# FDA WARNING_LETTER - JP & SN Enterprises Inc. d/b/a eCigs International - December 22, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/jp-sn-enterprises-inc-dba-ecigs-international/f1a3db69-d5a7-4c45-9c35-748bb535e9a1

> FDA WARNING_LETTER for JP & SN Enterprises Inc. d/b/a eCigs International on December 22, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: JP & SN Enterprises Inc. d/b/a eCigs International
- Inspection Date: 2022-12-22
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On December 22, 2022, the FDA issued a Warning Letter to JP & SN Enterprises Inc. d/b/a eCigs International for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that their "ZEN JUICE Absalom" e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The company failed to obtain a marketing authorization order under section 910(c)(1)(A)(i) or demonstrate an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided per section 905(j). The failure to provide such a report is a prohibited act under section 301(p).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

## Related Documents

- [WARNING_LETTER - 2021-05-18](https://www.globalkeysolutions.net/records/warning_letter/jp-sn-enterprises-inc-dba-ecigs-international/b20e6c7f-c766-4f4a-8081-0df6e7f0184d)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/jp-sn-enterprises-inc-dba-ecigs-international/a4f8e2a3-c652-4335-b5af-087d08ea7aec

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