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.
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,...
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...