The US Food & Drug Administration recently issued CSMS# 13-000181, providing guidance for importers of products subject to detention without physical examination (DWPE). In the case of such detention, FDA accepts private laboratory analysis reports in support of an importer’s case to address any alleged violation. Although the agency accepts both paper and electronic versions of these reports, it prefers that the analysis be submitted in an electronic format for faster review and processing by FDA.
Unfortunately, importers cannot submit the lab reports via ITACS, FDA’s current system that allows electronic submission of other documents related to import entry (and it’s not clear when, if ever, that will be the case). Instead, the agency requires that importers make any such electronic submissions in accordance with the rules of the specific FDA District having jurisdiction, which may, for example, have a special email account established for this purpose.