This article was originally published on Hoban Law Group, and appears here with permission.
This article is authored by managing attorney, Garrett Graff.
Finished products containing hemp-derived ingredients are becoming increasingly popular as a myriad of products have and continue to enter the market since the passage of the Agriculture Improvement Act of 2018 (“2018 Farm Bill”). The 2018 Farm Bill reserved regulatory authority over finished products that contain hemp-derived ingredients to the U.S. Food and Drug Administration (“FDA”), where FDA generally regulates products based upon the product type and intended use. Unfortunately, at this time, the FDA has not issued specific regulations for products that contain hemp-derived cannabidiol (“CBD”).
Finished products are not a category of their own; rather, finished products that contain hemp-derived ingredients fall under existing regulatory lanes for conventional products. Specifically, finished products are typically either a food, a supplement, a cosmetic, or a drug. Drugs impose the highest standard and require products to successfully complete clinical trials for efficacy purposes. At this time, FDA-approved Epidiolex is the only …