James R. Prochnow

James R. Prochnow

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Jim Prochnow concentrates his practice on Food and Drug Administration (FDA), Federal Trade Commission (FTC), and Drug Enforcement Agency (DEA) actions, advice and related litigation, which includes import detentions, government inspections, investigations and defense of class actions. He also counsels clients about regulatory issues associated with cosmetics, dietary supplements, homeopathic drugs, Over-the-counter (OTC) drugs, the use of CBD oil in products, the protocols and contracts associated with clinical trials, and cGMP compliance.

Concentrations

  • Defense of Federal Trade Commission and National Advertising Division investigations concerning false and misleading advertising.
  • Advice on aggressive marketing without violating advertising laws. This includes website and social media review and strategy.
  • Food and drug regulatory law, with emphasis on dietary supplements, OTC drugs, cosmetics, medical foods and homeopathic drugs.
  • Advice about FDA inspections, warning letter and defense of FDA enforcement actions: a review of clinical study reports.
  • Multi-level marketing agreements, related advice and litigation.
  • Preparation of ingredient formulation, manufacturing, and distribution agreements.
  • General IP advice with respect to patents, trade secrets, and trademarks, particularly for companies in the food and dietary supplement industries.
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Capabilities

Recognition & Leadership

  • Member, Natural Products Association
  • Member, American Herbal Products Association
  • Member, American Botanical Council
  • Member, United Natural Products Alliance
  • Member, American Bar Association
  • Member, Colorado Bar Association
  • Member, Denver Bar Association
  • Member, Federalist Society
  • Former trial attorney with the U.S. Department of Justice in Washington, D.C.
  • Former White House staff lawyer -Watergate
  • Former Adjunct Professor of Law at the University of Denver: Food and Drug Law

Credentials

Education
  • J.D., Mitchell Hamline School of Law, 1969
  • B.A., Hamline University, 1965
Admissions
  • Colorado