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FDA Issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products
FDA has issued draft guidance with updated CMC and quality recommendations for container closure systems used with human drugs and biological products.
FDA Finalizes Food Safety Guidance for Ready-to-Eat Fresh-Cut Produce Operations
The U.S. Food and Drug Administration (FDA) has released final guidance to help manufacturers and processors of ready-to-eat fresh-cut produce comply with requirements under the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF)...
FDA Proposes Mandatory GRAS Notifications for Human and Animal Food Substances
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would significantly change the process for substances determined to be Generally Recognized as Safe (GRAS) for use in human and animal food. Under the proposal, companies introducing certain substances into interstate...
FDA and NOAA Update Certification Procedures for Seafood Exported to the European Union
New Seafood Export Certification Procedures Take Effect September 3 The U.S. Food and Drug Administration (FDA) is updating its listing and certification procedures for seafood products exported to the European Union (EU) in response to new EU export certification requirements. Beginning September...
Dietary Supplement Testing and Specifications Seminar
Presented by Shelly BlackwellOctober 21, 2026 | 1:00 PM – 5:00 PM ETSpecifications and testing remain among the most frequently cited deficiencies during FDA inspections of dietary supplement manufacturers. While the requirements of 21 CFR Part 111 have been in place for years, many firms continue...
FDA Releases Agenda and Opens Public Docket for Listeria monocytogenes Prevention Meeting
FDA has released the agenda and opened a 90-day public docket for its August 2026 Public Meeting on Listeria monocytogenes Prevention, covering ready-to-eat foods, retail food safety, and emerging prevention strategies.
FDA’s Proposed GRAS Rule Clears White House Review
OMB review is one of the final procedural steps before publication of a proposed federal regulation. As FDA moves forward with its proposed GRAS rule, industry stakeholders should carefully review the proposal once released and evaluate any potential implications for their regulatory and product development activities.
The #1 FSMA Element Most Produce Importers Fail to Get Right
Many produce importers overlook one of the most frequently cited FSVP requirements: documenting supplier evaluations that demonstrate compliance with FDA’s Produce Safety Rule. Learn what FDA expects and how to strengthen your FSVP before an inspection.
FDA Announces FY2027 FSMA User Fees for VQIP and TPP
FDA Releases FY2027 User Fee Information The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year 2027 user fee rates for two voluntary programs established under the Food Safety Modernization Act (FSMA): Voluntary Qualified Importer Program (VQIP) Accredited Third-Party...
Drug and Device Corner 2026 July
Highlighted Guidance Documents Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs The Food and Drug Administration is announcing the availability of a final guidance for industry titled “Formal Meetings Between FDA and Sponsors...
FDA Rolls Out New Features in CTP Portal NextGen to Enhance Application Submission Process
FDA Enhances CTP Portal NextGen The U.S. Food and Drug Administration's Center for Tobacco Products (CTP) has announced additional enhancements to CTP Portal NextGen, the agency's electronic platform for tobacco product application submissions and regulatory communications. The updates are...
FDA Calls on Infant Formula Industry to Strengthen Supplier Oversight
FDA Urges Increased Vigilance Across the Infant Formula Supply Chain The U.S. Food and Drug Administration (FDA) has issued a letter to infant formula manufacturers, packagers, distributors, importers, exporters, retailers, and supply chain partners emphasizing the importance of stronger supplier...
FDA Announces Public Meeting on Listeria monocytogenes Prevention
FDA will host a public meeting on August 18-19, 2026, to discuss Listeria monocytogenes prevention, food safety best practices, and risk reduction strategies across the food supply chain.
Dean Cirotta Featured in Tobacco Reporter on FDA’s Proposed Foreign Tobacco Manufacturer Registration Rule
Dean R. Cirotta, President of EAS Consulting Group, recently contributed an article to Tobacco Reporter examining FDA's newly proposed rule, Establishment Registration and Product Listing for Tobacco Products. The proposed rule would require foreign tobacco product manufacturers to register their...
CFIA Food Fraud Report Highlights Ongoing Food Authenticity Challenges
CFIA Releases 2024-2025 Food Fraud Annual Report The Canadian Food Inspection Agency (CFIA) has released its Food Fraud Annual Report 2024-2025, summarizing the agency's efforts to prevent, detect, and deter food fraud in the Canadian marketplace between April 1, 2024 and March 31, 2025. The...
California Food Date Labeling Requirements Take Effect July 1
California Standardizes Food Date Labels Beginning July 1 Beginning July 1, 2026, food manufacturers, processors, and retailers selling products in California must comply with California's food date labeling law, Assembly Bill 660 (AB 660). The law establishes standardized terminology for food...
USDA Food Safety and Inspection Service (FSIS) Label “Approval Process”
USDA Food Safety and Inspection Service (FSIS) labels play a critical role in product compliance and market access. This article explores the FSIS label approval process, including generic, sketch, and temporary approvals, while highlighting common compliance challenges and the recordkeeping requirements establishments must maintain to support approved labeling claims.
FDA Updates 2026 Human Foods Program Guidance Agenda
FDA Releases Updated 2026 Human Foods Program Guidance Agenda The U.S. Food and Drug Administration has released an updated version of its 2026 Human Foods Program (HFP) Guidance Agenda, adding three new guidance topics for industry consideration. The Human Foods Program Guidance Agenda provides...
When AI Isn’t Enough: Human Expertise Remains Essential in Regulatory Affairs
Artificial intelligence is rapidly transforming how companies gather information, analyze data, and support decision-making. However, in highly regulated industries, technology alone cannot replace the experience, judgment, and practical understanding required to navigate complex regulatory...
Drug and Device Corner 2026 June
EAS has become aware of the agency’s increased enforcement policy described in their Guidance Document Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. For extension requests that identify the same reason for the request multiple times, FDA is beginning to...
FDA Proposes Rule to Strengthen Accountability for Foreign Tobacco Product Manufacturers
FDA Announces Proposed Rule Affecting Foreign Tobacco Product Manufacturers The U.S. Food and Drug Administration has issued a proposed rule designed to strengthen oversight of foreign tobacco product manufacturers and improve accountability for tobacco products entering the U.S. marketplace....
Basic Seafood HACCP In-Person Training
October 27- 29, 2026Presented by Mark MoenTraining in Hazard Analysis and Critical Control Point (HACCP) systems is required for seafood processors under FDA Seafood HACCP regulations (21 CFR Part 123). This 2.5-day in-person training course provides participants with the knowledge and practical...
USDA Opens Food Safety Outreach Grant Competitions
The USDA's National Institute of Food and Agriculture has opened applications for its 2026 Food Safety Outreach Grant Program, which will provide nearly $10 million in funding for food safety education, training, outreach, and technical assistance projects. Applications are due July 20. According...
FDA Updates Pesticide Monitoring Program for Domestic and Imported Foods
FDA Modernizes Pesticide Monitoring Compliance Program The U.S. Food and Drug Administration has announced several updates to its pesticide monitoring compliance program designed to strengthen oversight of pesticide residues in domestic and imported foods. The revisions update Compliance Program...
Import Seafood HACCP: Understanding FDA Requirements for U.S. Seafood Importers
Importing seafood into the United States carries specific responsibilities under FDA’s Seafood HACCP regulations. Firms importing fish and fishery products must comply with 21 CFR 123.12 and establish appropriate verification procedures to demonstrate seafood import compliance.
Animal Food GRAS: Unpacking the Essentials
This webinar explores the history and legal basis of GRAS, compares GRAS to alternative regulatory pathways, and reviews FDA notification and self-determined GRAS approaches. The presentation also discusses the role of qualified experts in establishing GRAS conclusions, species-specific safety considerations, and regulatory challenges associated with novel animal food ingredients.
USDA Launches Small Processors Action Plan to Support Meat and Poultry Industry Growth
USDA Announces New Support Initiatives for Small Processors The U.S. Department of Agriculture has released a Small Processors Action Plan aimed at strengthening the nation’s meat and poultry processing sector through technical assistance, workforce development, regulatory support, and targeted...
FDA Updates Food Traceability Rule FAQs with Six New Clarifications
FDA Adds New Frequently Asked Questions on the Food Traceability Rule The U.S. Food and Drug Administration has updated its Frequently Asked Questions (FAQ) resource for the Food Traceability Rule, adding six new questions and answers that address common implementation scenarios. The Food...
FSIS Launches Pilot Program to Expand Listeria Verification Sampling in Ready-to-Eat Meat and Poultry Establishments
FSIS Expands Environmental Sampling Activities Through New Pilot Program The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has announced a pilot program designed to strengthen oversight of ready-to-eat (RTE) post-lethality exposed meat and poultry establishments. The...
FDA Expands Sunscreen Options for the First Time in 20 Years
FDA Takes Action to Expand Available Sunscreen Ingredients The U.S. Food and Drug Administration has announced a significant milestone in sunscreen regulation by expanding the list of permitted sunscreen active ingredients for the first time in more than 20 years. The action adds bemotrizinol as...