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.
Drug and Device July 2023
Thinking about an FDA gap assessment this year? Contact EAS now to schedule your 2023 audit. Schedules toward the end of the year tend to book up suddenly, now is the time to lock in your audit, whether it be onsite or virtual. We would be happy to prepare an audit proposal so you can review and...
Congress Seeks Input on CBD Regulation by August 18
On July 27, 2023, the U.S. Congress requested information to guide the assessment of the potential for a regulatory pathway for hemp-derived Cannabidiol (CBD) products with the goal to prioritize consumer safety and bring certainty to the U.S. market. Since the passage of the 2018 Farm Bill,...
Labstat Inc., A Certified Group Company, Highlights Need for Enhanced Cannabis Regulations to Protect Consumers
TORONTO, Aug. 2, 2023/PRNewswire/ -- As Canada approaches the 5th anniversary of cannabis legalization, Labstat Inc., a leader in tobacco/nicotine, cannabis, hemp and NHP laboratory testing and research & development, underscores the need for more robust regulations and increased research...
Food Safety Net Services (FSNS) Moves to New Laboratory in Logan, Utah
LOGAN, Utah, July 26, 2023 /PRNewswire/ -- Food Safety Net Services (FSNS), A Certified Group Company, has moved to a new state-of-the-art laboratory with increased capabilities in Logan, Utah. The lab is equipped with the latest scientific instruments to provide a full range of microbiology and...
Labstat Inc., A Certified Group Company, Opens New Laboratory in Greensboro, North Carolina, Strengthening its Global Network
KITCHENER, Ontario, July 20, 2023 /PRNewswire/ -- Labstat Inc., an industry-leading provider of tobacco/nicotine, cannabis/hemp testing and research services, is excited to announce the opening of a new laboratory in Greensboro, North Carolina. This significant expansion of Labstat's global...
Biofilms and Healthcare
By David W Koenig, PhD., EAS Consulting Group Independent ConsultantHealthcare facilities -- such as hospitals, nursing homes and outpatient facilities -- are opportunistic locations for acquiring secondary infections unrelated to a patient's primary condition. Healthcare-acquired infections...
Drug and Device June 2023
The FDA has published a new Guidance Document Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 which explains in great detail the GDUFA program user fee obligations. GDUFA III made slight changes to the user fee structure. (API facility fees changed from 7% to 6% and the...
Review of the Foreign Supplier Verification Program’s Guidance for Industry
Review of Foreign Supplier Verification Program’s Guidance for IndustryAn EAS Complimentary WebinarPresented by Tim Lombardo, Senior Director for Food Consulting Services and Omar Oyarzabal, Ph.D., Senior ConsultantJune 22, 2023 11:00am (Eastern)The Food and Drug Administration has released the...
The Food Safety Language
By Rafael Olivares, EAS Independent ConsultantA career in food safety is not an easy one. It is a stressful profession that requires dedication and a commitment to learn continuously and to teach, to communicate effectively to an audience, in most cases, obstinate, and not open to listen. After...
Ensuring Compliance with FDA Guidelines for Glycerin Identity Testing
A recent FDA warning letter concerning identity testing and contaminated glycerin highlights the significance of a recurring potential public health hazard. After several lethal poisonings worldwide, it is apparent that high-risk drug components contaminated with diethylene glycol (DEG) or...
Drug and Device May 2023
As we approach June, keep in mind that drug establishment registrations and NDC listings that have had any changes to their information must update their files with the FDA within 30 days. Failing that, the agency expects updates to be submitted the JUNE or December following such a change. Do...
Claims Substantiation
Presented by Paula Brock, PhD., EAS Independent ConsultantJuly 13, 20231:00 – 3:00PM (Eastern)It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers, and endorsers, have adequate substantiation that the claims made about...
TMA 2023 Introduction to FDA Tobacco Product Manufacturing Practices
Introduction to FDA Tobacco Product Manufacturing PracticesDean Cirotta's presentation during the TMA 2023 Annual Meeting April 17-18, 2023 Leesburg, Virginia.
FDA Proposes Long-Awaited Tobacco Product Manufacturing Practices
By Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco ServicesOver 12 years after the FDA began regulating tobacco products, the long-anticipated Tobacco Product Manufacturing Practices (TPMP’s) have been proposed. The new requirements were proposed by the FDA on March 8, 2023,...
Drug and Device Corner April 2023
Reminder that the FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility Fee: $17,435. The annual fee...
Advanced Acidified Foods (AF) & Low-Acid Foods (LAF) Virtual Training
Instructed by Omar Oyarzabal, Ph.D. EAS Senior Consultant for Food Services and FDA-Recognized Instructor for BPCS and Dr. Kurt Wiese, Independent Consultant, EAS Consulting Group May 22, 24, 26, 31 and June 2, 2023 11:30 AM - 4:00 PM EST What Days and Times? This is a 5-day seminar, with 4 hours...
Certified Group Welcomes Nick Buschur as President of Food & Beverage Business Unit and Tim Daniels as Chief Information Officer
Executive Hires to Accelerate Growth and Strengthen Company’s Position in Laboratory Testing Services SAN ANTONIO, April 11, 2023 — Certified Group, a leading provider of testing, regulatory consulting, and certification & audit services in North America, has hired Nick Buschur as President of...
Claims Substantiation for Dietary Supplements: A Scientific and Legal Approach
By Paula Brock, Ph.D., MSCI, EAS Independent ConsultantIt is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers, and endorsers, have adequate substantiation that the claims made about their products are “truthful and not...
FDA Issues Draft Guidance on Dietary Guidance Statements in Food Labeling
FDA’s latest draft guidance document on Dietary Guidance Statements in Food Labeling shares FDA’s current thinking on label, labeling and marketing statements that aims to help Americans make informed food choices. FDA has long actively supported consumer awareness of scientific and independent...
FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP)
Contrary to the expectation in the cosmetic regulatory space, the FDA has stopped accepting submissions to the voluntary cosmetic registration and listing program and will not be transferring this data to the program the Agency is establishing for the mandatory submission of facility registration...