The FDA Releases Final Guidance For Cannabis Drug Development As Advocates Await Rules

That's right. January 23, 2023, is the date of the FDA drug information. Since the draft version was released, the guidance has been revised. It adds clarity to federal sources of cannabis for drug development. Marijuana is not considered a controlled substance by the DEA because it will not meet the federal definition of 'hemp.' There is more flexibility when it comes to legal cannabidiol. 

The National Institute on Drug Abuse contracted suppliers for cannabis as long as they were deemed of adequate quality by the FDA.

Scientists at the University of Mississippi could only get marijuana from one NIDA-approved farm for a long time. More manufacturers have been accepted by the Drug Enforcement Administration, giving researchers a new source of funding for cannabis research. A newly written section of the guidance addresses how to determine if a plant is a marijuana or not. The FDA advises researchers to calculate the delta-9thc content in their proposed cannabis or cannabis-derived components product early in the development process to gain insight into their product's potential cannabis abuse liability and control status.

Even if the starting materials meet the definition of legal hemp, intermediates or drug products that contain greater than 0.3 percent of Delta 8 and Delta-9 THC cannabis by dry weight may no longer meet the definition and may be considered a Schedule I controlled substance.

Farmers and researchers want more flexibility for the total concentration of the drug, as even environmental factors can affect it and potentially push a legal plant into a controlled substance area. Manufacturing processes can affect the final concentration of the drug.

FDA's guidance is meant to explain how new drugs work. There are basic standards for clinical studies, how combustible drug products differ from oral preparations, and more. Advocates, lawmakers, and stakeholders are still waiting to see what actions the FDA will take to allow for the marketing of cannabidiol oil in the food supply or as a supplement.

The chair of the House Oversight in the Senate and Accountability Committee said that he plans to take FDA officials to task for failing to create regulations to allow for such marketing. Late last year, top officials at the agency said they were several months away from releasing a regulatory cannabis assessment. Still, the FDA has maintained that it may take additional legislative work before it can finalize such rules.

FDA officials have said that they are concerned about the long-term safety of cannabis, as well as the impact it might have on pregnant women. 

The rise in popularity of products that the Drug Enforcement Administration says are not controlled substances has complicated rulemaking. The FDA helped a state agency crackdown on a company that they said was linked to "serious adverse events."

The agency sent warning letters to five companies. The government agency did not specify why it targeted those particular 5 cannabis companies out of the many more that similarly market cannabis-infused edibles. However, it said that they sell products that people may confuse for traditional foods or beverages.

In September, the two congressmen sent a letter to FDA Commissioner Robert Califf, demanding answers over the lack of regulations for the use of cannabidiol. The FDA commissioner received a letter from the lawmakers. They were frustrated by the agency's response to their bill, which called for regulating cannabidiol as a Food Additive. Technical assistance from the FDA was sought by the bill's sponsors.

The FDA returned a one-page response four months after they sent the inquiry. At a House Appropriations subcommittee hearing in May, FDA's Califf stated that the situation "looks pretty much the same in terms of where we are now" compared to when he first worked on the issue.

He said the FDA had taken steps to research the safety profile of cannabis to inform future corporate rules. 

Still, he also punted the mass criticism about inaction to Congress. Califf said they would have to develop something new. I want to do that. The FDA is currently conducting a scientific review into cannabis 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 the Drug Enforcement Administration to make a scheduling recommendation that aligns with their findings.

Keywords: FDA, Drug Enforcement Administration, FDA Drug Information, cannabis