Imports | Import Requirements
All imported products must meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; radiation-emitting devices must meet established standards; and all products must contain informative and truthful labeling in English. In addition, all products must conform to complex laws and regulations relating to their labeling.
Fresh produce (fruits and vegetables) must be grown, harvested and packed according to FDA's good agricultural practices (GAP).
Seafood and seafood products must be harvested, processed, and packed in accordance with FDA's Seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
Low Acid Canned Foods (LACF) and Acidified (canned) Foods (AF) must be manufactured in accordance with FDA regulations and are subject to additional food canning establishment registration and scheduled process filing requirements.
Drugs (finished drugs and drug ingredients, OTC and prescription (Rx) drugs) must be listed with FDA, manufactured and packed by an FDA registered facility, properly labeled, and are subject to an FDA approved new drug application (NDA) when required.
Medical devices must be listed with FDA, manufactured, packed, exported by, and imported by an FDA registered establishment, have proper pre-market notifications (PMN) or 510(k)s on file with FDA, and are subject to an FDA approved premarket approval (PMA) when required.
Cosmetics must be properly labeled, contain approved and permitted ingredients (particularly colors), and bear lawful cosmetic claims. FDA does not require cosmetics be manufactured in FDA registered establishments, and there is no comparable listing requirement for cosmetic products, although FDA does maintain a voluntary registration and ingredient listing program.
Electronic products that emit radiation (or that would emit radiation if not properly shielded) are subject to FDA's electronic product reporting requirements, resulting in FDA issuance of an FDA Accession Number for the manufacturer and the product. This requirement applies to all such products, even if they are not medical devices, if they emit ionizing or non-ionizing radiation.
FDAImports.com, LLC's primary business is ensuring foreign-made products are in compliance with the many requirements established by federal law before they are imported into the U.S. In addition, FDAImports.com, LLC assists foreign manufacturers and U.S. importers with obtaining required permits, certifications, licenses, and approvals as well as ensuring products are properly labeled prior to importing their products. Ensuring compliance with U.S. requirements is critical to obtaining and maintaining market share in the U.S. for FDA regulated products. FDAImports.com, LLC shows foreign manufacturers The Way Through the complex regulatory requirements and into the U.S. market.