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.
FDA Issues Draft Guidance on Dietary Guidance Statements in Food Labeling
FDA’s latest draft guidance document on Dietary Guidance Statements in Food Labeling shares FDA’s current thinking on label, labeling and marketing statements that aims to help Americans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...
FDA Issues Final Guidance on GRAS Panel Best Practices
The U.S. Food and Drug Administration (FDA) has issued a final guidance titled Best Practices for Convening a GRAS Panel. Although in most cases general recognition of safety can be supported without convening a GRAS panel, this guidance provides information to those assembling a panel of experts...
Drug and Device Corner January 2023
On 29 December 2022, the U.S. President signed H.R 2617 - the Consolidated Appropriations Act, 2023 into law which includes the Food and Drug Omnibus Reform Act. Of particular interest in this legislation for EAS drug and device clients, are the following: The FDA will establish a waiver of...
Guidance for Industry: Homeopathic Drug Products
What You Need to Know The U.S. Food and Drug Administration has issued a final guidance on Homeopathic Drug Products describing the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. The agency anticipates many homeopathic drug...
Importing: What Happens If Something Goes Wrong?
By Nick Lahey, EAS Consulting Group Independent ConsultantThe U.S Food and Drug Administration (FDA) works hand and hand with U.S. Customs and Border Protection (CBP) with the import process of FDA-regulated commodities. Importing FDA-regulated commodities can be a complicated process. It can be...
Drug and Device Corner December 2022
We wish you all a very happy holiday season and prosperous new year. Reminder of the deadline of 31 December 2022 for the establishment registration and product listing renewal period. For those that have not already submitted their CARES Act reporting for FY2020 and FY2021, do note per the...
What Not To Feed Your Dog
Originally posted on American Council on Science and HealthBy Jane Caldwell, Ph.D.We love our dogs and puppies. They are faithful, non-judgmental companions who delight in our presence. Many pet owners return this affection by feeding them treats. But some human foods and household products are...
Drug and Device Corner November 2022
Reminder that December is the deadline for the establishment registration and product listing renewal period. Kindly note the FDA has tightened up their validation process for drug listings. Although repack / relabeled listings have been submitted in the past without source NDC identification,...
Low Acid Canned Food and Acidified Foods – Current Topics for the Food Industry
EAS Consulting Group and partner organization and testing laboratory, Certified Laboratories, are co-presenting a complimentary webinar that will review the basic regulatory requirements of low acid canned foods and acidified foods …
How the Voluntary Qualified Importer Program (VQIP) Can Expedite Your US Imports
Most exporters of food products to the US are plagued by FDA import bottlenecks at the border. From paperwork to random and for-cause inspections, importing often feels like a waiting game. For everyone who has thought, Wouldn’t it be nice if FDA product imports could be expedited, this EAS Consulting Group, a Certified Group company, webinar discusses FDA’s “fast track” program for food imports called the Voluntary Qualified Importer Program (VQIP).
GDUFA III Targets New FDA Initiatives to Expedite Reviews and Inspections
FDA is pushing forward with new initiatives targeting enhancements to the Generic Drug User Fee Amendments (GDUFA) program as announced in a November 2021 commitment letter to industry. The current and third iteration of the GDUFA program, known as GDUFA III, enables FDA to continue assessing and...
Drug and Device Corner October 2022
As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below.Federal Register Vol 87, No. 195...
Listeria monocytogenes in Ice Cream and Frozen Novelties
Ice cream is often associated with childhood, special occasions, and moments of pleasure with family and friends. Everyone has special ice cream memories! However, memories of eating ice cream should not be associated with illness, hospitalization, or death.
Dietary Supplement Product Development for Commercial and Compliance Success
Dietary supplement product development requires diligent product design, qualification and launch strategies that position your products ahead of the competition. Innovation is key in this high-stakes industry, as is staying in compliance with FDA expectations. This webinar offers tools for the...
Establishing an Effective Environmental Monitoring Program
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.