Health claims on food labels

Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions.

Law in the United States
In the United States, these claims, usually referred to as "qualified health claims", are regulated by the Food and Drug Administration in the public interest. See 21 Code of Federal Regulations § 101.14.

On July 10, 2003, the Food and Drug Administration announced plans to permit the manufacturers of food products sold in the United States to make health claims on food labels which are supported by less than conclusive evidence.

The current rule requires "significant scientific consensus" before a claim can be made. The proposed rule, effective September 1, 2003, will permit characterization of health claims using a hierarchy of degrees of certainty:
 * A: "There is significant scientific agreement for [the claim]"
 * B: "Although there is some scientific evidence supporting [the claim], the evidence is not conclusive."
 * C: "Some scientific evidence suggests [the claim]. However, the F.D.A. has determined that this evidence is limited and not conclusive."
 * D: "Very limited and preliminary scientific research suggests [the claim]. The F.D.A. concludes that there is little scientific evidence supporting this claim."

The proposal is being criticized as opening the door to ill-founded claims. Advocates believe it will make more information available to the public.

European Laws
In the United Kingdom, the law requires that any health claim on food labels must be true and not misleading. Food producers may optionally use the Joint Health Claims Initiative to determine whether their claims are likely to be legally sustainable.

In Europe in early 2005 the project PASSCLAIM was ended (Process for the Assessment of Scientific Support for Claims on Foods). The project was sponsored by the European Union and coordinated by ILSI-Europe (http://europe.ilsi.org/). The aim of the PASSCLAIM project was to develop criteria for the scientific substantiation of claims on foods. Several hundreds of scientists from academia, research institutes, government and industry have contributed to the project. All the resulting papers can be downloaded for free from http://europe.ilsi.org/passclaim/. The final consensus paper, comprising the final set of criteria, will be published in June 2005 in the European Journal of Nutrition.

An overview about the current and future situations on health claims in the European Union including proposals, press releases and memos can be found at the website of the European Commission at http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm.