Cannabidiol supplements have been on the market for a number of years now. The supplement has taken various forms: oils, tinctures, edibles, and even lotions and other topical applications. The CBD trend rises the more research suggests that this non-psychoactive cannabis component counters struggles like anxiety and depression. CBD is even used to treat life-threatening, rare forms of childhood epilepsy.
GW Pharmaceuticals developed Epidiolex and submitted the drug to the FDA this year. The FDA approved the drug in June, and it will be on market as soon as it receives a schedule and classification. There is a lot of potential for the drug to improve the lives of so many children who would otherwise suffer. CBD’s medical advancement has a couple of specific drawbacks, though, too.
One concern is the cost of the drug – on track to be set at a whopping $32,000 or more annually. Those with Medicaid or who are uninsured are given some considerations, but the company decided on their price to be in line with other epilepsy drugs on the market. That price will certainly impact who can access Epidiolex. But a larger market, those who use CBD supplements available in health and natural goods stores, might see their products disappear completely if GW Pharma or the FDA decide so.
This is possible thanks to an FDA back-channel. If a company investigates the drug potential of a substance already on the market as a supplement, the FDA can give the company exclusive rights to the substance. Similarly, the company itself can request those rights, and if the FDA approves their request, the supplement comes off the market.
The substance in question is cannabidiol – in its entirety. CBD supplements in all forms will be pulled from the market if GW requests it or the FDA decides so. A substance, once made a drug, cannot be sold outside of prescribed medicines approved by the FDA, with few exceptions to that rule.
Exclusions and Complications
One exception is if the supplement hit market before 1994 – which CBD did not – or if supplement companies submitted ‘new supplement notification’ forms with the FDA prior to substance investigation (like GW’s trials). The FDA does not have complete policies on how companies can submit ‘new supplement notifications,’ so those seeking exception do not know how to comply.
Thanks in part to the FDA’s inconsistent and incomplete standards for natural supplement manufacturers, GW Pharma could easily monopolize CBD product availability. Natural supplements people rely on to treat inflammation and emotional stress could be pulled from shelves and online sales, relegated to the world of pharmaceutical companies and expensive prescription drugs.
Change Begins with You
Organizations like The Alliance for Natural Health USA (ANH-USA) encourage direct efforts like writing to Congress and the FDA. ANH-USA recommends writing to local and federal representatives in support of legislation that protects supplements from IND (Investigational New Drugs) exclusivity. Their site includes a fillable form that will return contact information for your representative. Legislators have an obligation to act in the best interest of their constituency. If you use CBD to manage any of the myriad conditions it treats, the time to act to protect your access is now.