FDA Food Law and Food Safety

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FDA food law and food safety requirements have been a cornerstone of OFW’s practice since its inception. Our attorneys understand the challenges food manufacturers face in complying with FDA requirements while providing safe, quality products to their customers. In assisting our clients navigate FDA requirements, OFW monitors the fast-moving developments in FDA policy and regulation under the Federal Food Drug and Cosmetic Act. As a result of our work, and the fact that many OFW attorneys have worked at FDA, we maintain regular contact with key FDA personnel. Some of the FDA-related matters we assist clients with include:

  • Enforcement response and advocacy, ranging from responding to inspectional observations and Warning Letters, to representing clients through injunction proceedings and criminal matters
  • Food Recalls
  • Food Safety requirements, including Hazard Analysis and Critical Control Point (HACCP), Hazard Analysis and Risk Based Preventive Controls (HARPC), and Current Good Manufacturing Practices
  • All requirements under the Food Safety Modernization Act (FSMA)
  • Labeling requirements, including Nutrition Facts and labeling claims
  • Export/Import issues, including Prior Notice and Foreign Supplier
    Verification Programs (FSVP), obtaining relief from Import
    Alerts/Detention Without Physical Examination, and
    Sanitary transportation.

Importantly, OFW proactively counsels clients on the establishment of policies and procedures to assure FDA compliance, as well as assisting clients in response to FDA inquiries made during or after an inspection.

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