FDA WARNING_LETTER - The Mad Alchemist LLC - January 29, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Nicole Pennington on January 29, 2021, after reviewing the website alchemistvapeshop.com. The review determined that e-liquid products manufactured and offered for sale, including "BB Queen Concord Grape," "Snow White’s Demise," "Fairy Dust Elixir," and "Ring Master Cotton Candy," are tobacco products under section 201(rr) of the FD&C Act.

These e-liquids are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these 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. 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 100 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm