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.
Food and Dietary Supplement Labeling: What Comes Next?
Labeling of food and dietary supplements in the United States involve several aspects and each must be approached with careful consideration. Regulatory, scientific, and business decisions need to be considered when working on labels’ mandatory elements and claims. The FDA released in December...
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 Australian and New Zealand based food businesses, it is also a great resource for businesses exporting...
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. For facility registrations, an update should be submitted within 60 days of any changes to the...
Audits: Internal, Regulatory, and Mock…. Oh, My!
Audits come in a variety of types, but the three main audit types that will be covered here are Regulatory Audits, Internal Audits, and Mock Audits. The ways a company handles, conducts and views these three categories of inspections will set them up for success. Read more of Jeb Hunter's featured...
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. The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any rulemaking or similar regulatory...
Drug and Device Corner January 2025
Effective January 20, 2025, The President issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries. The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any rulemaking or similar regulatory...
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, consistent with the actions of previous incoming administrations, effectively halts any rulemaking or...
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 Modernization Act Preventive Controls for Animal Food (PCAF) rule and using uncooked or unpasteurized materials...
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, at-a-glance information to help consumers quickly and easily identify how foods can be part of a healthy...
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 time, we also celebrate significant public health wins that have occurred over the past year,...
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 level of nicotine in those products. If finalized, the United States would be the first country...
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 Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5). This final guidance will replace both...
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 finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure...
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 provides recommendations regarding the contents of marketing submissions for devices that include...
Pet Supplement Industry on the Rise
Recent survey reports indicate that supplements for pets have reached US sales of nearly $3 billion, with dog and cat supplements comprising of approximately 75% and 20% of the total, respectively. The growing pet supplement market is aimed at pet health and wellness, particularly for issues like mobility, skin and coat health, and anxiety. Survey reports specifically indicate that hip and joint supplements are the most frequently type of supplement purchased.
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 decreasing toxic elements, including lead, in foods over time, including by setting action levels. The...
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....