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 De-Listing of Synthetic Flavors
By Steve Armstrong Question: FDA's recent announcement delisting seven synthetic flavors caused a flurry of conversation and some confusion within the flavor and extract world. Would you clarify? Armstrong: Thank you for the question and the opportunity to clear up confusion on FDA’s October 8,...
Farm Bill Solves “Added Sugar” Problem for Single Ingredient Products
The recently signed Farm Bill answers a number of questions, particularly for those manufacturers of single ingredient foods, jars of honey and maple syrup specifically, who objected to the requirement in FDA’s 2016 Final Rule of adding a declaration of daily value (DV) for added sugars as...
FDA Technical Amendments for Nutrition and Supplement Facts Panels Released
FDA released a technical amendment correcting or further explaining minor errors and omissions in the May 27, 2016, Final Rules for Food Labeling: Revisions of the Nutrition and Supplement Facts Labels and Food Labeling: Serving Sizes of Foods that Can Reasonably be...
Developing Standardized SOPs: The Foundation for Quality Compliance
AHPA Report http://www.ahpa.org/News/AHPAReports/TabId/136/ArtMID/607/ArticleID/1050/Developing-standardized-SOPs-and-updates-on-oils-kratom-and-facilities-registration-in-the-December-2018-AHPA-Report.aspx Amy Scanlin December 18, 2018
FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul
MedTech Intelligence https://www.medtechintelligence.com/feature_article/fda-encourages-innovation-and-safety-as-part-of-medical-device-regulatory-overhaul/ Amy Scanlin December 7, 2018
FDA’s CDRH Increasing Medical Device Inspections
FDA’s CDRH announced an increasing number of inspections of medical device manufacturers for a targeted risk-based approach for improved compliance in their recent Medical Device Enforcement and Quality Report. Since 2007, the FDA has increased its annual number of device inspections by 46 percent...
November 2018 Drug and Device Corner
Guidance Document updates on the FDA website: All centers: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for IndustryOn December 3, 2018, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Post-Complete Response...
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 to protect product identity and integrity. Join EAS Independent...
Essential Quality Systems for Own Label Distributors Discussed in Natural Products Insider
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., has written an article for Natural Products Insider on the intersection of OLD and Quality Systems. "The development and implementation of essential own label distributor quality systems and programs will go a long...
Appendix T Storm is Hitting the Grade A Dairy Industry
Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new...
New Report on the Sources of Foodborne Illnesses Highlights Urgency of FSMA Compliance
By Charles Breen, Independent Advisor for FSMA The Interagency Food Safety Analytics Collaboration (IFSAC) report, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data,...
Laser Products and 510(k) Requirements
By Jerry Dennis Each month EAS’ Ask the Expert answers questions sent in by readers on a variety of FDA regulatory topics. This month’s question on FDA’s regulation of lasers and 510(k) applications is answered by Jerry Dennis. Jerry is a former member of CDRH where he was responsible for...
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...
Contract Labs Best Practices
Natural Products Insider https://www.naturalproductsinsider.com/labstesting/contract-labs-best-practices Tara Lin Couch, Ph.D. November 27, 2018
The Appendix ‘T’ Storm is Hitting the U.S. Grade ‘A’ Dairy Industry
Dairy Foods Magazine https://www.dairyfoods.com/blogs/14-dairy-foods-blog/post/93262-the-appendix-t-storm-is-hitting-the-us-grade-a-dairy-industry Allen Sayler November 27, 2018
Essential Quality Systems for an Own Label Distributor
Natural Products Insider https://www.naturalproductsinsider.com/contract-manufacturing/essential-quality-systems-own-label-distributor Tara Lin Couch, Ph.D. November 2, 2018
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 …