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Keywords

food recall, Food and Drug Administration, FDA, FDA Form 483, administrative detention order, injunction, food supply, 2024 Boar’s Head deli meat recall, 2022 Abbott Nutrition infant formula recall, infant formula, deli meat, food inspection

Document Type

Article

Abstract

Food recalls in the United States often reveal serious mismanagement and structural issues in both government and private industry, yet they have become unremarkable and even expected in our modern world. The procedure employed by the U.S. Food and Drug Administration (“FDA”) to monitor food manufacturing is a valuable process which protects every person who lives in the United States. However, the effects of monitoring as a tool for oversight is limited if there is no efficient response when problems arise. FDA inspects pharmaceutical, cosmetic, and food manufacturing facilities both domestically and abroad. When those inspections reveal the presence of contaminants, poor hygiene practices, or problematic record keeping, FDA is empowered to use certain tools to encourage the manufacturer to get back in compliance, including filing and publishing an FDA Form 483, sending warning letters, and requesting voluntary recalls. In certain circumstances, FDA is also empowered to force the manufacturer to change their behavior by forcing a recall, issuing an administrative detention order, or seeking an injunction—although FDA has used these methods sparingly. In order to ensure the safety of the American food supply, FDA must use its current powers with more speed and rigor. FDA and Congress should also consider some new solutions that could allow the agency to respond more effectively when contamination is identified and correct or prevent shortages that might occur when critical foods must be removed from the market. In order to illustrate the need for such policy changes, it will be useful to examine two recent crises: the 2024 Boar’s Head deli meat recall and the 2022 Abbott Nutrition infant formula recall and resulting shortage. Unlike deli meat, infant formula is in a category described by FDA as “critical foods,” which are medical foods provided to patients with certain diseases as a part of disease management. Viewing FDA inspections through the lens of these recent recalls will provide a framework for suggested policy changes.

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