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Food and Drug Law

LeClairRyan’s Food and Drug Law practice covers every aspect of food and drug regulatory law in the United States, including all matters within the Food and Drug Administration’s (FDA) regulatory purview as well as state agencies charged with implementing state laws governing foods, beverages, dietary supplements, drug compounding as well as the marketing and labeling of these and similar products. For our food industry clients, we provide advice and counsel on all aspects of the Food Safety Modernization Act (FSMA) including assistance with hazard analysis, good manufacturing practices and risk-based controls throughout the supply chain from farm to table. Our food and drug law attorneys also prepare product recall manuals, negotiate appropriate food safety terms in supply chain distribution agreements and assist food and beverage companies in complying with the FDA’s ingredient and nutritional labeling requirements. In addition, we provide regulatory advice to a variety of pharmaceutical, biotechnology, durable medical equipment, and medical device companies. We also represent specialty pharmacies under investigation by state pharmacy boards.

Members of our team represent clients in compliance and enforcement actions brought by the FDA, the Department of Justice (DOJ), the Federal Trade Commission (FTC), and United States Department of Agriculture (USDA), as well as in litigation at all state and federal courts. We represent a full spectrum of clients in a variety of food and drug industry segments, including:

  • Human pharmaceuticals, including compounds
  • Medical devices
  • Radiological products
  • Human biological products
  • Biosimilars
  • Cosmetics
  • Medical foods
  • Food additives
  • Dietary supplements
  • Beverages, including dairy, alcoholic and non-alcoholic

We also assist food, drug, medical device and cosmetic companies with compliance audits, product recalls and employee training as well as conduct FDA and regulatory due diligence in merges, acquisitions and financial transactions.

Our in-depth knowledge of the inner workings of the FDA enables us to assist our clients in developing optimal strategies for product development, regulatory clearances and approvals, marketing and promotion, product distribution and product recalls.

Representative matters:

  • Prepared and updated product recall manuals, product safety and liability management plans and company compliance policies
  • Reviewed product labels, instructions for use, product manuals and service guides to assure regulatory compliance and to enhance risk management
  • Counseled on product recall strategies
  • Provided opinion letters on the regulatory compliance status of food products, food additives and substances used in the packaging and processing of foods
  • Counseled on good manufacturing practices for foods, drugs and devices and assisted clients in preparing and conducting facility audits, developing quality assurance and regulatory compliance programs and implementing product recall procedures
  • Reviewed product labeling and advertising to assure compliance with applicable laws and regulations
  • Established policies for timely and effective responses to consumer complaints
  • Advised on the classification of a product as a dietary supplement, conventional food or a drug based on the product claims
  • Prepared supply chain and product distribution agreements to address FSMA requirements, including records inspection, foreign-supplier verification, hazard analysis and risk-based preventive controls, sanitary transportation of food and liability and indemnification
  • Counseled restaurant and retail food companies on FDA menu and menu board labeling requirements