FDA WARNING_LETTER - Moonlight Vapers - May 18, 2022

On May 18, 2022, the FDA issued a Warning Letter to Moonlight Vapers, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Moonlight Vapers' "Fruit Rollup e-liquid products" are "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products are being sold without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. The letter states that the failure to provide such a report is a prohibited act under section 301(p).

Moonlight Vapers, a registered manufacturer with over 300 listed products, is required to ensure all its tobacco products comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days, detailing actions taken