Cloud Chasers Apothecary LLC – FDA Warning Letter, Jan 29, 2021

On January 29, 2021, the FDA issued a Warning Letter to Curtis Glardon regarding e-liquid products sold on https://ccapothecary.com. The FDA determined that products like Wizard’s Choice, Manhattan, CranPeary, and Riverside are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being offered for sale without the required premarket authorization order, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.