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.
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 …
Paper audits important step in contract lab qualification — podcast
Natural Products Insider Podcast September 25, 2019 https://www.naturalproductsinsider.com/labstesting/paper-audits-important-step-contract-lab-qualification-podcast Tara Lin Couch, Ph.D.
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 …
FDA Office of Regulatory Affairs – A Historical Look and Evolving for the Future
ISPE iSpeak blog July 22, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/fda-office-regulatory-affairs-historical-look-and-evolving-future Joel Martinez
US Regulatory Considerations for Infant Formulas
Natural Products Insider July 22, 2019 https://www.naturalproductsinsider.com/regulatory/us-regulatory-considerations-infant-formulas Robert Burns
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...
Warehousing Compliance and FSMA Reviewed in Food Safety Strategies
The requirement to comply with FSMA is well understood for food manufacturers, and there are no exceptions for warehousing facilities. FDA inspections of facilities that receive, store and distribute human or animal food can occur at any time and firms must be prepared for such an inspection 24...
EAS to Offer Training on Expert Witness Preparations
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony...
How Does USDA Labeling Differ From FDA Food Labeling?
By Susan Glenn Each month EAS experts answer one question sent in by readers. This month’s answer regarding USDA labeling is provided by Susan Glenn. Susan is an expert in matters pertaining to USDA and FDA regulations of the food industry with a particular focus on labeling, product standards and...
Did you know? EAS Consulting Group Offers Preparatory Assessments Against VQIP Requirements for Firms
The Voluntary Qualified Import Program (VQIP) enables qualified importers of food and food products into the U.S. an expedited review and entry. However, meeting the stringent requirements of the VQIP program requires a thorough demonstration of documented safety of foreign suppliers of human and...
What are SDSs?
By Robert Kapp, Ph.D. Safety Data Sheets (SDSs) (formerly known as Material Data Sheets (MSDSs) contain basic information about a chemical or product needed to insure the safety and health of the user at all stages of its manufacture, storage, use, and disposal. Interestingly, SDSs have a long and...
June 2019 Drug and Device Corner
As part of the FDA’s ongoing efforts in their goal of more ANDA approvals in order to increase access to high-quality lower cost generic drugs, the agency began on 18 June 2019 to publish additional data in the existing Paragraph IV Patent Certifications list. The FDA hopes to assist ANDA...
Challenges with Implementing Cleaning Validation
By Miguel Montalvo Though published well over 25 years ago, FDA’s guidance surrounding cleaning validation continues to cause industry confusion. While everyone agrees that cleaning validation is critical, the application of incorrect or ineffective approaches whether by misunderstanding the...
EAS Offers Pre-Clinical Safety/Tox Study Services for GRAS and NDI Submissions.
EAS offers holistic and cohesive services for clients looking to submit GRAS and NDI submissions to FDA. From the assessments to design of early feasibility studies, ongoing study oversight with the Contract Research Organization, strategy meetings with FDA and the preparation and dossier...
What are the Steps to Reporting an Adverse Event to FDA?
By Robert Fish Each month EAS independent consultants answer one question sent in by readers of EASeNews. This month’s question on adverse events reporting for both OTCs and dietary supplements is answered by Independent Advisor for Quality and Compliance, Robert Fish. Mr. Fish spent 33 years with...
Final Guidance for Food Contact Notifications – Infant Formula and / or Human Milk
FDA’s Final Guidance for preparation of Food Contact Notifications for substances that come into contact with infant formula and human milk is intended to help industry understand FDA’s process for evaluating the safety of food contact substances. It incorporates the latest scientific...