# FDA WARNING_LETTER - D & C Beckley, Inc d/b/a Kickin’ Ash Vapors - August 12, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/d-c-beckley-inc-dba-kickin-ash-vapors/80b7619b-1e93-4410-9996-4b030decea68

> FDA WARNING_LETTER for D & C Beckley, Inc d/b/a Kickin’ Ash Vapors on August 12, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: D & C Beckley, Inc d/b/a Kickin’ Ash Vapors
- Inspection Date: 2021-08-12
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to D & C Beckley, Inc d/b/a Kickin’ Ash Vapors for manufacturing and distributing an e-liquid product without required premarket authorization. The FDA determined that the "Kickin’ Ash Vapors Cinnamon Danish 3mg e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under sections 910(a) and 910(c)(1)(A)(i) of the FD&C Act, new tobacco products require a marketing authorization order or an exemption (e.g., substantial equivalence). The identified e-liquid product lacks this authorization, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The FDA emphasized that the firm, a registered manufacturer with over 200 listed products, is responsible for ensuring all its tobacco products comply with the FD&C Act. Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/d-c-beckley-inc-dba-kickin-ash-vapors/403cf756-5149-4e7d-8625-19b2c09c03e0

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