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C. Humphrey & Associates, P.A.  is a FDA Law Firm that represents domestic and international companies regarding  a range of regulatory food law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of food product development and marketing.

Our FDA Lawyers and FDA Consultants assist in array of FDA Legal Services including:

  • Developing substantiation to support product claims made in labeling, advertising, and promotions of food products

  • Working with federal agencies to gain approval of products and claims, including petitions for new ingredient and health claims and nutrient content claims

  • Advising on all aspects of label representations including statements of identity, net content declarations, nutritional information and ingredient listings

  • Product formulation including GRAS Self Affirmations, Fortification policies, cGMPs, GCP and GLP Compliance and Standard Operating Procedures (SOPs)

  • FDA submissions including Food Contact Notifications (FCN), Food Additive Notifications (FAN), GRAS Notifications, Statements of Nutritional Support, Citizens Petitions and FDAMA Notifications

  • Registration of food facilities under the Bioterrorism Act

  • Nutritional Labeling and Education Act of 1990 (NLEA)

  • Adulteration and Misbranding Issues

  • Website and advertising reviews

  • Nutrient content claims

  • Health claims

  • Allergen labeling

  • Food standards

  • Food Additives

  • Color Additives

  • Hazard Analysis and Critical Control Points (HACCP) Regulations

  • Low-acid canned foods

  • Percent juice declarations

  • cGMP compliance

  • Establishment registrations and process filings for acidified food and low-acid food in hermetically sealed containers

  • Medical foods

  • Genetically modified organisms (GMOs)

  • Import Alerts and Export issues

  • Recalls, Detentions and Reconditioning

  • State law requirements

Our FDA lawyers also prepare our clients for meetings with FDA personnel on compliance matters and represent clients before the Agency on enforcement, policy and rulemaking issues, and litigation.

Contact C. Humphrey & Associates
For an Initial Consultation

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