Although consumer appetite for CBD-containing products continues to grow, and the market for such products correspondingly expands, 2020 may be another year in which the regulatory roadmap remains unsettled. On one hand, legal hemp production is is expected to increase, as the USDA is in the process of reviewing hemp production plans submitted by various States and Tribes authorized under the 2018 Farm Bill. Furthermore, a majority of states now allow the use of CBD, and a new bipartisan bill, H.R. 5587, sponsored by Rep. Collin Peterson (D-MN) has been introduced in the House of Representatives. The proposed legislation (full text here) would amend Federal Food, Drug and Cosmetic Act to recognize edible hemp-derived CBD products as a dietary supplement. Such developments would loosen some restrictions on the marketing of CBD products and surely support the growth of hemp-derived CBD industry in 2020.
On another front, the most recent budget request by the Trump Administration, combined with the increase in FDA warning letters in late 2019 alleging unlawful marketing of CBD products, indicates a turbulent regulatory path for manufacturers and sellers. The FDA previously expressed concerns that a lack of appropriate processing controls and practices in the industry pose a real risk to consumers. Yet, it has exhibited reasonable restraint in bringing enforcement or a litigation action against such companies, appearing to focus on those companies making the most serious types of medical claims about their CBD-containing products or using CBD as a food additive.
The Trump Administration budget request for 2020-2021 hints that such restraint may soon be tested. With the Administration appearing to earmark $5 Million to prioritize activities relating to the regulation of cannabis and cannabis derivatives, and simultaneously focusing on “tracking and tracing of food from farm to fork,” the FDA will likely continue to ramp up its regulatory and enforcement efforts to review health and safety issues relating to the CBD containing products.
The Takeaway
We are witnessing a brewing conflict between Congress and the FDA about how to treat commercialization of the hemp-derived CBD products, with some uncertainty about what the future holds. While the regulatory frameworks governing this industry will not remain settled in 2020, what remains certain is that FDA will continue to initiate enforcement actions against companies that market their CBD products using unproven medical claims, and may target companies using CBD as an additive to food or drinks.
At Fox Rothschild and the In the Weeds blog, we will continue to follow these developments, and bring you the most up-to-date information on the “state of play” in the hemp and CBD industries. For further information about the FDA’s regulation of Cannabis and CBD-Containing Products, I encourage you to review this helpful page on the FDA’s website.
This post was co-authored by Shahnam Sharareh, PharmD, RAC, a Princeton, NJ-based Partner in Fox Rothschild’s Intellectual Property and Pharma & Biotech practices.
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