FDA and USDA Regulatory Updates
FDA Issues Foreign Supplier Verification Program (FSVP) Warning Letters
The FDA recently issued a series of warning letters citing companies for failure to comply with Foreign Supplier Verification Program requirements. In these cases, the FDA said the companies “did...
New FDA Guidance on Infant Formula Protein Efficiency Ratio (PER) Studies
The FDA has issued final guidance for industry on Protein Efficiency Ratio rat bioassay studies used to demonstrate that new infant formulas meet the required “quality factor of sufficient...
Publication of Final Rule: Visual Post-Mortem Inspection in Swine Slaughter Establishments
On May 21, 2026, the Food Safety and Inspection Service (FSIS or agency) published a final rule (Federal Register :: Visual Post-Mortem Inspection in Swine Slaughter Establishments) amending its...
Marty Makary Resigns as FDA Commissioner
Marty Makary Steps Down as FDA Commissioner Multiple news outlets are reporting that Dr. Marty Makary has resigned as Commissioner of the U.S. Food and Drug Administration after serving in the role...
FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products
FDA Updates Enforcement Priorities for Unauthorized Tobacco Products FDA’s Center for Tobacco Products (CTP) has issued guidance titled “Enforcement Priorities for Certain New Tobacco Products...
FDA Launches One-Day Inspectional Assessments to Expand Regulatory Oversight
FDA Introduces One-Day Inspectional Assessments The U.S. Food and Drug Administration has announced a new initiative called One-Day Inspectional Assessments, designed to expand oversight activities...
USDA Announces Creation of Office of Seafood to Strengthen Industry Coordination
USDA Establishes Office of Seafood The U.S. Department of Agriculture has announced the creation of a new Office of Seafood, aimed at strengthening coordination, policy development, and support for...
FDA Releases Draft Guidance on Impurity Specifications for Antibiotics
The U.S. Food and Drug Administration has issued a draft guidance titled “Establishing Impurity Specifications for Antibiotics.” The guidance provides recommendations for manufacturers on...
FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey
The U.S. Food and Drug Administration has released its FY2025 sampling results focused on economically motivated adulteration (EMA) in honey. The sampling program is part of FDA’s ongoing efforts to...
FDA to Host Public Meeting on the Scope of Dietary Supplement Ingredients
FDA Announces Public Meeting on Dietary Supplement Ingredient Scope The U.S. Food and Drug Administration will host a public meeting on March 27, 2026, focused on exploring the scope of dietary...
FDA Withdraws Temporary COVID FSMA Guidances Related to Onsite Audits
FDA Ends COVID-Era Flexibility for FSMA Onsite Audit Requirements The U.S. Food and Drug Administration has announced it is withdrawing two temporary guidances issued during the COVID-19 public...
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...