FDA revokes AOAC methods of analysis policy, affecting food and cosmetic testing

By Xiaolu Wang, Esq.

The FDA has finalized a rule revoking its long-standing policy of defaulting to certain AOAC International methods of analysis in enforcement programs when no method is specified in regulation. The move eliminates a provision incorporated in 21 CFR 2.19 and shifts the agency toward identifying preferred analytical methods through internal guidance and compliance resources.

The decision follows significant industry opposition and raises questions about regulatory predictability, global harmonization, and how manufacturers should evaluate testing methodologies in the absence of AOAC’s default status. While use of AOAC methods is not prohibited, the revocation may alter how analytical standards are selected and defended in enforcement contexts.

This AgencyIQ analysis explores the regulatory rationale, stakeholder concerns, and practical implications for food and cosmetic manufacturers operating domestically and internationally.

Fill out the form to read the full analysis.