FDA and USDA Regulatory Updates
FDA Announces New Steps to Streamline Biosimilar Development
FDA Takes Additional Steps to Support Biosimilar Development The U.S. Food and Drug Administration has announced new actions aimed at streamlining the development of biosimilar medicines and...
FDA Finalizes Rule Standardizing National Drug Code Format
FDA Final Rule Revises National Drug Code Format and Barcode Requirements FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode...
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections
FDA Releases Guidance on Responding to Form 483 Observations The U.S. Food and Drug Administration has issued a guidance document titled “Responding to FDA Form 483 Observations at the Conclusion of...
FDA Announces Public Meeting on Dietary Supplement Innovation and Ingredient Scope
FDA to Hold Public Meeting on Dietary Supplement Innovation and Ingredient Scope The U.S. Food and Drug Administration has announced an upcoming public meeting focused on dietary supplement...
FDA Expands Infant Formula Resources to Support Transparency and Access
FDA Enhances Resources Related to Infant Formula Oversight The U.S. Food and Drug Administration has announced updates to its infant formula resources aimed at improving transparency, safety, and...
California DTSC Proposes New Requirements for 1,4-Dioxane in Shampoos and Dish Detergents
The California Department of Toxic Substances Control (DTSC) is proposing to designate manual dish detergents and shampoos containing more than 1 ppm of 1,4-dioxane as “Priority Products” under the...
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity
FDA Emphasizes Role of Confidential Information in Its “Gold Standard” The U.S. Food and Drug Administration has published a new FDA Voices article highlighting the importance of protecting...
FDA Establishes Produce Regulatory Program Standards to Strengthen State Oversight
FDA Releases Produce Regulatory Program Standards (PRPS) The U.S. Food and Drug Administration has announced the establishment of Produce Regulatory Program Standards (PRPS), a new framework...
FDA Announces New Actions Related to Food Traceability Rule Implementation
The U.S. Food and Drug Administration has announced several actions related to the implementation of the Food Traceability Rule, a key component of the Food Safety Modernization Act (FSMA) aimed at...
FDA Initiates Review of BHA, a Common Food Preservative
The U.S. Food and Drug Administration has announced that it is launching a safety assessment of butylated hydroxyanisole (BHA), a synthetic antioxidant widely used in food products to prevent...
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...