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FDA’s quest to regulate CBD.jpg

FDA’s quest to regulate CBD

Through years of inertia, U.S. regulators have allowed the CBD market to become the “Wild West” when they could—and according to many hemp business executives and industry lawyers, should—have intervened long ago.

It’s the year 2024—and Elizabeth Warren is deep into her first term as president of the United States.

Student loans have been forgiven, automobiles are banned in national parks, the Kardashians are on an intergalactic vacation broadcast live via Instagram, and Congress has legalized recreational marijuana.

Buried on the inside pages of The Washington Post, The New York Times and Wall Street Journal: FDA has drafted a rule that, once finalized, will formally authorize the marketing of CBD in dietary supplements. The 2024 rule—a decade late and dollar short—is parodied on “Saturday Night Live” as “stoned” bureaucrats at FDA headquarters taste pot brownies on a 500-page “draft” packet and watch an episode of “The Flintstones” in which Fred fakes an illness.

The French philosopher Voltaire reportedly said, “The best is the enemy of the good.” FDA does not have the luxury of an eternity pondering the “best” or “perfect” rulemaking to police and regulate hemp-based CBD supplements.

Through years of inertia, U.S. regulators have allowed the CBD market to become the “Wild West” when they could—and according to many hemp business executives and industry lawyers, should—have intervened long ago to either actively regulate manufacturers and/or enforce vigorously against companies openly flouting the law.

FDA should establish dosage limits in an expedited rulemaking, but not for the express purpose of solving its growing safety concerns. The agency could, for example, address the “incentives” challenge to invest in costly drugs by setting a maximum level of CBD in supplements markedly lower than the dose in Epidiolex—the CBD medicine GW Pharmaceuticals markets for children with severe forms of epilepsy.

The regulation also would need to preserve the incentives of supplement manufacturers to go to market with an effective dose to promote health and wellness, including yet-to-be-proven structure/function claims for hemp extracts like “occasional sleeplessness.” In other words, the maximum dose allowed in a supplement couldn’t be so low as to eliminate the purported health benefits of non-FDA-approved CBD.

I’m not suggesting FDA would have an easy task or that its regulation would pacify all the stakeholders.

But FDA’s rule need not contain hundreds of pages of new safety requirements for CBD-containing supplements. Instead, the agency should demand compliance with a comprehensive law already on the books: the Federal Food, Drug and Cosmetic Act (FD&C), which has been amended over the years, including through DSHEA.

To read this article in its entirety, check out the “Hemp/CBD: Market evolution” digital magazine.

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