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 inconclusive evidence.
The rule in place before 2003 required "significant scientific consensus" before a claim could be made. A rule proposed in 2003 would have permitted 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."
See the Wikipedia article on dietary supplements for a description of current FDA policy.
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 (Discontinued in 2010) Joint Health Claims Initiative to determine whether their claims are likely to be legally sustainable.
In early 2005 the European PASSCLAIM project (Process for the Assessment of Scientific Support for Claims on Foods), sponsored by the European Union and coordinated by ILSI-Europe (http://europe.ilsi.org/), ended. The aim of this 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://www.ilsi.org/Europe/Pages/PASSCLAIM_Pubs.aspx. The final consensus paper, comprising the final set of criteria, has been published in June 2005 in the European Journal of Nutrition.
An overview of current and future situations on health claims in the European Union including proposals, press releases and memos can be found on the European Commission website: http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm.
All approved EU health claims translated into various European language available on http://www.healthclaimslist.com
- FDA's website on qualified health claims
- New York Times article, "Looser Rules Proposed for Health Claims on Food Labels"
- UK Food Standards Agency advice
- Process for the Assessment of Scientific Support for Claims on Foods
- Agriculture & Agri-Food Canada
- Proposed claims for functional ingredients send to be evaluated by EFSA from the European food industries
- Statutory Instrument 1996 No. 1499 UK Food Labelling Regulations 1996