Congress Tells FDA to Tighten Standards for Health Claims


WASHINGTON—The just-passed omnibus spending bill urges the Food and Drug Administration (FDA) not to permit so-called “qualified health claims” for foods until a Government Accountability Office report on the controversial program is completed. The step, first approved by the House of Representatives last August, has prompted the FDA to announce today that it is commencing a scientific review of several health claims previously permitted by the agency. The nonprofit Center for Science in the Public Interest welcomed the move.

Qualified health claims are often based on tenuous scientific evidence and are informally reviewed, but not officially approved by the FDA. They have triggered numerous misleading labels and advertisements ranging from claims about green tea and cancer to statements that adding almonds to desserts can reduce the risk of heart disease.

The FDA, since 1993, mandated that health claims be based on “significant scientific agreement” and required companies to obtain formal approval. However, under pressure from the Bush Administration and the food industry, the FDA reversed course in 2003 and began allowing food companies to make claims based on much weaker evidence.

The report for the 2008 appropriations bill criticized the FDA for devoting “literally thousands of hours of staff work to this undertaking at a time when the agency’s ability to carry out its public health responsibilities are severely stretched.”

“We look forward to working with the FDA for a moratorium on new qualified health claims and an orderly shut down of the program after the GAO investigation is complete,” said CSPI legal affairs director Bruce Silverglade.

“The FDA’s own consumer research shows that qualified health claims mislead consumers,” said CSPI senior attorney Ilene Ringel Heller. “It’s time that the FDA terminate what is no more than a food industry marketing gimmick and restore the integrity of the food label.”

The measure was championed by Congressman Henry Waxman (D-CA), chairman of the House Government Reform Committee. A coalition of medical, health, and consumer groups including the American Heart Association, the American Cancer Society, AARP, the American Dietetic Association, the Association of American Medical Colleges, the American Public Health Association, the Society for Nutrition Education, the American College of Preventive Medicine, Consumers Union, and the Alliance for Retired Americans urged Congress to take action.