FDA Should Be Empowered to Request Evidence for Structure-Function Claims, GAO Suggests

January 18, 2011

Claiming that FDA is currently hampered in evaluating “potentially false or misleading structure/function claims,” the U.S. Government Accountability Office (GAO) has recommended in a new report that the agency be given the power to request evidence of substantiation from companies.

Claiming that FDA is currently hampered in evaluating “potentially false or misleading structure/function claims,” the U.S. Government Accountability Office (GAO) has recommended in a new report that the agency be given the power to request evidence of substantiation from companies making the claims “to establish whether there is scientific support for the claims.”

The GAO report points out that while the FTC, which is responsible for protecting consumers from false advertising, can require companies to submit relevant evidence, including proprietary market and scientific research, when investigating whether claims are substantiated, FDA currently does not have that legal authority.

“GAO recommends FDA identify and request from Congress authorities to access companies’ evidence for potentially false or misleading structure/function claims on food to establish scientific support, provide guidance to industry on the evidence it needs to support such claims, and provide direction to FDA inspectors to help identify claims for further review,” the GAO report states.

The government watchdog is now awaiting FDA’s response to its recommendation.

Negative View

In general, the GAO report seems to take a negative view on qualified health claims and structure-function claims, calling them “a serous oversight dilemma” for FDA. The report states that consumers are becoming confused by the types of health claims on the market and states that more companies are now using structure-function claims in lieu of FDA-approved health claims.

“Research showed, and stakeholders indicated, that consumers find it difficult to understand the differences between health claims with significant scientific agreement and the lower level of scientific support for qualified health claims. Research also showed that consumers find it difficult to distinguish among the many different types of claims on food labels, including health claims, qualified health claims, and structure/function claims,” the report says.