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FDA Forces Recall

The Food Safety Modernization Act (FSMA) enacted in 2011 empowered the FDA to order mandatory recalls of food products determined to be potentially harmful to humans or pets due to adulteration such as pathogen contamination, or presence of allergens not indicated on the label. Before implementation of FSMA, the FDA could strongly suggest that a company issue a voluntary recall but did not have the authority to order a product to be pulled from shelves. Since FSMA, twice the FDA has begun the process of ordering a recall, but the company involved issued a voluntary recall before being mandated. On April 3, for the first time, the FDA issued a mandatory recall of a group of products containing the nutritional ingredient Kratom, due to Salmonella contamination. In this case, the FDA did attempt to convince the offending firm to issue the voluntary action, but when the company did not respond the FDA took this unprecedented action. Although the products were manufactured primarily as dietary supplements the FDA regulated them as food products, which is common for supplement products and ingredients. Note that if the product was classified as a drug product, the FDA would not have the authority to order a recall as the power is granted for food products only through FSMA.

FSMA Evolution

This is another milestone on the journey of FSMA implementation that the food industry has been on since 2011. As with any regulation, what is put on paper is not always verbatim how the law is enforced due to factors such as budget, resources, burden on manufacturers, and priorities. We now know the FDA will not hesitate to utilize the recall authority in cases where the manufacturer or distributor is uncooperative or doesn’t act expeditiously and decisively. While this should not concern firms that are exercising due diligence in their food safety activities, organizations that cut corners and do not execute a compliant preventive control program have been put on notice that the FDA will, if deemed necessary, enforce the strictest punitive action available to protect the public health.

Link to the FDA Announcement here.

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