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Is there a way to help ensure the CBD on shelves is safe while the FDA works on regulations?

The U.S. Hemp Roundtable thinks so.

The U.S. Hemp Roundtable has proposed a way to help ensure the CBD products on store shelves are safe while giving hemp extracts greater legitimacy under the federal Food and Drug Administration.

Quick background: After hemp was legalized at the federal level in 2018, the FDA was supposed to establish regulations for CBD products. It hasn’t. Last September, the agency argued that it was in a stalemate position, both required and unable to regulate the compound. Of course, in the years since 2018 an unregulated marketplace has flourished, in which not all products are tested or properly labeled before appearing on store shelves. Although reputable companies are voluntarily holding themselves accountable for testing and labeling, others have been caught with mislabeled ingredients or counterfeit test results.

The U.S. Hemp Roundtable thinks it has the first step toward a solution. Jonathan Miller, general counsel for the Roundtable, sent a letter May 23 to FDA Commissioner Robert Califf. In it, he suggested that the FDA issue an enforcement discretion policy for CBD and other hemp-derived cannabinoids being sold as dietary supplements.

As the term “enforcement discretion” implies, the agency would have discretion over whether to enforce regulations in the context of a complex but relatively low-risk situation.

Four days earlier, FDA head Califf had acknowledged that the FDA has done little to regulate CBD products since hemp was legalized in 2018, telling a House subcommittee, “It looks pretty much the same in terms of where we are now. We just know more because we’ve done more research.”

Although Congress tasked the FDA with regulating sales of CBD, one of the issues holding the agency back is that it’s never approved a compound as both a drug and a dietary supplement. That’s a problem because CBD is approved in a prescription drug treating rare forms of epilepsy in children, Epidiolex.

One of the issues holding the FDA back is that it’s never approved a compound as both a drug and a dietary supplement. That’s a problem because CBD is approved in a prescription drug treating rare forms of epilepsy in children.

The U.S. Hemp Roundtable suggested that recent developments with a different compound might offer guidance toward a solution for CBD.

“You expressed the need to identify a creative approach to this complex issue,” Miller wrote on behalf of the US Hemp Roundtable. “While FDA determines the appropriate next steps, we would like to offer an interim solution ….”

He went on to explain that the FDA recently announced plans to exercise enforcement discretion over dietary supplements containing N-acetyl-L-cysteine (NAC) while it assesses NAC's potential for permanent regulation as a dietary supplement.

What’s NAC? It’s a compound the body can use to build a potent antioxidant, glutathione. The FDA has approved its use as a prescription drug for acetaminophen (Tylenol) overdose. But it’s also sold as a dietary supplement. Importantly, the FDA has said in the past that because NAC is an approved drug its sale as a dietary supplement is technically illegal.

CBD is in an almost-identical situation. It’s been approved as a prescription drug but is also widely available in grocery stores and hemp shops as a supplement. Like NAC, the FDA considers its sale as a supplement illegal.

Could the FDA also exercise enforcement discretion over CBD while it works on a longer-term regulatory framework? That’s what the Hemp Roundtable suggested.

“Today, we ask FDA to take these same actions for dietary supplements that contain legal hemp-derived cannabidiol (CBD) and other lawful hemp ingredients,” Miller wrote, noting that a growing body of data supports the safety of CBD.

The Roundtable requested that the FDA immediately issue a policy of enforcement discretion for non-intoxicating cannabinoids and asked for a meeting with the FDA Cannabis Products Committee to further discuss the request.

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