- On May 28, 2025, the U.S. Food and Drug Administration (FDA) issued a “no questions” letter to Wildtype, Inc. in response to the California-based company’s pre-market evaluation filings for their
FDA Official Says FDA Plans to Issue Guidance as Normal Despite “10-1 Executive Order”
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- Senior FDA officials recently signaled that the agency does not anticipate major disruptions to the issuance of guidance documents, even as federal agencies brace for the impact of Executive Order
FDA Publishes Proposed 2025 Human Foods Program Guidance Agenda
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- On Monday, June 30, 2025, FDA’s Human Food Program published its proposed 2025 guidance agenda (FDA’s news release shown here). The agenda contains possible new topics for guidance documents
FDA Updates Food Labeling Requirements Compliance Program
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- FDA announced on Tuesday, June 24, 2025, that it has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample-Analysis – Domestic and Import. This
General Mills and Kraft Heinz Announce Voluntary Phase Outs of Synthetic Color Additives
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- On June 17, 2025, General Mills announced its plans to remove certified color additives from all of its U.S. cereals and what the company referred to as its K-12 school
FDA Opens Public Comment Period for Chemical Post-Market Assessment Regulation
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- On June 18, 2025, FDA announced its proposed “method for post-market assessments of chemicals in the food supply.” This “Post-market Assessment Prioritization Tool” will give chemicals an overall score that
House Appropriations Committee Releases FY26 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill
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- On June 10, the House Appropriations Committee released the full committee markup of Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill. A summary of
FDA Commissioner Outlines Priorities in JAMA Article
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- On June 10, 2025, FDA Commissioner Marty Makary and FDA CBER Director published an article in JAMA that listed their “priorities for a new FDA.” These priorities included accelerating drug
FDA Releases Educational Materials on the NDIN Process
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- Yesterday, the U.S. Food and Drug Administration (FDA) unveiled two educational videos and a supplemental fact sheet to help the dietary supplement industry with the New Dietary Ingredient Notification (NDIN)
FDA Reportedly Set to Define UPFs
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- Yesterday, the New York Times reported that the FDA, in collaboration with USDA and other government agencies, plans to establish a new definition of “ultraprocessed foods” (UPFs) that will be