Issue of the Month
Regulatory insights from EAS Consulting Group consultants.
Each month, EAS Consulting Group publishes an Issue of the Month examining emerging regulatory developments, compliance challenges, and quality system insights across FDA-regulated industries.
These articles are written by EAS consultants and industry specialists with decades of experience supporting companies in food, dietary supplements, pharmaceuticals, medical devices, tobacco, and related sectors.
Topics frequently explored include food safety systems, inspection readiness, regulatory strategy, and emerging industry risks such as why food recalls are increasing.
New this month
Featured Insight
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.
Archive of Past Issue of the Month Regulatory Insights
New York High Court Rejects Talc/Asbestos Causation Testimony, Reaffirming Need for Scientific Dose Assessment
By William A. Ruskin, EAS...
Adverse Event Reporting for OTC Drug Products
By Susan Crane, EAS Senior...
Botanical Drugs: What Might the Future Hold?
By Brad Douglass, EAS...
How Would FDA’s Dietary Supplement Listing Act of 2022 Impact Your Business?
A bill before U.S. Congress...
Establishment Registration and Drug Listing Still a Challenge for Some
By Susan Crane, EAS...
Understaffed Restaurants and the Risk of Foodborne Illness
By Jayne Roth, M.P.H, REHS,...
Selecting a CRO – an Important Consideration on the Path to Determining GRAS for a Food Ingredient
By Shawna Lemke, EAS...
Blended Learning – Part of a Culture of Learning
By Nancy Higley, EAS...
Roles and Responsibilities for Ensuring the Safety of Animal Food
By Johnny Braddy, DVM, MPH,...
Titanium Dioxide – What the EU Ban Means For You
By April Kates, EAS...
Regulatory Considerations for Novel Sports Nutrition Products and Ingredients
By EAS Independent...
Social Media Considerations for FDA Regulated Products
By Susan Crane, Independent...
What’s Hot in the Regulatory World
By Richard D’Alosio, EAS...
Labeling Risk Management – Five Step Plan
By Ronald J. Levine Food...
Supply Agreements-Defining Acceptable Quality Limits for Packaging
By James Goldman CPP, EAS...
Distilling FSMA – Alcohol Beverages and the FDA
By Charles Breen, EAS...
PCQI Training: Is it worth it?
by Elise Forward, EAS...
Top Five Considerations for Pre-Submissions
By Elvira Cawthon, EAS...
Regulatory Provisions that Can Help Provide Clear, “Clean” and Concise Label Declarations
By Gisela Leon, EAS...
Recall Plans and Strategies
Robert Fish, Independent...



















