Consumer groups Public Citizen and the Center for Science in the Public Interest (CSPI) are suing the US Food and Drug Administration (FDA), over its introduction in July of health claims qualified by disclaimers.
The campaign groups charge that current food labeling law requires health claims on food to be backed up by 'significant scientific agreement' and that the FDA's new requirements 'lower that threshold, allowing weaker claims as long as they are qualified with disclaimers'.
The groups are also alleging that the FDA is ignoring laws requiring the agency to respond to public comments and to justify its decisions regarding new health claims. Public Citizen said that FDA's decision to post on its website a food company's petition asking for permission to make a qualified claim, allowing people to submit comments on the petition, violates the Administrative Procedure Act by initiating the new regulatory scheme without going through notice-and-comment rulemaking.
The food industry has been campaigning for an alternative to current health claim evaluation for some time. The new qualified health claims, allow more foods to promote their health benefits, by offering a less time-consuming process. Although consumer groups warned that the system would prompt a flood of health claims backed by little scientific evidence, there has been only one formal petition filed so far - for omega-3s, an ingredient with significant and growing evidence to support its effect on human health.
However CSPI legal affairs director Bruce Silverglade claims that the system will mislead consumers with 'sketchy health claims' and that poorly backed claims will destroy the reputation of those with fully substantiated health claims.
"Food manufacturers could begin claiming that chocolate may reduce the risk of heart disease or that ketchup may reduce the risk of cervical cancer," Silverglade said. "If the FDA's unlawful plan goes forward, the supermarket aisle will turn into a Tower of Babble, replete with government-authorized wishy-washy claims. Ultimately, consumers will distrust all health claims, even well-substantiated ones."
"This is another example of the FDA caving in to one of the powerful industries it regulates," continued Silverglade. "It amounts to the most serious roll-back in food labeling in the last 20 years. It's doubtful that consumers will pay any attention to a vaguely written disclaimer when the claim itself is promising such great benefits."
The FDA however claims that the system will encourage companies whose research can stand up to consumer scrutiny and industry has generally backed this view.
Public Citizen has published the lawsuit documents online.