.CBD DOA: The Food and Drug Administration declines approving CBDs as dietary supplements

The Food And Drug Administration is just as bewildered by CBD as everybody else. That might not be a good thing, but it’s not shocking. CBD is bewildering. It might now be left to Congress to determine how to regulate the component of the cannabis plant that doesn’t get you high, which at the moment is being sold across the country by everyone from major pharmaceutical companies to fly-by-night sleazebags, based on health claims that range from rock solid to straight-up fraudulent.

This month, the FDA declined a request from Charlotte’s Web, a legit producer, for approval of its CBD products as dietary supplements. In its statement, the FDA noted that it had in 2018 approved Epidiolex for sale as a prescription pharmaceutical drug for the treatment of certain kinds of seizures. That marked the first time the federal government approved of a cannabis-derived remedy for sale, but it also meant that the regulator couldn’t then approve similar products for sale as dietary supplements.

At least, so says the FDA. “CBD is the active ingredient in the approved drug product, Epidiolex,” noted Cara Welch, acting director of the FDA’s Office of Dietary Supplement Programs, in the agency’s letter to Charlotte’s Web. “Furthermore, the existence of substantial clinical investigations involving CBD has been made public. Accordingly, your product may not be marketed as or in a dietary supplement.”

That means that, for the time being, CBD will continue to be essentially unregulated. Most legit companies are careful not to make specific health claims about the substance, but it’s sold all over the place, and the skeevier operators tend to make health claims anyway—even-skeevier ones sell oils branded as CBD that contain less CBD than labels indicate, or even none at all. You can buy it at gas stations and at the counter at vape shops. Federal regulation amounts to the FDA occasionally sending out warning letters to outfits making health claims for the products, but that hasn’t stopped CBD from growing into a $6-billion-a-year industry.

Legit producers like Charlotte’s Web want regulation, because that would—at least theoretically—dissuade less-responsible operators from trying to peddle the stuff. The rampant fraud is a huge headache for legit producers, who say the best bet for consumers in states like California with strong regulatory regimes is to buy CBD products from licensed cannabis dispensaries, where the products have been tested and where the labels accurately convey what the products contain.

The Colorado-based Charlotte’s Web was named for Charlotte Figi, whose Dravet syndrome—a form of childhood epilepsy—was successfully treated with CBD, which is most often derived from hemp. Dravet syndrome is one of the maladies for which Epidiolex can be legally prescribed.

The problem for Charlotte’s Web and the legit CBD industry as a whole is that, because of the dearth of research into the medical benefits of cannabis—thanks to pot being illegal—the business exploded despite a lack of knowledge. There are good indications that, besides certain kinds of seizures, CBD can help relieve pain, nausea, insomnia and other ailments. But nobody yet knows for sure how effective it is for those ailments.

The FDA’s decision seems to be the agency’s final word on the matter. In a statement, Charlotte’s Web CEO Deanie Eisner said: “While we disagree with FDA’s reasoning, believing we provided extensive and credible scientific evidence that supported a different outcome, this decision affirms the path to regulatory clarity must come from Congress.”

The U.S. Hemp Roundtable responded similarly. “This should be a clarion call to Congress that it is time to step in and pass legislation to ensure that CBD products are held to the same standard as all dietary supplements and food ingredients.

Of course, those standards themselves are iffy, as a quick look through the supplements aisle at Whole Foods makes clear. The supplements industry is rife with questionable marketing practices; for example, claims that a pill will help you lose weight “without diet or exercise.” But some regulation is better than none, and if CBD is approved as a supplement, it would at least give the feds a basis for taking action against the worst actors.

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