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title: "EAS-e-News: What’s Hot in FDA Regulatory Matters"
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Friend, Get the latest FDA and USDA regulatory information in our monthly EASeNews.

| View in browser Foods  •  Dietary Supplements  •  Drugs  •  Medical Devices  •  Cosmetics  •  Tobacco  •  Cannabis 1700 Diagonal Road, Suite 750, Alexandria, VA 22314  •  571-447-5500  •  easconsultinggroup.com/contact November 2024 Issue of the Month Are You as an Importer Ready for FSMA Traceability Rule? By Angel Suarez, EAS Consulting Group Independent Consultant Under the Food Safety Modernization Act (FSMA) the FDA has finalized several major rules to ensure the safety of the food supply is a shared responsibility across the global supply chain. The last of these major rules is the FDA Food Traceability Rule, also known FSMA 204, short for Section 204(d) of the U.S. FDA Food Safety Modernization Act. The FSMA 204 aim is to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.   The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026. As we approach the deadline, it is imperative that all those subject to the rule implement traceability of food products prior to the deadline. This rule will be binding and have the full force and effect of law after the effective date.   Are Importers subject to the traceability rule? Importers may not be subject to the rule depending on whether they manufacture, process, pack, or hold any Food Traceability List (FTL) foods. If an importer is subject to the rule, they are only responsible for complying with the portions of the rule that apply to them, based on the Critical Tracking Event (CTE) performed. Read Full Article EAS Trainings 21 CFR Part 11 and FDA Compliance Webinar November 8, 2024   Food and Dietary Supplement Labeling Compliance Seminar December 9, 11, 13, 2024 Upcoming Tradeshows and Conferences FDLI Enforcement, Litigation and Compliance Washington, DC December 10-11, 2024 Food Safety Net Services (FSNS) Education   Interested in more food safety training? FSNS offers live and virtual education events. Visit FSNS.com/education to learn more. FSPCA Preventive Controls for Animal Food or Human Food (PCQI)   HACCP Training Course   Advanced HACCP/Preventive Controls    FSSC 22000 and/or Internal Auditing   Microbiology and Food Safety 101 and 202   Preventive Maintenance   Sanitation Courses   Implementing SQF Systems Ed 9 and Internal Auditing   BRCGS Food – Issue 9 Sites Training and/or Internal Auditing   and many more... Under the Microscope Scrutiny on Food Traceability Lists Creates Havoc for Manufacturers 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. Read Full Article Read the Drug and Device Corner on the EAS Website What’s New on the FDA Website FDA and USDA Regulatory Updates Human Food Program (HFP) FY 2025 Priority Deliverables FDA Releases Supplement to the 2022 Food Code CVM GFI #294 – Animal Food Ingredient Consultation (AFIC) Food Traceability Rule (FSMA 204) – Coming Soon! Important Changes to OTC Monograph Listing Marketing Categories EAS in Action EAS is on the go. Find out about our latest seminars, webinars, speaking engagements, articles published in industry journals, tradeshows and more! Complimentary Webinar: 21 CFR Part 11 and FDA Compliance Sign up today for our complimentary webinar on Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance on November 8, 2024, from 1-4pm ET presented by EAS consultant Carolyn Troiano. This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. 21 CFR Part 11 and FDA Compliance Webinar – Register Today! Registration Open for Food and DS Labeling Compliance Seminar Join EAS Consulting Group for our semi-annual Food and Dietary Supplement Labeling Compliance Seminar happening December 9, 11, 13, 2024, from 11am – 5pm ET each day. Our experts will walk you through the requirements of a label, what information is required and in what order, how to determine amounts, and how to list ingredients. You’ll also learn the complex set of labeling rules and get answers to your most challenging questions. Food and DS Labeling Compiance Seminar – Sign Up Today! Registration Open for Health Canada Complimentary Webinar Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada. Presented by Dr. Paula Brock on Thursday, November 14, 2024 from 11:30am – 12:30pm ET. Health Canada Webinar – Sign Up Today! FDLI Enforcement, Litigation and Compliance Conference: For the Drug, Device, Food and Tobacco Industries FDLI’s annual Enforcement, Litigation, and Compliance Conference brings together industry, regulators, attorneys, litigators, academics, and consultants and other stakeholders to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements. This year’s conference will offer an opportunity to hear from and interact with top officials from FDA, DOJ, FTC, and other government agencies. Hear from your peers about how they are staying compliance- and inspection-ready, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year. Learn More at FDLI.org 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. Issue of the Month Author Angel Suarez EAS Consulting Group, EAS Independent Consultant Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role he had responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. He is the co-author of numerous publications including portions of the National Shellfish Sanitation Program’s Shellfish Equipment Construction Guide and the National Shellfish Sanitation Program’s Guide for the Control of Molluscan Shellfish Annotated Manual. In addition, he has developed training courses including FDA Certified Better Process Control School, Inspection and Sampling of Abnormal Food Metal Containers and the FDA Shellfish Officer Standardization Course. Angel has a B.S. with a major in Biology and minor in Chemistry and Physics from the Inter American University. Meet the EAS Consulting Group Cosmetics Team! Did you know the EAS Cosmetics Team includes former FDA and high-level industry experts? From colors to claims, from formulation to safety, our experts can answer any manufacturing and regulatory challenge you may have. Stay in compliance with the FD&C Act. Trust EAS! A few of our experts: Maged Sharaf, Ph.D. Senior Director for Labeling, Cannabis and Claims Consulting Services Paula Brock, Ph.D., MCSI Senior Regulatory & Scientific Consultant Jay Ansell EAS Independent Consultant Our team is available to answer your questions on all things Cosmetic, MoCRA and more including: Color Additive Petitions, Color Certifications Labeling and Claim Review and Substantiation Clinical and Preclinical Safety and Efficacy Evaluation Cosmetic Facility Registration Cosmetic Product Listing Product Safety Substantiation Adverse Event Reporting and Labeling Requirements Expert Witness Services Safety Requirements for Products and Manufacturing Facilities Import Assistance and US Agent Contact Our Cosmetics Team Today! Learn more about working with EAS Consulting Group Respected  •  Experts  •  Ethical  •  with Integrity EAS Consulting Group, 1700 Diagonal Road, Suite 750, Alexandria, VA 22314, USA, (571) 447-5500 Manage preferences |
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