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 Unveils Accredited Third-Party Certification Site
In one more step toward improved oversight of imported foods, FDA unveiled a new section of the FDA Industry Systems (FIS) websiteon June 21, 2017, to allow organizations – including foreign governments and agencies or private third-parties – to apply for recognition as third-party accreditation...
Foreign Supplier Verification Program – What Does It Mean For Your Business
If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug …
Process Labeling – Pathway to Transparency?
By Steve Armstrong, EAS Independent Advisor, Food Law & Regulation A thirty-year old federal court opinion that is well known to students of food and drug law holds that in the absence of a detailed, Congressionally mandated definition, courts and regulators should follow the common...
First FSVP Compliance Deadline Arrives
In a significant FSMA milestone, May 30, 2017 was the initial deadline for U.S. food importers to implement a foreign supplier verification program (FSVP). Beginning May 30, the U.S. Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system is requiring filers to enter at least...
EAS Offers U.S. Agent Services for Foreign Companies
By Bryan Coleman, EAS Senior Director Pharmaceutical & Device Consulting Services, and Victoria Pankovich, EAS Regulatory Specialist The FDA’s regulatory requirement for foreign firms to have a U.S. Agent can be confusing, to say the least. There are very specific requirements for foreign...
Book Chapter: Food Products in the Fundamentals in US Regulatory Affairs, 10th Edition
FDA Combines Old and New Inspection Tools for Imported Foods
The Food and Drug Administration is using a combination of old and new tools to improve the safety of imports and a quick look at the numbers explains why. We’ve seen the familiar statistics: Almost 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood is imported....
Safe Quality Food – Mitigation Strategies for Food Safety Fundamentals
The Facts About Supplement Facts
Wholefoods Magazine https://wholefoodsmagazine.com/blog/facts-supplement-facts/ Susan Crane April 19, 2017
The Food Processing Industry’s Newest Challenge: Safe Quality Food’s Edition 8.0
By Allen Sayler, EAS Senior Director for Food and Cosmetic Consulting Services The Safe Quality Food Institute (SQFI) is coming close to releasing its long-anticipated Edition 8.0. While many things could change during the final review and “sign-off” by the SQFI Technical Advisory Committee and...
Interview: Monitoring ingredient suppliers is imperative
Compliance With EU Food Regulation: What if Traceability and Food Recall are Not Enough?
EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to food firms wish to …
Understanding the Drug-Cosmetic Conundrum When Marketing Your Products
By John Bailey, EAS Independent Advisor, Colors and Cosmetics and Catherine Bailey, Independent Consultant Products marketed as cosmetics can easily find themselves the target of FDA compliance action based on improper claims and statements. FDA is charged with enforcing the laws and regulations...
FDA Urges Industry Groups to Develop FSMA Guidance
By Charles Breen, EAS Independent Advisor, FSMA Consulting Services The Food and Drug Administration is encouraging industry groups and trade associations to develop their own guidance to help their members comply with new requirements under the Food Safety Modernization Act. FDA laid out steps...
Using Temporary Marketing Permits for Food Products
By EAS Independent Consultant Geraldine June FDA food standards of identity are regulations that establish the names and define the basic nature of certain foods. Food standards prescribe, among other things, what ingredients are required or optional and may describe the manufacturing process when...
FDA’s Revised Draft Guidance on Listeria Controls
By Stephen Sundlof, D.V.M., Ph.D., EAS Independent Advisor, Animal and Human Food Safety FDA released updated draft guidance on preventive controls for Listeria monocytogenes in ready-to-eat foods last month, adopting the “seek and destroy” approach used by USDA’s Food Safety and Inspection...
Recent Developments in EU Food Regulation
By Alfredo Gris, Daniele Pisanello and Massimo Scuccato As part of a new series in EAS-E-News on services provided through EAS partnerships, Italy-based food technology and consulting firm Almater shares the following insights on regulatory developments in the EU in the area of foods, including...
Third-Party Certification Will be Critical for Import Safety
By Stephen Sundlof, D.V.M., Ph.D., EAS Independent Advisor, Animal and Human Food Safety The Food and Drug Administration released an amended final rule last month establishing user fees so the agency can administer the FSMA program for accreditation of third-party certification bodies to conduct...
On FDA’s Latest FSMA Guidance
The Food and Drug Administration recently issued three new guidance documents to help simplify compliance with Food Safety Modernization Act (FSMA) regulations and programs. On November 7, the agency released new draft guidance on registration of food facilities. The expanded registration...
Drug Master File Submissions – An Overview
By Naitry Shah, EAS Intern (This article summarizes a White Paper on DMF submissions prepared by EAS Independent Consultant Albert Yehaskel.) Drug Master Files (DMFs) are detailed submissions to the Food and Drug Administration (FDA) that may be used to provide confidential details about...
FDA Invites Comment on Two Draft CGMP Guidances
FDA is inviting public comments by November 23 on two draft guidances -- on current good manufacturing practices (CGMP) requirements for food for animals and on CGMPs for human food by-products for use as animal food. The two guidances are essential reading if your company is required to implement...
What Now for FSMA Compliance?
The sky did not fall on September 19, 2016, the compliance date for larger human food facilities to meet FSMA preventive controls and Current Good Manufacturing Practice (CGMP) requirements, and for larger animal food facilities to comply with CGMPs. In a September 19 poston the agency’s website,...
Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling
Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed (“RACCs”) that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the number of nutrients for customary …
Why FDA Views Registration as a FSMA Priority
The Food Safety Modernization Act’s provisions on food facility registration are especially significant from FDA’s perspective because they will enable the agency to know much more about the businesses whose products are covered by the landmark law. On July 14, 2016, the agency issued a final...
FDA’s Design Control Requirements for Medical Devices
By Kaiser Aziz, PhD., EAS Senior Consultant FDA reviewers and field investigators evaluate design control requirements and processes for medical devices and make recommendations based on whether the manufacturer has the required checks and balances in place. Design controls are a mechanism for...
FDA’s Design Control Requirements for Medical Devices
FDA reviews, evaluates, verifies and validates the implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, the manufacturing process to …
Analysis Of Final FDA Regulations Amending The Nutrition Facts Label – Focus On Added Sugars
This White Paper provides an analysis of FDA’s final regulation amending the Nutrition Facts label, focusing on FDA’s new requirement for added sugars content disclosure and disclosing a %DV for added sugars. The impacts of other provisions of the final rule related to the …
How to Successfully Respond to FDA 483s and Warning Letters
EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how to respond in a way to prevent the issuance of a Warning Letter.”
FDA Unveils FSMA Final Rule on Intentional Adulteration
FDA has now released its seventh FSMA rule – on intentional adulteration. Published May 27 in the Federal Register, the rule requires registered food facilities to develop a written food defense plan to address intentional adulteration. In an approach similar to developing a hazard analysis and...
FSMA and Dietary Supplements
By Charles Breen, EAS Senior Advisor for FSMA Consulting Services FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements (DS) from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111, and with adverse event...