FDA and USDA Regulatory Updates
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....
HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers
May 13, 2025 View on the FDA WebsiteThe U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of a public Request for Information...
FDA Approves Three Food Colors from Natural Sources
May 09, 2025The U.S. Food and Drug Administration announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to...
Front-of-Package Nutrition Information; Extension of Comment Period
In response to requests for an extension, the FDA is extending the comment period for the proposed rule entitled ‘‘Food Labeling: Front-of-Package Nutrition Information’’ that appeared in the...
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
May 06, 2025Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential...
Special Alert: FSIS Withdraws Proposed Salmonella Framework for Raw Poultry Products
Special Alert: Constituent Update April 24, 2025 FSIS is withdrawing its proposed rule and determination titled “Salmonella Framework for Raw Poultry Products”, published on August 7, 2024, to...
HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
For Immediate ReleaseApril 22, 2025The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all...
FDA hiring contractors to replace fired staff who supported safety inspections
The FDA is planing to hire contractors to replace fired staff who supported safety inspections, including those who arranged foreign travel and tested food samples. The cuts, which include...
Major Shakeup at FDA Continues as Tobacco Chief Removed
We wanted to share this important AP News article about the latest developments at the FDA, where tobacco director Brian King has been placed on administrative leave amid sweeping cuts to the...
HHS Restructuring and Organizational Streamlining
March 28, 2025View on the HHS WebsiteThe U.S. Department of Health and Human Services (HHS) announced significant organizational changes. Key Highlights of the HHS Restructuring: Organizational...
Webinar on the Updated “Healthy” Claim
March 27, 2025View on the FDA WebsiteThe FDA Webinar on the Updated “Healthy” Claim has been rescheduled for April 10, 2025, from 1-2 pm EDT. Please note, the webinar is open to new registrants, but...
New Searchable Web Page for the Food Allergen Labeling Guidance for Industry
March 26, 2025 View on the FDA WebsiteToday, the FDA published a web page, Frequently Asked Questions: Food Allergen Labeling Guidance for Industry, as a resource for the 5th edition of FDA’s...
HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
For Immediate Release: March 18, 2025View on FDA WebsiteToday, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug...
FDA Intends to Extend Compliance Date for Food Traceability Rule
Constituent Update March 20, 2025 View on the FDA WebsiteToday, the U.S. Food and Drug Administration (FDA) is announcing its intention to extend the compliance date for the Food Traceability...
HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
For Immediate Release: March 20, 2025View on FDA WebsiteToday, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug...
HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe
The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration are committed to promoting radical transparency to make sure all Americans know what is in their food....
2024 CARES Act Drug Volume Reporting Reminder
Final reminder that CARES volume reports for 2024 are due no later than 31 March 2025 for all registered drug establishments. Do remember how vital it is to ensure all NDC listings reflect their...
Food Standards Australia New Zealand
Food Standards Australia New Zealand (FSANZ) has compiled all 80 Standards and 29 Schedules of the Code into a single, easy-to-search and navigate guidance document. While an obvious resource for...
Cosmetic Registration and Listing Requirement Reminder
Now that we have entered the first year post cosmetic registration and listing requirements, it’s a good time to review your records and make sure you are prepared for your update / renewal process....