FDA has announced its latest development on cannabidiol (CBD) food and dietary supplements, concluding that its existing regulatory framework is inappropriate for the regulation of potential products moving forward. The agency also has denied three citizen petitions asking for the agency to engage in rulemaking to allow the marketing of CBD products.
In a statement from Principal Deputy Commissioner Janet Woodcock, the FDA convened its internal working group on CBD products deciding “that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency cited a lack of “adequate evidence” for CBD safety standards, such as product amounts and use, from various public comments and scientific studies. The agency also has now officially declined to engage in rulemaking allowing the use of CBD in animal food.
What does this mean for the CBD market? Those in the CBD market will need an act of Congress before any rules allowing CBD products are federally legal. By declining to engage in rulemaking, the FDA has effectively decided CBD does not fit into any of its existing pathways to introduce new foods or supplements. The agency specifically cited its “limited tools for managing many of the risks associated with CBD products” as to why its regulatory framework does not satisfy its safety concerns for CBD products. The FDA has repeatedly cited “various safety concerns, especially with long-term use” such as harm to liver and CBD exposure to vulnerable populations. Now, the market must look to Congress to introduce legislation to create a new regulatory pathway for “access and oversight” on CBD products before FDA will take steps to approve any CBD dietary supplements or food products.
Our Founding Principal, Courtney N. Moran, LL.M. provided the following comment on this Statement:
The Statement comes as no surprise as the industry has been asking both FDA and Congress to develop a regulatory pathway for CBD and hemp-derived products for years. With the 118th Congress beginning its work, it’s helpful to have this in black and white from FDA, with the affirmative statement they are looking "forward to working with Congress to develop a cross-agency strategy" for regulation. We have seen several pieces of federal legislation introduced in previous Congresses to address this issue, with no movement. We hope this statement from FDA shines a light on the need to create a federal regulatory program for CBD as well as other hemp-derived ingredients and products now.
With the lack of federal oversight to date, states have taken the lead in establishing regulatory frameworks for hemp-derived end products, focusing on providing for consumer safety through a variety of mechanisms such as requiring testing, specific labeling, age limits, and setting concentration limits for products. However, the patchwork of continually changing state regulations makes it challenging for businesses to comply with, creates a gap in enforcement, and further causes consumer confusion. The industry looks forward to broader collaboration with FDA and will continue to advocate for sound federal guidelines that protect consumers while providing opportunities for hemp businesses.
This is a pivotal time for our industry. We are eager to see this Congress address several outstanding issues: the regulation of CBD and hemp derivatives, protecting work-in-progress hemp, addressing the THC limit, creating grain and fiber industrial hemp exemptions, and facilitating approval of hemp ingredients in animal feed.
Have further questions about federal or state regulations on CBD and hemp products? Are you worried about receiving an FDA warning letter? Please schedule a consultation with EARTH Law, LLC to answer any questions regarding these updates, or for help with your 2023 license applications. You can contact us by email at info@earthlawllc.com or by telephone at 541-632-3946.