Keller and Heckman
This presentation will discuss the current status of cannabidiol (CBD) and other cannabis-derived ingredients as regulated by the Food and Drug Administration (FDA). It will review the legal/regulatory considerations for producing such ingredients, FDA’s position on the use of CBD and other ingredients in various categories of products, and practical considerations for companies seeking to market such products in the US.
Frederick A. Stearns is a partner in the law firm of Keller and Heckman LLP’s Washington, DC, office. For the past 27 years, he has worked on a wide range of FDA regulatory issues facing manufacturers of prescription and over-the-counter drugs, medical devices, food, dietary supplements, and cosmetics. He is also very involved in the regulatory issues surrounding cannabis- and hemp-based products, including cannabidiol (CBD) and related cannabinoids. He helps product manufacturers evaluate the need for marketing approval from FDA, pursue appropriate clearance when necessary, address regulatory compliance issues with marketed products, and respond to FDA enforcement actions. In addition, Mr. Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions.
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