Baby Formula Recall Raises Questions About Who Regulates Our Food

If you follow any media outlets, you have probably seen the baby formula shortage over the past few months. Mothers rushing to find the last canister at the grocery store or pharmacy, health care professionals advising how to stretch or supplement the formula available, and military deliveries arriving in Indianapolis from Germany, all to aid the shortage. The Food and Drug Administration (“FDA”) recalled Similac, Alimentum, and Elecare February 17, 2022, which exacerbated rippling COVID-19 supply chain issues causing the shortage. Abbott brands of baby formula has been one of one-hundred and forty-five FDA recalls so far in 2022. Amid all of the discussion and media attention around food and product recalls, the United States has a regulatory scheme that is designed to protect consumers.

The distinction between the FDA and the United States Department of Agriculture (“USDA”) is more difficult to discern than one might initially think. The FDA regulates dietary supplements, bottled water, food additives, infant formula, food products, livestock feed, pet foods, cosmetics, medicine, and even electronics that give off radiation like microwave ovens. The USDA oversees meat, poultry, and egg products. The differences seem fairly clear, when in reality they are not. The FDA regulates most seafood except catfish. The FDA regulates whole eggs in the shell, but the USDA regulates out-of-shell products like egg whites and powdered eggs. The real kickers are sandwiches—the FDA regulates sandwiches with two slices of bread, but the USDA regulates open-faced sandwiches where more than 50% of the contents are regulated by the USDA. With different agencies promulgating different laws, what laws are in place to limit illnesses contracted from products regulated by the FDA?

There are 31 pathogens known to cause food borne illnesses. In an attempt to limit these pathogens’ effects on the food supply chain, the Food Safety Modernization Act (“FSMA”) was enacted in 2011. FSMA modified the Federal Food Drug and Cosmetic Act. FSMA was designed to take a proactive approach to regulating and enforcing food safety. FSMA includes food safety plans, preventative controls like minimum safety standards for manufacturing, processing, packing, and holding of human food, employee training, safety compliance for produce producers, and inspections.

How does this Act affect you? If you are a U.S. food consumer (assumedly everyone reading this article is), you should have some peace of mind knowing that the statutes the legislature has enacted are promulgated at various levels throughout the food production supply chain. While there have been numerous recalls in 2022, the FDA claims that this is the system at work, and understands that “foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.” If you are a dairy or meat producer, you have likely seen the impacts of FSMA either on your own farm or down the supply chain. For produce producers, the FDA increased minimum safety standards in 2020 for even some of the smaller growers, requiring compliance for the growing, harvesting, packing and holding of fruits and vegetables.

The FDA website is a helpful platform to find the latest products that have been recalled and other resources to explain food safety protocols. While the challenges of food safety may seem insurmountable, the FDA and USDA regulate many of the products we use every day, giving the US consumer some assurance as they purchase goods.

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By Emma Wischmeier, Law Clerk for Janzen Schroeder Ag Law, June 9, 2022