FDA and USDA Regulatory Updates
Regulatory Freeze Executive Order
Effective January 20, 2025, President Trump issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries. Regulatory Freeze The regulatory freeze order,...
Cat and Dog Food Manufacturers Required to Consider H5N1 in Food Safety Plans
January 17, 2025Read on FDA WebsiteThe U.S. Food and Drug Administration has determined that it is necessary for manufacturers of cat and dog foods who are covered by the FDA Food Safety...
FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
On January 14, 2025, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require a front-of-package (FOP) nutrition label on most packaged foods to provide accessible,...
A Year in Review: FDA’s Progress on Tobacco Product Regulation in 2024
With a new year upon us, FDA’s Center for Tobacco Products (CTP) continues to work diligently to protect the public health of the U.S. population from tobacco-related disease and death. At the same...
FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
Today, the U.S. Food and Drug Administration issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the...
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
January 2025 Docket Number: FDA-2022-D-0099 Issued by: Human Foods ProgramFinal Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling...
Considerations for Complying with 21 CFR 211.110
January 2025 Docket Number: FDA-2024-D-5374 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary MedicineThis guidance, when...
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
Docket Number: FDA-2024-D-4488Issued by: Center for Devices and Radiological HealthCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and ResearchThis draft guidance document...
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children
January 2025 Docket Number:FDA-2022-D-0278 Issued by: Human Foods ProgramFDA is committed to reducing lead in food. FDA’s Closer to Zero initiative is a science-based, iterative approach to...
FDA Issues Final Guidance on Analytical Testing for Industry Use in Tobacco Product Applications
Agency remains committed to providing resources to support application submissionsJanuary 6, 2025Today, FDA issued “Validation and Verification of Analytical Testing Methods Used for Tobacco...
FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
For Immediate Release: December 26, 2024Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify...
FDA issues final rule to broaden types of nonprescription drugs available to consumers
Today, the U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A...
FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
December 19, 2024Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of...
FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes
WASHINGTON, December 17, 2024 – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced several new steps to strengthen the agency’s oversight of food...
FDA Submits Proposal to Set a Nicotine Limit on Tobacco Products
The U.S. Food and Drug Administration has submitted a proposal to the Office of Management and Budget (OMB) to limit the amount of nicotine in tobacco products, reports CNN. “A proposed product...
FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products
Read on FDA SiteCosmetics Constituent Update December 11, 2024The U.S. Food and Drug Administration (FDA) issued updated guidance entitled Guidance for Industry: Registration and Listing of Cosmetic...
VQIP Application Portal Opens for FY2026
Constituent Update December 10, 2024 Read on FDA site On January 1, 2025, the U.S. Food and Drug Administration (FDA) will open the Voluntary Qualified Importer Program (VQIP) application...
FDA Issues Guidance on Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula
Constituent Update December 2, 2024The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining the requirements and procedures that infant formula manufacturers should follow to...
FDA Issues 2024 Voluntary National Retail Food Regulatory Program Standards
Constituent Update December 2, 2024The U.S. Food and Drug Administration (FDA) today issued the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines the key...
FDA Updates Guidance for the Voluntary Qualified Importer Program (VQIP)
Constituent UpdateNovember 14, 2024The U.S. Food and Drug Administration (FDA) today released guidance with revisions to the FDA Food Safety Modernization Act (FSMA) Voluntary Qualified Importer...
FDA Seeks Public Input on Experiences with Export Certification in the Form of Lists (Export Lists) for Human Food Products
Constituent UpdateNovember 7, 2024The U.S. Food and Drug Administration (FDA) is seeking public input on its current approach to managing FDA certification for the export of human food products...
Human Food Program (HFP) FY 2025 Priority Deliverables
On this page: Introduction FY 2025 Priority Deliverables About the Human Foods ProgramIntroduction The FDA is responsible for regulating 80% of the U.S. food supply, with the Human Foods Program...
FDA Releases Supplement to the 2022 Food Code
The U.S. Food and Drug Administration (FDA) today has published the Supplement to the 2022 Food Code. The Supplement updates the 2022 Food Code with recommendations made by regulatory officials,...
Food Traceability Rule (FSMA 204)
Coming Soon!The FDA Food Safety Modernization Act (FSMA), enacted in 2011, empowers the FDA to bolster public health by strengthening the food safety system through new regulatory actions. FSMA is...
CVM GFI #294 – Animal Food Ingredient Consultation (AFIC)
The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are...
Important Changes to OTC Monograph Listing Marketing Categories
In addition to a reminder of the Drug Establishment Registration Renewal period (1 October – 31 December) EAS would like to remind you of significant changes being implemented for OTC monograph drug...
FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration (FFR) between October 1 and December 31, 2024
Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required...
Importing FDA-Regulated Seafood Products – New FDA Video Now Available
The U.S. Food and Drug Administration (FDA) has released the third video in the “Importing FDA-Regulated Products” series. This new video provides an overview of the process for importing seafood,...
New Webinar: Preparing and Submitting a Standalone Pre-Existing Tobacco Product Submission
CTP invites you to watch the tobacco compliance webinar, "Pre-Existing Tobacco Product Determination Program Webinar Series Part 2 of 3: Preparing and Submitting a Standalone Pre-Existing...
FY2025 Drug Program User Fees
Please see below information regarding FY2025 Drug Program User Fees which go into effect 1 October 2024. The FDA has announced FY2025 user fees for GDUFA, OMUFA (Order Requests only), PDUFA, BsUFA,...