FDA Consultants & Advocates
Get targeted help with FDA/USDA compliance so you can move your products with confidence.
Serving Companies Worldwide
At FDAImports, we solve the problems involved in bringing products to the highly regulated U.S. market. Our team has over 100 years of direct FDA experience, helping manufacturers, distributors, importers and exporters of regulated products navigate the regulatory maze and successfully enter and stay in U.S. markets.
Solutions for Every Business
Label Reviews
Ask an expert to check your product labels for regulatory compliance.
Facility Registration & Listing
Register your food facility, medical device facility, or drug facility with the FDA.
Claims Substantiation
Avoid costly mistakes by ensuring that your product claims are properly substantiated.
Import Alerts
Get your firm removed from FDA Import Alerts—and stay off them for good.
Holds & Detentions
Rescue your shipments from FDA detentions and move them back into the U.S. market.
SOPs / Quality Controls
Ensure that your manufacturing practices are in full compliance with the law.
Recalls
Learn the different types of FDA product recalls, as well as common causes and pitfalls.
Other Services
Get help with food, drug, dietary supplement, cosmetic, or medical device services.
Latest News
FDA Imports: Navigating Cross-Border Compliance with Attorney Benjamin L. England
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...
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...