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The FDA’s Authority to Recall Products

Over the past few months, the Food and Drug Administration (FDA) has fielded increasing numbers of questions regarding recalls of unsafe food imports, including pet food and toothpaste. Additionally, several domestic food products, from peanut butter contaminated with Salmonella to spinach linked to E. coli 0157:H7 to canned meat products such as chili sauce spoiled by Clostridium botulinum (botulism), have been voluntarily recalled by businesses in the last year. Recalls may decrease consumer confidence in the recalling company, food imports, or food safety agencies such as the FDA; products later subject to a recall may have sickened or killed people or pets. While the FDA only has the authority to order recalls of infant formula, medical devices, and human tissue products, the agency may request that a company recall other products, such as food, drugs, and cosmetics. This report provides an overview of the FDA's statutory authority with regard to the three types of products that it can recall, as well as FDA regulations for designating the particular class of recall, publicizing and monitoring the effectiveness of recalls, and carrying out recalls. Additionally, this report reviews the recall provisions in legislation proposed in the 110th Congress, which would give the FDA authority to require recalls of additional products. The 110th Congress has shown significant interest in the issue of food safety and several bills would grant the FDA the ability to order recalls of food products. The Senate approved, by a vote of 94-0, Senator Durbin's amendment to the FDA Revitalization Act (S. 1082), which would provide the FDA with greater recall and notification authority. The Family Smoking Prevention and Tobacco Control Act, S. 625/H.R. 1108, would provide the Secretary of Health and Human Services (HHS) with the authority to require recalls of tobacco products, while Representative Dingell's draft bill — posted for comment on the House Energy and Commerce Committee website — would grant the Secretary the authority to require food recalls. Other bills that would provide the FDA with recall authority include the Human and