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.
Safe Foods for Canadians Act (SFCA) Discussed in Food Safety Magazine
EAS Independent Consultant, Ramakrishnan “Rama” Narasimhan published an article in Food Safety Magazine on the Safe Food for Canadians Act, including areas where it is similar to FDA’s FSMA. Did you know EAS offers food safety services for Canadian firms and has a number of Canadian independent...
Dietary Supplements and FSMA Compliance – Fallacy or Fact? – A Complimentary EAS Webinar
Do you know which of the seven major FSMA regulations were designed to support the Food Safety Modernization Act (FSMA)? Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior...
FDA’s Approach to Intentional Adulteration
Joe Famiglietti Each month EAS selects one question sent in by readers of EASeNews to answer as part of our Ask the Expert column. This month’s question on how FDA is enforcing Adulterated Foods is answered by Independent Consultant, Joe Famiglietti, who works closely with EAS clients in...
EAS offers QMS Services for Medical Devices
Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a voluntary QMS switch from 21 CFR...
EAS Intern Publishes in FDLI Update Magazine
Neha Mookuparambil, a recent EAS intern focusing on pharmaceutical studies at Georgetown University published an article of FDA’s perspective on continuous manufacturing in FDLI Update, the bi-monthly magazine of the Food Drug Law Institute. EAS has partnered with Georgetown for a number of years...
Equipment and Utility Change Control for GMP Production Facilities
By Greg Weilersbacher Despite FDA’s guidance documents on change control, “…managing change to prevent unintended consequences,” many companies limit change control to documentation such as batch records, SOPs, protocols, and specifications and only sporadically evaluate that of equipment and...
Navigating CBP and Prior Notice of FDA’s Imported Products – October 29, 2019
As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of the U.S. consumer and integrity of the food-based products...
Menu Labeling
By Cathryn Sacra Each month EAS selects one question sent in by readers to be answered in EASeNews. This month’s answer is provided by Cathryn Sacra, Director of Labeling and Cosmetic Services. Cathryn oversees EAS’ labeling team, assisting clients with food and dietary supplement product labeling...
Cirotta Moderates Panel at FDLI Tobacco and Nicotine Product Regulation and Policy Conference
Dean Cirotta, President and COO, is moderating Multi-Stakeholder Reactor Panel at the FDLI 2019 Tobacco and Nicotine Product Regulation and Policy Conference at the National Press Club in DC October 24-25, 2019. The keynote speaker at this event is FDA’s Center for Tobacco Products Director...
EAS Offers OTC Labeling Review and Design in Compliance with FDA Monograph Regulations
Did you know that the current regulations for labeling of Over-the-Counter (OTC) drug products were initiated in 1972 as part of the OTC Drug Review? That’s over 50 years ago and the monograph system that arose from that process has not yet come to completion in terms of finalizing regulations for...
September 2019 Drug and Device Corner
The FDA has announced the Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality. This move is one critical component of the agency’s initiative to modernize the New Drugs Regulatory Program. The FDA...
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters – November 7, 2019
Though FDA’s 21 CFR 111 Good Manufacturing Practices (GMPs) for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance. The establishment of specifications for components, in-process materials, and finished products; and then...
EAS to Exhibit at ISPE Annual Conference Focusing on Pharmaceuticals
Bryan Coleman, Senior Director for Drugs and Medical Devices, and Robert Fish, Independent Advisor for Quality and Compliance will be at the EAS booth, #524, at the International Society of Pharmaceutical Engineers Annual Meeting and Expo October 27-29, 2019 in Las Vegas. We invite you to stop by...
Tajkarimi Discusses Food Fraud Detection Methods in MeatingPlace
Independent Consultant Mehrdad Tajkarimi, Ph.D. wrote about next-generation sequencing technology as it applies to detect plant and animal species in food adulteration cases for MeatingPlace magazine. NGS produces more variable and more in-depth genome sequencing datasets to find food-related...
EAS Exhibits, Presents Educational Sessions at SupplySide West
If you’ll be in Las Vegas October 15-18, 2019 attending the SupplySide West, stop by EAS booth #5409 and say hello to Tara Lin Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Products and Independent Consultant Heather Fairman. Both Tara and Heather will present educational...
FDA’s Transition from CFR 820 to the ISO 13485:2016 – Instituting a New Quality Management System (QMS)
FDA’s shift to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those …
Food Defense – Untangling the Challenges and Strengthening Opportunities
EAS Independent Advisor for FSMA, Charles Breen and Consultant Kathy Knutson, Ph.D. co-present a webinar on Food Defense. Food Defense is increasingly a worry for firms as our global business climate opens opportunities for intentional harm both domestically and overseas. The ability of food manufacturers …
GRAS Determination: Lessons and Pitfalls
By Tom Jonaitis Over the 14 years of working as a scientific and regulatory consultant in the food industry, I have had the opportunity to work with many companies that were bringing a wide range of exciting and innovative food ingredients to the marketplace in the United States and abroad. Beyond...
What Should We Consider When Exporting Our FDA Regulated Products to the US?
By Victoria Pankovich Each month EAS experts answer one question sent in by readers of EASeNews. This month’s question, on considerations for a reliable US Agent, is answered by Victoria Pankovich, Regulatory Specialist, who assists EAS clients with US Agent requirements. If you would like to ask...
Understanding GRAS Submissions and Avoiding Data Pitfalls- Meet FDA Requirements
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive or determined to be generally recognized as safe (GRAS) for use in food …
Avoiding Delays of Your Import Cargo Shipments through US Customs and Border Protection (CBP)
By William (Bill) Scopa The US Customs and Border Protection (CBP) has varied enforcement responsibilities, including detecting drug smuggling, weapons of mass destruction, and Immigration. Typically, these concerns are not what will cause the importer delays in their cargo shipments. The more...
EAS Assistance Simplifies FDA Registrations, Listings and Renewals
The FDA requires firms that manufacture foods, pharmaceuticals and medical devices to register their facilities on an annual or biennial basis, depending on the product category. Keep in mind, FDA assesses a Medical Device establishment registration user fee annually. Drug products and medical...
EAS to Present Webinar on Prior Notice of Imported Foods for NCBFAA
EAS Independent Consultant Angel Suarez will present a webinar on October 8, 2019 for the National Customs Brokers and Forwarders Association of America (NCBFAA). Discussing the Roles of Import Divisions Review and Compliance, Angel will share insights from his many years of experience as a...
Learn More about Infant Formula Considerations in Natural Products Insider
Independent Consultant and infant formula expert, Robbie Burns, Ph.D., published an article in Natural Products Insider on regulatory considerations for the development of infant formula for sale in the U.S. In addition to this article you may wish to review more on infant formula regulatory...
July 2019 Drug and Device Corner
The FDA recently issued a warning letter to a company for inaccurate information in one of their drug listings. Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act and 21 CFR Part 207) outlines the requirements for registration and listing of drug products. EAS would like to...
ISPE iSpeak Blog on FDA’s ORA – A Historical Look and Evolving for the Future
Joel Martinez, former FDA ORA BIMO FDA Investigator, and EAS Independent Consultant shared a historical look at this important office and the evolution of training for FDA’s investigators of pharmaceutical products. Learn more here.
Determining the Risk-Base of High-Risk Foods
Each month EAS answers one question sent in by readers of EASeNews. This month’s question on the risk-base of high-risk foods is answered by EAS Independent Advisor for FSMA, Charles Breen. Question: How do you determine the Risk-Base of High-Risk Foods? Breen: With the passage of the Food Safety...
FDA Inspections Webinar with Recent Trends in Observations
EAS has posted our latest webinar to the On-Demand webinars page. Presented by Sophia Lily, Preparing for FDA Inspections, is free to view on-demand - along with numerous other webinars presented by our consultants on a variety of topics. EAS regulatory webinars provide timely and relevant content...
Preparing for FDA Inspections, a Look at Recent Observations and Trends
Foreign companies exporting FDA regulated products to the United States can at any time expect an FDA announcement of facility inspection. Looking at the complete safety package from record keeping and retention, to specifications and testing to …
Risks to OLDs Discussed in Natural Products Insider
Independent Consultant Bruce Elsner discussed considerations of Own Label Distributors for the assurance of GMP compliance and certificates of analysis in Natural Products Insider. Dietary supplement companies that contract out some or all their operations often fail to consider how little...