Opinion

So, why not use the authority granted under the FSMA and use the FDA’s mandatory recall authority?

According to the FDA, before the FSMA (Food Safety Modernization Act) was enacted, the FDA relied on responsible parties to voluntarily recall violative food products — except infant formula recalls which are described under section 412 of the FD&C Act – Food, Drug and Cosmetic Act.

The FDA continues to rely on responsible parties to voluntarily recall violative food products; however, FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary
Continue Reading Publisher’s Platform: Hey FDA, Listeria can cause SAHCODHA ( Serious Adverse Health Consequences or Death to Humans or Animals)

Timely and efficient food recalls would cut down on foodborne illnesses, but the U.S. Food and Drug Administration has yet to figure out to do it.

That’s the bottom line of another report on FDA food recalls by the Office of the Inspector General for the federal Health and Human Services Department. The OIG put out an “early alert” on the work last June.

Titled “FDA’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply,” the latest OIG report was an audit of the documentation “for 30 voluntary food recalls judgmentally selected from the 1,557 food
Continue Reading FDA chasing after voluntary recalls, but doesn’t often take mandatory route

Until the passing of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration did not have the authority to mandate a food recall. Food recalls were done by food companies on a voluntary basis – sometimes at the suggestion of FDA, but not through mandatory action. Since gaining the power to mandate recalls, FDA has only used it once: Last year’s recall of Salmonella-tainted pet treats produced by Kasel Associates Industries, Inc. The FDA summarized the rationale behind the enforcement in a new report submitted to Congress, as required by law under FSMA. That recall occurred in
Continue Reading FDA Reports Only One Use of Mandatory Recall Authority To Date