# FDA WARNING_LETTER - Mystic Juice USA LLC - August 31, 2021

Source: https://www.keypedia.com/records/warning_letter/mystic-juice-usa-llc/181a1039-fe43-4a63-9dc1-982f51daaf91

> FDA WARNING_LETTER for Mystic Juice USA LLC on August 31, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mystic Juice USA LLC
- Inspection Date: 2021-08-31
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Christopher Schmitz regarding e-liquid products manufactured and sold by Mystic Juice USA. The FDA reviewed the website mysticjuiceusa.com and determined that e-liquid products, specifically "Mystic Juice Jolly Hard Candy" and "Mystic Juice Razzleberry," are tobacco products under section 201(rr) of the FD&C Act.

These products are considered "new tobacco products" because they were not commercially marketed in the United States as of February 15, 2007. The FDA found that these e-liquid products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt from this requirement. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,100 listed products, to ensure compliance with the FD&C Act and FDA regulations for all tobacco products, labeling, and advertising across all platforms. Failure to correct these violations may result in regulatory actions, including civil money penalties, no-tobacco-sale orders, seizure, and/or injunction. The FDA

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Christopher Schmitz](https://www.keypedia.com/people/christopher-schmitz/27f6f21f-4579-494e-a648-f24ebe58cdfa)

Company: https://www.keypedia.com/companies/mystic-juice-usa-llc/b662fd43-1d8a-47de-9974-c1292f98d5cb

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