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.
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,...
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,...
FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on...
FDA Issues Import Alert for Food Products with Chemical Contaminants Including PFAS
On March 20, 2024, the US FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, gives the FDA...
FDA Launches Searchable Tobacco Products Database
Database Lists Tobacco Products—Including E-Cigarettes—That May Be Legally MarketedToday, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve...
Drug and Device March 2024
Reminder that CARES volume 2023 reports are due no later than 1 July 2024.Highlighted Guidance Documents Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide FDA is issuing this Technical Conformance Guide to assist registrants of drug establishments in submitting...
Reassessment of EMPs
Reassessment of EMPs: Have You Identified the Correct Sampling Locations to Protect Your Product?An EAS Complimentary Webinar Presented by Rocelle Grabarek, EAS Independent ConsultantMarch 27, 2024 • 1pm (Eastern) 1.5 hoursMany of the environmental monitoring programs (EMP) have been established...
FDA Proposed Rule on “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs”
FDA proposes to revise the existing regulations regarding the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). These proposed regulations would...
USDA Finalizes Voluntary “Product of USA” Label Claim to Enhance Consumer Protection
USDA today published its “Product of USA” final rule, which will allow voluntary “Product of USA” or “Made in the USA” label claims to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the United States. Under the final...
Are You Ready for the Unspoken Challenges of FSMA 204?
By Norman Alayan, EAS Independent Consultant“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability record-keeping requirements, beyond those in existing regulations, for persons who manufacture, process,...
FDA Announces Release of First Final Guidance Section for NDIN – NDI Notification Procedures and Timeframes
The FDA recently announced final guidance for industry on “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes.” This guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary...
Drug and Device February 2024
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for...
FDA Issued a Final Guidance Document on CARES Act Reporting Requirements
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for...
FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance
The FDA has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry" (PCHF Draft Guidance). The changes address comments received on the drafts made...
FDA Issues Final QMSR Regulation and FAQ
The Food and Drug Administration (FDA) issued a final rule on January 31, 2024, to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation defined in 21 CFR Part 820 to harmonize and modernize the regulation. The reason for the change...
FDA Issues Revised Draft Guidance for Topical Ophthalmic Drug Products
The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023. The guidance specifically notes recent cases of...
The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications
By Kevin Walls, MBA, EAS Independent Consultant The Medical Device Single Audit Program (MDSAP) is a certification program many medical device manufacturers are incorporating into their quality system. The US Food and Drug Administration (FDA), Health Canada, Brazil Agência Nacional de Vigilância...
Drug and Device January 2024
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA has recommended February for...
Upcoming FDA Food Guidance Materials for 2024
On January 25, 2024, the U.S. Food and Drug Administration’s Foods Program posted a list of new / updated food regulations it plans to publish in 2024 and beyond. These include:Amendments to Registration of Food Facilities February 2024. The proposed rule would make clarifying changes to general...
FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products
The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation on Harmonisation of Technical...
Cosmetic Safety Substantiation
MoCRA, effective December 2023, requires safety substantiation. It amends the FD&C Act. MoCRA mandates maintaining safety records, facility registration, product ingredient registration, and reporting serious adverse events. This seminar, with insights from experts, will overview cosmetic safety assessment.
Shaping the Future: Revolutionizing Food Safety and Quality
By Vera K. Petrova Dickinson, EAS Independent ConsultantIn the ever-evolving landscape of the food industry, the quest for ensuring Food Safety and Quality (FSQ) faces both new challenges and age-old dilemmas. As we navigate this intricate space, it becomes increasingly evident that the current...
Drug and Device December 2023
With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program –...
FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. A responsible person is required to report serious adverse...
FDA Announces Availability of Draft Supplemental Guidance on Menu Labeling
The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled Menu Labeling: Supplemental Guidance for Industry (Edition 2). To respond to frequently asked questions regarding menu labeling requirements, the draft guidance, once finalized,...
Drug and Device November 2023
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be updated and submitted to...