FDA Issues New Guidance to Food Industry Amid Recall Criticism

Jan. 9, 2018
The agency issues FSMA guidance to the food industry about what it will and will not enforce in an Obama-era food safety law.

Reports this week say the FDA has issued guidance to the food industry, detailing how it plans to enforce the Food Safety Modernization Act (FSMA), which was signed into law during the Obama administration.

The agency characterizes the act, which is intended to make sweeping changes to the safety of nation's food supply, as "the biggest overhaul in our nation's food safety laws in more than 70 years," shifting the system "from being reactive to preventive.

The FSMA is designed to be preventative rather than reactive, according to FDA commissioner Scott Gottlieb. "We recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated," the agency said in a statement. It mentions getting feedback from the food industry and farmers, suggesting there were challenges following some of the rules.

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 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 fire recently about taking 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 FSMA 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 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 a reported 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.

"Our review found that FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls," said report author George Nedder, an auditor with the Office of the Inspector General. "This means that dangerous food products may have remained in our nation's food supply for weeks after FDA was aware of the contamination."

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