Dietary supplement industry stakeholders are defending the use of qualified health claims, which came under fire in a Government Accountability Office report on shortcomings in FDA's food labeling enforcement.

In the report released in September, GAO lays out criticisms of QHCs for conventional foods by medical, health and consumer associations, saying "consumers cannot distinguish among" the levels of scientific evidence FDA uses to support health claims.

The American Medical Association and other groups recommend eliminating QHCs, but in comments submitted for GAO's report, FDA said it is unsure whether it has the authority to eliminate the use of such claims.

The Center for Science in the Public Interest Oct. 10 says the GAO report should compel more food labeling enforcement by FDA.

CSPI Director of Legal Affairs Bruce Silverglade said the report proves "FDA is looking the other way while consumers are being misled" by packaging that links foods to dubious health benefits.

However, QHCs provide useful information for consumers and are appropriate marketing tools for food and supplement firms, according to stakeholders.

Dan Fabricant, VP of scientific affairs for the Natural Products Association, noted QHCs are "important for bridging the gap between" structure/function claims and unqualified health claims.

Further, with additional research, QHCs could become full health claims, Fabricant said.

Council for Responsible Nutrition VP of Scientific and Regulatory Affairs Andrew Shao said QHCs provide firms with incentive to invest in nutrient studies.

Eliminating QHCs removes that incentive, Shao added. "That, in turn, does a disservice to consumers who rely on this kind of information to make informed decisions."

The use of QHCs was sanctioned in the 1999 federal court decision in Pearson v. Shalala, which struck down a regulatory prohibition on "potentially misleading" health claims - as opposed to "inherently misleading" claims.

Silverglade sees the opinion, however, as giving FDA latitude to refuse to authorize QHCs if data show them to be misleading. Recent consumer surveys have shown confusion resulting from QHCs, he said.

In 2005, FDA conducted a consumer survey on four dietary supplement/disease claims, using letter-grade disclaimers to denote the degree of scientific certainty linked to a claim.

An FDA report on the survey concluded that "none of the different ways tested to communicate the strength of science supporting a food label health claim performed very satisfactorily."

The Consumer Healthcare Products Association questions whether such graphics are appropriate given consumers' personal biases (¹ Also see "Qualified Health Claim Study Should Test Letter Grades, SSA Claims – CHPA" - Pink Sheet, 10 July, 2006., p. 11).

Fabricant said the 2005 survey, in fact, demonstrated consumers could differentiate between QHCs, structure/function claims and unqualified health claims, though "not in the same way a scientist would understand."

CSPI joined several other consumer and public health groups in March in requesting that FDA cease use of appropriated funds for researching QHCs that fall short of reaching the significant scientific agreement standard (² Also see "Consumer Groups Add Pressure To Stop QHCs Program For Conventional Foods" - Pink Sheet, 7 April, 2008., p. 5).

Congressional appropriators instituted a temporary freeze on FDA's review of QHC requests for conventional foods before requesting GAO's investigation in January (³ Also see "Congress Urges FDA To Stop Conventional Food QHCs Pending GAO Evaluation" - Pink Sheet, 7 January, 2008., p. 9).

Members of Congress reminded FDA of the freeze in March, after the agency had continued reviewing QHCs, and suggested that food QHC staff be reassigned to review misleading food packaging statements (⁴ Also see "Capitol Hill Has No Appetite For FDA Continuing Food QHC Reviews" - Pink Sheet, 24 March, 2008., p. 13).

- Dan Schiff (d.schiff@elsevier.com)

Trade Groups Defend Qualified Health Claims Following Critical GAO Report

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