By Mark Moen, EAS Consulting Group Senior Regulatory Consultant
Products imported into the US may be assessed and inspected by US Customs and Border Protection (CBP), the Food and Drug Administration (FDA), and US Consumer Products Safety Commission (CPSC).
US Customs and Border Protection (CBP) is the unified border agency that falls under the Department of Homeland Security and is charged with the comprehensive management, control and protection of our nation’s borders, combining US Customs, immigration, border security and agricultural protection at and between ports of entry. CBP also protects the American consumer and the environment against the introduction of hazardous, toxic or noxious products into the United States, and protecting industry and labor against unfair foreign competition; and detecting, interdicting, and investigating smuggling and other illegal practices aimed at illegally entering narcotics, drugs, contraband, and other prohibited articles into the US.
The Food and Drug Administration (FDA) is tasked with protecting the public health by assuring the safety, efficacy, and security human ad veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
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.”
The U.S. FDA can detain your imported food products at any time for any reason. Whether for sampling, testing, or detention without physical examination, when your products are detained, following FDA sampling guidelines and having an FDA sampling plan is a must.
You can choose whichever FDA import sampling and testing laboratory you wish. But, make sure the lab follows FDA sampling guidelines and can seamlessly navigate the FDA import process.
In this post, we will outline the FDA sampling plan that we use at Certified Laboratories, a Certified Group Company, to help ensure our clients' products are quickly released from FDA detention.
Sign up today for our upcoming webinar on Good Auditing Practices, Making the Most of Your Internal Review presented by EAS Consulting Group Senior Consultant Jeb Hunter. This virtual short course will take place on July 17 and 18 from 11am-3pm ET. Pricing and information are available at: https://easconsultinggroup.com/good-auditing-practices-making-the-most-of-your-internal-review/
July 25, 2024 at 11am ET, presented by Paula Brock, Ph.D., MCSI, EAS Senior Regulatory Consultant
The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) became effective in December 2023 and includes a requirement for safety substantiation, mandatory registration of facilities, registration of product ingredients (product listing), and reporting of serious adverse events (online via MedWatch). With perspectives from pharmacologists/toxicologists and regulatory experts, this seminar will provide an overview of safety assessment of cosmetics. Learn more and Register: https://easconsultinggroup.com/cosmetic-safety-substantiation/
Heading to the Institute of Food Technologists’ IFT First Annual Event & Expo starting July 14 in Chicago? Meet EAS staff Tim Lombardo and Mark Moen at this year’s IFT First Booth #3375! Event information and registration details are available at IFTevent.org.
EAS Senior Consultant Jeb Hunter will join the Healthcare Distribution Alliance 2024 Traceability Seminar happening August 26-28 in Washington, DC, for a special panel on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance.” HDA’s annual Traceability Seminar brings together healthcare supply chain leaders to learn more about upcoming DSCSA implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.
Join the EAS team at CHPA’s Regulatory, Scientific and Quality Conference September 17-18, 2024, where EAS Senior Director Lisa El-Shall will moderate a panel on Hot Topics from the FDA.
John Bailey will speak at the Naturally Kiawah Symposium happening October 8-11, 2024, in Kiawah Island, SC, on regulation updates, MoCRA, product testing, PFAS, and more. Visit scconline.org/CarolinaSCC/Naturally-Kiawah for more information.
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EAS Consulting Group, Senior Regulatory Consultant
Mark Moen has spent over 25 years in the Seafood and Food Industry, from his beginning as a Sea Sampler for the International Pacific Halibut Commission during the summer months of college years at Washington State University. He went onto work at all levels in the Seafood Industry, and joined FDA as a CSO, and spent several years doing Seafood HACCP, LACF, AF, Food and worked at the FDA Prior Notice Center. He then went on to work for various Seafood and Food firms as a Quality Director or Quality Assurance Manager and moved onto his own Consulting firm the last few years, working with small to medium size firms assisting them with their Food Safety concerns.
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