Profile
Justin J. Prochnow assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries. Justin works closely with companies to ensure regulatory compliance with statutes and regulations enforced by the Food and Drug Administration, the Federal Trade Commission and other regulatory agencies. This includes the review of product labels, labeling, advertising, websites and other marketing materials. Justin assists companies with responding to governmental and regulatory actions, including FDA inspections and warning letters, FTC Civil Investigative Demands, and ASRC and NAD cases. He prepares and reviews business documents for industry members, including consulting, manufacturing, supply and distribution agreements. Justin and his team also defend industry companies from both governmental agencies and civil litigators in litigation ranging from breach of contract cases to the growing number of class actions alleging false and misleading advertising.
Concentrations
- Advising companies about the introduction and proper classification of products in the U.S. marketplace
- Reviewing labeling, advertising and marketing materials to ensure compliance with the applicable state and federal statutes and regulations
- Facilitating interaction with the FDA, including FDA Warning Letters, inspections and investigations
- Assisting companies with the decision to initiate voluntary recalls and facilitating cooperation and communication with the FDA
- Counseling companies regarding compliance with Good Manufacturing Practices (GMPs), including the implementation of SOPs and other testing requirements
- Facilitating the release of products detained by U.S. Customs and Border Protection and the FDA
- Assisting companies to resolve advertising issues, including investigations initiated by the FTC, NAD and ERSP
- Preparing and reviewing business documents, including manufacturing, distribution and supply agreements
- Defending companies in private actions for statutory violations, including class actions over labeling claims such as "All Natural" brought pursuant to state Consumer Protection Acts, the Lanham Act or other common law claims
Capabilities
Experience
- Represented Blue Wolf Capital Partners, LLC in connection with the acquisition of CIVCO Radiotherapy, a global leader of radiotherapy patient positioning and immobilization equipment.
- Assistant City Attorney, Denver City Attorney's Office, prosecuting numerous criminal court cases.
Recognition & Leadership
- Listed, Chambers USA Guide, Food & Beverages: Regulatory & Litigation, 2021-2024
- Listed, The Best Lawyers in America, Advertising Law; FDA Law; Food and Beverage Law, 2017-2025
- Listed, NOSH, "NOSH Notables: Superheroes," 2023
- Team Member, a Law360 “Product Liability Practice Group of the Year,” 2021-2022
- Selected, LMG Life Sciences, "Life Science Star," 2016-2024
- Team Member, a Law360 "Food & Beverage Practice Group of the Year," 2015
- Team Member, a U.S. News - Best Lawyers® "Government Relations Law Firm of the Year," 2014
- Rated, AV Preeminent® 4.8 out of 5.0
- Member, American Bar Association
- Member, Colorado Bar Association
- Member, Denver Bar Association
- Member, American Herbal Products Association
- Member, UNPA (United Natural Products Alliance)
- Member, Naturally Boulder
- Member, Board of Directors, Junior Achievement
- Member, MENSA
Credentials
- J.D., Arizona State University Sandra Day O'Connor College of Law, 1994
- B.A., International Relations and Political Science, Tufts University, 1991
- U.S. Magistrate Judge Bruce D. Pringle, U.S. District Court for the District of Colorado
- Colorado
- U.S. Court of Appeals for the Tenth Circuit
- U.S. District Court for the District of Colorado