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.
Is it a Drug or Cosmetic? EAS Podcast hosted by CPhI
As more and more companies operating in the pharmaceutical space are moving into cosmetics, the temptation is to think that life will be much easier from a regulatory and compliance perspective. However, while it is true that pharmaceuticals are more heavily regulated, this does not mean that...
Validación de limpieza CIP
Presentado por Bernardo Clavijo. Para dar cumplimiento a los requisitos legales y normativos vigentes, es importante realizar la validación de las medidas de control de la inocuidad, entre las cuales está la limpieza y desinfección de las superficies de contacto. ¿Qué significa esto para su...
What are the Requirements for a Successful DMF Submission for an Active API?
EAS independent consultant, Radhika Rajagopalan answers your questions on DMF submissions in Tablets and Capsules magazine. Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical ingredients (APIs), featuring...
Find the Right Mix: Flavors and Textures and the Discerning Consumer
By Joe Yun Ph.D. Reprinted with permission from Dairy Foods Magazine. You may have heard the statement, “milk is nature’s perfect food.” Nutritionally speaking, that is true. But is the quality of dairy products we consume always perfect? Have you noticed that when you lift a freshly baked pizza...
Pharmaceutical GMPs, Quality Control, and Data: A Deeper Look at FDA’s FY 2020 FDA Observations
By Amy Scanlin Reprinted with permission from FDLI UpdateGood Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products.1 Though clearly articulated by FDA, a review of FY 2020 pharmaceutical inspection...
Drug and Device Corner July 2021
The FDA has planned a public webinar titled Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency. Please follow the link to register for this webinar scheduled for 25 August 2021. Recently published in the Federal Register, FDA has issued their final...
USDA News: USDA Announces $500 Million for Expanded Meat & Poultry Processing Capacity
USDA has announced a $500 million for expanded meat and poultry processing capacity as part of efforts to increase competition and level the playing field for family farmers and ranchers. This is one of several key steps that USDA intends to take that will increase competition in agricultural...
Did You Know? EFSA No Longer Considers Titanium Dioxide E 171 a Safe Food Additive
The European Food Safety Authority (EFSA) no longer considers titanium dioxide E 171 a safe food additive after safety assessments prompted by a request by the European Commission in March 2020. Using Nanotechnology as part of its assessment, the EFSA determined that titanium dioxide E 171...
Labeling Risk Management – Five Step Plan
By Ronald J. Levine Food labels are under attack. Every day new lawsuits are filed, often as class actions, as well as through regulatory actions. Legal actions concerning words such as “natural,” or “healthy” are all too common. THE FIVE STAGES OF GRIEF While some of the large food manufacturers...
CBP and FSVP: Has Your Product Undergone Substantial Transformation?
Are your FDA-regulated food products made with ingredients sourced from outside the U.S.? If so, and if they are further processed, your food product may have resulted in a new or different product that differs substantially from its original state before processing. In FDA’s and CBP’s (U.S....
FSNS Announcement
We are excited to announce that Certified Group has signed an agreement to merge with Food Safety Net Services (FSNS), a leading provider of laboratory testing services for customers in the food & beverage end-markets. As a result, the newly combined entity will grow to an impressive ~1,580...
Tara Couch Discusses FDA Enforcement of Dietary Supplements in RAPS Regulatory Focus
The pandemic has resulted in an increase in the number of misbranded dietary supplements. As a result, FDA is using updated, alternative, and remote enforcement tools to ensure compliance. Tara Couch, Senior Director for dietary supplement and tobacco services covers what you need to know in a...
Cleaning Validations – Your GMPs Depend on It
An EAS Premium Webinar Presented by Joe McGuinness, EAS Independent Consultant. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s current Good Manufacturing Practices (cGMPs), the...
Did You Know? FDA Amends Standard of Identity for Yogurt
On June 11, 2021, FDA published in the Federal Register a final rule amending the standard of identity for yogurt, 21 CFR 131.200. The final rule, more than a decade in coming, (proposed rule was published in 2009) has been a priority under FDA’s Nutrition Innovation Strategy. Under the final...
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...
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...
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...
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...
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...
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...
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,...
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...
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...
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...
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...
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...
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...
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...
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...