The U.S. Food and Drug Administration is not being strict enough in requiring companies to recall products that are potentially contaminated. That troubling statement was made last week by the office that acts as a watchdog for the FDA -- the Department of Health and Human Services' Office of Inspector General -- in a letter known as an "early alert."
Lack of Designated Timelines for Recalls
The main problems outlined by the OIG are the lack of timelines that companies must meet for voluntary product recalls and the lack of procedures in place for the FDA to instruct companies how to initiate the recalls. These are putting consumers "at risk of illness and death," according to the letter, which was directed to the FDA commissioner.
By not having designated timelines for voluntary recalls and not initiating mandatory recalls, contaminated food can remain on shelves for as long as months. The letter noted one instance in which potentially-contaminated products weren't recalled for 165 days after the FDA had learned about the problem.
This early alert is particularly disturbing because it comes just a month after the FDA finalized the implementation of the 2011 Food Safety Modernization Act. This was intended to strengthen agency procedures in order to reduce food-borne illness outbreaks.
Congress and FDA React to the Early Alert
Both Democratic and Republican members of Congress called on the FDA to heed the OIG's recommendations. Connecticut's Rep. Rosa DeLauro urged the FDA to issue more mandatory recalls. She noted, "This report demonstrates that the FDA's action or inaction can have life-threatening consequences for American families."
FDA officials responded by trying to assure consumers that "the FDA is totally committed to its public health mission of ensuring the safety of the food supply." They admitted that the instances of lack of action for months were "unacceptable." However, they countered that timelines for companies should be set "on an individual basis rather than by setting arbitrary deadlines."
It remains to be seen if this early alert prompts more oversight by lawmakers and those within HHS who are charged with overseeing the FDA. In the meantime, one of the best incentives for companies to prevent contamination and to remove products from the market quickly is the threat of costly litigation -- often coupled with bad press. When victims of contaminated food products take legal action, they aren't just seeking compensation for their personal damages. They are helping to hold companies accountable for the safety of the food they produce and sell.
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