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This bill amends the Federal Food, Drug, and Cosmetic Act to require standardized pathogen and microorganism testing of infant formula products and manufacturing facilities, mandate notification of positive test results and certain inspection classifications, and update good manufacturing practices.
Sec. 2, Measures to enhance the safety of infant formula: The bill requires the Secretary to update good manufacturing practices for infant formula. Manufacturers must test their facilities and finished products for pathogens and microorganisms, including clostridium botulinum and others designated by the Secretary. The regulations must specify environmental testing frequency, including in Zones 2 and 3 of facilities. Manufacturers must notify the Secretary within one business day of any positive test result, even if the formula has not left their control. They must also retain records of positive test results. The Commissioner must establish and enforce consistent inspection and compliance standards for all infant formula products regardless of origin. The Secretary must issue final regulations within 90 days of enactment. The bill also adds congressional notification requirements: if the Secretary receives a positive test result notification from a manufacturer, or if the FDA issues an 'official action indicated' classification after an inspection, the Secretary must notify the appropriate committees of Congress within one business day. The appropriate committees are the House Committees on Appropriations and Energy and Commerce, and the Senate Committees on Appropriations and Health, Education, Labor, and Pensions. A conforming amendment updates a cross-reference in existing law.
Summary of the bill text as introduced in House (Mar 9, 2026), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
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Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.