FDA has just submitted its much-awaited “Report in Response to Further Consolidated Appropriations Act, 2020,” cannabidiol (CBD) report to the Senate and House Appropriations Committees (enclosed here as an attachment), and Peter, Patricia and I wanted to give you our initial reaction as quickly as possible.
This report, to fulfill FDA’s requirement to provide an update on the agency’s evaluation of potential regulatory pathways for CBD products and efforts to gather data to support evaluation of a policy of enforcement discretion is disappointing but not unexpected. FDA continues to commit only to continued exploration of a regulatory pathway. It is clear that even after over a year of working on this, the agency is far from making a decision about whether or how to propose a regulatory pathway for dietary supplements containing CBD.
The one bright spot is the agency's commitment to develop a process, whereby proprietary product-specific safety information can be submitted to FDA without being made public. It is disappointing, however, that FDA did not discuss providing a mechanism for submission of NDIs.
Further, after submitting this report to appropriators today, FDA Commissioner Hahn sent an update to all congressional offices (attached and available at this link). That message was much less specific and, in some ways, detracted from the Appropriations report in that it focused more on the risks of using CBD products rather than how to fulfill consumer demand for safe products.
We believe the FDA report and statement should bolster our case to Congress that it needs to take prompt legislative action to protect consumers and provide clarity to the marketplace by making CBD, hemp extracts and other hemp-derived cannabinoids legal dietary ingredients subject to all other relevant requirements of the Food, Drug, and Cosmetic Act.
Here are further notes on other points of interest in the Appropriations report:
A dietary supplement pathway
Specifically, FDA says it is “actively considering potential pathways for certain CBD products to be marketed as dietary supplements.”
Noting that the law allows an exemption [the so-called 321(ff) provision] so that the agency could allow CBD dietary supplements through a rule-making, even though a CBD drug has already been approved, FDA says it is “actively evaluating what and how much data would be sufficient to support a conclusion that CBD can be safely allowed in dietary supplements under certain conditions.”
Use in Foods
The agency is not enthusiastic about CBD in foods for animals and humans, saying, “The data currently available to FDA raise concerns about the use of CBD in foods.” FDA encourages submission of data on the conditions of use under which CBD would be added to foods.
Continued Safety Concerns
FDA indicates that one of its top priorities has been to evaluate the safety of CBD for all available sources. The agency then cites on-going concerns about potential liver toxicity, drug-drug interaction, male reproductive issues, and drowsiness which could affect driving. FDA is particularly concerned about the effects of sustained and/or cumulative exposure to CBD [which seems to remain as FDA’s primary question]. FDA will be establishing a “clear process by which proprietary information regarding specific products can be submitted to the agency,” which could help inform the agency’s future direction. FDA is also re-opening the May 2019 public docket to accept safety information.
The report indicates that FDA’s time period for evaluating a DS pathway is “over the coming months” and during that time it will also be considering issuance of a “risk-based enforcement policy” that would provide “greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rule-making.” In the interim, the FDA plans to “initiate and expand appropriate compliance and enforcement action against unlawful CBD products that pose the greatest risk of harm to the public.”
Noting a lack of uniformity in the definition of such products, FDA says it is actively seeking information from manufacturers and trade groups about the process by which they are derived, the content of the extracts and how they compare to CBD isolates.
Mechanism for Sharing Proprietary Product-Specific Safety Data
In a positive development, FDA says is working to develop a process to protect proprietary product-specific safety data.
FDA says it is actively working to generate data to help inform its CBD work. It will launch a study this year through its National Center on Toxicological Research on the effect of CBD on pregnancy, FDA is also doing a study through UNPA MOU partner, the National Center for Natural Products Research at Ole Miss, on cosmetic applications of CBD.
Additional Next Steps - Factors to be Considered
These include: Potential health impacts of exposure if CBD products are used over a long period of time and what measures could mitigate those risks; the impact of a potential rulemaking on FDA’s ability to provide adequate and effective oversight of DS in general and CBD products in specific; FDA’s inability to know what products are on the market [no doubt a tie-in to the mandatory listing proposal]; funding for the Office of Dietary Supplement Programs and FDA because of the new workload that would be generated; and how FDA can inform consumers of where the agency does and does not have regulatory oversight.
Our take on the FDA report
While FDA is clearly advancing its CBD/hemp extracts knowledge base, it is still moving slowly. The market stresses now being felt by farmers, extractors and brand holders requires a much more rapid timeline to clarify a regulatory pathway and open that pathway.
UNPA will continue to urge Congress (and FDA) to act swiftly to allow industry to formally file new dietary ingredient submissions (by congressional action). Otherwise, farmers and our industry will suffer the financial impact of continued regulatory uncertainty, and consumers will not be properly protected by the full exercise of FDA’s regulatory authority.
The objectives of the 2018 farm bill will not be realized unless Congress takes a final step, this year, to confirm the regulatory status of CBD, hemp extracts and other cannabinoids.