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The FDA Strengthens Its Stance Regarding CBD

By- Susan “Lily” Cromer, Founder of LilyHemp

 

The passage of the Farm Bill of 2018 in December ended the prohibition of hemp and opened the floodgates on hemp-derived CBD sales nationwide. CBD (Cannabidiol) is the most prevalent compound in hemp and is touted to have an almost miraculous effect on modern day maladies.  Although CBD is also present in marijuana, only hemp and hemp-derived extracts such as CBD have been removed as a scheduled drug placing the regulation of it firmly in the hands of the FDA.

The FDA has unequivocally stated that CBD may not be used in products designed for human or animal consumption, or in dietary supplements, prior to FDA approval for such use.  According to Amy Abernathy, MD, PhD, the FDA’s Principal Deputy Commissioner and Lowell Schiller, J.D., Principal Associate Commissioner for Policy, “Science forms the basis for decisions at the United States Food and Drug Administration (FDA) and is paramount when it comes to making decisions that will impact the health and safety of the American public.” So, while public interest and support of CBD is ever increasing, the FDA remains firm that many questions regarding the safety of CBD remain unanswered.  Hopefully the myriad public and written comments and research provided by industry stakeholders during the agency’s recent request for public comment will provide some much-needed guidance. In addition to requests for industry standards regarding formulation, packaging and marketing, the public shared scientific literature and data to help the FDA determine appropriate dosing levels, possible risk of long term or cumulative exposure if used in various consumer products daily, and the impact on “special populations, like children, the elderly, and pregnant or lactating women.” They are currently reviewing the information and anticipate reporting on its progress by late summer or early fall.

 

In the meantime, on July 22,  the FDA flexed its muscle and issued a warning letter to Curaleaf for violations including claiming their CBD products are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”  This proves that any company making mis-leading or false medical claims or selling interstate a CBD product designed for ingestion by humans or animals may be on the FDA’s radar.  Until the questions regarding CBD are successfully answered and regulations are put in place, the state of CBD remains in limbo and manufacturers, retailers and buyers beware.