FDA Presents Potential Framework For CBD, From Edibles To Delta-8, Reaffirms Congress Is In Charge

The U.S. Food and Drug Administration has not given up on regulating CBD and hemp-derived products in a way that would be safe for consumers and producers. Last week, the administration held a virtual panel “A New Way Forward for Cannabidiol and Other Hemp Products” for stakeholders, reported Cannabis Wire.

The panel came some four months after the FDA stated that it will not regulate CBD as a food and dietary supplement ingredient and that it intends to collaborate with Congress to establish "safeguards and oversight to manage and minimize risks related to CBD products."

Challenge Of Regulating CBD

The new panel, with Patrick Cournoyer, senior science adviser in charge of the FDA's Cannabis Product Committee addressed the causes that led to the previous statement. The administration is now reiterating its intention to work on a “harm reduction approach rather than what is essentially a harm elimination approach.” 

“We’re not talking about marijuana here or changing the federal status of marijuana through this work. We’re simply talking about the products that were descheduled and were descheduled in a way that left them lacking an appropriate regulatory framework,” Cournoyer said.

Norman Birenbaum, a senior public health advisor was also involved in the panel’s question and answer section.

What is the legal status of hemp? Under the 2018 Farm Bill, hemp became legal and defined as containing 0.3% or less THC (the compound that makes you high) by dry weight. Shortly thereafter, the hemp or CBD industry kind of exploded. CBD, a different cannabinoid found both in cannabis and hemp, is viewed as providing various health benefits. But, the hemp industry didn’t stop there, it also started exploiting other cannabinoids like cannabigerol (CBG), cannabinol (CBN), and cannabichromene (CBC). At the same time, cannabis is considered a Schedule 1 drug under federal law.

To make things more complicated, the FDA approved Jazz Pharmaceuticals' JAZZ Epidiolex, which is a CBD-based drug for treating children with severe forms of epilepsy.

Epidiolex was initially approved for treating seizures connected to Lennox-Gastaut and Dravet syndromes and in 2020 for treating seizures related to tuberous sclerosis complex. Under the Food, Drug and Cosmetic Act, it remains illegal to sell and advertise food or dietary supplements that contain a drug approved for a medical indication, making regulations for CBD products more complex and challenging.

Nonetheless, CBD products are still widely sold from pharmacies to gas stations to online sites. “It’s essentially a form of self-medication that is motivating a lot of people to use CBD,” Cournoyer said. 

Panel Key Takeaways 

• It’s up to Congress, but the FDA is willing to collaborate on everything from CBD edibles to pet and delta-8 products;

• CBD must meet safety standards for ingredients in food and supplements;

• The FDA found “important safety concerns” with CBD’s potential to negatively affect the liver, and male reproductive system, and potential for drug interaction;

• Other high concerns include regulating products that are high-appealing to children;

• Synthetic cannabinoids make “a serious public health issue and a solution is urgently needed;” The administration is ready to work with Congres on it. 

• A potential new framework could contain a “basic degree of regulatory oversight,” precise labeling standards, CBD content limits, and more;

In the meantime, the administration plans to continue taking action against CBD producers that present “immediate risk.” On several occasions, the FDA sent warning letters to various CBD companies. 

More details on the FDA's CBD regulations can be found on Cannabis Wire.

Related links: 

FDA's Scarce CBD Regulations, MO Weed Measures, Cannabis In NJ, Kratom's Legal Statues & More 

FDA Funds Cannabis Study; NIDA Confirms 5 Entities Seek $25M Contract To Supply Research Weed 

Photo: Benzinga edit with images by IRA_EVVA on Shutterstock and Zebulon Rogerson on Wikimedia Commons