Frederick A. Stearns

Frederick (Rick) Stearns provides his clients with experience on a wide range of issues affecting makers of prescription and over-the-counter (OTC) drugs, medical devices, dietary supplements, cosmetics, food, and food ingredients. He is also deeply involved with the regulatory issues surrounding cannabis and hemp-based products, including cannabidiol (CBD) and related cannabinoids. Rick helps manufacturers evaluate the need for marketing approval from the U.S. Food and Drug Administration (FDA) to pursue appropriate clearance where necessary and address regulatory compliance issues with a range of marketed products. He also works with clients in responding to FDA enforcement activities, such as inspections, warning letters, and import detentions, and advises on the interaction between patent laws and the FDA drug approval process. Rick communicates effectively with agency officials and develops innovative strategies to deal with evolving FDA regulatory requirements. He also advises clients on the complex federal and state issues surrounding the potential use of CBD and other cannabinoids in consumer products. Rick also works with companies to conduct FDA due diligence reviews for internal controls and external acquisitions. Rick is a sought-after lecturer and speaks frequently at conferences regarding the regulation of drugs, medical devices, food, dietary supplements, cosmetics, and CBD-containing products, including Keller and Heckman's annual Practical Food Law Seminar. Rick joined Keller and Heckman upon receiving his law degree. Prior to law school, he worked for a scientific consulting firm in Washington, DC, where he applied his engineering background to regulatory issues, thus introducing him to a career in food and drug law.