Frederick A. Stearns

Frederick A. Stearns: Attorney with Keller and Heckman LLP
Attorney Awards
  • Martindale-Hubbell Peer Distinguished Rating
About Attorney Awards

Biography

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.

Awards

•Chambers USA: Food and Beverages: Regulatory & Litigation - Nationwide, 2025
•The Best Lawyers in America: Cannabis Law, 2023 - 2026
•The Best Lawyers in America: FDA Law, 2025 - 2026

Insights & In the News

Food & Chemicals Unpacked: Making-Up for Lost Time: FDA’s Increased Oversight of Cosmetics

02.25.2025
Podcast

FDA Issues Final Guidance Document on MoCRA Requirements for Cosmetic Facility Registrati...

12.19.2023
Publication

FDA Issues Draft Guidance Document on MoCRA Requirements for Cosmetic Facility Registrati...

08.08.2023
Publication

More Insights

Best Law Firms Features Keller and Heckman in 2026 Edition

Press Release
11.06.2025

See more ›

Areas of Practice (18)

  • Alternative Proteins
  • Advertising and Promotion
  • Animal and Veterinary Food and Drug
  • Biotechnology
  • Cannabis, Hemp, and Cannabinoids (CBD)
  • Cosmetics
  • Dietary Supplements
  • Food and Drug
  • Food and Food Ingredients
  • Medical Devices
  • Pharmaceuticals
  • Chemicals and Plastics
  • Consumer Products and Retail
  • Digital Media, Technology, and Telecommunications
  • Food & Life Sciences
  • Packaging
  • Tobacco and E-Vapor
  • Trade Associations

Education & Credentials

University Attended:
Cornell University, B.S., 1988
Law School Attended:
George Washington University Law School, J.D., with honors, 1993
Year of First Admission:
1993
Admission:
1993, Virginia; 1995, District of Columbia
Memberships:

Memberships

•Food & Drug Law Institute (FDLI), 2025 Cannabis-Derived Products Committee and Cosmetics Task Force

Reported Cases:
Representative Matters: 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, and oral healthcare products (fluoride and 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
ISLN:
900647169

Peer Reviews

4.4/5.0
Peer reviews submitted prior to 2008 are not displayed.
Martindale-Hubbell® Distinguished Rating Badge
Peer reviews submitted prior to 2008 are not displayed.

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Location

Contact Frederick A. Stearns

Contact Information:

202-434-4646  Fax

www.khlaw.com

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