“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability record-keeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA)” – (FDA.gov website).
It was said that the new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths." FSMA Rule 204 intends to create a more transparent supply chain that ensures safer food for all Americans. The rule also encourages companies in the food value chain to invest in digital traceability technology.
As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.”
FDA’s laser focus on food traceability as part of a Smarter Era of Food Safety under the Food Safety Modernization Act (FSMA) has translated into great strides in the protection of the U.S. food supply. In January 2023, FDA strengthened these efforts with a final rule that established Additional Traceability Records for Certain Foods, produced domestically and imported, included in the Food Traceability List.
From farm to table, firms producing foods on the Food Traceability List must track specific Key Data Elements (KDE) for Critical Tracking Events (CTE), both forward and backward in the supply chain. This framework forms the foundation for effective and efficient tracing of food.
EAS is on the go. Find out about our latest seminars, webinars, speaking engagements, articles published in industry journals, tradeshows and more!
Tim Lombardo Presenting at 2024 Petfood Forum
EAS Senior Director for Food and Beverage Consulting Services Tim Lombardo will present Pet Food Safety and Regulatory Updates during the 2024 Petfood Forum covering pet food FSMA compliance.
Claims Substantiation Seminar
Presented by Paula Brock, PhD., EAS Senior Regulatory Consultant March 14, 2024
It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers, and endorsers, have adequate substantiation that the claims made about their products are “truthful and not misleading”. The Federal Trade Commission (FTC) released an update of their substantiation guideline in December 2022. Combined with the FTC guideline, the Food and Drug Administration (FDA) guidelines and regulation provide the framework for claims and claims substantiation for U.S. dietary supplements.
This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.
Thank you all who joined our recent seminar on Cosmetic Safety Substantiation presented by Paula Brock, PhD, MCSI. Due to popular demand, we will schedule a repeat of the seminar this spring. Sign up to be directly notified when our new date is announced!
Media Spotlight: Cosmetic Safety Seminar and EAS Senior Consultant Paula Brock
Just Announced: OTC Labeling and Claims GMP Spring Course
Sign up today for our seminar starting March 27, presented by the EAS Consulting Group team.
If you manufacture products in the OTC-drug space, including homeopathic, the challenges of FDA regulatory requirements become confusing. With a mixture of regulations spanning pharmaceutical Good Manufacturing Practices (GMPs) per 21 CFR Part 110 for pharmaceuticals, and proscriptive monographs categorized by therapeutic classes, covering labeling and claims, as well as registration and listing requirements under 21 CFR 207, these nonprescription products are held to intense scrutiny.
EAS’s five-part series on OTC GMPs and Labeling Compliance covers what you need to know to manufacture and market your products in accordance with FDA requirements. Covering inspection enforcement, labeling requirements, private label distributors, registrations and listings of your facilities and products as well as how to design an effective Adverse Events Reporting program, our team of experts will help you to understand what is required and how to comply.
EAS Consulting Group and Labstat are proud sponsors of this year’s Tobacco Merchants Association Annual Meeting happening April 22-24, 2024, in Arlington, VA.
EAS Consulting Group and Labstat are proud sponsors of this year’s Tobacco Merchants Association Annual Meeting happening April 22-24, 2024, in Arlington, VA. Visit our booth or join a discussion with industry professionals. Registration is now open at TMA.org/2024. We’ll see you at TMA 2024!
Submit Your Questions to the EAS Team Today!
Do you have a regulatory question or concern? Are you interested in seeing a particular topic covered in a future issue of eNews? We want to hear from you! Use the EAS Contact Us form to send a note or question to our team any time.
Get Notified When Trainings Are Scheduled
Are you looking for training in a particular industry or regulatory topic? Review our list of available topics and sign up to be notified when your course of interest is scheduled next.
We’re Hiring Independent Contractors!
EAS is always interested in broadening our industry experience and expanding our independent consultant team. If you’re interested in joining EAS as a 1099 contract employee, please email your CV to Dean Cirotta at dcirotta@easconsultinggroup.com.
Consultant Corner
EAS offers over 150 independent consultants strategically located around the globe whose expertise provide core value for clients.
Norman Alayan has extensive experience in the fields of Quality Assurance, R&D, Production, Operations, Auditing, Consulting, and Training in Management Systems (Quality, Food Safety/HACCP, OH&S, Environment) in food manufacturing industries managing company’s QA, R&D, Production, and other areas of Operations Management. He has a proven history of success in developing, implementing, and maintaining Integrated Management System (ISO9001, HACCP, GFSI, SQF, BRC, FSMA Preventive Control, FSVP, ISO22000, FSSC22000, IFS Food and Logistics, Trace Gains, Supplier Management, OH&S and Environmental Standards, FDA, and USDA standards). Norman is an experienced manager, auditor, consultant, and trainer with practical skills obtained from work in the USA, Australia, New Zealand, Asia, and other countries. He has audited numerous global companies including Sara Lee, GE Healthcare, Kraft Heinz, Mondelez, Nestle, Con-Agra, Cargill, Anheuser Busch, ADM, Costco, Walmart, ALDI, Gate Gourmet, Newrest, Novozymes, and more.
Jeff is a Medical Device RA/QA professional with over 30 years of experience in developing Quality Systems that meet or exceed FDA and ISO requirements and Regulatory Submissions. He has hosted numerous FDA and Notified Body Audits wherein no or very few nonconformances were raised/found and has prepared several successful FDA Meeting Requests and IDE submissions as well as MDD submissions and an MDR submission that recently obtained the CE mark. For over 12 years, he has worked auditing Clinical Research Organizations used for Clinical Research Studies, as well as providing updates to Clinical Investigators and the FDA on the progress of Clinical Studies.
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