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 you recall, CBD was approved as a drug ingredient in Epidiolex in July 2018, just a few months before hemp and its derivatives became federally lawful. Although it is true that the FDA is required to follow and enforce the FDCA, the agency also has the authority to exempt substances from the Drug Exclusion Rule, at which point the agency can regulate the substance as any other dietary ingredient or food ingredient. In the case of hemp and CBD, the FDA has simply chosen not to act upon this authority.
Since the passage of the 2018 Farm Bill, Congress has repeatedly attempted to compel the FDA to serve its administrative functions by introducing bills that proposed to expressly exempt hemp-infused dietary supplements and/or foods from this federal prohibition.
In 2020, Congress introduced H.R. 5587 and H.R. 8179, bipartisan bills that proposed to exempt CBD products from the Drug Exclusion Rule so they could be regulated as dietary supplements, which failed to pass, thanks in part to COVID and the need to solve more pressing issues.
This year, once again, federal lawmakers came together and introduced versions of H.R. 5587 and H.R. 8179, namely:
- The Hemp and Hemp Derived CBD Consumer Protection and Market Stabilization Act (HR 841) that seeks to authorize the use of CBD in dietary supplements only, provided they meet existing federal requirements imposed on these products.
- The Hemp Access and Consumer Safety Act ( S. 1698), which proposes to legalize the use of hemp-derived cannabinoids, including CBD, in foods and dietary supplements. Specifically, the bill would amend the FDCA definitions of dietary supplement and food to exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from the Drug Exclusion Rule. Moreover, the bill would enable companies to proceed with the FDA’s existing clearance process for these products, namely the New Drug Ingredient Notification and GRAS Notice. S. 1698 would also prioritize consumer protection by requiring these products meet all applicable regulations for products containing hemp cannabinoids and ensure they are properly labeled.
The enactment of these Congressional bills would evidently help alleviate regulatory uncertainties surrounding the legality of hemp-derived products and raise the quality and safety of these products, and thus, assure consumers that these products are safe.
Industry leaders, including the U.S. Hemp Roundtable, the U.S. Hemp Authority, the National Industrial Hemp Council (NIHC), but also national groups such as the Wine and Spirit Wholesalers of America and Consumer Brands Association, and major herbal products associations like the American Herbal Products Association (AHPA), have expressed strong support for one or both of these bills, suggesting a strong likelihood of seeing CBD and hemp-derived products federally regulated by the end of this year – assuming the FDA doesn’t push back on these provisions, further delaying Congress’ ability to finally legalize these products.
We will continue to monitor these bills and keep you informed of future developments.