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FDA Reports Only One Use of Mandatory Recall Authority To Date

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 February 2013, several months after Kasel had voluntarily recalled a number of pet treat products.

It all started with FDA investigators conducting an inspection of Kasel’s Denver-based production facility in September 2012, where they collected dozens of samples from products and the environment of the facility itself.

Of those, all the pet treat samples and more than half of the environmental samples tested positive for Salmonella. In fact, investigators found more than 10 different species of Salmonella, suggesting multiple sources of contamination. Inspectors also found Kasel’s facility in a general state of uncleanliness, including pests.

The FDA did not connect any human illnesses to the contaminated pet treats, but did receive some reports of dogs who allegedly fell ill after eating the company’s products.

As a result, the company voluntarily recalled a select variety of products made at the facility between April 20 and Sept. 19, 2012. Kasel did not, however, recall all products made during that time, and the company failed to recall one of the products with a sample that had tested positive for Salmonella.

On a follow-up inspection, FDA found the company had taken some corrective actions to prevent contamination, but had still not recalled all products made between April 20 and Sept. 19, 2012, as the FDA had recommended.

The FDA gave Kasel two days to comply with their requests to recall all products, threatening to enact a mandatory recall within two days if necessary. The company complied.

The remaining products were recalled from a number of retailers, including Target, Petco, Sam’s Club and Costco. The full report details the complete list of recalled products.

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