On July 24, 2016, Kraft Heinz Co. announced its issuance of a recall of Taco Bell cheese sauce, indicating that the products present a botulism risk. The recall notice, found here, indicates that this a voluntary recall, which is undertaken by the company responsible for the affected products without order by the government.
Although the Food Safety Modernization Act (FSMA provides the U.S. Food & Drug Administration (FDA) with the authority to issue mandatory recalls for unsafe food products, most companies issue voluntarily recalls when a mislabeling or adulteration issue arises. One reason that we continue to see voluntary recalls is that the FDA must undertake certain procedures before ordering a mandatory recall.
In order to issue a mandatory recall, the FDA must first determine that the criteria for mandatory recall has been met. Criteria for a mandatory recall may be that the food is adulterated under Section 402 of the Federal Food Drug & Cosmetic Act (FDCA). Adulteration occurs when the food (including dietary supplements) contains poisonous or deleterious substances or a substance that is otherwise unfit for food. A food may be misbranded under the FDCA when the product labeling does not meet federally mandated requirements. For mandatory recall authority, misbranding under Section 403(w) of the FDCA would be where required major allergens are not displayed in product labeling, thus creating risk to consumers who rely on allergen warnings when making food choices.
Once mandatory recall authority has been established, the FDA must then give the company an opportunity to issue a voluntary recall. If the company still does not undertake a voluntary recall, despite FDA correspondence indicating that the criteria for recall has been met, then FDA can issue a mandatory recall. Because FDA must follow this protocol, it is unlikely that FDA’s exercise of mandatory recall authority will ever become the rule rather than the exception.
If you have any questions about FDA regulation or how you can establish and maintain compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.