EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Investigating Pesticide Tolerance
By Dr. Bill Reeves, EAS Regulatory ConsultantConsistent, scientifically justified regulations enable over $1.5 trillion in global agricultural exports every year. The world economy depends on these regulations to ensure whatever goes onto a ship is legal to sell when it reaches port. One key...
Drug and Device September 2024
The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate. Any NDC SPL file requiring updates should be done prior to 31 December 2024. The marketing...
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 to register the facility with the FDA. The registration and renewal period is open between October 1...
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, focusing on key regulatory requirements. It is designed to help importers, brokers, and foreign...
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 Submission.” This webinar is part two of a three-part webinar series providing details on various topics...
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, and animal user fee programs. Please see the Federal Register notices for details on each. FR Vol....
Claims Substantiation of Cosmetic Products
An EAS Consulting Group Complimentary On Demand WebinarPresented by Paula Brock, Ph.D., MCSISeptember 9, 2024 • 11:30 AM (Eastern) • Length: 45 minutesSubstantiation of product claims is required by law in the USA and this is not different for cosmetics. All types of claims need to be...
FY2025 Medical Device Fees
Please see below information regarding FY2025 Medical Device User Fees which go into effect 1 October 2024. Keep in mind, the FY2025 facility user fee must be paid prior to processing your annual renewal during the renewal period Oct 1 – Dec 31. FY2025 Medical Device facility registration user...
Product Imports Into the U.S That Contain Meat and Poultry: Maneuvering the Process?
By Ronnie Dunn, EAS Consulting Group Independent ConsultantImporting meat, poultry, and egg products into the U.S. can be a daunting and confusing task. There are numerous regulations and processes that must be followed spanning many U.S. government agencies. Much research needs to be done prior...
AHPA Claims Substantiation Tools and Trends
AHPA Claims Substantiation Tools and TrendsPresented by Paula Brock, Ph.D., MCSIThis is a portion of a webinar produced by the American Herbal Products Association (AHPA) originally held July 9, 2024.Enter Your Information to Watch NowBy clicking submit above, you consent to allow EAS Consulting...
Ensuring Food Safety from the farm to the table is crucial. How inspections and audits play a key role.
Ensuring Food Safety from the farm to the table is crucial. How inspections and audits play a key role. by Don Abbott, EAS Consulting Group Independent Consultant Published in Food Safety Tech
USDA Releases Updated Guideline to Strengthen Substantiation of Animal-Raising and Environment-Related Claims on Meat and Poultry Labels
WASHINGTON, August 28, 2024 – The U.S. Department of Agriculture (USDA) announced today the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry product labeling. Today’s action...
HDA 2024 Traceability Seminar: What to Expect From FDA Inspections
In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.
Drug and Device August 2024
FDA issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the labeling of OTC internal...
FDA Announces Proposed Rule to Require Submission of Tracking Numbers for Imports of E-Cigarette Products
Recently, FDA and the Department of the Treasury are announcing a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of Electronic Nicotine Delivery System (ENDS) products into the electronic imports system operated by U.S. Customs and Border...
How to Build an Achieving Team
By Eiman Raouf, EAS Senior Regulatory ConsultantUpon entering various organizations, scenarios often unfold where operational efficiency falls short. Quality lapses in production, a surge in customer grievances, or perpetual crisis management seem to be the norm rather than the exception....
Durbin Introduces Legislation To Improve Safety And Ensure Transparency Of Dietary Supplements
9 Out Of 10 American Adults Support Listing Requirements For Dietary SupplementsWASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today introduced the Dietary Supplement Listing Act of 2024, legislation to require dietary supplement manufacturers to list their products with the Food and...
FDA Announces Registration and Listing Updates: The Release of New Discontinuation/Relisting Features in Cosmetics Direct
Cosmetics Constituent Update Today the U.S. Food and Drug Administration (FDA) announced the release of the following enhancements to help industry keep their registration and listing submissions up to date: the availability of two new features in Cosmetics Direct, the electronic submission portal...
Drug and Device July 2024
FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory. The FDA had previously...
FDA Enhances Tobacco Retailer Inspection Database
This week, FDA’s Center for Tobacco Products updated the presentation of information about tobacco compliance check outcomes on the FDA website and expanded the information available. The newly-named Tobacco Compliance Check Outcomes database provides an enhanced user experience by housing results...
Import Refusals – “Don’t Panic”
By Mark Moen, EAS Consulting Group Senior Regulatory ConsultantProducts imported into the US may be assessed and inspected by US Customs and Border Protection (CBP), the Food and Drug Administration (FDA), and US Consumer Products Safety Commission (CPSC). US Customs and Border Protection (CBP) is...
Drug and Device June 2024
Final reminder that CARES Act drug amount reports for 2023 are due by 31 July 2024. If you need assistance with this process, reach out to Victoria Pankovich for support.The FDA announced the availability of a final guidance for industry titled “Facility Readiness: Goal Date Decisions Under...
FDA Releases Update of Priority Guidance Topics for Foods Program
Earlier this year, the FDA released the draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. Since January, the FDA has issued the following guidances that were on the list: New Dietary Ingredient (NDI) Notifications and Related Issues: NDI...
Product Claim Substantiation
By Jay Ansell, EAS Independent ConsultantSubstantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade Commission (FTC), responsible for enforcing federal laws...
Drug and Device May 2024
Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of receiving such report. Cosmetic labels are required to include a domestic address, domestic phone number,...
Quality Management System (QMS) Documentation
By Jeff VanderHoek, EAS Independent ConsultantThe design and manufacturing of medical devices requires a high level of quality and reliability to ensure patient safety and regulatory compliance. The Quality Management System (QMS) that a company creates and puts in place plays a key role in...
Drug and Device April 2024
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June 2024. Regarding fee specifics,...
US label and EU label: food labeling in comparison
Gisela Leon, EAS Consulting Group Independent ConsultantInterviewed for Industrie- und Handelskammer HannoverApril 4, 2024Published in GermanWithin the European Union, food labeling is clearly regulated. In the USA, too, it is - but different. The Food and Drug Administration (FDA) and the United...
Control of Cronobacter in Dairy Dryer and Packaging Rooms
By Beth Koenig, EAS Independent ConsultantWhat Is Cronobacter and Why Should We Be Concerned About It? Cronobacter, a genus of bacterial pathogens in the Enterobacteriacea family is of considerable concern in infant formula manufacturing and in the manufacture of products for populations with...
FY2024 OMUFA User Fees Announced by FDA
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June 2024. Regarding fee specifics,...