CBD: FDA Advisor Calls For Fair Rules Amid SAMSHA's Critical Report On Side Effects And Unknowns

The Food and Drug Administration (FDA) announced in January it will not regulate CBD as a food and dietary supplement ingredient and that it plans to work with Congress to create "safeguards and oversight to manage and minimize risks related to CBD products."

While this announcement did nothing to the existing status of CBD products, people across all spheres of the industry found it to be a disappointing move. After all, they have been waiting since 2018 for the FDA to come up with rules. But instead, the agency passed the ball off to Congress.

Less than a month after the report, in the virtual discussion titled “Regulating Hemp Cannabinoids Cannabinoids: Opportunities and Challenges," hosted by the Council for Federal Cannabis Regulations (CFCR), FDA senior public health advisor Norman Birenbaum discussed the challenges around CBD regulation.

Potential Harms

Birenbaum, former director of cannabis programs for New York, former cannabis czar for Rhode Island and founding president of the Cannabis Regulators Association, raised concerns over the potential for CBD to cause liver toxicity, reproductive problems, drug and metabolic interactions, first reported Cannabis Wire.

“These are concerns that we don’t have in the food category and that we don’t have in the dietary supplement pathway. And it’s not appropriate for these products to be under those regulatory frameworks,” Birenbaum said.

Congress legalized non-psychoactive hemp (cannabis with less than 0.3% delta 9 THC) in the 2018 Farm Bill signed into law by Trump. CBD is one of the compounds that can be derived from hemp. Nevertheless, after several years of careful review, it turns out it was impossible to establish similar regulations for CBD as it exists for foods and supplements.

“This industry is a large industry,” Birenbaum said, adding that consumers have “folded these products into their daily lives” and “we need to make sure that consumers are aware of the potential risks.”

Pandora’s Box

To make things more complicated, the 2018 Farm Bill turned out to be Pandora’s box, opening doors to a lot of other cannabinoids, not just CBD. For example, delta-8 THC and delta-9 THC, which are chemical components of the cannabis plant that occur naturally in small concentrations and can produce mild psychoactive effects in some people similar to delta-9 THC (the compound that gets you high).

New industrial methodologies enable delta-8 THC to be converted from CBD derived from hemp. Products developed as a result of the 2018 federal Farm Bill that legalized hemp are therefore not subject to the same testing requirements as cannabis, creating a legal loophole. Problems connected to delta-8 THC have mostly to do with the question of safety. It takes a proficient and experienced chemist to ensure the safe conversion of CBD molecules into THC molecules. Inappropriate or imprecise techniques can potentially result in dangerous impurities in the final product.

“It made a new world for all hemp derivatives,” Birenbaum said, referencing delta-8 and delta-10 products, which he called extraordinarily concerning.

“We’re seeing products that just didn’t exist several months ago come into the market, and they have been associated with adverse events that have resulted in hospitalizations or in some cases even death,” Birenbaum said. “This industry is very innovative. And consumers and industry participants deserve the regulatory certainty that can come with an appropriate regulatory pathway.”

Birenbaum reiterated what has been said across the industry and by the FDA on multiple occasions, the industry needs more research. On the other hand, he is aware that something needs to be done sooner rather than later to make the existing market safer.

Not Letting Perfect Be The Enemy Of Good

“At the center of what we are hoping to put in place with Congress is a regulatory framework that takes into consideration the realities of the market, the realities of consumers right now, and is focused on harm mitigation. It is not saying we need to understand every single facet of the safety profile of this product, but being able to say to consumers, here’s what we don’t know or here’s what we do know, here is what the risk profile may be,” Birenbaum said,

“There is a huge wide open lane to move down in terms of pursuing harm reduction and harm mitigation and not letting the perfect be the enemy of the good.” 

Federal Health Agency Issues Advisory On CBD

Meanwhile, a federal health agency Substance Abuse and Mental Health Services Administration (SAMSHA) has issued a new advisory on “Cannabidiol (CBD) – Potential Harms, Side Effects, and Unknowns,” reported Marijuana Moment. In the announcement, SAMSHA notes that the purpose of the advisory is to inform the public about how CBD is derived, and how it differs from delta-9 THC and other cannabinoids.

“The advisory focuses on the risks and harms of CBD, especially those sold over the counter,” the agency wrote. “This advisory also clarifies common misconceptions about CBD, given its broad availability and marketing for several medical conditions despite limited evidence of efficacy. It is critical that the general public be made aware of the potential harms associated with CBD use, and parents, in particular, should be advised to not let their children use non-FDA-approved CBD products.” 

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