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Why It's Critical that the FDA Act on CBD

June 18, 2019

A year ago, the U.S. Food and Drug Administration (FDA) approved the medical use of cannabidiol (CBD) to treat epileptic seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome – two of the most difficult-to-treat forms of childhood-onset epilepsy – in patients 2 years of age or older. This was a major breakthrough. Children with these syndromes have historically not responded well to available medications. This new drug approval addressed a long and urgent search for therapies that would reduce the frequency and impact of seizures.

My concern today is that this important medical development may come to be seen as a glaring exception rather than the rule when it comes to CBD-related pharmaceuticals. Even though CBD is being used widely in various products in the marketplace, we do yet have a reasonable pathway for the approval of appropriate therapeutic applications that contain CBD and widespread misunderstanding and lack of knowledge regarding the substance is making it difficult to create one.

Because CBD occurs naturally in the flower of cannabis, a certain stigma is attached even though CBD is a safe, nonaddictive substance from a plant with a long history of therapeutic benefits.

CBD is commonly confused with tetrahydrocannabinol (THC), the cannabis compound that causes a person to become intoxicated or feel “stoned.” CBD and THC act in different ways on different brain receptors. While THC causes the intoxicating “high” that the public normally associates with cannabis, CBD can actually lessen or neutralize the psychoactive effects of THC.

This confusion is standing in the way of essential medical progress that could affect patients with a range of illnesses. Given the lack of public awareness regarding the differences between CBD and THC, both substances are enmeshed in the national debate surrounding the legalization of marijuana for medical and recreational use.

And by not creating a pathway for approval of safe and effective medications containing CBD, a potentially perilous environment is being created for consumers. Throughout the country, many different compounds containing CBD are readily available over the counter as a food additive, much like one would take vitamins, with various claims of health benefits. Because these uses of CBD are not regulated, the level of purity in these compounds is unknown and many of them actually can contain varying quantities of the psychoactive THC. Yes, by allowing worries over THC to slow progress in approving CBD-focused treatments, we’re actually making Americans more vulnerable to the “high” version of cannabis.

Without the FDA’s seal of approval, some of these unregulated compounds can easily be confused for medical CBD, putting the users at risk.

This confusion, and the continuing national debate over marijuana legislation with all of its social baggage, has stymied appropriate and necessary research and policy development around medical applications of CBD. We’re seeing very little federally supported research, and no policy regarding CBD therapies is emerging from federal agencies or major national advocacy organizations. We’re at a standstill.

This has to change. Patients shouldn’t have to suffer because potential game-changing treatments are being blocked by a marijuana debate that actually has nothing to do with CBD. Organizations like the National Academy of Science or the American Public Health Association need to launch a national conversation about the benefits of CBD and how we can spur research and deliver safe medicines to the public. It is time to build a consensus around recommendations to Congress and the administration on how to use CBD to protect and promote public health.

I am thrilled for the children who will receive treatments that can prevent devastating epileptic seizures. But we should all be distressed if those kids turn out to be an anomaly rather than the beginning of a new wave of healthcare breakthroughs. A new avenue of medical progress is right in front of us, but we need to get past the needless barriers that are preventing us from traveling it.

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