FDA Regulation Consultation Services

With the Food Safety Modernization Act (FSMA) there are an increasing number of foods being tested by the FDA at the time of import. Illegal residues and contaminants are often detected through routine sampling, which leads to a refusal of entry for that shipment and automatic detention going forward. Food products under FDA import Alert and Detention without Physical Examination (DWPE) must be sampled and tested by qualified independent sampling and laboratory companies.

Once a product has been shown to contain an illegal residue or contaminant, the shipment is refused entry in the United States, and either must be re-exported to another country or destroyed. US FDA places the Exporter of that product under its DWPE program. Under the DWPE Program, every new shipment from that exporter must be analyzed by a private laboratory for the same illegal residue or contaminant. Only if the new shipment is found to be below established tolerance will the FDA allow it to be released into the channels of trade.

Everything from sampling to analytical methodology to reporting must be performed using extremely strict protocols, or the analytical data package will be rejected, subjecting the importer to further delays, or possible refusal of entry. Generally after 5 clean shipments in a row the exporter may petition to be removed from Automatic Detention.

We offer a network of independent ISO17025 accredited testing laboratories and provides the assurance required to meet strict US FDA food regulations. Whether you are an importer, custom broker or retailer, IEH can be your partner protecting your brand, products and assisting you with FDA DWPE specific cases.

To start sampling for FDA DWPE services IEH needs:

  • A copy of the “notice of FDA Action” form (as received from the FDA).

  • A copy of the commercial invoice(s) for the product being detained.

  • The product being detained with packing information.

  • The street address where the product is being held with the hours the lot(s) is/are available for sampling.

  • The name and phone number of a contact to be reached if the sampler cannot gain access to the lot for sampling.

  • Specific analyses being requested.

Contact us and make us your expert partners in ensuring that your business complies with all and any FDA food regulations.