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.
“Tree Nut” Allergy; Is It a Misnomer?
By Lisa Zitiello, EAS Consulting Group, Independent ConsultantFood safety professionals across the globe will agree that one key safety factor in food production today is the avoidance of allergen cross-contact. This is closely followed by declaring an allergen ingredient on the finished product...
FDA Extends Comment Period for TPMP Proposed Rule
On March 10, the U.S. Food and Drug Administration published a proposed rule titled, Requirements for Tobacco Product Manufacturing Practice. FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit comments. Comments on the proposed...
Drug and Device August 2023
We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have. If you wish for us to handle the annual requirements, please email Victoria Pankovich to get on the schedule. The annual...
Federal Judge Strikes Down FDA Regulation of Premium Cigars
In a major win for the premium cigar industry, Judge Amit Mehta of the U.S. District Court for Washington D.C. has vacated FDA’s deeming regulations for premium, hand-rolled cigars. As a result, the regulations introduced by the FDA in 2016 do not apply to cigars that meet the following criteria:...
Beverage Manufacturing
What’s Hot in the Beverage Industry? A look at trends and regulations for beverage manufacturingSeptember 12, 2023 at 1 p.m. EasternPresented by Omar Oyarzabal, Ph.D., EAS Consulting Group and Alex Brandt, Ph.D. Certified GroupThe beverage industry is thriving. From sports recovery to hydration,...
Status of Regulatory Compliance of Establishments Under USDA FSIS Jurisdiction
By Omar A. Oyarzabal, PhD, EAS Senior ConsultantThe U.S. Department of Agriculture’s Food Safety and Inspection Services (USDA FSIS) collects information on compliance under its jurisdiction. The data collected include enforcement actions related to establishments’ food safety regulations...
FDA Releases New Guidance on Cosmetic Facility and Product Registration
On August 7, FDA issued a new draft guidance on the registration and listing of cosmetic product facilities and products, which is mandated by the Modernization of Cosmetic Regulations Act of 2022 (MoCRA). This guidance is not legally enforceable, but it provides recommendations and instructions...
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 Seminar
Presented by Paula Brock, PhD., EAS Senior Regulatory ConsultantMarch 14, 2024 1:00 – 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...
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.