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Many products imported into the United States are regulated by the U.S. Food and Drug Administration (FDA) in addition to U.S. Customs and Border Protection...

FDA jurisdiction depends on the product and its intended use. The fact that a shipment is small, low value, promotional, a sample, or shipped by parcel carr...

FDA clearance and FDA compliance are not the same thing. Entry data tells FDA what is being imported and supplies the information used for screening. It do...

FDA entry requirements vary by commodity and intended use. There is no single field set that applies to every FDA-regulated product. Common data elements ...

The FDA Product Code identifies the type of regulated product being imported. It is separate from the HTS code used for customs classification. Product Cod...

The FDA Product Code answers approximately “what is the product?” The Intended Use Code (IUC) answers “how or why is it being imported?” Intended Use Code ...

FDA entries can involve several different parties. These roles should not be treated as interchangeable simply because the same company sometimes performs m...

Food imports have several requirements that are separate but often encountered together. A shipment may require valid food facility registration, Prior Noti...

Labeling is one of the most avoidable causes of FDA import problems. A product can be correctly declared to FDA and still be detained if its label appears t...

An FDA Import Alert tells FDA field personnel that certain products, manufacturers, shippers, countries/regions or other defined categories may be subject t...