- 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
INFANT FORMULA
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- On February 9, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to assist in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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Canada Establishes New Maximum Levels for Arsenic in Certain Foods
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- On August 17, effective immediately, Health Canada announced the addition of the following two maximum levels (MLs) for inorganic arsenic to the List of Contaminants and Other Adulterating Substances in
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FDA to Develop Framework for Continued Expanded Access to Infant Formula
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- As we previously have reported, in May FDA announced an enforcement discretion policy which would allow certain non-compliant infant formula to be marketed in the U.S. The policy, which
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HELP Committee Approves Bill to Address Infant Formula Shortage
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- The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the FDA Safety and Landmark Advancements Act of 2022 (FDASLA) to introduce policies in response to the infant formula
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