Formula recall rules
This article was originally published in The Tan Sheet
Executive Summary
Infant formula recall requirements have been approved by the Office of Management & Budget, FDA announces in the Aug. 23 Federal Register. The agency requested OMB's approval on several information collection requirements, including reporting health risks to FDA district offices within 24 hours; submitting written reports to the agency; and keeping distribution records for at least one year after the formula's expiration date "to facilitate location of the product being recalled." Based on the past three years, FDA estimates that there will be two recalls per year that would carry a cost of $237,711 to the federal government per recall. The estimated compliance cost for manufacturers is $631,003 per year, according to FDA. The agency solicited comments on the requirements in February, but received none (1"The Tan Sheet" Feb. 7, 2005, In Brief)...