FDA WARNING_LETTER - Cloud Hempistry - October 19, 2022

The FDA issued a Warning Letter to Cloud Hempistry on October 19, 2022, following a review of submissions and inspection records. The FDA determined that Cloud Hempistry manufactures and distributes e-liquid products, specifically Cloud Hempistry Honey Circles, Cloud Hempistry Forest Fruit, and Cloud Hempistry Pumpkin Spice, which are deemed tobacco products under the FD&C Act.

The core violation is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization from the FDA. Consequently, these products are cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of a marketing authorization order or a substantial equivalence report. The failure to provide such a report is also a prohibited act under section 301(p).

The FDA requires Cloud Hempistry to submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.