# FDA WARNING_LETTER - Adirondack Juice LLC d/b/a Adirondack Vapor & Co. - May 25, 2021

Source: https://www.keypedia.com/records/warning_letter/adirondack-juice-llc-dba-adirondack-vapor-co/11b0963f-c4ca-4a75-b8f7-3aebf767b98e

> FDA WARNING_LETTER for Adirondack Juice LLC d/b/a Adirondack Vapor & Co. on May 25, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Adirondack Juice LLC d/b/a Adirondack Vapor & Co.
- Inspection Date: 2021-05-25
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Shane Carter of Adirondack Vapor on May 14, 2021, following a review of their website, adirondackvapor.com. The FDA determined that e-liquid products manufactured and sold by the company are tobacco products under the FD&C Act, subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid products Placid, 24 Karat, and Peace were found to be commercially marketed without an FDA marketing authorization order, as they were not commercially marketed in the U.S. as of February 15, 2007. This renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 5,800 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations could result in civil money penalties, seizure, and/or injunction. The company is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products, and their plan for maintaining compliance.

## Related Officers

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

Company: https://www.keypedia.com/companies/adirondack-juice-llc-dba-adirondack-vapor-co/9904128e-d641-4f1e-a75c-1fccc088dc80

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