FDA WARNING_LETTER - Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid - January 15, 2021

On January 15, 2021, the FDA issued a Warning Letter to Kevin Lynch, based on a review of the website https://www.drcrimmy.com. The FDA determined that e-liquid products, specifically "Project S" and "Rootbeer Float," were manufactured and offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation identified is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 19,700 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and