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 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.
Rick joined Keller and Heckman LLP upon his graduation from law school and has spent his entire legal career with the firm. Prior to law school, Rick worked for a scientific consulting firm in Washington, D.C., where he was able to apply his engineering background to regulatory issues, introducing him to food and drug law and starting him down that path. The opportunity to find creative solutions to clients’ problems is one aspect of this field of law that he likes best.
- Worked with companies to develop acceptable formulations and labeling for OTC drug products in various categories (including topical antiseptics (hand sanitizers); antiacne; cough/cold remedies; sunscreens; external and internal analgesics (pain relievers); antidandruff shampoos; oral healthcare products (fluoride, antiplaque/antigingivitis))
- Assessed the regulatory status of ingredients for dietary supplements and evaluated claims for such products; successfully defended a dietary ingredient supplier in a Federal Trade Commission (FTC) investigation of claims for the ingredient
- Helped food ingredient suppliers reach “generally recognized as safe” (GRAS) conclusions for new food ingredients or expanded uses of existing ingredients
- Advised cosmetic ingredient and finished cosmetic producers on safety substantiation and claims issues to ensure the appropriate marketing of the products
- Counseled medical device raw material and component suppliers on risk management strategies to limit potential liability, including protections available under the Biomaterials Access Assurance Act of 1998
- Helped clients respond to FDA Warning Letters following manufacturing inspections or FDA assessments of product claims
- Member, Food and Drug Law Institute