FDA Has Many Efforts to Address Economic Adulteration but Has Missed Opportunities to Communicate and Coordinate

FDA primarily approaches economic adulteration as part of its broader  efforts to detect and prevent adulteration of food and medical products in  general. Such efforts include, for example, the agency’s actions to ensure  the safety of imported products. Agency officials noted that the Federal Food, Drug, and Cosmetic Act  does not distinguish among motives or require motive to be established to  determine whether a product is adulterated. Rather, when the agency detects any form of adulteration  that poses an adverse public health effect, it can conduct an investigation,  request a recall to get the product off the market, and take enforcement  action. A senior FDA official told us there is value in making a distinction  between economic adulteration and other forms of adulteration to guide  the agency’s thinking about how to be more proactive in addressing this  issue. In addition to these broader efforts, some FDA entities have undertaken  efforts specific to economic adulteration. Key Challenges Include Increased Globalization and Lack of Information from Industry

FDA officials and stakeholders told us that responding to increased  globalization and the expanding complexity of the supply chains for both  food and medical products is a key challenge in addressing economic  adulteration. Globalization has led to an increase in the variety,  complexity, and volume of imported food and drugs, which complicates  FDA’s task of ensuring their safety. In addition to globalization, an  increase in supply chain complexity—the growth in the networks of  handlers, suppliers, and middlemen—also complicates FDA’s task. However,  agency officials and industry representatives said industry is often  reluctant to share such information when an adulterated ingredient has  not entered into commerce. Some Stakeholders Cited Greater Oversight and Information Sharing as Options to Address Economic Adulteration

Some stakeholders supported increased oversight by FDA, in particular,  as an option to obtain more information on supply chains—information  that is useful in tracing the source of economic adulteration. For example,  one stakeholder suggested that the use of track-and-trace technology— such as using standard numerical identifiers on prescription drug  packages—could facilitate FDA’s oversight of the supply chain by making  it easier for FDA and industry to trace adulterated ingredients back to the  point of contamination. Many stakeholders also suggested that FDA increase its regulatory and  enforcement actions to address economic adulteration. These  stakeholders said that public health risk should be FDA’s priority in taking  such actions, but many also told us that FDA should pursue those who  adulterate for economic gain, including in instances that may not have a  large negative public health impact. Even with the challenges related to the disclosure of proprietary  information, stakeholders also suggested that greater communication with  industry could enhance FDA efforts to gather information on economic  adulteration. In the view of these stakeholders, this type of  information may help both industry and FDA better target their efforts to  detect and prevent economic adulteration. Some entities have undertaken efforts  that specifically focus on economic adulteration, but they have not always  communicated or coordinated their efforts with other FDA entities. Recommendations for Executive Action

To enhance FDA’s efforts to combat the economic adulteration of food  and medical products, we recommend that the Commissioner of FDA  take the following three actions:    adopt a working definition of economic adulteration,    provide written guidance to agency centers and offices on the means  of addressing economic adulteration, and   enhance communication and coordination of agency efforts on  economic adulteration. HHS neither agreed nor disagreed with our recommendations. Appendix I: Objectives, Scope, and Methodology

This report examines (1) the approaches the Food and Drug  Administration (FDA) uses to detect and prevent economic adulteration of  food and medical products, and (2) the challenges, if any, FDA faces in  detecting and preventing economic adulteration and stakeholder views on  options for FDA to enhance its efforts to address economic adulteration.
Why GAO Did This Study

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..

What GAO Found

FDA primarily approaches economic adulteration as part of its broader efforts to combat adulteration in general, such as efforts to ensure the safety of imported products. Agency officials noted that the Federal Food, Drug, and Cosmetic Act does not distinguish among motives or require motive to be established to determine whether a product is adulterated. However, a senior FDA official told GAO that there is value in making a distinction between economic adulteration and other forms of adulteration to guide the agency's thinking about how to be more proactive in addressing this issue. An FDA official told GAO when the agency detects any form of adulteration that poses an adverse public health effect, it can conduct an investigation, request a recall to get the product off the market, and take enforcement action. In addition to these broader efforts, some FDA entities also have undertaken efforts that specifically focus on economic adulteration. For example, FDA's Office of Regulatory Affairs has contracted with a research center to model risk factors for improved detection of economic adulteration of food. However, FDA entities have not always communicated or coordinated their economic adulteration efforts. For example, FDA's Center for Veterinary Medicine was unaware of and did not participate in two other entities' economic adulteration efforts involving products the veterinary center regulates. FDA officials and stakeholders GAO interviewed cited several key challenges to detecting and preventing economic adulteration, including increased globalization and lack of information from industry. Globalization has led to an increase in the variety, complexity, and volume of imported food and drugs, which complicates FDA's task of ensuring their safety. In addition to globalization, an increase in supply chain complexity--the growth in the networks of handlers, suppliers, and middlemen--also complicates FDA's task, making it difficult to trace an ingredient back to its source. FDA officials and stakeholders also said that gathering information from industry, such as information on potentially adulterated ingredients, presents challenges for FDA in detecting and preventing economic adulteration due to industry's reluctance to share such information because it is proprietary. Stakeholders cited greater oversight and information sharing as options to improve FDA's ability to combat economic adulteration. Specifically, some stakeholders supported increased oversight, such as the use of technology to trace adulterated ingredients back to the point of contamination, as an option to obtain more information on supply chains. Many stakeholders also suggested that FDA increase its regulatory and enforcement actions to address economic adulteration, including in instances that may not have a large negative public health impact. Stakeholders also suggested that greater communication with industry, through such means as an information clearinghouse or more informal interactions, could enhance FDA efforts to gather information on economic adulteration.

What GAO Recommends

GAO recommends that FDA adopt a working definition of economic adulteration, enhance communication and coordination of agency efforts, and provide guidance to agency centers and offices on the means of addressing economic adulteration. HHS neither agreed nor disagreed with GAO's recommendations, but cited planned actions related to adopting a definition and enhancing communication and coordination.