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FDA Showcases Mandatory Recall Powers Under FSMA


by Abhishek Gurnani -

Food-borne illness affects approximately 48 million people each year. Recalling contaminated products can be costly, both to a company’s pocketbook and to its reputation. FDA has shifted the focus of recalls from reaction to prevention with its new power to enforce mandatory recalls under Section 206 of the Food Safety Modernization Act (FSMA). If a company fails to perform a voluntary recall when given the chance, FDA can now legally mandate a recall under its newly established authority. Manufacturers are being held responsible for their own preventive controls, and in the event of a recall situation, have the option to do so voluntarily. If the opportunity for a voluntary recall is forfeited, FDA has legal authority to stop distribution as there is reasonable probability that the food products are adulterated and could cause harm to humans or animals.  Once this action has been taken, an informal hearing may be held to convince FDA that the product(s) should not be recalled. Once the recall decision has been made, FDA bears the burden of ensuring all efforts are focused on identifying the root cause, recalling the product and determining appropriate termination of recalls. Previously, recalls were considered to be voluntary, but under FSMA, FDA has the power to demand a recall, with increasing risk of criminal charges for adulteration and civil liability to consumers.

Kasel Associates Industries Inc. gave FDA its first opportunity to flex its newly instated recall muscle when it discovered salmonella in the company’s finished and unfinished pet treats. In addition, food contact surfaces tested positive for salmonella. This was classified as a class I recall given a reasonable probability that the use of or exposure to products would cause adverse health consequences to humans or animals. Kasel completed its initial recall of contaminated products on Oct. 2, 2012. The company completed another recall of contaminated products on Oct. 17, 2012, following an inspection by Colorado’s Department of Agriculture. On Nov. 19, 2012, a final positive test result for salmonella was discovered. FDA suggested Kasel issue another recall, but it failed to do so. As a result, FDA issued a public health warning regarding the contaminated products. Another inspection was performed at Kasel’s Colorado facility in February 2013, resulting in FDA’s notification to the company regarding the failure to recall additional contaminated products, the extensive salmonella contamination, and poor conditions of surfaces in the plant. FDA subsequently released a public notice announcing Kasel was recalling all products manufactured at its Colorado plant from April 20, 2012, to Sept. 19, 2012, due to possible salmonella contamination.

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