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U.S. Hemp Roundtable Calling On FDA to Apply “Enforcement Discretion” for CBD Products

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Written by The CBD Insider

Referencing the FDA’s recent decision to use enforcement discretion for the antioxidant N-acetyl-L-cysteine (NAC), which legally frees the amino acid to be included in dietary supplements, sold, and consumed, the U.S. Hemp Roundtable is suggesting the FDA could approach CBD in the same way while Commissioner Robert Califf devises a regulatory pathway. 

As the FDA defines it, enforcement discretion describes a situation in which an article that technically qualifies for FDA regulation enforcement is not subjected to these requirements because of an overwhelming consensus that the associated safety risks are negligibly low.

In a letter to the FDA written today (Mar 23), the U.S. Hemp Roundtable’s general counsel drew parallels between N-acetyl-L-cysteine, which qualified for enforcement discretion because of the amino acid’s well-established safety profile, and CBD, which has by now accrued an ample array of safety studies painting a similarly innocuous picture. 

“The Roundtable requests that FDA take the same incremental steps for CBD and issue a similar policy of enforcement discretion for dietary supplements that contain CBD,” wrote Jonathan Miller, General Counsel for the US Hemp Roundtable. “We also request that the Agency consider a rulemaking to provide that CBD is lawful in dietary supplements.”

One legal obstacle in doing so involves the stipulation that any “article” previously approved or investigated as a drug (FDA approved CBD drug Epidiolex for seizures) cannot be included in the legal definition of “dietary supplement,” but as pointed out in the letter, the FDA is also empowered to explicitly include said article(s), which it may do for NAC.

The tone coming from the Roundtable and other industry supporters is decidedly more hopeful than it has been at previous opportunities such as this one, mostly because of the Roundtable’s expressed optimism for the intent of FDA Commissioner Califf to address the frustrating post-Farm-Bill stalemate that has shackled many in the hemp industry.

“It looks pretty much the same in terms of where we are now,” said Califf of 2018-era CBD regulations during a recent budget request hearing, before adding, “I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”

Apply discretion in the short term while formulating more robust regulatory oversight, says U.S. Hemp Roundtable and supporters, and the CBD industry can wait more patiently as it enjoys the added breathing room.

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