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.
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December 2023. This draft guidance describes how the FDA will request and conduct voluntary remote interactive...
Review of Food Safety Needs to Export from the USA
By Omar Oyarzabal PhD., Senior Consultant for Food ServicesExporting foods from the USA to other countries, such as Canada and those in the EU block, has been a lucrative option for some segments of the food industry. This short article reviews some or the current trade with the European Union...
MoCRA: Facility Registration and Product Listing for Cosmetics
The Clock is Ticking: Are you Ready for Facility Registration and Product Listing under MoCRA?An EAS Complimentary Webinar Presented by John and Catherine Bailey, EAS Independent Consultants and Victoria Pankovich, Manager of Regulatory ServicesOctober 30, 2023 • 12pm (Eastern) 1 hourThe new...
Drug and Device October 2023
The FDA published a new Guidance Document - Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications which articulates the agency’s evolving policy which has grown from the Pandemic era use of alternative tools in evaluating drug manufacturing facilities...
MoCRA Preparations Should be in Progress
As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA. For facilities that need to register [every person who...
A Decade of Vigilance: FDA’s Battle Against Imported Foodborne Illness
By Don Abbott, EAS Independent ConsultantIntroduction Over the past decade, the Food and Drug Administration (FDA), particularly its Center for Food Safety and Applied Nutrition (CFSAN), has been at the forefront of safeguarding the American public against foodborne illnesses originating from...
The FDA Has Updated the Food Traceability Frequently Asked Questions on the Website
On September 28, 2023, the U.S. Food and Drug Administration (FDA) has updated its Food Traceability Frequently Asked Questions (FAQ) to provide additional information about this rule. The Food Traceability Final Rule was published in November 2022 and requires the implementation of traceability...
FDA Issues New Guidance for Allergen Management and Control
On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter specific to allergens. Key take-aways include: Establish and Implement a Food Allergen Program. The...
Drug and Device September 2023
Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline deems any generic drugs...
FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of Cosmetic Product Facilities and Products” gives an overview of the process. In addition to the guidance...
“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...
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,...