Navigating the U.S. Food Additive Regulatory Program

The Food Additives Amendment of 1958 is the foundation for the U.S. food additive regulatory program, which oversees most substances added to food.  This webcast reviews the recent article describing the system, including original analysis of pre- and post market safety standards for various categories and subcategories of substances and their uses; assigning the more than 10,000 substances currently allowed in human food to those categories; and analyzing FDA's review of more than 1,900 petitions and notifications received from 1990 to 2010.

Overall, federal agencies made approximately 40% of the 6,000 safety decisions allowing substances in human food.  These decisions allowed an estimated 66% of the substances currently believed to be used in food.  Manufacturers and a trade association made the remaining decisions without FDA review by concluding that the substances were generally recognized as safe (GRAS).  In the late 1990s, FDA moved from promulgating rules for its decisions for food contact and GRAS substances to reviewing manufacturer safety decisions and posting the results of the review on the agency's website.  This shift appears to have encouraged manufacturers to submit their decisions to FDA for review but has limited public opportunity to provide input.

Learning Objectives:

  • Describe trends in FDA food additive-related filings from 1990-2010
  • Explain how many substances are in each of the seven categories of substances added to food

Intended Audience(s): Product Developers, Company Management, Sales & Marketing Personnel, Plant Production Personnel, Quality Assurance Managers and Supervisors, Food Safety Specialists, Product manufacturers, Research Staff, Regulators, Academics, Students
Learning Level(s): Beginner, Intermediate, Advanced
Non-Member Registration Fee: $145
Member Registration Fee: $95
Student Registration Fee: $49
Presentation Date: 05/23/12 12:00 PM
Duration: 90 Minutes


Martin James Hahn
Hogan & Lovells US LLP

Dr Haley Curtis Stevens
Acct Exec
The Kellen Co

Neal Fortin

Neesha Kulkarni
Sr Assoc
The Pew Charitable Trusts

Thomas G Neltner