Food Contact Notification Process and Regulatory Considerations

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  • Author: Ralph Simmons
  • Level: Advanced
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Course overview
This course provides an overview of how the U.S. Food and Drug Administration (FDA) regulates food contact materials and food contact substances. Participants will learn the legal framework underlying food additive and food contact substance regulation, including key definitions, statutory exclusions, and the evolution of FDA’s Food Contact Notification (FCN) program.Insert course description here
  • Course Length: 35 mins.

Course Highlights

participants will gain insight into FDA’s increasing emphasis on post-market surveillance and enforcement, current regulatory trends, and considerations for demonstrating the safety and compliance of food contact substances.

FDA Regulatory Framework

Explain the FDA’s regulatory framework for food contact substances and food additives.

The FCN Program

The purpose and advantages of the FDA Food Contact Notification (FCN) program.

Direct vs. Indirect Additives

Distinguish between direct food additives and indirect food contact substances.

FCN Submission Requirements

Recognize the information and supporting data required for an FCN submission.

Migration and Food Additive Status

Understand the role of migration and how it affects food additive status.

Key Regulatory Exemptions

Identify statutory exemptions, including GRAS and prior sanctions.Please add a quick note for what this section is about

Compliance Responsibilities

Explain the responsibilities of manufacturers and suppliers in ensuring regulatory compliance.

When New Notifications Are Needed

Identify circumstances that require a new notification or additional FDA review.

Ralph Simmons

Former Senior Policy Advisor, FDA, Associate and Partner, Keller and Heckman, LLP, Of Counsel, Foster Garvey, PC
ABOUT 
Ralph Simmons is an experienced attorney with a career spanning both private practice and federal government service. He advises companies on the regulation of foods, dietary supplements, drugs, cosmetics, medical devices, and other consumer products, with expertise in FDA, FTC, USDA, and state requirements.

Mr. Simmons has extensive experience in product labeling, ingredients, advertising claims, and regulatory compliance. He has also served as trial counsel in consumer protection matters, including California Proposition 65 cases, and has significant experience with commercial contracts.