March 23, 2023

Volume XIII, Number 82


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March 20, 2023

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The FDA Gets Blunt: “New Regulatory Pathway for CBD is Needed”

On January 26, the Food and Drug Administration (“FDA”) threw up its hands, concluding cannabidiol (“CBD”) products are not a good fit for the agency’s food and supplement framework. Instead, the FDA is calling on Congress to develop a new regulatory pathway for CBD “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” 

The development comes after the growing CBD industry pushed for the FDA to allow the products to be marketed as dietary supplements. In response, the FDA convened a high-level internal working group to evaluate such requests. Rather than finding a “place” for CBD in existing regulations, the FDA fixated on known and unknown risks associated with CBD. The agency believes its existing food and supplement regulations are ill-fit to manage such risks, and will work with Congress to find “a new way forward.”

A new regulatory pathway will likely include safeguards such as labeling requirements, content limits, quality assurance requirements related to contamination prevention, and a minimum age to purchase. The FDA acknowledges that such a pathway may extend to both human and animal CBD products.

As we have previously reported, the FDA has closely monitored the CBD industry in recent years. In its statement, the agency writes that it will remain diligent in monitoring the CBD marketplace, and will continue to take action against CBD and other cannabis-derived products as a new strategy for regulation develops.

© 2023 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume XIII, Number 31

About this Author

Daniel S. Zinsmaster, Dinsmore Law Firm, Health Care Lawyer

Dan provides trusted counsel and advocacy to health care clients on a variety of matters, such as corporate compliance, provider credentialing, administrative proceedings and litigation.  He also advises clients on practice formation and acquisition, as well as contract review and preparation.  In recent years, Dan has helped health care companies and providers navigate through fraud and abuse investigations, antitrust reviews, and other white collar criminal matters.  He is a frequent author and lecturer on telehealth and telemedicine issues.


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Ashley E. Durner Corporate Law Dinsmore and Shohl

Ashley focuses her practice on corporate law and health care. Her experience includes drafting and reviewing contracts and corporate policies, advising on regulatory compliance matters, and assisting with corporate matters, such as entity formation and mergers and acquisitions.

Ashley received her J.D. from University of Cincinnati College of Law. During law school, in addition to working as a law clerk at Dinsmore, she was a legal intern for UC Law’s Entrepreneurship & Community Development Clinic where she gained firsthand experience...

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