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 Expert Panel on Food Allergies
The FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s...
What Do I Need to Know About My Testing Lab?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
FDA issues final guidance on using remote oversight tools to help approve drugs
FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug review process. FDA uses a...
FDA Detained My Product – Now What?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
Heads-up: Front-of-Pack labels, GRAS changes, and supplement definition update
FDA has signaled three significant rulemakings in the Unified Agenda that could affect food and dietary supplement companies. These are not official final rules—but they’re far enough along that your regulatory, R&D, and labeling teams may want to prepare.1) Front-of-Package (FOP) Nutrition...
FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89
September 04, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previously unpublished CRLs issued from 2024 to...
How to Export Food from the U.S. to Mexico: A Practical Regulatory Guide
By Carolina Herrera Samaniego, EAS Consulting Group Independent Consultant As global food markets evolve, Mexico offers growing opportunities for U.S. exporters seeking to expand their international reach. Exporting food to Mexico from the United States requires more than compliant product...
FDA Releases Results on Economically Motivated Adulteration (Short Weighting) in Seafood
September 02, 2025 Constituent Update Read on FDA WebsiteThe U.S. Food and Drug Administration (FDA) is releasing the results from a sampling assignment conducted during 2022 to 2024 on testing of frozen seafood products for short weighting. Short weighting can occur in frozen seafood when the net...
FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure
September 02, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine...
Drug and Device Corner 2025 August
Generic Drug User Fee Amendments (GDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due 1 October 2025. User Fee Type FY 2026 ANDADMF $ 358,247$ 102,584 Program Large SizeMedium SizeSmall Size $ 1,918,377$ 767,351$ 191,838 Facility Domestic...
FDA to Hold Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications
August 18, 2025 Constituent Update Read on FDA WebsiteSave the Date Dates Virtual Presentations and Panel Discussions – November 18, 2025 Virtual Listening Sessions – November 19-20, 2025 Event Overview The FDA will host a three-day, virtual public meeting from November 18-20, 2025, to discuss...
Elevating Allergen Testing: Capabilities, Challenges, and the Path Forward
Food allergies are a growing public health concern, affecting millions and shaping the way food is produced, labeled, and regulated. As the regulatory landscape tightens and consumers demand safer, more transparent food options, accurate and robust allergen testing has never been more essential.
Certified Group invites you to a customer-focused webinar designed to empower food industry professionals with the latest knowledge on allergen detection. Discover cutting-edge technologies, industry challenges, and the evolving solutions that protect your brand and your consumers.
FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
August 7, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United...
FDA Issues Proposed Rule to Amend Standard of Identity for Pasteurized Orange Juice
August 5, 2025 Constituent Update Read on FDA Website The U.S. Food and Drug Administration has issued a proposed rule to amend an over 60-year-old Standard of Identity (SOI) for pasteurized orange juice to promote honesty and fair dealing for consumers. The proposed rule will also provide...
Compliance Requirements for U.S. Food Products Commercialized in Mexico: NOM-051 and the Mandatory Evaluation Documents
By María Fernanda Mandujano Morales, EAS Consulting Group Independent ConsultantExporting food products from the United States to Mexico requires compliance with specific regulations—particularly NOM-051-SCFI/SSA1-2010, which governs front-of-pack and nutritional labeling for prepackaged foods and...
FDA Releases New Tool for Toxicity Screening of Chemicals in Food
July 30, 2025 HFP Constituent Updates Read on FDA WebsiteToday, the U.S. Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool that advances the agency’s commitment to transparency and enhancement of the food chemical safety program....
Drug and Device Corner July 2025
The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA regulated products will be reviewed...
Senators Markey and Booker Introduce Legislation to Get Dangerous Chemicals Out of Food
July 17, 2025 View Full Press ReleaseThe Ensuring Safe and Toxic-Free Foods Act of 2025 aims to enhance food safety by tightening the FDA's regulations on food chemicals. Key provisions include: Manufacturers must submit GRAS notifications for all ingredients currently marketed under "self-GRAS"...
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
July 16, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products...
cGMP Responsibilities for Own Label Distributors and Brand Owners
cGMP Responsibilities for Own Label Distributors and Brand OwnersPresented by Shelly BlackwellDecember 18, 2025, 1pm (eastern)Own Label Distributors (OLD) in the dietary supplement industry often question their responsibilities for complying with current Good Manufacturing Practices (cGMP’s)...
FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline
July 14, 2025 View on FDA Website On January 15, 2025, the U.S. Food and Drug Administration issued an orderrevoking the authorization for the use of FD&C Red No. 3 in foods, including dietary supplements (permitted under 21 Code of Federal Regulations (CFR) 74.303), and in ingested drugs...
US Food and Drug Administration FDA Embraces Radical Transparency by Publishing Complete Response Letters
FDA News Release July 10, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological...
Comparative Perspective on Thermal Processing: Regulations and Practices in Mexico and the U.S.
By Fernanda Estefanía Jiménez Garzón, EAS Consulting Group Independent ConsultantWhat if the foodborne illness you experienced… could have been prevented? According to the World Health Organization (2024), approximately 600 million people worldwide suffer from foodborne illnesses each year, with...
Conducting Remote Regulatory Assessments Questions and Answers
Docket Number: FDA-2022-D-0810 Issued by: Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Tobacco Products Center for Veterinary Medicine Human Foods Program Office...
Foods Program FDA Guidance Under Development
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA is considering for Human and Animal Foods. The lists below include some of the guidance documents under consideration to be developed. That said,...
FDA Updates General Food Labeling Requirements Compliance Program
Constituent Updates June 24, 2025 Read on FDA Website The U.S. Food and Drug Administration has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import. This update replaces the previous 2010 version of the...
Drug and Device Corner June 2025
The FDA has released two proposed administrative orders for requesting minor dosage form changes to certain OTC monograph drugs. These administrative orders are open for comment. Proposed Administrative Order OTC000038 If finalized, this proposed order will specify requirements for industry to...
FDA Seeks Input on a New Method for Ranking Chemicals in Food for Post-market Assessments
Constituent Update June 18, 2025Today, the U.S. Food and Drug Administration (FDA) released for public comment its proposed method for ranking chemicals in the food supply. This method provides a transparent, systematic, and science-based approach to determine which chemicals the agency would...
FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests
For Immediate Release: June 17, 2025The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the...
Raising Your Nutrition Label IQ
Many people have difficulty understanding the Nutrition Facts label, especially with regards to properly interpreting and using the information about serving sizes and the percent Daily Values. This webinar will clear up some of the confusion about these and other labeling issues. This webinar will also discuss some of the science that went into developing the Nutrition Facts label and explain why FDA decided to update and modernize the label in 2016. By attending this webinar, you will become a more knowledgeable label reader.