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 Finalizes Rule Standardizing National Drug Code Format
FDA Final Rule Revises National Drug Code Format and Barcode Requirements FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode requirements. The National Drug Code is a unique identifier assigned to drug products marketed in the...
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections
FDA Releases Guidance on Responding to Form 483 Observations The U.S. Food and Drug Administration has issued a guidance document titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance provides recommendations for pharmaceutical manufacturers on...
FDA Announces Public Meeting on Dietary Supplement Innovation and Ingredient Scope
FDA to Hold Public Meeting on Dietary Supplement Innovation and Ingredient Scope The U.S. Food and Drug Administration has announced an upcoming public meeting focused on dietary supplement innovation and the scope of dietary ingredients under the Dietary Supplement Health and Education Act...
Why Food Recalls Are Increasing — And What Companies Must Do Differently
Food recalls are increasing despite stronger regulations and expanded food safety systems. In this Issue of the Month, EAS consultant Amandeep Dhillon examines the systemic causes behind this trend and what companies must do differently to reduce risk.
FDA Expands Infant Formula Resources to Support Transparency and Access
FDA Enhances Resources Related to Infant Formula Oversight The U.S. Food and Drug Administration has announced updates to its infant formula resources aimed at improving transparency, safety, and access for consumers and stakeholders. The Agency stated that these enhancements are intended to...
California DTSC Proposes New Requirements for 1,4-Dioxane in Shampoos and Dish Detergents
The California Department of Toxic Substances Control (DTSC) is proposing to designate manual dish detergents and shampoos containing more than 1 ppm of 1,4-dioxane as “Priority Products” under the Safer Consumer Products program. If finalized, this designation would introduce new regulatory...
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity
FDA Emphasizes Role of Confidential Information in Its “Gold Standard” The U.S. Food and Drug Administration has published a new FDA Voices article highlighting the importance of protecting confidential information as a cornerstone of the Agency’s regulatory framework. The article explains how...
FDA Establishes Produce Regulatory Program Standards to Strengthen State Oversight
FDA Releases Produce Regulatory Program Standards (PRPS) The U.S. Food and Drug Administration has announced the establishment of Produce Regulatory Program Standards (PRPS), a new framework designed to strengthen and standardize produce safety oversight activities conducted by state programs. The...
Drug and Device Corner 2026 February
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. 2025 reports are due no later than 31 March 2026. Reminder that the agency began their policy enforcement late in 2025 contacting facilities that had not reported all NDC volumes. If you have...
Dietary Supplement Finished Product Testing and Specifications
Presented by Shelly BlackwellThursday, April 16, 2026 | 3:00 PM ETThe FDA requires that dietary supplement manufactures establish finished product specifications and test to ensure the specifications are met. However, the process of implementing this requirement is not always straightforward. What...
FDA Announces New Actions Related to Food Traceability Rule Implementation
The U.S. Food and Drug Administration has announced several actions related to the implementation of the Food Traceability Rule, a key component of the Food Safety Modernization Act (FSMA) aimed at improving the ability to track and trace foods through the supply chain. The update provides...
FDA Initiates Review of BHA, a Common Food Preservative
The U.S. Food and Drug Administration has announced that it is launching a safety assessment of butylated hydroxyanisole (BHA), a synthetic antioxidant widely used in food products to prevent rancidity in fats and oils. BHA has been authorized for use in food for decades within established...
Food Safety Foundation: Developing a Risk-Based Supplier Approval Program
Presented by Dr Susan Moyers and Tim LombardoApril 2, 2026 | 1:00 PM ETA risk-based supplier approval program is essential not only for ensuring the safety of the ingredients and packaging materials used in your facility, but also for ensuring the safety, quality and traceability of your products....
FDA Updates Approach to “No Artificial Colors” Claims and Expands Natural Color Options
FDA Takes New Approach to “No Artificial Colors” Claims The U.S. Food and Drug Administration has announced an updated approach to how food manufacturers may use “no artificial colors” claims on product labels. Under this policy, FDA will exercise enforcement discretion to allow the claim when...
Congressman Langworthy Introduces Dietary Supplement Regulatory Uniformity Act
Rep. Nick Langworthy (R-NY) has introduced the Dietary Supplement Regulatory Uniformity Act, legislation intended to reaffirm a single federal standard for dietary supplement regulation under the U.S. Food and Drug Administration (FDA). The proposal comes amid increasing state-level activity —...
FDA Publishes 2026 Foods Program Guidance Agenda: What Industry Should Know
FDA Outlines Foods Program Guidance Documents Under Development for 2026 The U.S. Food and Drug Administration has published its guidance documents under development list for the Human Foods Program for 2026, giving industry stakeholders insight into topics the Agency is considering for future...
Building Food Safety Culture When No One Is Watching
What does food safety look like when no one is watching? In this Issue of the Month, EAS Independent Consultant Sebnem Karasu explores how real food safety culture is built, sustained, and revealed under pressure, and why systems, not slogans, make the difference.
Drug and Device Corner 2026 January
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. 2025 reports are due no later than 31 March...
Bipartisan HEMP Act Aims to Create FDA Framework for Hemp-Derived Products
On January 22, 2026, U.S. Representatives Morgan Griffith (R-VA) and Marc Veasey (D-TX) introduced the Hemp Enforcement, Modernization, and Protection (HEMP) Act, bipartisan legislation designed to establish the first federal regulatory pathway for hemp-derived products intended for human use...
FDA Records Access Authority for Cosmetics: Draft Guidance Now Available
The U.S. Food and Drug Administration has announced the availability of a new draft guidance titled “FDA Records Access Authority for Cosmetics: Guidance for Industry.” The document addresses frequently asked questions about FDA’s authority to access records related to cosmetic products. The...
Durbin Introduces Legislation To Improve Transparency and Safety of Dietary Supplements
U.S. Senate Democratic Whip Dick Durbin has reintroduced the Dietary Supplement Listing Act, legislation aimed at improving transparency and safety in the dietary supplement market.
Amazon Tightens GMP / cGMP Requirements for Dietary Supplements
Amazon has expanded its compliance requirements for dietary supplements sold on its marketplace. Effective now, all dietary supplement products must demonstrate current Good Manufacturing Practice (cGMP) compliance verified by an accredited third-party Testing, Inspection, and Certification (TIC) organization. This is an expansion of previous testing requirements that had initially applied only to certain high-risk categories (e.g., sexual enhancement, weight management, sports nutrition).
Artificial Intelligence: Quality Friend or Foe
This Issue of the Month explores how artificial intelligence is being applied in regulated industries, examining potential benefits for quality and compliance programs while highlighting risks and considerations companies should evaluate before integrating AI into regulatory operations.
Drug and Device Corner 2025 December
Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the blanket no change certification...
cGMP Responsibilities for Own Label Distributors and Brand Owners
This webinar will help you understand how to meet the requirements of an Own Label Distributor and comply with FDA regulations.
Medical Device QMSR (ISO 13485)
This webinar will highlight the major changes to the regulations and give an overview of how the regulations have updated. Also covered are implementation of the new final rule, and what steps to take to best prepare for the start of enforcement by the FDA.
Health Canada
Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.
FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now available through CTP Portal Next Generation (NextGen), the agency’s enhanced portal for electronic tobacco...
Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.
21 CFR Part 11 (Electronic Records & Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated, or “GxP” computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in 1997 and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic, or system of record.