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
Hazard Analysis and Critical Control Points (HACCP) Regulations
Percent juice declarations
Establishment registrations and process filings for acidified food and low-
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.
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