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Groups Sue FDA on Weakening Rules Governing Health Claims on Food

From Public Citizen 9/23/03

WASHINGTON - September 23 - The Center for Science in the Public Interest (CSPI) and Public Citizen today filed suit against the U.S. Food and Drug Administration (FDA) to challenge the FDA's recently announced scheme to permit food companies to make health claims based on weak or inconclusive evidence.

Prior to 1990, food companies were not permitted to make claims that their products helped to prevent, treat or cure any disease. Under the Food, Drug and Cosmetic Act, such claims were limited to drugs, and if a company wanted to make such a claim, it first had to apply for permission through the statutory process for approval of new drugs.

In 1990, Congress enacted the Nutrition Labeling and Education Act, which allows food companies to petition the FDA for approval of health claims. The statute authorizes the FDA to approve a health claim for a food only if the FDA determines that the claim is supported by "significant scientific agreement." The law further requires that before approving a health claim for food, the FDA solicit public comment on a proposed regulation authorizing the claim. Only after the FDA reviews the comments and issues a final regulation authorizing the claim may companies make that health claim. Until this year, the FDA followed these statutory requirements.

However, the FDA announced in July that it will now allow food companies to make health claims even when the evidence is too weak or inconclusive to meet the statutory standard. The FDA has announced that it will even permit claims where the weight of the evidence suggests that the claim is likely false, as long a disclaimer accompanies the claim. The FDA calls food claims that do not meet the statutory standard and are accompanied by a disclaimer "qualified claims."

Moreover, the FDA has stated that it will not follow the notice-and-comment rulemaking procedure that Congress required as a prerequisite for allowing a health claim for food. The FDA will post on its Web site a food company’s petition asking for permission to make a qualified claim and will allow people to submit comments on the petition. However, the agency will not issue a proposed rule and notice informing the public of its preliminary thinking on the petition, as required by the law; it will not respond to any comments received, as required by the law; and it will not issue a regulation to authorize the claim, as required by the law.

"The FDA’s new plan is a dereliction of its duty to enforce the law that Congress enacted," said Peter Lurie, deputy director of Public Citizen’s Health Research Group. "The FDA is essentially saying that unproven or misleading claims are okay, as long as the food label also says that the claims might not be true. The agency’s scheme is another in a growing list of Bush administration actions that put business’s financial interests ahead of consumer health."

In the lawsuit, the groups say that the agency is violating the substantive and procedural requirements of the food labeling statute and the regulations issued to implement that law. The groups also say that the agency is violating the Administrative Procedure Act by initiating the new regulatory scheme without going through notice-and-comment rulemaking.

Congress enacted the high standard and procedural requirements of the law to protect consumers from false and misleading claims and from claims based on evidence still too preliminary to be trusted. The groups allege that by announcing its intent blatantly to violate the statute, the FDA threatens to injure consumers’ health, as many will make decisions regarding their health based on the specious claims that the FDA is choosing to permit.

"The FDA is illegally putting consumers’ health at risk and allowing food companies to turn the supermarket aisle into a Tower of Babble," said Bruce Silverglade, director of legal affairs for CSPI.

The complaint was filed in federal district court in the District of Columbia. Public Citizen Litigation Group attorneys Allison Zieve and Scott Nelson represent CSPI and Public Citizen.

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