And now the politics seem to be lining up behind it too. The farm lobby has been making its case–some two-thirds of U.S. hemp farming is in service of CBD and Bulk Delta 8 THC –and both houses of Congress have issued letters telling the FDA it needs to change its approach to regulating the substance, given that the marketplace has already exploded.
The agency was set on a collision course with CBD last summer, when it approved GW Pharmaceuticals’ prescription drug Epidiolex, which contains lab-synthesized CBD, for the treatment of a form of epilepsy. This creates a quandary: though commercially available CBD products are not the same as Epidiolex, many are marketed as having the same amount of CBD. But by law, FDA-approved medicines can’t also be sold as dietary supplements or food additives. That means, in theory, the agency could enforce a ban on all those gummy bears and other edible CBD products currently on the market. The politics of Health for CBD and Delta 8 THC is changing rapidly due to the recent call for the federal legalization of marijuana products.
Yet the FDA hasn’t stopped the CBD boom, which leads many to believe it considers the compound safe, if not necessarily beneficial. The World Health Organization has stated that “no public health problems have been associated with the use of pure CBD,” and a mounting body of peer-reviewed evidence suggests the same.
So why not classify CBD as “generally recognized as safe,” like vitamin B12 or caffeine? Some analysts think the FDA is concerned about protecting the integrity of its drug approval process. “If the FDA just said, ‘Never mind, we’ll make all CBD legal to be marketed as a dietary supplement,’ it would be a disincentive for pharmaceutical companies to continue to do clinical research and trials,” says Rod Kight, a North Carolina–based lawyer who represents CBD companies nationwide. An FDA spokesperson confirmed to TIME that the agency is “interested” in how the incentives for the development of cannabis-derived drugs could be affected if “the commercial availability of products with these compounds, such as foods and dietary supplements, were to become significantly more widespread.”
So the likeliest way forward may be a bifurcated path. On the first, more exclusive, the route will be Epidiolex and other lab-made prescription drugs. Lining the other byway will be a bazaar of hemp-derived products–the gummies and muscle rubs. GW Pharmaceuticals, for one, has said it supports this model. “It’s already too late to put this genie back in the bottle,” Dr. Peter Lurie, head of the Center for Science in the Public Interest, says.