FDA 2025 — Compliance Program 7304.019: Toxic Elements in Food and Foodware
FDA’s Compliance Program Guidance Manual (CPGM) Program 7304.019, implemented 8 August 2023 and corrected 19 September 2025, is the operational directive governing FDA field staff inspection, sample collection, analysis, and regulatory follow-up for toxic elements in foods and foodware (glazed ceramicware, silver-plated hollowware) and radionuclides in food. It covers all food industry codes except Industry 53 (cosmetics) and Industry 16 (seafood), which are addressed in separate programs. The program is organized into three sections: 04019A (Toxic Elements in Food), 04019B (Toxic Elements in Foodware), and 04019C (Radionuclides in Food), each with distinct sampling protocols and regulatory strategy guidance.
Key numbers
This document is a procedural compliance program, not a concentration-reporting survey. It does not contain food concentration data. Key structural parameters:
- Implementation date: 2023-08-08; correction date: 2025-09-19
- Covers all food product codes except seafood (Industry 16) and cosmetics (Industry 53)
- Problem Area Flag (PAF) codes: ELE (toxic elements in food), CDW (toxic elements in foodware), NUC (radionuclides in food)
- Reporting system: FACTS (Field Accomplishment and Compliance Tracking System); imports via OASIS Work Types FEX and SAM
- 36-page document with three independent sub-programs
Methods (brief)
Operational guidance document. Section 04019A directs collection and analysis of food samples for toxic elements across all import and domestic food categories except seafood. Section 04019B covers ceramicware and hollowware leaching tests. Section 04019C covers radionuclides in food. Analytical methodology references are given in the respective Part IV analytical sections of each sub-program. No concentration data are reported.
Limitations
This is a regulatory program manual, not a surveillance report. It describes how FDA monitors and enforces; it does not report detection frequencies or concentration distributions. Concentration data are found in separate FDA survey reports (e.g., Total Diet Study, Closer to Zero analytical results). Seafood toxic elements coverage lives in a separate compliance program.
Implications
- Certification: Directly relevant as the operative FDA enforcement framework for toxic elements in domestic and imported food. HMT&C certified products are subject to this program’s inspection, sampling, and regulatory follow-up protocols.
- Courses: Key reference for understanding FDA’s field-level enforcement mechanism for heavy metals in food; explains the FACTS/OASIS reporting infrastructure.
- App: Not applicable for contamination_profile data.
- Microbiome: Not applicable.