FDAImports is excited to participate in the 2025 Seafood Expo North America in Boston, March 16th-18th. Ben England, our Founder and CEO, is going to speak on “Customs and FDA Enforcement: Challenges for Imports in 2025.” Ben’s presentation is March 16th, 2025,...
Shifts in FDA and Customs Regulations Under Changing Administrations As we see new leadership in Washington, there’s no shortage of questions surrounding customs and FDA regulations for imported goods. The back-and-forth between administrations can often bring about...
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 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 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...
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...
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...
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...
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...
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...
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