Croke Fairchild Duarte & Beres’ Food and Drug practice draws on more than 30 years of experience providing a complete range of advisory, compliance, and enforcement defense services for clients in Food and Drug Law matters.

Our comprehensive Food and Drug Law practice involves advising and representing companies involved in the development, manufacture, production, packaging, and distribution of products regulated by the Food and Drug Administration (FDA), including food, food additives, dietary supplements, drugs, cosmetics, and medical devices. We regularly advise clients on regulatory compliance with requirements of the FDA and state and local laws, and represent them in actions related to alleged violations.

We work with clients and their products from initial development, through pre-approval, approval, and entrance into the market. Our assistance also extends beyond that point, as we have extensive experience troubleshooting inspection or violation issues. Our experience in product crisis management prepares us to support clients facing a sudden product problem or potential recall, including helping them evaluate the legal and practical factors at issue and creating a plan to address them effectively.

Our assistance for clients in these industries includes:

  • Food, drug, dietary supplement, medical device, and cosmetic regulatory requirements
  • Labeling issues
  • Commercial agreements, co-packaging and co-manufacturing agreements
  • Packaging compliance (Food Contact Notifications, and Food Additive Petitions, Generally Recognized as Safe opinions and notifications)
  • Developing and implementing FDA compliance procedures
  • Preparation for and response to government inspections
  • USDA Compliance for meat and poultry producers and packagers
  • FDA and state enforcement action defense
  • Product crisis management (recalls and related actions)