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Highlights

In recent years, the United States experienced public health crises suspected to have been caused by the deliberate substitution or addition of harmful ingredients in food and drugs--specifically melamine in pet food and oversulfated chondroitin sulfate in the blood thinner heparin. These ingredients were evidently added to increase the apparent value of these products or reduce their production costs, an activity GAO refers to as economic adulteration. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has responsibility for protecting public health by ensuring the safety of a wide range of products that are vulnerable to economic adulteration. This report examines (1) the approaches that FDA uses to detect and prevent economic adulteration of food and medical products and (2) the challenges FDA faces in detecting and preventing economic adulteration and views of stakeholders on options for FDA to enhance its efforts to address economic adulteration. GAO reviewed FDA documents and interviewed FDA officials and stakeholders from academia and industry, among others..

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. To enhance FDA's efforts to combat the economic adulteration of food and medical products, the Commissioner of FDA should adopt a working definition of economic adulteration.
Closed - Implemented
FDA is using the working definition of economically motivated adulteration that was developed for use at its May 2009 public meeting as a framework for communications on the topic across the agency, as well as with external stakeholders. Specifically, it is using the definition in FDA's Workgroup on Economically Motivated Adulteration, which meets regularly, as well as in recent presentations to external groups.
Food and Drug Administration 2. To enhance FDA's efforts to combat the economic adulteration of food and medical products, the Commissioner of FDA should provide written guidance to agency centers and offices on the means of addressing economic adulteration.
Closed - Not Implemented
FDA has not taken any action on this recommendation in at least a year. Therefore, we are closing this recommendation as not implemented.
Food and Drug Administration 3. To enhance FDA's efforts to combat the economic adulteration of food and medical products, the Commissioner of FDA should enhance communication and coordination of agency efforts on economic adulteration.
Closed - Implemented
FDA formed an agency work group on economically motivated adulteration that includes every FDA product center. The meetings include opportunities for sharing and discussing information of mutual interest. In addition, the work group has established a subgroup on internal communications. The agency has also taken actions to improve communication of the agency's economic adulteration with officials from USDA, members of academia, and industry groups.

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