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.
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 Products,” a final guidance providing tobacco manufacturers with information and recommendations to aid...
Claims Substantiation Seminar
This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.
Drug and Device Corner December 2024
The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user completes an ACNU...
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 asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect...
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 nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if...
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 preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy”...
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...