Food and Drug Law

This law practice emphasizes achieving the best possible results for clients through experience, knowledge, and creativity. Mr. Wisniewski resolves issues and develops effective strategies in FDA, FTC, State Attorneys General, U.S. Customs, EPA, Consumer Product Safety Commission, USDA, and other regulatory agency compliance and enforcement matters. He represents a wide array of clients, from entrepreneurs, family businesses, and health professionals to domestic and international corporations. Clients may manufacture, import, export, distribute, or license dietary supplements, conventional foods, medical devices, OTC drugs, pharmaceuticals, homeopathic preparations, biologics, animal foods and drugs and food additives or any combination of the aforementioned activities. The spectrum of client activities can include a variety of legal and regulatory matters.

Mr. Wisniewski provides professional advice during and following FDA inspections, assistance in responding to Warning Letters, “Cyber” Letters and “Courtesy” Letters and an aggressive defense of product seizures, injunction actions and other formal prosecutions. Mr. Wisniewski’s expertise extends to import detentions, refusals, customs penalty proceedings and other regulatory and administrative matters. His more than twenty years of practical experience and success in resolving a wide range of complex legal issues involving the FDA and other regulatory agencies ensures that the products and business efforts of all his clients are
expertly protected.

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