FDA Import Success Series | Mastering Compliance at Every Step
FDA Detained My Product – Now What?
Session 1 of 4
Presented by Annie Hughes and Maged Sharaf
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
- Understand why FDA detentions occur and the regulatory basis behind them.
- Learn how to break down and interpret an FDA Notice of Action.
- Gain step-by-step guidance on resolving a detention efficiently.
- Discover how to read and leverage an Import Alert to your advantage.
- Explore proactive steps you can take now to minimize risk and streamline compliance.
- Get clear, actionable answers to common questions about FDA detentions.
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About the Presenters
Annie Hughes
Key Account Executive, Certified Group
Annie Hughes brings over 13 years of specialized experience navigating the complex landscapes of food safety, import compliance, and international trade within the food and beverage industries. She is a trusted authority for importers facing FDA detention.
As a Key Account Executive at Certified Group, she bridges the gap between regulatory hurdles and actionable solutions, empowering food and beverage importers to overcome compliance challenges.
Her extensive background in food testing gives her an understanding of both the technical and financial challenges confronting the industry. She provides practical, revenue-preserving solutions.
Annie’s academic foundation, with BS and MS degrees in Agricultural Economics from the University of Florida, complements her ability to address the financial, logistical, and regulatory pain points of importers. She has served as a subject matter expert at several import industry events.
Maged Sharaf, Ph.D.
Senior Director for Labeling, Cannabis, and Claims Consulting Services, EAS Consulting Group
Dr. Maged Sharaf specializes in FDA and FTC compliance, including label reviews, claims substantiation, 21 CFR 111 audits, and support for dietary supplements, cosmetics, and cannabis. An expert in botanical sciences and regulations, Dr. Sharaf has extensive experience guiding clients through product detentions, NDI submissions, and safety-focused compliance strategies.
He holds a Ph.D. in Pharmaceutical Sciences from the University of Pittsburgh and is a recognized authority in 21 CFR 111 and 21 CFR 117. Dr. Sharaf has served with the U.S. Pharmacopeia since 2015, contributing to standards in nomenclature, labeling, and dietary supplements. He is also active with the American Herbal Pharmacopeia, the American Botanical Council, and the HPTLC Association.
Prior to consulting, he held leadership roles at CAMAG Scientific, the American Herbal Products Association, and the U.S. Pharmacopeia, where he advanced standards for foods, dietary supplements, and herbal medicines.
Posted in Foods, On Demand Webinar.