Government Failure: Audit Finds FDA's Inadequate Policies Are Leaving The Nation At Risk

If it is ever discovered that tainted food has been released to the public for consumption, it is the Food and Drug Administration's (FDA) responsibility to ensure a recall of the product takes place.

In a very disturbing audit finding Wednesday, the Department of Health and Human Services' Office of Inspector General has determined that due to inadequate policies and procedures, the FDA is too slow in ordering companies to recall tainted foods.

Here are some comments from the memo sent to the FDA from the Inspector General regarding the audit findings.

The audit memo opens by stating that the FDA doesn't have an efficient and effective food recall process to ensure the safety of the Nation's food supply.

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.

 

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 firms1 or responsible parties2 (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.

Two examples from the findings were specifically called out, with one case being a strain of Salmonella found in nut butter in which 165 days passed before a recall was issued. Another example involved various cheese products in which people became ill from Listeria - 81 days passed before a recall was issued. In that instance, one infant even died.

For all 30 voluntary recalls in our sample, after FDA first became aware that an adulterated or misbranded product could be in the food supply chain, it did not prescribe a timeline for each firm to initiate a recall. For two recalls, the firms did not initiate the recall of all potentially harmful products until 165 days and 81 days after FDA became aware of the potential contaminations. The delays in the firms’ recalls may have occurred because FDA did not have policies and procedures that instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls. As a result, consumers remained at risk of illness or death for several weeks after FDA knew of potentially hazardous food.

 

For example: 

 

  • In a recall involving nut butter at least 14 people became ill with a strain of Salmonella indistinguishable from or linked to the strain found at the firm’s manufacturing facility. 165 days passed from the date FDA identified the potentially adulterated product and the date the firm initiated a voluntary food recall. See Attachment A for a timeline of events for this recall.
  • In a series of recalls involving various cheese products, at least nine people became ill from Listeria monocytogenes, including one infant who died. According to FDA records, the Centers for Disease Control and Prevention (CDC) also linked two fetal losses to these illnesses. 81 days passed from the date FDA became aware of the adulterated product and the date the firm had voluntarily recalled all affected products. See Attachment B for a timeline of events for this recall.

And in conclusion, the memo reiterates its finding that there are inadequate policies in place to take prompt actions in order to initiate a recall, and that consumers remained at risk because of that.

FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls. As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.

 

We suggest that FDA revise its policies and procedures to instruct recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.

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In summary, everyone should feel good about the precision in which the government runs its programs, especially as it relates to the health and safety of an entire nation.

Here is Attachment A, which walks through the timeline for the Salmonella finding.

And attachment B, which walks through the timeline of the Listeria finding.