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Thursday, May 13, 2010

The FDA’s Authority to Recall Products

Vanessa K. Burrows
Legislative Attorney

The Food and Drug Administration (FDA) has fielded increasing numbers of questions regarding recalls of unsafe imports, including jalapeño peppers, pet food, the blood thinner heparin, and toothpaste. Additionally, several domestic drug and food products—such as over-the-counter children's medications, adult pain relief and allergy drugs, spinach, chili, and peanut products— have been voluntarily recalled by businesses in the last few years. Recalls may decrease consumer confidence in the recalling company, food imports, or product safety agencies such as the FDA. The products later subject to a recall may have sickened or killed people or pets. The FDA has the authority to order recalls of four types of products: infant formula, medical devices, human tissue products, and tobacco products. The agency may request that a company voluntarily recall other FDA-regulated products, such as food, drugs, and cosmetics. 

Congress has demonstrated a significant interest in the issue of food safety, holding several hearings and introducing many pieces of legislation. The 110th Congress passed P.L. 110-85, the FDA Amendments Act of 2007 (FDAAA), which contained provisions addressing communications and information postings during a food recall. Among other items, FDAAA directed the FDA to establish an electronic registry through which companies are required to report food for which there is a reasonable probability that the use of, or exposure to, such article of food would cause serious adverse health consequences or death to humans or animals. 

The 111th Congress passed the Family Smoking Prevention and Tobacco Control Act, P.L. 111-31, which provided authority for the Secretary of the Department of Health and Human Services, acting through the FDA, to order a recall of tobacco products if there is a reasonable probability that the tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death. 

Additionally, the 111th Congress has introduced several bills that would grant the FDA the ability to order recalls of food and other products, including H.R. 841, the Protect Consumers Act of 2009; H.R. 875, Food Safety Modernization Act of 2009; H.R. 999, Keeping America's Food Safe Act of 2009; H.R. 2726, Counterfeit Drug Enforcement Act of 2009; H.R. 2749, Food Safety Enhancement Act of 2009; and S. 510, FDA Food Safety Modernization Act. H.R. 2749 is a revised version of H.R. 759, the Food and Drug Administration Globalization Act of 2009. 

In July 2009, the House passed H.R. 2749, a comprehensive food safety measure that would provide the FDA with authority to require recalls of food products after issuing an order to immediately cease distribution of a food (either after an opportunity for an informal hearing or on an emergency basis if there is credible evidence that a food presents an imminent threat of serious adverse health consequences or death), require facility food safety plans to describe their procedures for recalling articles of food, and enable the FDA to assess and collect fees from entities for the fiscal year in which the entity is subject to a food recall. S. 510 would similarly enable the FDA to order a recall of a food product and would require the FDA to assess and collect fees to cover food recall activities associated with a recall order. It has been reported by the Senate Committee on Health, Education, Labor, and Pensions and is expected to see floor action this year. 

This report provides an overview of the FDA's statutory authority with regard to the products that the agency 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.

Date of Report: May 6, 2010
Number of Pages:18
Order Number:RL34167
Price: $29.95

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