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