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.
Own Label Distributor Responsibilities Discussed in Natural Products Insider
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. was interviewed for an article in Natural Products Insider on Own Label Distributors and challenges of industry to establish product specifications. According to FDA data, in fiscal year 2018, about 24 percent of...
Food Safety Magazine Part II of Series on FSMA Training
Independent Consultant Mehrdad Tajkarimi has published part two of his three-part series in Food Safety Magazine on designing food safety training programs to meet FSMA compliance expectations. Food safety training is critical, not only in meeting FDA requirements, but in protecting consumers and...
January 2019 Drug and Device Corner
With the Federal Register (FR) publication unavailable, the FDA has published Safety and Performance-Based Pathway on the Guidance Document webpage. Full details will be available in the Federal Register once that site is again functioning. The existing Docket Number for this document is ...
Pharmaceutical GMPs for Safer Products and Swifter Approvals
EAS published a blog on the International Society of Pharmaceutical Engineers’ iSpeak blog on how GMPs and data integrity align for safer products and swifter approvals. FDA has noted that in recent years, findings from pharma facility inspections show increasing challenges with meeting data...
Qualified Individual and Preventive Controls Qualified Individual – What’s the Difference?
By Charles Breen The Food Safety Modernization Act (FSMA) Preventive Control for Human Foods (PCHF) regulation (21 CFR 117) signed into law in 2011 offers a wealth of opportunity (and a requirement) for companies to improve their food safety procedures and protocols through the implementation of a...
How GMPs & Data Integrity Align for Safer Products & Swifter Approvals
ISPE iSpeak blog https://ispe.org/pharmaceutical-engineering/ispeak/how-gmps-data-integrity-align-safer-products-swifter-approvals January 23, 2019 Amy Scanlin
Own-Label Distributors of Supplements Still Failing to Produce Product Specifications
Natural Products Insider https://www.naturalproductsinsider.com/regulatory/own-label-distributors-supplements-still-failing-produce-product-specifications January 22, 2019 Tara Lin Couch, Ph.D.
Steps to Develop Compliant SOPs Discussed in AHPA Report
The December American Herbal Products Association (AHPA) Report (subscription required) included an EAS authored article on steps to develop fully compliant Standard Operating Procedures. Though the development and detail of each SOP is at the discretion of individual companies, they should...
FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul
EAS authored an article in MedTech Intelligence on FDA’s efforts at encouraging innovation while keeping a close eye on safety as part of a medical device regulatory overhaul. FDA is working to retire outdated predicates for 510(k) submissions as well as improve their post-market surveillance...
Couch Shares Thoughts on Contract Laboratory Best Practices as Part of Insider Q&A
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. participated in a discussion with other industry leaders on best practices for contract laboratories in a recent Natural Products Insider. Contract labs are often enlisted to certify that products are fully and...
2019 Produce Compliance Dates for FSMA
By Charles Breen, EAS Independent Advisor for FSMA Consulting Services January 28, 2019, marks the compliance date for four categories of produce growers: Sprouts from Very Small Farms (with certain exemptions), Sprouts from Very Small Farms eligible for a qualified exemption to comply with...
Dietary Supplement Specifications Development – Still Challenging the Industry Ten Years Later
By Tamika Cathey Specifications Development, as defined in FDA’s Good Manufacturing Practices for dietary supplements (21 CFR §111) have posed one of the biggest challenges to industry since the inception of the requirements in June 2007. Specifically, 21 CFR §111.70 requires manufacturers to...
December 2018 Drug and Device Corner
Guidance Document updates on the FDA website All centers: Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products CDER: Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Post-Complete...
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...