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.
Supply Agreements-Defining Acceptable Quality Limits for Packaging
By James Goldman CPP, EAS Independent Consultant “It’s the packaging supplier’s fault!” Package quality disputes between suppliers and customers often start with someone in the filling plant stating “these packages aren’t as good as the ones we ran last week” without any data to support their...
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 and EAS Independent Consultant & Moderated by Michael Bond, President of Labstat International. You are anxiously waiting to hear from FDA about your...
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. The question of which federal government agency(s) regulate alcohol beverages should be easy to answer. But, because beverages are also...
Foreign Supplier Verification Program Virtual Training
A Seminar for importers, brokers and distributors of foods, food ingredients and food packaging imported into the United States. FSPCA Developed Curriculum developed by industry, academia and FDA Instructor: Jenifer Kane, FSPCA FSVP Lead Instructor and Trainer of TrainersSeptember 13 & 15,...
Our Consultants are Traveling
and are excited to provide onsite services again!Many EAS consultants are fully vaccinated and are back to traveling to client sites providing that in-person and focused support that sets EAS apart. When you are ready to schedule your next in-person consulting – whether a GMP inspection, mock-FDA...
Did You Know? FDA CTP Aims for Two New Product Standard Proposals Within the Year
FDA recently announced a plan to propose product standards banning menthol as a flavor in cigarettes and banning all characterizing flavors (including menthol) in cigars within the next year. If implemented, this ban will apply to all manufacturers, distributors, wholesalers, importers and...
Drug and Device Corner May 2021
With the Over-The-Counter Monograph User Fee Program (OMUFA) 2021 facility user fee now past due, the FDA would like to remind all drug establishment manufacturers to make payment immediately. Please note the FDA has not issued invoices for this fee. The agency’s only communication, other than the...
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...
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
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...
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.
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...
Drug and Device Corner March 2021
Client UpdatesThe FDA has finally taken steps to stop companies that use ‘FDA Certificates’ as marketing tools. The FDA has 2 websites with further information, FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates” and Are There "FDA Registered" or...
Medical Foods – When Will the FDA Enforcement “Shoe” Drop?
The industry’s interest in Medical Foods is growing with many new products as well as the repositioning and relabeling of existing products that places them into the medical foods space. FDA’s oversight and enforcement effort focused on Medical Foods has been limited partly …
Top Five Considerations for Pre-Submissions
By Elvira Cawthon, EAS Independent Consultant Premarket submissions for medical devices are costly, time-consuming, and denial of a submission can be devastating. Though the FDA Q-Submission (Q-Sub) Program, designed to minimize risk by enabling Sponsors and Manufacturers the opportunity to attain...
Meet Our Cosmetics Team
Did you know the EAS Cosmetics Team includes former FDA and high-level industry? From colors to claims, from formulation to safety, our experts can answer any manufacturing and regulatory challenge you may have. Stay in compliance with the FD&C Act. Trust EAS!Here Are Just a Few of Our EAS...
June Drug Registration / Listing
As you are probably aware, per 21 CFR 207.57 FDA drug establishment registrants must review and, if necessary, update listing information each June and December. This includes all drug listings, including bulk products. EAS provides support with facility registrations and product listings and we...
Acidified Foods (AF) & Low-Acid Canned Foods (LACF) Virtual Training
Better Process Control School (BPCS) Training: Acidified and Low-Acid FoodInstructed by Omar Oyarzabal, Ph.D. EAS Senior Consultant for Food Services and FDA-Recognized Instructor for BPCSOctober 14, 15, 17, 18, & 21, 2024 9am - 5pm eastern each day (break for lunch)(October 22 - for...
Do You Have GMP Grief?
EAS pharma expert, Joe McGuinness, published an article in Tablets and Capsules on coming to terms with the requirement of GMP implementation. While GMPs have always been required (in theory) for Active Pharmaceutical Ingredients (APIs), the FDA often found itself at odds with this industry as it...
Distilling FSMA – Alcohol Beverages and the FDA
By Charles Breen, EAS Independent Advisor for Food Safety The popularity of new breweries, wineries and craft distilleries has created a community of devoted followers. Many producers do not realize one crucial thing—in addition to the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau...
Medical Device Manufacturing – A Look at FDA Enforcement Trends
EAS Complimentary Webinar Presented by George Calafactor, Ph.D., EAS Independent Consultant. A look at FY 2020 FDA observations for medical device manufacturers shows a clear focus on procedural integrity and quality systems. Good Manufacturing Practices for medical devices, as found in 21 CFR...
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...
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...
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...
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
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,...
Of the Package, By the Package and For the Package
By Thomas Dunn, EAS Independent ConsultantProviding 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...
EAS Due Diligence Assessments Support Private Equity and Venture Capital Firms with Acquisitions in FDA and USDA Regulated Industries
In the competitive FDA and USDA space, mergers and acquisitions of brands and companies lead to increased synergies and market share. Without careful and early due diligence assessments, however, these transactions can also increase exposure to regulatory risk. Having a clear and unbiased picture...
Clear Regulatory Framework for Hemp and Hemp-derived CBD Products Urged in Bill H.R. 841
EAS is closely monitoring progress of bi-partisan legislation introduced to the 117th Congress on February 4, 2021, H.R. 841, the Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2021. The bill seeks a federal regulatory framework for hemp and hemp-derived CBD products...
Did You Know? Medical Foods and FDA – Regulatory Scrutiny Ahead
A medical food per FDA is a specific category “formulated to be consumed… under the supervision of a physician and which is intended for the specific dietary management of a disease or condition” which need “distinctive nutritional requirements.” This means that medical foods are not those simply...