Syndicated Columnists

Don’t let ‘anything goes’ rule in the CBD industry

CBD products on the market today include personal lubricants, lollipops and body lotion.
CBD products on the market today include personal lubricants, lollipops and body lotion. The New York Times

Years ago, I was a leukemia patient and bone marrow transplant recipient confronting an extremely difficult decision: Do I continue down an uncontrolled, life-threatening spiral caused by wasting syndrome (persistent and potentially fatal weight loss), or do I try an unproven, unregulated, illegal and potentially toxic approach: cannabis?

My oncologist was reluctant to make a recommendation because of the lack of credible information, not to mention safety and legal concerns. But as a scientist with decades of experience at pharmaceutical companies, I chose to roll the dice.

I opted to try “medical” cannabis based on anecdotal reports from my hematologist, colleagues and friends, despite my anxiety over inhaling what was at the time an unregulated substance with no evidence-based science to support its use, nor assurances against harmful contaminants. I was fortunate then, and subsequently opted to serve as commissioner on the Maryland Medical Cannabis Commission, in an effort to ensure no one else would have to take such a gamble in deciding on a treatment.

Both my career and my experience as a patient have given me a unique perspective as to how cannabis and cannabis-derived products such as cannabidiol, or CBD, should be regulated. CBD, a cannabis plant extract that doesn’t cause intoxication, is now being touted as a potential fix for everything from anxiety to inflammation. It’s added to lotions, oils and gummy candies, and is even sold as an additive for your coffee.

But regulators are beginning to recognize the dangers inherent in our current “anything goes” environment of unregulated CBD products: The Food and Drug Administration held a day-long hearing on the issue on May 31.

A 2017 paper in the Journal of the American Medical Association highlighted the lack of quality and consistency in CBD products — something that poses risks to consumers. Standardizing formulations in compliance with good manufacturing practice is one of many critical needs. Experts are calling for the creation of a national standard for CBD, while others focus on label standardization and the need to incorporate into the CBD category rules that currently regulate dietary supplements, foods and cosmetics. I strongly agree with these experts.

Much of the data we rely on today for safety, efficacy, bioavailability and human abuse potential was generated by traditional drug development companies that committed the time and expense required to conduct robust pre-clinical and clinical trials. Society must continue to support these types of traditional research protocols for all medical products.

I would like to suggest a “three-lane highway” approach that would enable the FDA to work within its existing structure to create a regulatory framework for CBD products:

First, the “slow lane”: Purified, high-concentration products are defined as drugs and are required to undergo robust clinical trials to demonstrate safety and efficacy in ways that meet the agency’s standards.

Next, the “middle lane”: Lower-concentration oral dosage forms are regulated as dietary ingredients or foods.

Last, the “fast lane”: Topical dosage forms are regulated as cosmetics.

While all patients deserve the ability to make informed decisions through conversations with their physicians, the most vulnerable patients with serious conditions require assurances that the safety and effectiveness of the medical products they take have been established. This can be achieved through the FDA’s stringent regulatory process.

Perhaps the best incentive for the continuance of traditional research was removing from the Controlled Substances Act both hemp and hemp derivatives, which contain less than 0.3% tetrahydrocannabinol or THC, the intoxicating substance that induces marijuana’s psychological effects.

Another very important incentive could be giving automatic fast track status to all cannabis-based investigational products, or treating them as if they had “breakthrough therapy” designation, which would expedite their development and review — if they show promise and are intended to treat a serious condition.

The FDA has a unique role to play at this moment in history, and I recommend the agency follow words that have inspired me throughout my career and my life: listen, anticipate, guide.

We don’t need 50 different sets of state regulations. But we do need to protect patients against having to take the risks that I did in terms of safety, efficacy, potency, product integrity and the myriad unknowns that exist with today’s unregulated CBD products. Today’s patients should not be forced to leave the comfort and relative safety of the existing medical system in order to seek potential relief, as I once was.

Debby Miran is a former member of the Maryland Medical Cannabis Commission.