Navigating CBP and Prior Notice of FDA’s Imported Products

Presented by William Scopa and Angel Suarez, EAS Independent Consultants

As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.

Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be covered in some detail in this webinar. Qualifying for these “expedited” programs is critical to meeting shipment timelines in order to maintain successful business relationships with U.S. wholesalers and retailers.

As the U.S government increases its focuses on and enforcement of food fraud, food defense, and food safety regulations, existing companies or new companies intending to import food-based products into the US must be aware that requirements have changed substantially over the past year, with many more regulatory obstacles that must be addressed in order to continue a successful import business.

Additionally, of great importance to dietary supplement firms, FSMA gave new authorities to import under Subpart L Foreign Supplier Verification Program for Importers Section1.511 Importing foods subject to dietary supplement CGMP regulations. Under the prior notice all food including dietary supplements are required to file and import admissibility require follow the CGMP plus the FSVP.

Join EAS Consulting Group’s Independent Consultants William Scopa and Angel Suarez for a deep dive into the regulatory challenges of importing FDA regulated products into the US and opportunities for streamlining procedures for companies able to demonstrate a record of safety and compliance.

About the Presenters

William Scopa

William Scopa

William (Bill) Scopa has over 30 years at Customs and Border Protection (CBP) at both ports of entry and Headquarters. During his 15 years at the ports, he processed import and export clearance of cargo and passengers. At Headquarters, as a Branch Chief, he led the development of policies and procedures addressing such areas as, intellectual property rights, anti-dumping and countervailing duties, and revenue collections. He spent several years leading CBP’s trade enforcement efforts in targeting evasions such as misclassification and undervaluation. His last position was CBP’s liaison to other government agencies to develop CBP import processing of imports for EPA, FDA, and DEA.

Angel Suarez

Angel Suarez

Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role, he had the 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.

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