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..
Recommendations for Executive Action
|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.|
|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.|
|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.|