About 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.

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FDA Issues Draft Guidance Document on MoCRA Requirements for Cosmetic Facility Registrati...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

Frederick Stearns Interviewed for Nutraceuticals World Article on the Evolving Regulatory...

In The News
03.09.2026

 

Awards

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Services

Areas of Law

  • Technology and Science 1
    • Biotechnology
  • Other 17
    • Alternative Proteins
    • Advertising and Promotion
    • Animal and Veterinary Food and Drug
    • 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

Practice Details

  • Firm Information
    Position
    Partner
    Firm Name
    Keller and Heckman LLP
  • Representative Cases & Transactions
    Cases
    Representative Matters: Worked with companies to develop acceptable formulations
    labeling for OTC drug products in various categories, including topical antiseptics (h
    sanitizers), antiacne, cough/cold remedies, sunscreens, external
    internal analgesics (pain relievers), antid
    ruff shampoos,
    oral healthcare products (fluoride
    antiplaque/antigingivitis)
    Assessed the regulatory status of ingredients for dietary supplements
    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 exp
    ed uses of existing ingredients
    Advised cosmetic ingredient
    finished cosmetic producers on safety substantiation
    claims issues to ensure the appropriate marketing of the products
    Counseled medical device raw material
    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

Experience

  • Bar Admission & Memberships
    Admissions
    1993, Virginia
    1995, District of Columbia
    Memberships

    Memberships

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

  • Education & Certifications
    Law School
    George Washington University Law School
    Class of 1993
    J.D.
    with honors
    Other Education
    Cornell University
    Class of 1988
    B.S.

Activity

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Attorneys FAQs

  • What year was this attorney first admitted to the bar?
    Frederick A. Stearns was admitted in 1993 to the State of Virginia.
  • Is this attorney admitted to the bar in more than one state?
    Yes, Frederick A. Stearns is admitted to practice in District of Columbia and Virginia.
  • Is this attorney Martindale-Hubbell Peer Review rated?
    Yes, Frederick A. Stearns has a 4.4 Peer Rating from Martindale-Hubbell.
  • What law school did this attorney attend?
    Frederick A. Stearns attended George Washington University Law School.
  • What year was this attorney's law firm established?
    Keller and Heckman LLP was established in 1962.