# FDA WARNING_LETTER - DNA Distributors, INC - October 12, 2021

Source: https://www.keypedia.com/records/warning_letter/dna-distributors-inc/43a8587d-6fe6-46f4-a3ab-16fefa81f156

> FDA WARNING_LETTER for DNA Distributors, INC on October 12, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DNA Distributors, INC
- Inspection Date: 2021-10-12
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On October 12, 2021, the FDA issued a Warning Letter to DNA Distributors, Inc. following a review of submissions and inspection records. The FDA determined that DNA Distributors, Inc. manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products "Just Juice Regular Tobacco - 24mg 30ml," "Just Juice Strawberry - 24mg 30ml," and "Just Juice Watermelon - 12mg 30ml" were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports under section 905(j) is a prohibited act under section 301(p).

DNA Distributors, Inc. is a registered manufacturer with over 100 products listed with the FDA. The FDA emphasizes that

## Related Officers

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

Company: https://www.keypedia.com/companies/dna-distributors-inc/f2e2a69c-3efb-474d-98f1-158dbdfca1bf

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