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.
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Latest Blog Posts
FSVP Records Submission to FDA Now has a Portal on FURLS to Streamline Process
The Foreign Supplier Verification Program for Food Importers (FSVP) is one of the most significant Food Safety Modernization Act (FSMA) provisions and greatly impacted the food industry. On May 10, 2021, the Food and Drug Administration (FDA) opened a specific “FSVP...
Kratom-Navigating the Murky Regulatory Waters
On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as Kratom. Kratom is a botanical...
Is Sesame Going to be a New Major Food Allergen?
Update 04/27/2021 On April 23, President Biden signed the FASTER Act into law, requiring that all packaged food labels disclose sesame ingredients beginning January 1, 2023. Orignal Post 04/05/2021 Sesame is a common ingredient in many of the foods in the U.S.,...