafted e-juice and vaping supplies since June 14, 2014," violates section 301(tt) of the FD&C Act (21 U.S.C. § 331(tt)). This statement misleads consumers into believing the tobacco

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Dennis Carman](https://www.keypedia.com/people/dennis-carman/b24d2e77-551c-47b7-9c55-2cbf2498bc3b)

Company: https://www.keypedia.com/companies/big-ds-vape-house/638fa05e-be6a-4dc5-a469-baf879e5416e

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