Is the FDA Too Slow in Recalling Dangerous Products? You bet it is…

Abstract

FDA Is Too Slow in Recalling Dangerous Products, Report Finds, Time, 09 June, 2016.

” The purpose of this memorandum is to alert you to a preliminary finding from our ongoing audit of the Food and Drug Administration (FDA) food recall program. One of the objectives of our audit is to determine whether FDA has an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.

Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process, Department of Health and Human Services, Office of Inspector General, June 8, 2016.

We found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties (collectively referred to in this document as “firms”) initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA’s immediate attention.

We suggest that FDA update its policies and procedures to instruct its recall staff to establish set time frames for

1. FDA to request that firms voluntarily recall their products
2. and firms to initiate voluntary food recalls.

Our audit is a followup of our June 2011 report, Review of the Food and Drug Administration’s Monitoring of Imported Food Recalls. In that audit, we found FDA’s food recall program was inadequate because FDA did not have the authority to require firms to recall certain foods and FDA did not always follow its own procedures. To help ensure the safety of the Nation’s food supply, we recommended that FDA consider our findings when implementing the FDA Food Safety Modernization Act (FSMA) and follow its own procedures for monitoring recalls. FDA agreed with our recommendations. “

For the record, despite what many tend to believe, the FDA never really banned DES : in 1971, the FDA issued a contraindication to the use of DES in pregnancy and required a warning in its labeling… not the same thing…