On July 21, the U.S. Food and Drug Administration (FDA) released a much-anticipated document that the federal Office of Budget and Management (OBM) had been reviewing since late May.
While the document did not provide an update on regulating consumer cannabidiol (CBD) products, as some in the hemp industry had hoped, it did provide guidance on regulating cannabis in drugs as well as present a new way to calculate tetrahydrocannabinol (THC) in finished products.
The nine-page document, titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” covers sources for clinical research, information on quality considerations and other recommendations for those pursuing investigational new drug (IND) applications and new drug applications (NDAs) for both cannabis and hemp-derived compounds.
Prior to the U.S. Agriculture Improvement Act of 2018 (the 2018 Farm Bill) legalizing hemp and its derivatives, those who wanted to conduct clinical research on any type of cannabis needed to source it from the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP), which is grown under contract by the University of Mississippi at the National Center for Natural Products Research.
The document clarifies that those pursuing INDs and NDAs for hemp—defined to contain no more than 0.3% THC—and its derivatives are now open to source from anywhere compliant with a state or federal hemp plan. Meanwhile, those seeking INDs and NDAs for non-hemp cannabis compounds must still source it from NIDA.
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area,” says FDA Principal Deputy Commissioner Dr. Amy Abernethy. “It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis.”
Except for the title, the content in this latest document from the FDA was private up until its public release July 21.
Due to the FDA’s recent report on products in the CBD marketplace, some in the hemp industry had hoped this latest report would bring about a framework for regulating CBD in consumer products such as dietary supplements and food additives. That, however, is not the case.
“This is our latest disappointment,” says Jonathan Miller, general counsel of the U.S. Hemp Roundtable. “There had been a lot of speculation about what the FDA might be up to. … Many of us were real hopeful this might be the long-awaited effort to regulate CBD as a dietary supplement. Unfortunately, this document—this public guidance—is exclusively focused on CBD as a drug and does not have any applicability as a food additive or dietary supplement.”
Despite its mention of cannabinoid research, as well as operating within a legal hemp framework, some think the document overall has little implication for the CBD industry.
“I don’t think this is a directive to the CBD industry other than messaging that is conveyed through a lack of action. FDA has invested in addressing the cannabis regulatory scheme, but the investments do not yet appear to support finding a path of compliance for the manufacture and sale of hemp-derived CBD products as a food or supplement. This continues to be very frustrating for the industry,” says Stef Fogel, a partner at global law firm DLA Piper. “The FDA has commented that it recognizes the importance of CBD to the market, but the agency’s public comments do not appear to provide an indication of upcoming regulatory change or guidance.”
In addition, while the report clarifies how researchers may pursue INDs and NDAs for cannabis above the 0.3% THC threshold, it does little to revise the arduous process.
“The medicinal aspects of the cannabis plant might extend beyond products that are just derivatives from federally legal hemp, so I still think that developers of drugs are going to want to study cannabis that doesn't comport with the definition of hemp. And I still think they're going to continue to face the challenge of how [to] source that product given that, to date, the DEA still hasn't opened up the research supply of cannabis that they said they were going to in recent years,” says Jonathan Havens, a partner at Maryland-based law firm Saul Ewing Arnstein & Lehr LLP.
THC Limit Discussions
A sole silver lining from the document for the hemp and CBD industries may come in the FDA’s discussion of how to calculate THC levels for finished products.
The FDA says calculating the THC limit in products by dry weight is “not appropriate” for finished products. Instead, it recommends basing the calculation of the delta-9 THC percentage on “the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.”
“I think there's a broader discussion here about FDA's comment on how delta-9 THC is calculated and what, if any, impact that has on the ability of folks to develop products and study cannabis and its derivatives without blowing that delta-9 THC [limit],” Havens says.
Miller says he plans to consult with a team of scientists to uncover whether the recommended calculation could provide an advantage for CBD products down the road, such as dietary supplements or food additives.