- 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
Enforcement Discretion
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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FDA Releases Guidance on Infant Formula Enforcement Discretion Policy
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- Yesterday FDA released a guidance document which lays out the Agency’s plan to help increase the supply of infant formula in the U.S through the exercise of its enforcement discretion
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FDA Announces New and Extended FSMA Enforcement Discretion Policies
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- As we reported, FDA released a list on January 31, 2022 of important guidance topics that are a priority for completion this year. The list includes enforcement policy guidance
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FDA Enforcement Discretion for Agricultural Water
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- On January 26, 2022, FDA published a constituent update reminding produce stakeholders about FDA’s intention to exercise enforcement discretion for agriculture water requirements for covered produce, except for those related
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FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements
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Congress Continues to Seek Regulatory Clarity on CBD from FDA
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- A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food
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Mitch McConnell Introduces Bill Amendment That Would Compel FDA to Issue CBD Enforcement Discretion Policy
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- Senate Majority Leader Mitch McConnell (R-KY) has introduced language into a Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).
FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions
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- Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA).