Balmford, Kathryn E.

Current Employment Position(s)

Associate

Lawyer Overview

Ms. Balmford is a Principal at OFW Law.  Ms. Balmford's practice focuses on issues related to the formulation, manufacture, labeling, advertising, and importation of dietary supplements, foods, medical devices, over-the-counter drugs, and cosmetics.  She handles matters involving regulation and enforcement by federal and state agencies, including the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and U.S. Customs and Border Protection (CBP).  She also handles matters involving self-regulatory bodies, such as the National Advertising Division of the Council of Better Business Bureaus (NAD). 

With regard to agency enforcement, Ms. Balmford advises clients concerning FDA inspections and helps clients respond to inspectional observations (FDA Form 483) and Warning Letters from FDA.  Companies manufacturing FDA-regulated products abroad often encounter issues as they attempt to import their finished product or ingredients into the United States.  Ms. Balmford assists companies with navigating the complex and overlapping requirements of FDA and CBP, which both have roles in the admission of FDA-regulated products into the country.  She routinely works with FDA and CBP District Offices to gain expeditious entry of compliant products.

Ms. Balmford’s representation of dietary supplement companies has included work on two separate federal court cases involving First Amendment commercial speech.  Both cases challenged FDA’s prohibition of constitutionally protected speech in the labeling of dietary supplement products.  Moreover, she has assisted clients with the preparation and filing of health claim petitions and new dietary ingredient notifications with FDA, including several successful qualified health claim petitions.

Ms. Balmford also serves as Counsel to the Association of Medical Device Reprocessors (AMDR).  Ms. Balmford’s representation of AMDR includes counseling on legislative, legal, and regulatory matters that impact the third-party reprocessing industry in the United States and around the world. 

Ms. Balmford was born in Youngstown, Ohio and was graduated magna cum laude with a B.A. in Politics-Philosophy from the University of Pittsburgh in 1999.  Ms. Balmford received her J.D. in 2002 from The George Washington University Law School.  She is a member of the Virginia State Bar and the District of Columbia Bar.

Areas of Practice:

Food and Drug Law
Medical Device Law
Advertising Law
Constitutional and Administrative Litigation

Bar Admissions:

Virginia, 2002
District of Columbia, 2003

Education:

The George Washington University Law School, Washington, District of Columbia, 2002
Juris Doctor

University of Pittsburgh, 1999
Bachelor of Arts
Honors: Magna Cum Laude

Court Admissions:

Supreme Court of the United States, 2007
United States Court of Appeals for the District of Columbia, 2005
United States Court of Appeals for the Fourth Circuit, 2004
United States District Court for the Eastern District of Virginia, 2005
United States District Court for the District of Columbia, 2002

Professional Associations and Memberships:
District of Columbia Bar Association
Virginia Bar Association

West Practice Categories

Administrative Hearings & Adjudication, Advertising, Constitutional Law, Food & Drug Administration, Pharmaceutical Products

Address

The Watergate
600 New Hampshire Avenue, N.W. Suite 500
Washington, DC 20037

Phones

202-518-6378

Faxes

202-234-3550

Emails

kbalmford@ofwlaw.com