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
Navigating FDA Imports and Compliance Risks
What is the statutory basis for the FDA's authority over imports and exports? The FDA's authority over imports and exports stems from the Food and Drug Cosmetic Act, which mandates the agency to ensure the safety, effectiveness, and wholesomeness of FDA-regulated...
Post-Market Problems: When FDA Comes Knocking After Your Product Is Already on Shelves
What is the process like for imported cargo after it clears customs? After cargo clears customs, it can still be subject to questioning by customs. The cargo is initially held in a warehouse under a bond, giving customs the power to ask questions about duties,...
Supreme Court IEEPA Tariff Challenge: How Importers Can Preserve Refund Claims(180 Day Protest Rule)
What is the significance of the Supreme Court challenge involving tariffs under IEEPA for importers? The Supreme Court challenge involves tariffs imposed under the International Emergency Economic Powers Act (IEEPA) by the president. IEEPA allows the government to...