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.
EAS Consulting Group Welcomes Tim Lombardo as Senior Director for Food Consulting Services
EAS Consulting Group is pleased to welcome Mr. Tim Lombardo as the new Senior Director for Food Consulting Services. Tim is a widely regarded expert in food safety and microbiology with over 25 years of direct experience leading these programs at a variety of manufacturing facilities. Tim’s direct...
Drug and Device Corner April 2021
After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC drug manufacturing facility...
Remote Interactive Evaluations – FDA’s New Tool for Drug Facilities… And Beyond?
Amy Scanlin, M.S. In April 2021 FDA issued Final Guidance for Industry concerning Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. In an effort to meet designated timelines, including user fee commitments and...
“Own Label” and “Private Label” Distributor Responsibilities
A complimentary EAS Consulting Group webinar Presented by Bruce ElsnerIf you are an “Own Label Distributor” (OLD) or “Private Label Distributor” (PLD) it is imperative that you understand FDA compliance expectations. With more and more of the OTC drug and dietary supplement industry turning to...
PMTA State of the Union
A Situational Review with Jeff Stier Moderated by Dean Cirotta, EAS Consulting GroupAs filers of FDA Premarket Tobacco Applications (PMTA)s wait for substantive reviews, the industry remains in flux due to several unresolved issues, namely the potential implications of FDA policy on flavors, the...
Sesame Allergen Declaration
On April 14, 2021 the US House of Representatives passed a bill (S. 578) entitled the “Food Allergen Safety Treatment Education and Research ACT” designating sesame as a major food allergen, and directing the Secretary of Health and Human Services to submit a report to Congress in 18 months with...
Foreign Supplier Verification Program Failures – FDA’s Number One FSMA Citation
Presented by EAS Independent Consultant, Carlos Ortiz July 15, 2021, 1:00pm easternDid you know that FSMA requires an established FSVP that places the onus of compliance verification for all aspects of FSMA on the importers? Failure to meet FSVP requirements can jeopardize any food or food...
FDA Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children
FDA has released an action plan, called Closer to Zero, that aims to reduce exposure to toxic elements in foods intended for babies and young children. This multi-phased approach focuses on levels of arsenic, lead, cadmium and mercury in these foods to the greatest extent possible while staying...
PMTA Deficiency Letter Readiness and Response Preparation
Part 2 of a special series focusing on CTP’s requirement of PMTA submissions With Willie J. McKinney, Ph.D., Scientific Advisor for Labstat International and CEO and Founder of McKinney Regulatory Science Advisors, LLC & Moderated by Michael Bond, President of Labstat International May 26,...
Medical Device or a Wellness Device?
Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special
PCQI Training: Is it worth it?
by Elise Forward, EAS Independent ConsultantI will admit to being biased on the many benefits of becoming your food firm’s Preventive Controls Qualified Individual (PCQI). It’s an important position, one required by FDA for ALL food manufacturing and warehouse facilities. The PCQI has...
Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC drug manufacturing facility...
EPCRA SARA SDS RCRA An Alphabet Soup and Customer Notifications Post FDA Regulations
Ingredient suppliers have an alphabet soup of compliance requirements, beyond those of FDA. From EPA to OSHA to even DOT, all product ingredients are regulated depending on the hazards
Flour HACCP Begins with Food Safety Inspections
Consultant Steve Hufford wrote an article on the importance of equipment inspections in support of HACCP efforts, with a discussion of their application specific to flour mills. Read more in Snack Foods and Wholesale Bakery online.
The Human Factor of Regulatory Compliance
Robert Lavieri discussed the human factor of meeting compliance requirements in Food Safety Magazine. Have you asked yourself how best to hold operational, maintenance, quality, and folks on floor, accountable for reliably executing their part of a compliance plan? From FDA to USDA to EPA to OSHA,...
Regulatory Cross Cutting with Artificial Intelligence and Imported Seafood
Angel Suarez shares information on an FDA pilot program that will study and evaluate the utility of AI in support of import targeting, ultimately assisting with the implementation of an AI model to target high-risk seafood products—a critical strategy as the United States imports nearly 94% of its...
Food Safety – Of the Package, By the Package and For the Package
By Thomas Dunn, EAS Independent Consultant Providing safe food requires both safe food packaging materials and risk prevention by that packaging. As an integral part of the food supply chain, packaging may pose biological, chemical, or physical hazards to the food supply. But as soon as packaged...
Scientifically Sound Specifications – No “By-Inputs” Here
Learn how to develop scientifically sound Finished Product Specifications, even when no analytical test method is available to test the final product. An EAS Complimentary Webinar June 8, 2021 at 1pm eastern presented by Steve Cammran, Ph.D., Independent Consultant.
FDA’s Food Safety Enforcement – a Look at 483s and Warning Letters
A complimentary webinar presented by Bryan Armentrout, EAS Independent Consultant May 11, 2021, 1pm EasternA look at FY 2020 FDA observations for foods shows clear shortfalls in industry compliance with regards to sanitation hazards, and a lack of traceability, (particularly with regards to...
Distilling FSMA – Alcohol Beverages and the FDA
A complimentary webinar presented by Charles Breen, Senior Advisor FSMA, EAS Consulting Group and John Messinger, Senior Attorney, Lehrman Beverage Law June 9, 2021 at 1pm easternThe question of which federal government agency(s) regulate alcohol beverages should be easy to answer. But, because...