Alibi V.28 No.30 • July 25-31, 2019 

Cannabis Manual

Go Easy

FDA regulation of CBD inches forward

experiment

A recent Gallup poll found that a majority of Americans want cannabidiol aka CBD made available as an over-the-counter drug. But authorities say that their enthusiasm to rush approval through could be misplaced.

In June, Gallup reported that 39 percent of those polled wanted to see CBD made available to adults, 21 percent thought it should be available by prescription only and only 2 percent—that’s not a typo—are CBD teetotalers who don’t believe CBD should be available at all.

Strangely, a whopping 36 percent didn’t even know what CBD was, despite its seeming ubiquity. That skewed the data some, leaving us with 61 percent of respondents in favor of adult (over age 21) availability, 33 percent calling for prescription-only CBD and just 4 percent on the anti-CBD bandwagon.

The CBD love train is comfortably chugging down the track. You can find the compound all over the place—in coffee shops, health food stores and your grandmother’s medicine cabinet. It has been touted as a treatment for pain, anxiety, acne, neurodegenerative diseases and cancer symptoms.

Over one year ago, the US Food and Drug Administration approved Epidiolex, a drug that is used to treat seizures in children suffering from Lennox-Gastaut syndrome and Dravet syndrome. The active ingredient in that drug is none other than CBD.

For activists, the approval of Epidiolex was a sign of something shifting behind the curtain. A federal agency had approved a compound—that is derived from cannabis—as a medicine. The government would have to start tap dancing around its own words with a quickness to avoid contradicting itself.

The rush continued earlier this year when the Farm Bill legalized hemp, making hemp-derived CBD legal for the first time. But the FDA was quick to remind everyone that their previous win—the approval of Epidiolex—meant that CBD was considered a pharmaceutical drug and so couldn’t be included in over-the-counter consumables until more research is conducted. (Tap, tap, tap.)

That rubbed many in the cannabis industry the wrong way, but it’s also a great example of wanting to eat your cake and have it, too. If CBD is medicine, then it should be treated as such. No one, after all, would want an unscrupulous company injecting experimental pharmaceuticals into candy bars and sports drinks without supervision. It probably shouldn’t be any different with this issue.

Nevertheless, millions of Americans are consuming CBD each and every day, and so far, no untoward side effects have been reported. If anything, the pile of anecdotes that illustrate its effectiveness as a medicine seems to grow ever larger.

And with an uncharacteristically responsive attitude, the FDA seems to be taking action in regard to instituting regulations. In May, it held its first public hearing to discuss CBD regulations. That hearing lasted nearly 10 hours and brought forward testimony by business owners, researchers, hemp farmers and consumer advocates. There was a great deal of discussion about the veracity of health claims made by CBD manufacturers.

The FDA has yet to make public any final decisions about regulating CBD, though. In June, the agency did publish a press release titled “FDA Is Committed to Sound, Science-based Policy on CBD.” The article was written by Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller. It seemed to be preparing consumers for a substantial wait while the compound is thoroughly tested.

“While we recognize the potential benefits of CBD,” the piece reads, “questions remain regarding its safety. During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. Furthermore, unsubstantiated therapeutic claims—such as claims that CBD products can treat serious diseases—can lead consumers to put off getting important medical care.”

Apparently lawmakers weren’t happy with that sentiment. In late June, a policy amendment compelling the FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations” cleared the House of Representatives.

Meanwhile former FDA chief Scott Gottlieb said claims that CBD could calm down pets were “pretty hokey” during an appearance on CNBC’s “Fast Money.” The claims’ “hokiness” have yet to be tested.

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