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.
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...
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
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...
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...
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 …
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...
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...
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...
Safe Foods for Canadians – What you Need to Know
The Canadian Food Inspection Agency (CFIA) is responsible for the safety of food products sold in Canada by enforcing the recently implemented Safe Foods for Canadians Regulation (SFCR). It is a compilation of 14 sets of regulations governing safety of human …
Drug and Device Corner February 2021
CDER's Work to Meet User Fee Goals During the Pandemic website includes an overview of the agency’s thinking regarding manufacturing facility inspections during the age of COVID-19. As always, the FDA will use a risk-based approach to identify facilities that require pre-approval inspection for...
EAS Senior Director Tara Lin Couch, Ph.D. Featured in NCIA Podcast on the Future of Cannabis Consumerism
EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. was interviewed for the National Cannabis Business Industry’s podcast on the future of cannabis consumerism. Listen now on Apple podcast and Stitcher and hear more about the importance of Good Manufacturing...
Did You Know? FDA Compliance Includes 21 CFR Part 11 for Electronic Records and Signatures
In addition to Good Manufacturing Practices, supply chain oversight, labeling, registrations, listings, adverse event tracking and all the other regulatory requirements required by FDA, use of electronic records and submissions adds an additional compliance requirement - 21 CFR 11 except for...
USDA Regulatory Requirements for Food Safety
Instructor EAS Independent Consultant Armia Tawadrous, DVM A 12-hour seminar in three-parts, taking place June 14, 16, 18, 2021 From 11am-3pm eastern each day The sensitivity of meat and poultry products to microorganism contamination by bacteria, viruses and parasites renders them an...
USDA Labeling Compliance Virtual Seminar
Instructor EAS Independent Consultant Susan GlennApril 5-6, 2022 12pm-3pm eastern each dayIf you develop USDA-regulated products you need to understand USDA labeling requirements. USDA labeling has its own set of allowable product names, claims and nutrition labeling requirements. EAS Consulting...
Did You Know? Biopesticide Registration is Required by the EPA
Derived from natural materials, biopesticides, are inherently less toxic than conventional pesticides and when used as a component of Integrated Pest Management (IPM) programs, can greatly reduce conventional pesticide use and improve crop yields. EPA has regulatory authority over biopesticides as...
Noted Tobacco Expert Joins Labstat’s Scientific and Strategic Advisory Board
EAS sister organization under the Certified Group of companies, Labstat International Inc., has announced that Willie J. McKinney, Ph.D., D.A.B.T., has joined their Scientific and Strategic Advisory Board (SSAB). Dr. McKinney’s regulatory and scientific expertise of nicotine and cannabidiol...
Cosmetic Regulations, Labeling and Safety Seminar
How to Ensure Your Products Comply with the US RequirementsInstructors Catherine and Dr. John Bailey, Dr. Jay Ansell, Victoria PankovichDecember 17, 2025 | 11:00am-4:00pm EasternCosmetic products are expected to only exert superficial, not physiological, effects on the human body, meaning they can...
Drug and Device Corner January 2021
EAS Client UpdatesBreaking News: FDA Places All Alcohol-Based Hand Sanitizers from Mexico on Import Alert As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand...