FDA and USDA Regulatory Updates
FDA Updates Approach to “No Artificial Colors” Claims and Expands Natural Color Options
FDA Takes New Approach to “No Artificial Colors” Claims The U.S. Food and Drug Administration has announced an updated approach to how food manufacturers may use “no artificial colors” claims on...
Congressman Langworthy Introduces Dietary Supplement Regulatory Uniformity Act
Rep. Nick Langworthy (R-NY) has introduced the Dietary Supplement Regulatory Uniformity Act, legislation intended to reaffirm a single federal standard for dietary supplement regulation under the...
FDA Publishes 2026 Foods Program Guidance Agenda: What Industry Should Know
FDA Outlines Foods Program Guidance Documents Under Development for 2026 The U.S. Food and Drug Administration has published its guidance documents under development list for the Human Foods Program...
Bipartisan HEMP Act Aims to Create FDA Framework for Hemp-Derived Products
On January 22, 2026, U.S. Representatives Morgan Griffith (R-VA) and Marc Veasey (D-TX) introduced the Hemp Enforcement, Modernization, and Protection (HEMP) Act, bipartisan legislation designed to...
FDA Records Access Authority for Cosmetics: Draft Guidance Now Available
The U.S. Food and Drug Administration has announced the availability of a new draft guidance titled “FDA Records Access Authority for Cosmetics: Guidance for Industry.” The document addresses...
Durbin Introduces Legislation To Improve Transparency and Safety of Dietary Supplements
U.S. Senate Democratic Whip Dick Durbin has reintroduced the Dietary Supplement Listing Act, legislation aimed at improving transparency and safety in the dietary supplement market.
FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now...
FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
The U.S. Food and Drug Administration has announced a significant expansion of its internal artificial intelligence capabilities through the deployment of agentic AI tools across the agency. The new...
Update October 23, 2025 – Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications
Constituent Update FDA Human Foods Program October 23, 2025 Read on FDA WebsiteDue to the lapse in appropriations, FDA is postponing the virtual public meeting on November 18, 2025, and listening...
FDA Announces First Use of Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137
October 3, 2025 Constituent Update Read on FDA WebsiteThe FDA announced today that, effective October 31, 2025, the agency will require import certification for shrimp and spices from certain...
HHS, FDA and USDA Extend Comment Period for Data and Information on Ultra-Processed Foods
September 18, 2025 Constituent Update Read on FDA WebsiteThe U.S. Food and Drug Administration and the U.S. Department of Agriculture are extending the comment period by 30 days for the Request for...
FDA Expert Panel on Food Allergies
The FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer...
FDA issues final guidance on using remote oversight tools to help approve drugs
FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug...
Heads-up: Front-of-Pack labels, GRAS changes, and supplement definition update
FDA has signaled three significant rulemakings in the Unified Agenda that could affect food and dietary supplement companies. These are not official final rules—but they’re far enough along that...
FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89
September 04, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are...
FDA Releases Results on Economically Motivated Adulteration (Short Weighting) in Seafood
September 02, 2025 Constituent Update Read on FDA WebsiteThe U.S. Food and Drug Administration (FDA) is releasing the results from a sampling assignment conducted during 2022 to 2024 on testing of...
FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure
September 02, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from...
FDA to Hold Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications
August 18, 2025 Constituent Update Read on FDA WebsiteSave the Date Dates Virtual Presentations and Panel Discussions – November 18, 2025 Virtual Listening Sessions – November 19-20, 2025 Event...
FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
August 7, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by...
FDA Issues Proposed Rule to Amend Standard of Identity for Pasteurized Orange Juice
August 5, 2025 Constituent Update Read on FDA Website The U.S. Food and Drug Administration has issued a proposed rule to amend an over 60-year-old Standard of Identity (SOI) for pasteurized orange...
FDA Releases New Tool for Toxicity Screening of Chemicals in Food
July 30, 2025 HFP Constituent Updates Read on FDA WebsiteToday, the U.S. Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool that...
Senators Markey and Booker Introduce Legislation to Get Dangerous Chemicals Out of Food
July 17, 2025 View Full Press ReleaseThe Ensuring Safe and Toxic-Free Foods Act of 2025 aims to enhance food safety by tightening the FDA's regulations on food chemicals. Key provisions include:...
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
July 16, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary....
FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline
July 14, 2025 View on FDA Website On January 15, 2025, the U.S. Food and Drug Administration issued an orderrevoking the authorization for the use of FD&C Red No. 3 in foods, including dietary...
US Food and Drug Administration FDA Embraces Radical Transparency by Publishing Complete Response Letters
FDA News Release July 10, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were...
Conducting Remote Regulatory Assessments Questions and Answers
Docket Number: FDA-2022-D-0810 Issued by: Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation...
Foods Program FDA Guidance Under Development
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA is considering for Human and Animal Foods. The...
FDA Updates General Food Labeling Requirements Compliance Program
Constituent Updates June 24, 2025 Read on FDA Website The U.S. Food and Drug Administration has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and...
FDA Seeks Input on a New Method for Ranking Chemicals in Food for Post-market Assessments
Constituent Update June 18, 2025Today, the U.S. Food and Drug Administration (FDA) released for public comment its proposed method for ranking chemicals in the food supply. This method provides a...
FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests
For Immediate Release: June 17, 2025The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans....