- FDA updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program comprehensively outlines the agency’s approach towards inspections, sample collection, sample analysis, and compliance
INFANT FORMULA
FDA Provides Update on the Cronobacter Prevention Strategy in Powdered Infant Formula
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- Continuous collaboration with industry,
FDA Issues Warning Letters to Three Infant Formula Manufacturers
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- On August 30, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to three infant formula manufacturers as part of the Agency’s recent push to enhance regulatory oversight
Bipartisan Lawmakers Seek to Remove Tariffs on Infant Formula with Proposed Formula 3.0 Act
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- On June 1, a group of bipartisan lawmakers led by Senator Mike Lee, R-UT, introduced the Formula 3.0 Act which would permanently remove tariffs and other trade restrictions on imported
FDA Publishes Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
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- On March 28, FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy follows a months-long infant formula shortage sparked by
Update: Letter to Powdered Infant Formula Industry
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- Yesterday, on March 8, 2023, the U.S. Food and Drug Administration (FDA) sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of
FDA Issues Guidance on Protein Quality Studies for Infant Formula
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- On February 9, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to assist in
FDA Webinar Series on Infant Formula Transition Plan
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- On October 12, 2022, FDA announced that it would be hosting a 4-part webinar series to provide more information regarding the Infant Formula Transition Plan for Exercise of Enforcement Discretion
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New FDA Guidance Allows Companies to Continue Marketing Infant Formula Under an Enforcement Discretion Letter Beyond November 14, 2022
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- After the publication of its May 2022 Enforcement Discretion Guidance (discussed here), FDA issued letters of enforcement discretion to various companies for marketing specific infant formula products in the
FDA Publishes Internal Evaluation of Infant Formula Response
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- In May, FDA Commissioner Robert M. Califf, M.D., requested an internal agency review of the FDA’s actions related to multiple reports of Cronobacter in infants, the temporary shutdown of Abbot
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