The GAO report examined the FDA’s response to economically motivated adulteration of both food and medical products, referring specifically to the melamine-tainted milk scandal of 2007-2008 and the contamination of the blood thinner heparin, also in 2008. Its review was carried out at the request of Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), and John Dingell (D-MI).
FDA officials and stakeholders interviewed for the report noted several key challenges for detecting and preventing economically motivated adulteration, according to the GAO, including increased globalization, which has led to a complex food supply chain – as well as difficulties in gathering information from manufacturers.
Although companies are obliged to report potential contamination of food that is already for sale, via the Reportable Food Registry, industry is often reluctant to share information if an adulterated ingredient has not entered into commerce, the report said.
“They [FDA officials] said that a wrongful accusation can have serious consequences, such as compromising the integrity of the company’s brands and products if certain information became public,” the GAO said.
It added that officials had said that more precise testing methods were needed for detecting adulterants.
“Industry may be the best source of tests to detect adulteration because companies develop such tests to monitor the products they receive from their suppliers; however, industry officials indicated that they are often reluctant to share such information because it is proprietary,” the report said.
In order for the agency to deal more effectively with adulteration, the GAO said the FDA should establish more opportunities for informal communication with industry, and adopt a definition of economic adulteration.
The report concluded: “Senior FDA officials, including the Commissioner, have often spoken publicly about the threat posed by economic adulteration. However, FDA does not have a definition of economic adulteration. Without such a definition, when FDA detects adulteration, it is more difficult for the agency to make a distinction between economic adulteration and other forms of adulteration to guide the agency’s thinking about how to be more proactive about this issue.
“…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. Without such communication and coordination, in these times of economic uncertainty, FDA may not be making the best use of its scarce resources.”