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 Corner June 2022
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or relabeled product will fail...
Environmental Monitoring Programs in Tablets and Capsules Magazine
EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers assistance with design and...
Botanical Drugs: What Might the Future Hold?
By Brad Douglass, EAS Consulting Group Independent ConsultantThe Food and Drug Administration’s approval of Fulyzaq (crofelemer), an anti-diarrheal drug for HIV/AIDS patients, was a first for an oral, prescription botanical drug. Prior to that approval, the topical preparation Veregen...
What is Chemical Testing in Food?
In a nutshell, chemical testing helps confirm the contents of the food you manufacture. It enables you to maintain the quality of your products, ensuring that they are safe. Chemistry testing aims to verify the food's chemical composition, such as how much sugar, protein, or fat it has. It also...
EAS and Labstat Welcome New Incoming CTP Director, Brian A. King, Ph.D., M.P.H.
FDA’s Center for Tobacco Products (CTP) has announced the selection of a new CTP director, Brian A. King, Ph.D., M.P.H. Dr. King previously worked at the Centers for Disease Control and Prevention’s Office on Smoking and Health. Dr. King is charged with furthering CTP’s efforts to improve the...
How Would FDA’s Dietary Supplement Listing Act of 2022 Impact Your Business?
A bill before U.S. Congress proposes a new requirement that all dietary supplement products be electronically listed with Secretary of Health and Human Services. This move will enable the creation of a publicly available on-line registry in support of consumer decision making and to provide FDA...
The Importance of Testing Pet Food for Possible Contamination
The American Pet Products Association (APPA) estimates that 68% percent of U.S. households own a pet, according to the 2017-2018 National Pet Owners Survey. That means roughly 85 million families in the U.S. have a pet in their household. Many households treat their pet as a member of the family...
Food Allergens and the FDA
An EAS and Food Safety News Complimentary Webinar. What’s Happening. Presented by Steve Gendel, EAS Independent Consultant. July 20, 2022, at 1pm eastern. As we approach 20 years since the passage of the Food Allergen Control and Consumer Protection Act of 2004 (FALCPA), industry and the FDA...
Drug and Device Corner May 2022
The passing of the CARES Act in 2020, built on the authorization given to FDA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), to address the problem of drug supply disruptions and shortages. The agency released a draft guidance to assist stakeholders in developing a...
Assume Nothing: What You Think You Know About the Cannabis Industry May Not Be True
An EAS and Food Safety News Complimentary Webinar. Presented by Kathy Knutson, Ph.D., EAS Independent Consultant. The food industry is built on a history of Good Manufacturing Practices, Hazard Analysis and Critical Control Points (HACCP), and the Food Safety Modernization Act (FSMA) with its...
EAS Partner Laboratory Assist with Cosmetic Degradation Studies
EAS partner laboratory was mentioned in a recent article published in Beauty Independent on their partnership with a major brand to verify degradation of skincare ingredients. Micro Quality Labs, and all of the Certified Group, FSNS testing laboratories offer sound science in support of FDA, USDA...
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
As has long been anticipated, FDA, on April 28, 2022, announced a proposed rule that would prohibit menthol as a characterizing flavor in cigarettes, and all characterizing flavors other than tobacco in cigars. Once finalized and implemented, FDA enforcement will address manufacturers,...
CTP’s Draft Guidance on Analytical Testing Methods Validation and Verification for Tobacco Products
What You Need to KnowPresented by Charlotte Peyton, EAS Independent Consultant. FDA’s December 2021 draft guidance on validation and verification testing methods used in analytical testing of tobacco products creates an opportunity and defined mechanism by which tobacco product manufacturers and...
EAS Publishes Article on Packaging Challenges for FDA Industries in Tablets and Capsules
EAS Independent Consultant and expert in packaging solutions for FDA industries, Jim Goldman, wrote an article on quality considerations and mitigations of supplier and customer challenges that was published in Tablets and Capsules. EAS experts such as Jim help clients to develop quality assurance...
Establishment Registration and Drug Listing Still a Challenge for Some
By Susan Crane, EAS Independent ConsultantIt’s now been 5 years since FDA updated the regulations for establishment registrations and drug listings. Despite numerous on-line reference materials and tutorials available, it appears that some companies still have difficulties understanding and...
Environmental Impact Assessments are Required by FDA, NEPA
By Charles Eirkson, EAS Independent ConsultantThe National Environmental Policy Act (NEPA, 1969), requires that potential environmental impact of actions, e.g., approvals of new drugs, biologics, food additives, be addressed by the U.S. Food and Drug Administration (FDA). In addition to FDA, NEPA...
Food Fraud Mitigations and Testing
EAS and Food Safety News Complimentary WebinarPresented by EAS Senior Directors,Tim Lombardo, Food Consulting Services andMaged Sharaf, Ph.D., Labeling, Cannabis and Claims Services. April 20, 2022, at 1pm easternFood Fraud is a global challenge, costing billions to the food industry and consumers...
Drug and Device Corner April 2022
We are 5 months out from the UDI / GUDID enforcement date of 22 September 2022 for Class I and unclassified devices, are your processes in place? Do you know what requirements are applicable to your operation? Helpful information can be found on FDA’s webpage GUDID Guidance, and in the Guidance...
U.S. FDA’s Latest Requirements for the 510(k)
Presented by John Lincoln, EAS Independent Consultant. The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. The FDA holds...
Good Auditing Practices, Making the Most of Your Internal Review
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …