# FDA WARNING_LETTER - mjm distribution inc  - May 28, 2021

Source: https://www.keypedia.com/records/warning_letter/mjm-distribution-inc/40231b66-3bc7-45fa-b745-d6b5f9b40c71

> FDA WARNING_LETTER for mjm distribution inc  on May 28, 2021. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: mjm distribution inc 
- Inspection Date: 2021-05-28
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On May 28, 2021, the FDA issued a Warning Letter to Michael Cotellese of MJM Distribution, Inc., following a review of their website, https://mjmdistribution.net. The FDA determined that e-liquid products, specifically Artifact Vapor Craft e-liquids: Buckland, Skullflower, and Widow's Walk, were manufactured and offered for sale or distribution in the U.S. without the required premarket authorization.

These e-liquids are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they require a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or an exemption, neither of which was in effect. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 50 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 11

## Related Officers

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

Company: https://www.keypedia.com/companies/mjm-distribution-inc/ad465cac-f642-4cc5-88e4-37010301e6fc

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