The FDA Import Refusal Report: Many Ways In, No Way Out?
FDA re-posted its Import Refusal Report on its website, as we reported in March. For each refused-entry, FDA gives the manufacturer’s name and address, the importer’s product description, and FDA’s rationale for the refusal, along with other information. FDA, like everyone, occasionally makes mistakes and wrongly refuses some entries. Thankfully, when confronted by the right arguments, FDA will rescind a refusal upon demonstrating that it made a clear and unmistakable error.
However, even if FDA rescinds the refusal, the FDA refusal website page continues to post the entry as refused. Furthermore, the website does not specify that FDA rescinded the refusal, nor does the data-entry system allow FDA to remove a single posting. The only resolution available is an FDA letter on official letterhead specifying that FDA rescinded the refusal. Often the FDA Release Notice will not suffice because that FDA Notice will still reflect the fact that the shipment was refused.
What You Don’t Know Can Hurt You
Sometimes non-U.S. government agencies or importers review the FDA Import Refusal Report during their own background checks, research and company evaluations. An importer may hesitate to purchase from the manufacturer without additional assurances. Additionally, a government agency may engage in enforcement activities as a result of an import refusal report. If FDA rescinded the refusal, however, the manufacturer can alleviate these problems by supplying any interested parties with FDA’s rescind-refusal letter.
The first problem for the manufacturer is simply learning about the FDA refusal or even the initial FDA detention. FDA engages the Importer of Record (and not the manufacturer) during the entry review process leaving the manufacturer out of the loop. The manufacturer might never learn about the detention because the Importer of Record never tells them about it. The manufacturer might not learn about the refusal until it is too late – rescinding a FDA refusal must happen within the first 90 days to avoid the FDA refused shipment being destroyed or exported. This inability-to-know problem is exacerbated when a manufacturer sells to a foreign exporter, which then sells to a U.S. importer.
Manufacturers should specify in their contracts with the U.S. importer that they must notify the manufacturer when FDA inspects, detains, and/or refuses an entry. Manufacturers should obtain a similar notice requirement when selling to a foreign exporter for U.S. distribution.
Requiring the Importer of Record to notify the manufacturer allows the manufacturer to remain up-to-date about the products it exports and its online presence on www.FDA.gov. If FDA detains a product, the manufacturer can work with the Importer of Record to seek an FDA release. If refused, the manufacturer can work with the Importer of Record to seek a rescission of the refusal within the first, critical 90 days. Also, requiring notice prevents the manufacturer from being blindsided if a government agency or an importer one day asks about a refused entry.