The irrational enthusiasm for the medical use of cannabidiol, or CBD, is unique and frightening. We are watching the explosive creation of a multi-billion dollar industry poised to make tremendous profits off desperate patients and their loved ones.
I commend the Food and Drug Administration for tackling the enormous challenge of creating a regulatory pathway for cannabis-derived products. Congress had products like these in mind when it passed the Food, Drug and Cosmetic Act in 1906. Yet, even a century ago, people couldn’t have imagined the deceptive advertising we’re seeing today for CBD.
Anecdotes and testimonials, not science, are driving the marketing of unregulated, nonprescription forms of CBD. This scenario is reminiscent of 19th century patent medicines. These concoctions claimed to cure every known condition; their peddlers were commonly known as “snake oil” salesmen.
The CBD industry is sidestepping the great advances made over the past 113 years to subject health claims to careful investigation. It’s the manufacturer’s responsibility to provide accurate information to the public and ensure the safety, efficacy, and purity of health-related products.
The FDA must require CBD product manufacturers making health claims to subject their products to robust preclinical and clinical trials, and ultimately submit their data to FDA for review and, if appropriate, clearance for marketing.
I recognize that if CBD-based products are made available only through a prescription, they will be more expensive and more difficult to access. But CBD products for medicinal use should be of the highest quality — meaning they won’t be cheap to manufacture or sell. Safety is paramount; we should not cut corners for the sake of reducing costs. Patients and their clinicians have fought for and deserve the ability to rely upon the FDA’s regulatory process and enforcement mechanisms when making decisions about what they ingest to improve their health and treat disease.
I enthusiastically support the development of cannabinoid-based medicines, but today, scientific support for using these unique chemicals for medical purposes is scant, outside of three seldom-used FDA-approved drugs.
At present, there are no robust clinical studies that demonstrate safety and efficacy, no dosing guidelines, and no standardized products to assess concentration and purity for CBD. Every “dose” is different due to wide variations in the amounts of CBD, tetrahydrocannabinol or THC, other potentially active ingredients, additives, and toxins that are present in these products. The public deserves to know what they’re buying and consuming.
It is also of deep concern that the THC levels in most CBD products, even those derived from the hemp plant, could upend the drug testing systems currently in place in substance use disorder treatment centers, the workplace, the transportation sector, and elsewhere in which safety is paramount. We may increasingly find ourselves in situations where people using marijuana in violation of legal statutes or employer regulations claim that they tested positive for marijuana because their CBD product must have contained THC.
An unregulated CBD industry thus creates a wide-open path for that bogus defense, but also for the wrongful termination of employees who did nothing wrong. For people using CBD products with no knowledge or expectation that they contained THC could be fired from their jobs due to testing positive on drug screens. Those unjust terminations could follow them for the rest of their lives.
We are sitting back while a tidal wave of CBD seems to be making its way into everything from candy bars to cappuccinos, claiming to cure all ills. Shouldn’t this set off alarms? What other medicine or health product cures everything?
I urge FDA to respond to this need to protect all Americans through the Food, Drug and Cosmetic Act mandate. Use the tools the organization already has in place to subject CBD to the same scrutiny faced by other products making health claims.
The public health demands this. The country deserves it.
Robert L. DuPont. MD, is a former director of the NIH National Institute on Drug Abuse and president of the Maryland-based Institute for Behavior and Health.