Major public health and consumer groups are urging FDA to stop evaluating qualified health claims for conventional foods and "reallocate the funds used to review" the claims to enforcement efforts.

Specifically, 11 groups request FDA rescind its QHC policy for conventional foods "unless the petition is based on the 'significant scientific agreement' standard set forth" in the Food, Drug and Cosmetic Act, says a March 27 letter addressed to FDA Commissioner Andrew von Eschenbach.

The signatories - including the Center for Science in the Public Interest, the National Consumers League and the Association of American Medical Colleges - also ask the agency to "no longer issue letters permitting qualified health claims through the exercise of its enforcement discretion."

The groups' message echoes a March 12 letter sent to FDA by four leading Congressional Democrats: Reps. Rosa DeLauro (Conn.) and Henry Waxman (Calif.) and Sens. Richard Durbin (Ill.) and Ted Kennedy (Mass.) (¹ Also see "Capitol Hill Has No Appetite For FDA Continuing Food QHC Reviews" - Pink Sheet, 24 March, 2008., p. 13).

That letter reminds FDA of Congress' request that the agency not spend 2008 appropriations on QHCs for conventional foods because of concerns that the claims mislead consumers and are not supported by "significant scientific agreement," as required by the Nutritional Labeling Education Act.

The advocacy groups' letter urges FDA "to reallocate funds used for the review and authorization of [QHCs for conventional foods] to enforcement efforts aimed at preventing manufacturers from making claims that mislead consumers about health benefits of their products."

"We wanted to suggest a potential course of action on how FDA should handle QHC petitions for conventional foods," said Ilene Ringel Heller, senior staff attorney for the Center For Science in the Public Interest.

It is not clear whether a moratorium would provide the agency with significant funds to redirect considering the dwindling number of requests for QHC evaluations for conventional foods in recent years.

In 2007 the agency "did not receive any petitions for qualified health claims for conventional foods," Barbara Schneeman, director of the Center for Food Safety and Applied Nutrition's Office of Nutrition Products, Labeling and Dietary Supplements, said at the Food and Drug Law Institute's annual meeting March 26 in Washington.

During the meeting, Schneeman acknowledged the agency received many requests for QHCs related to conventional foods in 2003 when the task force initially was charged to review the claims, but since then "the number of petitions has declined."

However, she did not say whether FDA expects the industry's current lack of interest in new QHCs for conventional foods to continue in 2008 and beyond.

Even though there are no food QHCs pending currently, Heller said a moratorium is needed.

Under a moratorium, if food petitions are submitted "at some point, FDA will just put them aside and not do anything with them at this point until" the Government Accountability Office completes a study of how consumers interpret QHCs for conventional foods, she said.

The House and Senate appropriations committees requested GAO determine whether these claims mislead consumers after an FDA study released in 2005 found consumer-respondents misunderstood when a claim is adequately substantiated by science (² Also see "Qualified Claims Language And Grading Confuses Consumers – FDA Study" - Pink Sheet, 10 October, 2005., p. 7).

Partly in response to Congress' request for a GAO review of how consumers interpret QHCs, FDA also is "looking at the specific language [in existing QHC for conventional foods] and testing to understand how consumers understand the language," Schneeman said (³ Also see "Congress Urges FDA To Stop Conventional Food QHCs Pending GAO Evaluation" - Pink Sheet, 7 January, 2008., p. 9).

Schneeman did not discuss how many QHC petitions for dietary supplements the agency received during the same time period because she had not reviewed that data recently, she said.

Both the congressional and consumer group letters request a moratorium only on QHCs for conventional foods.

- Elizabeth Crawford (e.crawford@elsevier.com)

Consumer Groups Add Pressure To Stop QHCs Program For Conventional Foods

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