Dietary Supplement Manufacturers Score a Victory on Health Claims

The U.S. Court of Appeals for the District of Columbia has overturned the Food and Drug Administration's (FDA) rejection of four dietary supplement health claims as imposing an unconstitutional burden on protected commercial speech. The court indicated that instead of banning the claims outright, FDA needs to at least consider the use of disclaimers to avoid what the Agency might consider deceptive health claims.

The court also found that the criteria --"significant scientific agreement"-- that FDA uses in rejecting the claims is so vague as to constitute arbitrary and capricious action. The court's ruling sends FDA a clear signal that it needs to bend, at least a little, in terms of what it will allow a dietary supplement manufacturer to say about its products.

The Nutrition Labeling and Education Act (NLEA) addresses the use of health claims for both food products and dietary supplements. Under the NLEA, health claims for food may be made if the claim has been certified by FDA as supported by "significant scientific agreement." Health claims on dietary supplements may also be made under the Act, but for these Congress directed FDA to establish a standard through a rulemaking proceeding. Despite objections from dietary supplement manufacturers, FDA decided to use the same "significant scientific agreement" criterion that the statute sets for food products.

Thereafter, the appellant in this case sought approval of health claims for four different products establishing a connection between a particular ingredient in the supplement and a reduction in risk for certain diseases. The health claims addressed the connection between (1) dietary fiber and cancer, (2) antioxidant vitamins and cancer, (3) omega-3 fatty acids and coronary heart disease and (4) the effectiveness of folic acid in a dietary supplement form as compared to its presence in food.

FDA rejected all four claims, not because they were without support, but because the evidence was inconclusive and thus failed to give rise to "significant scientific agreement." FDA also declined to consider permitting the claim while requiring a disclaimer such as "the FDA has determined that the evidence supporting this claim is inconclusive."

Allow Disclaimers

In defending its refusal to permit disclaimers for the proposed health claims, FDA maintained that health claims lacking "significant scientific agreement" are inherently misleading and thus entirely outside the protection of the first amendment. Second, FDA argued that even if the claims are only potentially misleading, the government is not obliged to consider requiring disclaimers in lieu of an outright ban on all claims that lack significant scientific agreement.

The court dismissed FDA's first argument as "almost frivolous." With respect to the government's second argument, the court concluded that FDA does have a substantial interest in ensuring the accuracy of commercial information. However, the court found that there was not a reasonable fit between the government's goal of ensuring the accuracy of such information and its refusal to consider the use of disclaimers.

Although the court agreed that the government may have more leeway in choosing suppression over disclosure as a response to the problem of consumer confusion where a product may affect health, the court did not see that as a factor here because no potentially adverse health effects were presented by use of the dietary supplements in question. Thus, the court decided that there should be a general preference for disclosure over suppression and that the Agency should take steps to permit health claims, but with appropriate disclaimers as necessary.

In the court's opinion, this would establish a more reasonable fit between the government's legitimate goal of protecting the public and the restrictions on speech chosen to advance that goal.

Set Clear Standards

The court also is requiring FDA to give "some content" to the phrase "significant scientific agreement." The court was concerned that in rejecting each of the health claims at issue, FDA never adequately explained what it meant by this term. In so deciding, however, the court is not requiring the Agency to define the term in a comprehensive manner. Rather, the Agency may proceed on a case-by-case basis, but "it must be possible for the regulated class to perceive the principles which are guiding agency action."

FDA is considering appealing this decision. But, given the reputation of the D.C. Circuit on regulatory questions of this nature, it's a good bet that the U.S. Supreme Court will not substitute its judgment for that of the court below.

George Misko, Partner, Keller & Heckman

Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlw.com

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