APR 05, 2019 9:45 AM PDT

FDA to Start Regulating CBDs

WRITTEN BY: Amy Loriaux

According to Leafly.com, the unofficial source of all things cannabis, the Federal Food and Drug Administration (FDA) is starting to catch up with the business of cannabidiol (CBD) - containing products. In this specific case, the FDA is trying to get a handle on CBD oil regulation. As of now, CBDs have been classified as dietary supplements. However, until it goes through FDA processing, it cannot be called a drug, claim it treats or heals conditions, and provide dosage information. Will this be difficult on the CBD industry? Most definitely so, as to be cleared as a drug requires multiple tests, including clinical trials, could make their product more valuable than those who do not.

Photo source: UnSplash.com

Lowell Schiller, the FDA’s acting associate commissioner for policy, published a Federal Register Filling last week. Within it, he states, "While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products.”

FDA will not allow CBD companies to claim any medical or treatment claims on its label unless it has gone through the FDA's screening process. This includes both animal studies and clinical trials and can be a costly and long process. While this may be a setback for the industry, ultimately it could be a boon for CBD companies because to be able to claim safety and efficacy may place their product ahead of the competition.

A federal register filling is not to be confused with the passing of a regulation. Actually, it is a public announcement to allow citizens to weigh in on the idea. In fact, the meeting for this filling is scheduled for May 31st near Washington DC. So, if you are motivated enough, YOU, dear reader, have a chance to have your voice heard. The official filling's purpose is to "obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds". Comments can also be submitted online or by mail

Photo source: UnSplash.com

This is a well-welcomed decision for clinicians and patients. Doctors may recommend CBD oil to their patients at their discretion, but they cannot prescribe these as medications because the FDA has not cleared it as a drug. FDA clearance will also provide dosage recommendations and which dose should be used to treat a particular condition. Also, this is beneficial in terms of research purposes. As of now, there is still very little research to support or discredit medicinal claims by CBD companies. The research that would be required for FDA clearance would provide a better understanding of how CBD works, and, more importantly, whether it works at all.

Sources: Leafly, Federal Register, regulations.gov, WebMD

About the Author
  • I currently work at a small CRO involved in clinical trial management.
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