‘New path’ to market for legal CBD in U.S. looks like it will be a long one

Resolving safety issues and setting a legal path for CBD looks like it won’t come anytime soon, according to comments during a webinar held by the U.S. Food & Drug Administration (FDA) Thursday.

“We understand the urgency of establishing a regulatory framework for these products and providing regulatory certainty to consumers and industry,” said Norman Birenbaum, a senior advisor who is the FDA’s cannabis expert. 

”Historically there’s been bi-partisan interest in addressing this issue, particularly as the market has evolved,” said Birenbaum, who noted that resolving issues regarding CBD rests first with Congress, which must decide if CBD and other cannabinoids inherent in hemp are legal.  

Patrick Cournoyer, Senior Science Advisor who leads the agency’s Cannabis Product Committee, noted that even once legality might be established, FDA rulemaking that would follow is “quite a long process.”

‘Harm reduction’

FDA is promoting a “harm reduction” approach to hemp-derived cannabinoids that would ensure the kind of safety controls that consumers expect, according to Cournoyer. 

Such a new pathway would establish a category for CBD and other hemp cannabinoids outside of the current categories for which the FDA sets rules: drugs, food supplements and food. Cournoyer said such rules under a cannabinoid-specific regime could cover content limits, truth in labeling, full disclosure of ingredients in the products, assurances that they contain no contaminants, and measures to mitigate accidental ingestion by children.

The webinar was intended to address questions raised by stakeholders following a January statement by the agency that it could not regulate hemp-derived cannabinoids unless they are declared legal by legislation. 

Following passage of the 2018 Farm Bill that legalized hemp and all of the plant’s derivatives, stakeholders have repeatedly urged the FDA to set regulations for less concentrated non-medical forms of CBD, to no avail.

Review started in 2019

According to Cournoyer, the agency started looking at CBD in 2019, conducting some internal toxicology studies and reviewing existing research while monitoring reports of “adverse events” by consumers. 

He said the agency arrived at several safety concerns consistent with those indicated by the global scientific community such as potential harm to the liver and male reproductive system, adverse interactions with certain medications, and worries over CBD’s effects on vulnerable populations and pregnant women. 

“These types of safety red flags are . . . not what we normally see for typical food ingredients like sweeteners or preservatives or emulsifiers,” Cournoyer said. “The safety concerns we’re seeing set CBD apart from some of the more run-of-the-mill types of food ingredients.”

Balancing act

FDA is endeavoring to balance “highly protective safety standards for foods and dietary supplements” with any potential risks posed by CBD and other minor cannabinoids such as CBG, CBN and CBC — lesser known hemp derivatives that are rising in popularity while the effects on humans remain “largely unknown,” Cournoyer said.

“It’s a combination of red flags we see in science and the way these highly protective safety standards are written in statute that really do not allow for any risk at all. It’s a very minimal type of risk tolerance pathway,” he added.

FDA has repeatedly held that CBD products remain illegal to sell because the agency has not approved them, but the products have proliferated despite being subject to the Federal Food, Drug and Cosmetic (FD&C) Act. Under that law, FDA holds jurisdiction only if the products fit into categories that it regulates, Cournoyer said, repeating that only Congressional action can determine if CBD and other hemp cannabinoids are safe enough to be marketed. That leaves such products caught in the middle.

Concerns over delta-8

Responding to a webinar participant who asked about the FDA’s potential stand on synthetically produced psychoactive compounds made from hemp, Birenbaum noted that the market for such products – such as delta-8 THC and HHC – “arrived rapidly” over the past year and that little is known about them. The compounds, made by putting hemp-derived CBD through a process in the lab, have spread wildly over the past two years as growers of hemp flowers and processors of CBD extracts desperately seek an outlet for supplies pent up by a lingering crash in the sector

Birenbaum said the FDA has received numerous reports of “adverse events” among children who consumed such products, and that the agency has concerns that some contain byproducts and chemical residue. In some cases, the agency has investigated and taken enforcement action, including a crackdown in Minnesota that recently led to an embargo aimed at removing hemp-derived synthetic THC products valued at $7 million from the market.

The FDA spokesmen also urged caution on administering CBD or other cannabinoids to livestock, warning that traces of the compound could reach unwitting consumers via the food chain through meat and dairy products.

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