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.
FDLI Cannabis Conference Covers Possible Pathways to Regulation
The first annual FLDI Cannabis Conference was held in Washington D.C. on November 2nd. What made this cannabis conference unique for me was not the content or the speakers but the audience attending. I have been part of the cannabis industry for the past four years, from the start of recreational...
Mutual Recognition Agreements for Monitoring US Drug Supply Written for Tablets & Capsules
James Evans expanded on his September 2018 issue of the month article on MRAs in an article published in Tablets and Capsules magazine. He discusses MRAs in-depth, as well as Field Action Reports, Med-Watch Reports, and Drug Quality Sampling and Testing as methods of monitoring the U.S. drug...
EAS to Present Two Sessions at Food Safety Consortium
EAS will be presenting two sessions at the upcoming Food Safety Tech’s Food Safety Consortium taking place November 13-15, 2018 in Schaumburg, IL. Independent Consultant Andrea Yablunoksy will present on Recall Readiness: Understanding Requirements, Similarities & Differences in a USDA and FDA...
How to Prioritize Planning for Food Safety Emergencies
By Charles Breen This month’s Ask the Expert is on how to prioritize planning for food safety emergencies, particularly in light of the challenges of not only the emergency itself but recovering from it with your company’s reputation intact. It is answered by Charles Breen, EAS Independent Advisor...
Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen
Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted by processors, wholesalers, and retailers to protect product...
FDA Proposes Releasing Retailer Names in Most Serious Recalls
By Charles Breen, Independent Advisor for FSMA In an effort at greater transparency as well as consumer safety, FDA issued Draft Guidance this month proposing how and when FDA would publicize the identities of retail consignees that may have received recalled human or animal foods. This release of...
EAS Consultants Present FSVP Webinar for NCBFAA
EAS Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant, Bryan Armentrout are presenting a webinar focusing on FSVP requirements for the National Customs Brokers and Forwarders Association, NCBFAA. Titled “Foreign Supplier Verification and How to Protect Your Business”the...
Four Common Mistakes When Selecting a Rapid Method for Environmental Testing
By Bryan Armentrout We are now firmly in the era of the Food Safety Modernization Act. It’s no longer theoretical, it’s real world, and FDA is auditing and asking questions about what they are seeing. I think we can all agree on one thing. The way we looked at environmental pathogen testing in the...
Crozier-Dodson Article on Pathogen Control in Poultry Processing Published in Meating Place
Beth Crozier-Dodson published an article in Meating Place discussing top tips for proactive pathogen control in poultry processing. “One of the most significant aspects of any poultry food safety plan is the implementation of pathogen control measures at each critical control point identified in...
Own Label Distributor Responsibilities Discussed in Natural Products Insider
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. discussed challenges facing Own Label Distributors in the Natural Products Insider. Although a firm may contract certain dietary supplement manufacturing operations, it cannot contract out ultimate responsibility...
Good Food Movement Discussed in Natural Product Insider
Independent Advisor for Food Law and Regulation, Steve Armstrong, JD, has written an article on the Good Food Movement for Natural Products Insider. “Consumers are increasingly looking for foods with clean labels,” he says. Unfortunately, there is no regulatory definition to guide the terms “clean...
Photos of Old Town Alexandria Put Final Touch on EAS Office Expansion
EAS Headquarters has just undergone a renovation to add additional space to its headquarter offices in the heart of Old Town Alexandria. Included in the buildout is more office space to accommodate expanding staff and the inclusions of a larger conference and training room equipped with state of...
Being a Third-Eye in a Plant with a Problem – Discussions on Listeria and Salmonella Protection in Food Safety Magazine
Carl Custer wrote about the challenges of Listeria, Salmonella, extraneous materials and worse in an article published in Food Safety Magazine. Carl also shared some of his experiences at problem-solving both while at FSIS and working with clients as a consultant, observing plant practices as...
Medical Device Regulatory Landscape Discussed in Post AdvaMed MedTech Wrap Up
Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways that allow...
Pharma’s Problems with Data Integrity
FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity, or lack thereof …
EAS Presents at United Nations to SIDS DOCK Assembly
For Immediate Release EAS Consulting Group, LLC Alexandria, VA 571-447-5500 easconsultinggroup.com October 5, 2018: EAS Consulting Group, LLC Announces Collaboration with Small Islands and Presents on FDA Regulatory Services to Fourth Session of the SIDS DOCK Assembly at the United Nations...
FDA Announces Export Certifications and Fees for Certain Food Products
By Charles Breen, Independent Advisor for FSMA On August 31, 2018, FDA announced a new voluntary export certification option for certain foods as authorized under FSMA, similar to that available for qualified pharmaceuticals and medical devices. This new export certification program and its...
Fairman Discusses Tips to Ensure Compliance with Audits in Natural Products Insider
EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract manufacturer audits often have critical...
Couch Shares Dietary Supplement OLD Responsibilities in AgroFOOD Industry HI Tech
Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze - AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the...
Skolnik Discusses AERs in Natural Products Insider
Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as...
Cirotta to Moderate Panel at FDLI Conference Focusing on Tobacco and Nicotine Products
Dean Cirotta will moderate a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference concerning “The Latest on Product Standards and Other Potential Regulatory Action”. The conference, which takes place October 25-26, 2018 in Washington, D.C., will address issues...
Breen Co-Authors Article in Food Quality and Safety Magazine on Responding to Food Safety Emergencies
Independent Advisor for FSMA, Charles Breen has co-authored an article with Stacey Stevens, Senior Vice President of FoodMinds, a food PR firm with which EAS has a collaborative partnership on responding to a food safety emergency. The article, published in Food Quality and Safety magazine...
Legislation to Reform the OTC Drug Monograph System: The OTC Drug Safety, Innovation, and Reform Act
By Norma Skolnik, Independent Consultant With the aim of overhauling the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey recently sponsored bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018, S.2315. The...
September 2018 Drug and Device Corner
EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period....
Are Industry Initiated Environmental Swab-a-Thons a Benefit?
The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in …
What Exactly is the Foreign Supplier Verification Program (FSVP)?
By Allen Sayler Ask the Expert offers a chance for our readers to submit questions to EAS regarding areas of regulatory confusion. This month’s question is answered by Allen Sayler, Senior Director of Food Consulting Services. If you’d like to submit a question, please use the “contact us” link on...
Couch Discusses Contract Manufacturing Partnerships in Natural Products Insider Podcast
Senior Director for Dietary Supplements, Dr. Tara Lin Couch was interviewed for a Natural Products Insider podcast on contract manufacturing partnerships. Dr. Couch is one of two EAS presenters for the upcoming SupplySide West trade show taking place in Las Vegas. Stay tuned for more information...
Tajkarimi and Sayler Discuss RTEs in Natural Products Insider
Independent Consultant Mehrdad Tajkarimi and Senior Director Allen Sayler co-wrote an article for Natural Products Insider discussing Cause, Effect and Impact of RTE Operations on complying with FDA’s draft Listeria guidance. Food manufacturers are expected to operate within an entirely new scheme...
FDA Mutual Recognition Agreements
By James Evans, EAS Independent Consultant FDA has been implementing the Safety and Innovation Act since it was passed by Congress in 2012. The Act requires FDA to establish Mutual Recognition Agreements (MRAs) which are agreements between two or more countries to recognize a specific process or...
Sayler Discusses Fast Tracking FDA FURLS in Food Safety Tech
Senior Director for Food Consulting Services, Allen Sayler, has written an article for Food Safety Tech on FDA Fast-Track Unified and Listing Systems (FURLS) program and whether it is expediting or impeding access to overseas markets. “The FDA recently released a notification that their FURLS...