It has been well over two years since Congress enacted the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which legalized the commercial production of hemp and tasked the Food and Drug Administration (the FDA) with the regulation of hemp-derived products intended for human consumption. Nevertheless, the FDA has yet to carve a legitimate legal pathway for these products.
The FDA’s failure to fulfill its regulatory authority has resulted in the creation of a vastly unregulated market in which many products’ safety is questionable and where states have had to take up the reins by developing their own sets of rules and regulations for the manufacture, sale, and marketing of these products. This, in turn, has resulted in a patchwork of requirements that have made it incredibly difficult – if not impossible – for the industry to ensure compliance.
The FDA has attempted to justify its failure to regulate hemp-derived products, particularly CBD products, by hiding behind the Food, Drug and Cosmetic Act (the FDCA), which prohibits any new dietary ingredient, food, or beverage from entering the U.S. market if it has been studied and approved by the agency as a drug ingredient (the Drug Exclusion Rule) – if