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

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