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.
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...
Preparing for an FDA CTP PMTA Pre-Approval Inspection
Join EAS Consulting Group’s Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and EAS Independent Consultant, Charlotte Peyton, for a comprehensive look at preparing for FDA’s PMTA pre-approval inspections. July 14, 2021 from 12pm-4pm eastern.
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
Instructor EAS Independent Consultant Susan Glenn July 27-28, 2021 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
How to Ensure Your Products Comply with the US Requirements Instructors EAS Independent Advisor for Colors and Cosmetics, John Bailey, Ph.D. & EAS Independent Consultant, Catherine Bailey April 28, 2021, 11am-3pm easternCosmetic products are expected to only exert superficial, not...
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...
Preventive Controls for Human Foods Training with Preventive Controls Qualified Individuals (PCQI) Certification
Using the Official Food Safety Preventive Controls Alliance (FSPCA) Training Curriculum Recognized by the US Food & Drug Administration (FDA)Presented by EAS Independent Consultant, Elise Forward April 27, 29, May 4 & 6, 2021, 10am-3pm easternThe Current Good Manufacturing Practice, Hazard...
Streamline Food Exports to the US
Six Steps to Compliance SuccessEnsuring compliance with FDA’s Food Safety Modernization Act (FSMA) can be confusing, particularly for foreign-based companies trying to comply with the additional traceability requirements of FSMA’s Foreign Supplier Verification Program (FSVP). Did you know that EAS...
Medical Device Manufacturing – A Look at FDA Enforcement Trends
EAS Complimentary Webinar Presented by George Calafactor, Ph.D., EAS Independent Consultant May 26, 2021, 1:00pm easternA 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...
Regulatory Provisions that Can Help Provide Clear, “Clean” and Concise Label Declarations
By Gisela Leon, EAS Independent Consultant and Instructor for Food and Dietary Supplement Labeling Seminar In times of COVID-19, many people are restricted to staying at home, working from home, and cooking at home more than ever before. Cooking at home requires the consumer to make informed...
FDA’s Final Guidance on Animal Food Additive Petition and GRAS Notice Reviews
Aiming to facilitate consultations for and submissions of an animal food additive petition (FAP) or a notice concluding that a substance is generally recognized as safe (GRAS) for its intended use in animal food, FDA released final guidance, with recommendations for: submissions to investigational...