Supreme Court Upholds FDA Authority Against Free Speech Labeling Challenge

14 December 1998 00:00  [Source: ICB Americas]

The Supreme Court last week rejected a challenge to the government's practice of barring health claims on labels of dietary supplements unless the Food and Drug Administration says there is "significant scientific agreement" that such claims are valid.

The court, without comment, turned away an argument that the FDA regulations violate free speech. A 1990 federal law, the Nutrition Labeling and Education Act, empowers FDA to monitor health claims for dietary supplements sold over the counter.

The agency has since issued regulations defining significant scientific agreement as the standard for deciding whether health claims are valid.

Anyone may petition FDA to authorize a health claim on a dietary supplement's label, and the agency must respond within a certain period, although a final rule can be put off for up to 18 months.

The Nutritional Health Alliance, a group of manufacturers, retailers and consumers of dietary supplements, filed suit over the FDA regulations, as did a health food store, New Nutrisserie. They contend that the labeling restrictions amount to an unlawful prior restraint against truthful commercial speech.

A federal judge in New York and the 2nd US Circuit Court of Appeals ruled against the challengers.

"Given the need to protect consumers before any harm occurs, we conclude that the...prior restraint is sufficiently narrowly tailored" to be deemed constitutional, the appeals court ruled. "It grants a limited, but reasonable, time within which the FDA can evaluate the evidence in support of the labeling claims."

In an appeal to the Supreme Court, lawyers for the health alliance and the health food store argued that the 2nd Circuit Court used a too-deferential standard in judging the government's restriction.

Justice Department lawyers defended the regulations' constitutionality and urged the court to reject the appeal. They also contended that the appeal is premature because the challengers have not asked FDA to authorize any particular health claims.

The appeal noted, however, that the claim that vitamin E helps prevent heart attacks is currently banned from dietary supplement labels "even though the claim is supported by several reputable research studies published in recent years."

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