AHPA submits comments on proposed methods of analysis rule revocation

• By: AHPA
• On: 09/29/2022 22:14:51
• In: Regulation / Legislation

September 29, 2022

In comments submitted to the U.S. Food and Drug Administration (FDA) on September 28, AHPA expressed reservations about the agency's proposed revocation of the “methods of analysis” regulation. Initially issued in 1977, this regulation establishes that FDA enforcement programs will use AOAC International's (AOAC's) officially published methods of analysis whenever a different method is not established in other regulations.

Although AOAC regularly publishes a new edition of its methods of analysis, the regulation currently still incorporates the 1980 version. FDA argues that this regulation should be revoked so that the agency methods can be more flexibly published in guidance documents.

In its comments, AHPA encourages FDA to not revoke the methods of analysis regulation, and to instead update it to reflect the most current AOAC analysis methods. AHPA argues that if FDA requires greater flexibility, this can be accomplished by amending current regulations to allow the publication of analytical methods in specifically identified publicly available sources.

“AHPA has been involved with the AOAC review process for years, and the AOAC official methods have been a bastion of consistency for stakeholders across FDA regulated industry,” said Holly E. Johnson, Ph.D., AHPA's Chief Science Officer. “AOAC approved methods undergo public comment and rigorous scrutiny from scientists within the industry, academy and FDA.”

AHPA also commented that if FDA does choose to revoke the methods of analysis regulation, the agency should first publish a guidance that will avoid any gap in the use of appropriate analytic methods and ensure continued transparency for consumers and regulated industry.