FDA Responds to Congress and Seeks Guidance About CBD
Editor’s Note: In this article, Kight Law attorney Kamran Aryah addresses the FDA’s report to Congress last week about CBD. While acknowledging the FDA’s apparent willingness to work with the industry to create fair rules, Kamran reminds us that the proof is in the proverbial pudding and that industry engagement is crucial. -Rod Kight
Recent developments suggest that the FDA may finally be willing to make some progress toward allowing a wider range of products containing CBD to get to market. Unfortunately, the most recent “Report to the US House Committee on Appropriations and the US Senate Committee on Appropriations” on Cannabidiol (CBD) (Report) did not represent a substantive policy shift by the Agency. It remains a violation of the Food Drug and Cosmetics Act (FDCA) to introduce food products to which CBD has been added into interstate commerce, and products containing CBD cannot be marketed as dietary supplements.
For the first time, the FDA has acknowledged that it may reconsider its position on Dietary Supplement labeling, stating: “Under current law, CBD products cannot lawfully be sold as dietary supplements, but FDA has the authority to remove this exclusion through rulemaking.”
The FDA continues to justify its prohibition on marketing CBD as a dietary supplement by highlighting the lack of information on many issues pertaining to CBD, such as potential drug interactions and the possibility of a general “negative impact” of CBD on human health. Many of these concerns have been dispelled by the World Health Organization (WHO), which considers CBD to be safe.
As an effort to bridge this supposed information gap, the FDA has declared its desire to get industry feedback, stating in the Report:
“…for CBD, we currently lack much of the product-specific information that is submitted to FDA for dietary supplements containing new dietary ingredients.”
The FDA acknowledges that some of these product formulations and processes may be proprietary, and has demonstrated a renewed commitment to establish a clear process to protect relevant proprietary information to encourage companies to share product information with the Agency.
“It is our hope that this process will enable responsible industry participants to share relevant information with FDA about specific products, which could help inform appropriate regulatory steps.”
While I have been skeptical and even questioned the motives of the FDA in the past, I will think we should take it at its word on this one. The FDA has realized that it simply cannot regulate this industry out of existence, and that its resources are better put toward expanding transparency and creating new legal avenues for CBD products to get to market. To this point, FDA Commissioner Hahn acknowledged that CBD products are here to stay in a public statement on February 27, 2020 :
“We have to be open to the fact that there might be some value in these [CBD] products and certainly American’s think that’s the case. But we want to get them information to help them make the right decisions.”
In addition to information about product formulation, the FDA seeks honest feedback from the industry to inform its policy on full and broad spectrum hemp extracts, which we’ve written about extensively.
“We are actively seeking information from individual manufacturers, trade groups, and others regarding the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products. Such information will be critical to informing our evaluation of the regulatory status of such products.”
This represents a significant shift by the FDA, which has not previously acknowledged the distinction between CBD isolate and hemp extracts containing it. The FDA has further acknowledged that this information can be proprietary, and that for some companies exposing the information could be detrimental to their businesses. The FDA is attempting to present itself as a “partner” to the industry with the Report, looking to foster a sense of trust and commitment to protecting proprietary information submitted by companies that might be helpful to the FDA’s understanding of the CBD industry.
“To this end, we are working to establish a clear process by which proprietary information regarding specific products could be submitted to the Agency, with appropriate protection against disclosure of trade secret or confidential commercial information.”
This appears to be the most forthright and honest representation of what the FDA does and does not know about CBD at this point, and a distinct shift in tone when talking about the future of the industry.
Of course, actions speak louder than words and it remains to be seen whether the FDA will respond to the comments and information it receives in as earnest a fashion as it has asked for them. The best way for the industry to respond is to give the FDA everything it asks for. The FDA received over 4,500 comments pertaining to hemp and CBD as a result of the May 2019 hearing, and comment session that followed. In line with its stated goal to promote open communication with the industry, the FDA has opened the docket for comment again, leaving it open indefinitely this time.
The FDA’s failure to regulate represents perhaps the biggest bottleneck for our industry. Let’s do our best to help it open up the floodgates for safe, legal hemp and CBD products to reach the market. If you have questions about the FDA, how to submit a comment, or the impact of FDA policy on your hemp business, please contact the CBD lawyers at Kight Law Office. We are happy to consult with you on these matters.
March 9, 2020
This post was written by Kight on Cannabis attorney Kamran Aryah. Kight on Cannabis is a law firm founded by attorney Rod Kight that represents legal cannabis businesses. You can contact us by clicking here.