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Publication Date

3-2005

Document Type

Article

Abstract

The Food and Drug Administration ("FDA") recently issued an enforcement policy identifying the types of health claims in the disclaimers that are constitutionally permitted on foods and dietary supplements. In 1990 Congress required that before a company could make a health claim on a food product, the FDA must approve the claim as based on significant scientific agreement. While the 1990 law gave the FDA discretion to establish a lesser standard for nutritional supplements than for food products, the FDA chose to apply the same standard. Thus, claims on nutritional supplements had to be supported by significant scientific agreement. Supplement marketers successfully challenged this requirement in Pearson v. Shalala. In Pearson the United States Court of Appeals for the District of Columbia held, based on the First Amendment, that the government could not suppress claims that lacked significant scientific agreement when disclosures were sufficient to prevent consumer confusion. The court suggested that the FDA consider the use of disclaimers, such as a warning that the claim was inconclusive, but left the exact language of the disclaimers to the FDA. Moreover, the court suggested that product claims made contrary to the weight of the evidence might be barred when the potential for deception could not be cured by disclaimers. A district court later found that claims with disclaimers may not be barred if there is credible evidence for them. The FDA has now identified the types of claims and disclaimers it will accept for foods and supplements.

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