FDA Releases Guidance on Implementation of FSMA Fee Provisions

The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and importers.

Persons responsible for facilities subject to the fees should review the guidance and note that although the FDA began assessing fees for reinspection of domestic and foreign facilities and for failure to comply with a recall order on October 1, 2011, the fees for import reinspection will not be assessed until the FDA has resolved the issues raised in comments on the fee schedule released in the August 1, 2011 Federal Register.