While FDA has not invoked this mandatory recall authority, it has issued several 423(a) letters. In 2013, FDA issued a letter to Kasel Associated Industries, Denver, Colo., because of Salmonella in its pet food products. The company initiated a voluntary recall. Earlier this year, the agency sent a 423(a) letter to USP Labs over its dietary supplement linked to liver toxicity. USP also conducted a voluntary recall.
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If your company is involved in a recall, “your odds of being inspected skyrocket,” Dr. Acheson says. “You then better ensure that all your food safety programs including your environmental monitoring, cleaning, and sanitation practices are in top-notch shape, and you identified the root cause of the recall and eradicated it. Otherwise you risk inspectors citing you for insanitary condition violations—which are on the rise.”
FSMA Section 207 allows for enhanced administrative detention of food, which means FDA can hold adulterated or misbranded food to prevent it from entering the marketplace. The original threshold granted under the BT Act was “credible evidence or information that the food presents a threat” of SAHCODHA. “We never quite met that threshold” to use the authority, Wagner said. Under FSMA, the standard has been expanded to “reason to believe that an article of food is adulterated or misbranded.” FDA has invoked this authority seven times since 2011 for fishery products, dietary supplements, and other foods, she said.
But as industry representatives agree, hewing to the regulations alone is not sufficient. “We know that FSMA will have a positive impact on food safety, but it cannot be viewed as a magic bullet,” Wagner said. “It will take everyone—food processors, manufacturers, suppliers, third-party auditors and labs, and regulators—acting vigilantly and responsibly to assure that no one segment of the food supply chain or firm is enabling or permitting poor performance, resulting in unsafe food making its way into consumers’ homes.”
Agres is based in Laurel, Md. Reach him at firstname.lastname@example.org.