Understanding the Role of the FDA and U.S. Customs in Regulating Imports When it comes to regulating imports, two key agencies play crucial roles: U.S. Customs and Border Protection (CBP) and the Food and Drug Administration (FDA). Here's a breakdown of how these...
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...
On March 26, 2021, the Food and Drug Administration (FDA) republished the Over the Counter (OTC) Monograph Drug user fee rates for the fiscal year 2021 under the OTC Monograph Drug User Fee Program (OMUFA). While most OTC facilities will now be required to pay a...
The Food and Drug Administration (FDA) started 2020 off strong; on January 1, 2020, FDA required compliance with new food and dietary supplement labeling regulations for manufacturers with ten million dollars in annual sales. Manufacturers with less than ten million...
Update 01/13/2019:Commissioner Scott Gottlieb announced that they have increased surveillance sampling of imported high-risk products. Additionally, the FDA has expanded other activities that they have deemed "excepted, unpaid work because they're necessary to...
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