# FDA WARNING_LETTER - American Wholesale Distribution, Inc. d/b/a Lunar E-Cigs - April 14, 2020

Source: https://www.keypedia.com/records/warning_letter/american-wholesale-distribution-inc-dba-lunar-e-cigs/82499d04-ffbb-46ad-b73e-628dd4d78735

> FDA WARNING_LETTER for American Wholesale Distribution, Inc. d/b/a Lunar E-Cigs on April 14, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: American Wholesale Distribution, Inc. d/b/a Lunar E-Cigs
- Inspection Date: 2020-04-14
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to David Ross on March 6, 2019, following a review of the website https://lunar-ecigs.com, which offers e-liquid products for sale in the U.S. These products are classified as tobacco products under the FD&C Act.

The letter identifies two primary violations:
1.  **Sales to Minors:** The "Caramel Stardust 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.
2.  **Failure to Include Required Nicotine Warning Statement:** Numerous ENDS and e-liquid products advertised on the website lacked the mandatory warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or (b), leading to misbranding under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act.

The FDA requires immediate corrective actions for these and similar violations, including discontinuing violative sales, labeling, and advertising

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Acting Director](https://www.keypedia.com/people/ele-ibarra-pratt/c1e13bd6-9779-4877-a361-7b4bac089697)
- [David Ross](https://www.keypedia.com/people/david-ross/e496b541-eb3f-437d-a3af-b97a4f18d61c)

Company: https://www.keypedia.com/companies/american-wholesale-distribution-inc-dba-lunar-e-cigs/53341e73-8c49-4ee4-90f6-871d2fa3c495

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