Let me start with the regulatory status of CBD (right, not fish oil). CBD, the non-psychoactive ingredient of marijuana or industrial hemp, which supposedly treats everything under the sun now. Putting aside any claims of efficacy, what is its regulatory status?
The 2018 Farm Bill removed cannabis with extremely low concentrations of THC from the definition of marijuana in the Control Substances Act. Marijuana and industrial hemp are cultivated from the same species. Hemp and recreational cannabis are essentially the same plant. Industrial hemp has low concentrations of the psychoactive component, THC (less than 0.3%). The Farm Bill expanded the definition of hemp from stalky cannabis plants with small leaves to any cannabis plant with less than 0.3% THC. Sale of CBD from cannabis which has less than 0.3% THC no longer violates the Control Substances Act.
What about heat from any other federal agencies? Any challenges? Well, yes, one from the FDA.
Amy Abernathy, MD, PhD, Principal Deputy FDA Commissioner said:
“At present, any CBD food or purported dietary supplement products in interstate commerce is in violation of the FD&C Act.”
The reason:
Epidiolex.
Epidiolex is a CBD product, FDA approved, to treat specific types of medication-resistant seizures. Under the FD&C Act, it is illegal to sell across state lines a product that contains an active ingredient in an approved drug. The FDA considers products that contain CBD to be unapproved new drugs that violate the FD&C Act, even if such products claim to be dietary supplements. To the FDA, the same compound cannot be both a drug and dietary supplement.
The FDA has actually taken action; mainly where manufacturers claim the products treat, prevent, diagnose, treat, or cure serious conditions, such as cancer. Or those products marketed to infants and children. As of mid-November 2019, it had sent 47 warning letters (in 2019) regarding CBD products.
Oddly enough, once Epidiolex was approved by the FDA as a CBD compound to treat seizures, over the counter CBD became illegal as a supplement.
This seems confusing. In other words, the compound went from OK to illegal.
There is an FDA approved fish oil, Vascepa. Yet, I can still walk down the aisle in Costco and see plenty of over the counter fish oil.
Plus, there are pharmaceutical grade vitamins and dietary supplements, eg. Carnitine, Niacin. Likewise, walk into GNC and you’ll see scores of such supplements.
Trying to think this through from a regulatory standpoint is enough to make your head explode.
Back to CBD.
CBD was formerly banned under the Control Substances Act. No longer. A CBD compound was recently approved by FDA to treat seizures. The FDA is now stating that because Epidiolex is an FDA approved drug, other brands of CBD (not approved by the FDA) sold across state lines violate the FD&C Act.
CBD is still being sold. Manufacturers who make audacious claims will be targeted. That is just the FDA judiciously allocating its scarce resources in addressing what it views as high priorities for enforcement. The FDA is hinting if it had unlimited resources, it might shut all manufacturers down.
But, if it did that to manufacturers of all supplements with prescription analogues, it would meet the wrath and fury of the supplement industry. Hell hath no fury like a supplement manufacturer scored.
The take-home-point: If the manufacturers are at risk here, the doctors prescribing and endorsing these supplements are also at risk. Before offering or endorsing any product to your patients, do your research. As a doctor, you are equipped to approximate the efficacy of a treatment. Don’t fall for fads – and don’t let your patients stake their wellness on marketing puffery. If you do endorse a product, set the correct expectations.
If this is a challenge for you, become members of Medical Justice. Member physicians enjoy access to a plethora of medico-legal resources and counsel. We’ll work together to determine whether an emerging treatment plan is worth your consideration.
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Jeffrey Segal, MD, JD
Chief Executive Officer and Founder
Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.
Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.
