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It appears that the new path to the legal CBD market in the US will be a long one

Fixing safety issues and setting a legal path for CBD doesn’t appear to be coming any time soon, according to comments during a webinar hosted by the US Food & Drug Administration (FDA) Thursday.

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

There has historically been a bipartisan interest in addressing this issue, particularly as the market has evolved, said Birenbaum, who noted that resolving CBD-related issues rests first with Congress, which must decide whether CBD and other cannabinoids inherent in hemp are legal.

Patrick Cournoyer, senior scientific adviser who leads the agency’s cannabis products committee, noted that even once the legality is established, the FDA regulation that would follow is a lengthy process.

Damage reduction

The FDA is promoting a harm-reduction approach to hemp-derived cannabinoids that would ensure the kind of safety controls 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, dietary supplements, and foods. Cournoyer said such rules in a specific cannabinoid regimen could cover content limits, truth in labeling, full disclosure of ingredients in products, assurances that they do not contain contaminants and measures to mitigate accidental ingestion by children.

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

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

Overhaul started in 2019

According to Cournoyer, the agency began looking into CBD in 2019, conducting some internal toxicology studies and reviewing existing research while also monitoring consumer reports of adverse events.

He said the agency had come to several safety concerns consistent with those pointed out by the global scientific community, such as potential damage to the liver and male reproductive system, adverse interactions with some medications, and concerns about the effects of CBD on vulnerable populations and women. pregnant.

These types of safety red flags are . . . not what we typically see for typical food ingredients like sweeteners or preservatives or emulsifiers, Cournoyer said. Safety concerns were seeing CBD separated from some of the more common types of food ingredients.

Balancing act

The FDA is struggling to balance highly protective safety standards for foods and dietary supplements with the potential risks posed by CBD and other minor cannabinoids such as CBG, CBN and CBC – lesser known hemp derivatives that are becoming increasingly popular as the effects in humans remain largely unknown, Cournoyer said.

It’s a combination of red flags that we see in science and the way these highly protective safety standards are written into a statute that actually allows for no risk. It’s a very minimal type of risk tolerance path, he added.

The FDA has repeatedly said that the sale of CBD products remains illegal because the agency has not approved them, but the products have proliferated despite being subject to the federal Food, Drug and Cosmetics (FD&C) Act. Under that law, the FDA only holds jurisdiction if products fall into the categories it regulates, Cournoyer said, reiterating that only congressional action can determine whether CBD and other cannabinoids in hemp are safe enough to be marketed. This leaves those products caught in the middle.

Concerns about delta-8

Responding to a webinar attendee who asked about the FDA’s potential position on synthetically produced psychoactive compounds made from hemp, Birenbaum noted that the market for products such as delta-8 THC and HHC has come in rapidly over the past year, and that little is known about them. The compounds, made by putting hemp-derived CBD through a lab process, have spread wildly over the past two years as hemp flower growers and CBD extract processors desperately seek an outlet for supplies stifled by a persistent slump in the sector .

Birenbaum said the FDA has received numerous reports of adverse events among children who have consumed such products and that the agency is concerned that some contain chemical byproducts and residues. 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 $7 million worth of hemp-derived synthetic THC products from the market. of dollars.

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

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