FDA-Regulated Products in Importation
The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating a significant portion of imports, overseeing about 40% of the U.S. GDP. FDA regulations impact various product categories, including: Food Products: FDA regulates most food products,...
Understanding the Complexities of Importing FDA-Regulated Products
Understanding the nuances of FDA regulations, especially when selling products online or conducting international research, is important to successfully bring products into the U.S. market. There are some critical but often overlooked issues regarding the importation...
Benjamin England: Navigating FDA Regulations and Customs Compliance
Benjamin England has a unique and extensive background at the intersection of FDA regulations and customs law. With over 20 years of experience, he has worked across various sectors, providing both legal counsel and consulting services to businesses engaged in...
FDA 2025 Registration Renewal Season Opens October 1, 2024
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
FDA Updates Drug Reporting Requirements
On February 5, 2024, FDA issued a final guidance regarding reporting by drug establishments for listed drug and biological products manufactured, prepared, propagated, compounded, or processed for commercial distribution. The upshot is that drugs listed with FDA must...
New FDA Draft Guidance Impacts Seafood Importers and Processors
On February 9, 2024, FDA issued “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s...
New Pet Food Regulations from AAFCO
The Association of American Feed Control Officials (AAFCO) recently developed new Model Regulations for Pet Food and Specialty Pet Food. AAFCO model rules are used by most states as part of their charge to regulate the manufacture, sale, and distribution of animal...
Registration Season is Coming! FDA has announced the Medical Device User Fees for Fiscal Year 2024
FDA recently announced the updated medical device fees for the 2024 fiscal year (October 1, 2023 – September 30, 2024). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait until the...
FDA Registration Renewal Season Opens Oct 1, 2023
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
FDA Cancels Food Facility Registrations for Failure to Comply with UFI Requirement by Final Deadline
During the 2020 biennial renewal period, FDA began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through third-party company Dun & Bradstreet. FDA extended this due...