Addressing safety concerns and legalizing CBD appears unlikely, according to comments on the US Food and Drug Administration’s (FDA) website Thursday.
“We recognize the urgency of establishing a regulatory framework for these products and providing regulatory certainty to consumers and industry,” said Norman Birenbaum, the FDA’s top cannabis expert.
“Historically, there’s been a bipartisan interest in solving this problem, especially as the market evolves,” says Birenbaum, adding that solving CBD issues first rests with Congress, which must decide whether CBD and other cannabinoids in hemp are legal.
Once legality is established, FDA rulemaking is “a very long process,” said Patrick Cournoyer, senior science adviser who chairs the agency’s Cannabis Products Committee.
The FDA is introducing a “harm reduction” approach to hemp-derived cannabinoids that will ensure the safety controls consumers expect, Cournoyer said.
Such a new approach would establish a category for CBD and other hemp cannabinoids outside of the existing categories of drugs, dietary supplements, and food for which the FDA has issued regulations. Cournoyer said such regulations could include content restrictions in the cannabinoid-based regime, truth in labeling, full disclosure of the ingredients in the products, assurances that there are no contaminants, and measures to reduce accidental consumption by children.
The webinar was intended to address questions raised by stakeholders about the agency’s January statement that hemp-derived cannabinoids cannot be regulated until they are legalized.
After the passage of the 2018 Farm Bill, which legalized hemp and all derivatives of the plant, stakeholders repeatedly urged the FDA to release less-advised, non-medical forms of CBD, to no avail.
Review started in 2019.
According to Cournoyer, the agency began looking at CBD in 2019, conducting some internal toxicology studies and reviewing research that is tracking consumer reports of “adverse events.”
The agency said it has reached several safety concerns consistent with those identified by the international scientific community, including potential liver and male reproductive damage, adverse interactions with certain medications, and CBD’s potential for anxiety in vulnerable populations and pregnant women.
“These kinds of safety red flags . . . are not what we typically see with sweeteners or preservatives or emulsifiers,” Cournoyer said. “The safety concerns we’re seeing are that CBD is different from some of the more common food ingredients.”
The FDA is trying to balance “more protective safety standards for food and dietary supplements” with any potential risks from CBD and other smaller cannabinoids like CBG, CBN, and CBC — lesser-known hemp derivatives — that are still growing in popularity. “Mostly unknown,” Cournoyer said.
“The combination of the red flags we see in science and the way these high-security standards are written into law is such that there’s absolutely no risk. It is a very low risk tolerance approach,” he added.
The FDA frequently says CBD products remain illegal to sell because the agency doesn’t approve them, but the products are becoming more common even though they are subject to the federal Food, Drug, and Cosmetic (FD&C) Act. Under that law, the FDA only has jurisdiction if the products fit the categories it regulates, Cournoyer said, adding that only congressional action can determine whether CBD and other hemp cannabinoids are safe to market. Such products will remain in the middle.
A threat to Delta-8
Birenbaum like delta-8 THC and HHC. He responded to a webinar participant who asked about the FDA’s potential position on hemp-derived psychoactive compounds, to say the least, that the market for such products “expanded” last year. It is known about them. Compounds made by processing hemp-derived CBD in the lab have been in the last couple of years, with hemp growers and processors of CBD extracts scrambling to find supplies due to a conflict in the sector. .
Birenbaum said the FDA has received reports of “adverse events” among children consuming such products, and the agency is concerned that some of the products may contain chemical residues. In some cases, the agency has investigated and taken enforcement action, including a ban in Minnesota aimed at removing an estimated $7 million worth of hemp-derived synthetic THC products.
An FDA spokesperson also urged caution when administering CBD or other cannabinoids to livestock, warning that traces of the compound could reach unsuspecting consumers through meat and dairy products through the food chain.