FDA Dumps Rigid Methods Rule to Streamline Enforcement Testing
Published Date: 2/19/2026
Rule
Summary
The FDA is officially scrapping a rule that told them which testing methods to use when no specific method was required by law. This change affects anyone involved in FDA enforcement programs but won’t cost extra or cause delays. The new rule kicks in on March 23, 2026, making things simpler and more flexible for everyone.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Validation and accreditation remain required
FDA states the revocation does not permit use of unvalidated methods and that methods used by FDA will continue to undergo qualification, validation, and fitness-for-use, including under ISO/IEC 17025 accreditation frameworks and the Laboratory Accreditation for Analyses of Foods (LAAF) program where applicable.
FDA drops AOAC default rule
The FDA removed 21 CFR 2.19, which said the Agency would default to AOAC (13th Ed., 1980) methods in enforcement programs when no method is specified by law. The revocation becomes effective March 23, 2026 and means FDA is no longer required to use that single compendium as its default.
No monetized costs or savings
FDA estimates the final rule will produce $0 in annualized monetized costs and $0 in monetized benefits (at both 3% and 7% discount rates, annualized over 10 years). The Agency also certified the rule will not have a significant economic impact on a substantial number of small entities.
FDA will list preferred methods in guidance
Instead of relying on a single incorporated compendium, FDA will identify preferred and validated analytical methods in documents that can be updated more frequently (for example, Agency methods compendia, compliance program guidance, and other resources). This is intended to allow more flexibility and quicker updates as science advances.
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