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.
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,...
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...
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...
An Introduction to Proposed FDA Tobacco Product Manufacturing Practices (TPMPs)
An EAS Complimentary On Demand Webinar Presented by Dean Cirotta, EAS Consulting Group President and Shelly Blackwell, EAS Consulting Group Senior Director for Dietary Supplement and Tobacco Services.Long anticipated by the tobacco manufacturing industry, the FDA has proposed the establishment of...
Drug and Device Corner March 2023
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 is due no...
An Introduction to Upcoming Modernization of Cosmetics Regulation Act (MoCRA)
An EAS Complimentary On Demand Webinar Presented by John and Catherine Bailey, EAS Independent Consultants. The Modernization of Cosmetics Regulation ACT (MoCRA) of 2022 was signed into law at the end of December 2022, and will start being implemented at the end of 2023. MoCRA adds significant new...
FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry
On March 8, 2023, US FDA issued a “Call to Action” letter to all powdered infant formula manufacturers, packers, distributors, exporters, importers, and retailers in order to help protect our most vulnerable population. The FDA has reviewed conditions during recent inspections of powdered infant...
USDA FSIS Announces Draft of New Requirements for Voluntary Use of ‘Made in the USA’ Labels
The US Department of Agriculture Food Safety Inspection Service (USDA FSIS) announced draft of a proposed change to voluntary labeling requirements for meat, poultry and eggs that use the claim ‘Made in the USA’ or ‘Product of the USA.’ Under the proposed change, use of this voluntary claim would...
Developing a Food Safety Culture: Challenges and Best Practices
By Angie Surtani, EAS Consulting Group Independent ConsultantFood safety culture is a journey that requires significant hard work, time, effort, persistence, and commitment for fruition. I consider food safety culture to be the behavior of employees toward food safety when nobody is watching and...
New Dietary Supplement Ingredients Directory Launched by FDA
FDA has launched an on-line directory that lists 27 articles used in dietary supplements enabling quick references to any information FDA currently has pertaining to these articles and any actions taken such as constituent updates and warning letters. Additionally, any FDA webpages pertaining to...
Drug and Device Corner February 2023
The FDA sent email reminders in February re mandatory CARES annual reporting for drug establishments, which are due now. CARES volume reporting has been an annual requirement since passing of the CARES Act in 2020. If you have not already submitted your 2020 and 2021 reports, do plan to submit...
USDA Announces National Organic Program (NOP) previewed the Strengthening Organic Enforcement (SOE) Final Rule
Earlier this year, USDA announced the National Organic Program (NOP) Strengthening Organic Enforcement (SOE) final rule (https://www.federalregister.gov/documents/2023/01/19/2023-00702/national-organic-program-nop-strengthening-organic-enforcement). This rule is an update to the USDA organic...
FDA Seeks Maximum Allowable Civil Monetary Penalties Against Unlawful E-Liquid Manufacturers
In a first for FDA’s Center for Tobacco Products, Civil Monetary Penalty complaints have been filed against four manufacturers of e-liquids for violation of the Food Drug and Cosmetic Act (FD&CA) by selling tobacco products without an FDA marketing order. FDA had previously notified each of...
FDA Issues 2022 Food Code
Late last year, the FDA issued the 2022 edition of the FDA Food Code providing guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a uniform set of national standards for retail food safety. The 2022 edition commemorates 30 years of...
FDA Enforcement Discretion for Certain Qualified Health Claims and Cocoa Flavanols
FDA has indicated enforcement discretion for certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods. With “very limited credible scientific evidence” supporting a qualified...
FDA Proposes Restructuring Food Safety Efforts into New Human Foods Program
In a January 31, 2023 announcement, FDA proposed a vision to restructure the oversight of food safety and informed consumer choices into a new organization which will be known as the Human Foods Program. As part of this restructuring, the Center for Food Safety and Applied Nutrition (CFSAN), the...
Process and Manufacturing Optimization to Minimize Inflation Impact on the Pharmaceutical Industry
By Ibrahim Khattab, EAS Independent ConsultantRising inflation rates, the Russian invasion of Ukraine and the associated rise in energy prices, and the numerous logistical interruptions leading to an increase in freight charges, are all having a substantial global impact on the pharmaceutical...