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.
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 processing facilities it regulates (meat, poultry and egg products) and ensure safe food. These steps...
Infant Formula Regulations in Australia and the United States: A Brief Comparison
By Julie Cottle - Regulatory Matters Global Technical & Compliance Specialist | Food & Complementary MedicinesInfant formula is an important product for infants who cannot be breastfed, and ensuring its safety and nutritional adequacy is a global priority, guided by standards established...
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 standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain...
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 Product Facilities and Products. In summary, the guidance finalizes the frequently asked questions...
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 portal for fiscal year (FY) 2026. VQIP is a voluntary fee-based program that provides importers, who...
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Constituent Update December 2, 2024The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining the requirements and procedures that infant formula manufacturers should follow to notify the FDA of a permanent discontinuance or an interruption of the manufacture of infant formula...
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 elements of an effective retail food regulatory program for state, local, tribal, and territorial...
Drug and Device November 2024
This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024. If you need help with your submissions, please reach out to EAS for support....
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 Program (VQIP). VQIP offers importers who achieve and maintain a high level of control over the safety...
Health Canada
Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.
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 regulated by the agency. Firms exporting products from the U.S. are often asked by foreign customers or...
21 CFR Part 11 and FDA Compliance
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
Are You as an Importer Ready for FSMA Traceability Rule?
By Angel Suarez, EAS Consulting Group Independent ConsultantUnder the Food Safety Modernization Act (FSMA) the FDA has finalized several major rules to ensure the safety of the food supply is a shared responsibility across the global supply chain. The last of these major rules is the FDA Food...
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 (HFP) overseeing all activities related to food safety and nutrition. The FDA launched the HFP as part...
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, industry, academia, and consumers at the 2023 Biennial Meeting of the Conference for Food Protection. ...
Drug and Device October 2024
Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact Victoria Pankovich at EAS. The...
Good ANDA Submission Practices
Proactive Planning for the Best Possible OutcomesPresented by Radhika Rajagopalan, Ph.D., EAS Independent ConsultantFDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to spurring competition with the aim of lowering the high cost of...
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 the compilation of many FDA food regulations, encompassing stringent rules for food production,...
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 generally recognized as safe (GRAS) for their intended uses in food. Since 1920, the Association of...
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 product listings. The changes were announced by FDA last year and reminders were included in EAS’...
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...
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 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....
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...