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FDA Issues New Guidance To Give Food Industry A Road Map For The New Rules

- Jan 09, 2018 -

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The US Food and Drug Administration issued guidance to the food industry Thursday detailing how it plans to enforce the FDA Food Safety Modernization Act, which was signed into law during the Obama administration. 

The new guidance is supposed to give the food industry a road map for the new rules, but it also details parts of the act that the agency does not intend to enforce for now, to allow time to "consider changes or other approaches to address concerns."

The FDA itself has come under recent criticism that it takes too long to order companies to remove contaminated food and supplements from store shelves, according to a recent report from the Department of Health and Human Services' inspector general.

Though recalls are almost always voluntary, and it's up to the companies themselves to recall food, the FDA helps monitor the food supply and has the legal tools to aid companies in taking appropriate steps. The FDA also lets the public know about a recall if it is what the agency considers a serious hazard.

Before President Obama signed the Food Safety Modernization Act in 2011, the FDA did not have the authority to issue a mandatory recall. The agency could warn manufacturers or distributors of possible health risks, but ultimately, it was up to food companies to recall tainted products. According to the inspector general, the FDA has used its recall authority only twice.

The inspector general's office said it conducted the new review "to determine whether FDA is fulfilling its responsibility in safeguarding the nation's food supply now that it has mandatory recall authority."

This investigation, which reviewed 30 of 1,557 food recalls between 2012 and 2015, found that the FDA "did not always have an efficient and effective food-recall process that ensured the safety of the nation's food supply."

In these cases, food companies took an average of 57 days to recall items after the FDA learned of the possible health hazards, the report revealed.

In one case, Nutrex Research, a supplement company, did not recall its product until 303 days after receiving a warning letter from the FDA. The company also distributed free samples of the adulterated product for more than eight months after it got the FDA warning letter, according to the inspector general's report.

In a case involving cheese contaminated with listeria, it was 81 days from the date the FDA became aware of the adulterated product to the date Oasis Brands recalled it. At least four people were hospitalized after eating the recalled cheese, and there was one known death reported.

Dr. Scott Gottlieb, the FDA's commissioner, agreed with the findings and said "immediate action" needed to be taken.

"I take these obligations very seriously. Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities -- and how we deploy them -- are a cornerstone of our vital, consumer protection mission." Gottlieb said in a December 26 statement.

In several incidents, like the listeria cheese outbreak, the FDA struggled to evaluate health risks in a timely manner or ensure that companies initiated recalls quickly, according to the report.

Many of the procedural problems presented in the new report were also raised by the inspector general in a preliminary audit published in 2016. The FDA responded by creating a team called Strategic Coordinated Oversight of Recall Execution, or SCORE. It investigates cases that pose a significant health hazard to consumers and expedites the decision-making process.

In the new report, the inspector general's recommendations included that the FDA use its SCORE initiative "to establish set timeframes, expedite decision-making and move recall cases forward and improve electronic recall data."


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