Gates Calderon, Kaplan & Sellers: FDA Says Again that Hemp Extracts Containing CBD Cannot be Marketed as a Dietary Supplement
The CBD industry is still trapped in a regulatory tangle with no clear pathway out following the Food and Drug Administration’s denial of requests by Charlotte’s Web and Irwin Naturals to market hemp extract containing CBD as a dietary supplement. FDA released these denials on August 11, 2021, with no press, but the message is clear: products cannot contain CBD (even as part of a full spectrum hemp extract) and be marketed as dietary supplements. Furthermore, FDA asserted that the submitted evidence was insufficient to reasonably expect that the product is safe. Without Congressional action, the industry must continue to operate in a legally gray area.