# FDA WARNING_LETTER - SIMPLYEJUICE, LLC d/b/a Simply E-Juice - April 30, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/simplyejuice-llc-dba-simply-e-juice/b11ea172-872c-48fe-9c55-3cf188c68ae2

> FDA WARNING_LETTER for SIMPLYEJUICE, LLC d/b/a Simply E-Juice on April 30, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SIMPLYEJUICE, LLC d/b/a Simply E-Juice
- Inspection Date: 2021-04-30
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Steven Manley regarding e-liquid products sold on https://simplyejuice.net. The FDA determined that e-liquids, including "Simply Bodacious Blueberry" and "Simply Glorious Grape," are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. A "new tobacco product" is defined as one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after that date. Since the identified e-liquids were not commercially marketed by February 15, 2007, and lack FDA marketing authorization, they are deemed 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 200 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to address these violations may result in regulatory actions such as civil money penalties

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/simplyejuice-llc-dba-simply-e-juice/c8560cfa-4b3a-4544-baee-3f613f78a47d

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