The Food and Drug Administration (FDA) has released its finalized guidance on developing cannabis-based drugs, outlining the process and unique considerations for scientists when it comes to hemp and marijuana.
The guidance—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—was announced in a notice set to be published in the Federal Register on Tuesday. The agency previously released a draft version that went through a White House review in 2020.
Part of the reason for the guidance is the federal legalization of hemp in the 2018 Farm Bill, which makes the drug development protocol different for that version of the cannabis crop than it is for marijuana, which remains in Schedule I of the Controlled Substances Act (CSA).
“This guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research,” FDA said. “This guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs.”
FDA made several non-binding recommendations for researchers interested in developing cannabis drugs that could go to market. The advice is “intended to address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.”
Today, FDA issued a final guidance which provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds: https://t.co/wCsVRpi8J6 pic.twitter.com/F2UgQXY9uO
— FDA Drug Information (@FDA_Drug_Info) January 23, 2023
The guidance has been revised since the draft version’s release. It adds clarity around federally authorized sources of cannabis for drug development purposes, for example.
As a general rule, cannabis containing no more than 0.3 percent THC by dry weight meets the federal definition of hemp and is not considered a controlled substance like marijuana, which continues to fall under the purview of the Drug Enforcement Administration (DEA).
To that end, there’s more flexibility as it concerns sourcing federally legal hemp. Such products don’t need to come from the limited number of National Institute on Drug Abuse- (NIDA) contracted suppliers for marijuana as long as they are “deemed to be of adequate quality by FDA.”
The agency points out that for “many years,” scientists could only get marijuana from one NIDA-approved farm at the University of Mississippi. DEA has since accepted more manufacturers, giving researchers “new sourcing option” as they pursue cannabis research.
There’s also a new section of the guidance that addresses calculating THC to distinguish hemp from marijuana. FDA largely defers to DEA on the matter, but it also advises researchers to “calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product early in the development process to gain insight into their product’s potential abuse liability and control status.”
Early analysis may prove “useful,” but FDA noted that, “even if the starting materials meet the definition of hemp, intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight may no longer meet the definition of hemp and may be considered Schedule I controlled substances.”
Farmers and researchers have highlighted that concern and called for additional flexibility for the total THC concentration, as even environmental factors can affect THC levels and potentially push a legal crop into a controlled substance territory. Extraction and other manufacturing processes can also inadvertently influence final THC concentration.
Overall, FDA’s guidance is meant to walk people through its regulatory mechanisms and explain how investigational new drugs work. It details basic standards for clinical studies, how combustable drug products differ from oral preparations, storage requirements for researchers and more.
Meanwhile, advocates, lawmakers and stakeholders are still waiting to see what actions, if any, FDA will take to allow for the marketing of hemp-based products like CBD oil in the food supply or as dietary supplements.
Rep. James Comer (R-KY), who chairs the House Oversight and Accountability Committee, said recently that he plans to take FDA officials to task over their failure to enact regulations to allow for such marketing.
Late last year, top officials at the agency said they are months away from releasing a regulatory assessment on the issue, though FDA has maintained that it may take additional legislative work before it’s able to finalize such rules.
FDA officials have said that a couple of points that they are assessing concern whether CBD can be used safely in the long-term, and what impacts consumption might have during pregnancy. The rise in popularity of delta-8 THC products, which the Drug Enforcement Administration (DEA) says are not controlled substances, has further complicated rulemaking.
FDA recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”
In November, the agency sent warning letters to five companies that sell foods and beverages containing CBD.
The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf in September, demanding answers over the continued lack of regulations for CBD for those purposes.
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.
After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said
At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”
All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect DEA to product a scheduling recommendation that’s consistent with their findings about its risks and benefits.
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