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.

After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing any food products. A copy of the suspension order may be accessed here. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), any facility that manufactures, processes, packs or holds food for consumption in the United States must maintain an active registration with the FDA. The suspension of Sunland’s Registration came under the authority of § 102(b) of the recently-adopted Food Safety Modernization Act (“FSMA”). Under this provision, the FDA has authority to suspend the registration of a facility where:

the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals . . . .

Interestingly, under this provision the FDA may suspend the registration of a facility that: (1) created, caused, or is responsible for the public health issue, or (2) the packer or holder of such food, where this party either knows or has reason to know of such issue. In the present circumstances, because Sunland is the party responsible for processing these peanut butter products, the FDA’s suspension order alleged that the Company was responsible created the probability of adverse health consequences.

This suspension marks the first use of this new enforcement mechanism, which was granted to the Agency under the FSMA. Signed into law on January 4, 2011, the FSMA is frequently cited for expanding the FDA’s powers to proactively handle potential food-related outbreaks. However, with the Agency struggling to develop its regulations under the FSMA, industry has yet to observe much of this new authority in action. Thus, the suspension marks the beginning in what we may see as several “firsts” with respect to the Agency’s new enforcement capabilities.

For more information about maintaining compliance with the FSMA or FDA regulations pertaining to foods generally, feel free to contact us at contact@sglawfl.com.