Health claims on food labels
Encyclopedia
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
cereal
s that oat bran can reduce cholesterol
, which will lower the chances of developing serious heart
conditions.
, 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
:
See the Wikipedia article on dietary supplements for a description of current FDA policy.
, 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 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.
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
products that their food will reduce the risk of developing a disease
Disease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
or condition. For example, it is claimed by the manufacturers of oat
Oat
The common oat is a species of cereal grain grown for its seed, which is known by the same name . While oats are suitable for human consumption as oatmeal and rolled oats, one of the most common uses is as livestock feed...
cereal
Cereal
Cereals are grasses cultivated for the edible components of their grain , composed of the endosperm, germ, and bran...
s that oat bran can reduce cholesterol
Cholesterol
Cholesterol is a complex isoprenoid. Specifically, it is a waxy steroid of fat that is produced in the liver or intestines. It is used to produce hormones and cell membranes and is transported in the blood plasma of all mammals. It is an essential structural component of mammalian cell membranes...
, which will lower the chances of developing serious heart
Heart
The heart is a myogenic muscular organ found in all animals with a circulatory system , that is responsible for pumping blood throughout the blood vessels by repeated, rhythmic contractions...
conditions.
Law in the United States
In the United StatesUnited States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, these claims, usually referred to as "qualified health claims", are regulated
Regulation
Regulation is administrative legislation that constitutes or constrains rights and allocates responsibilities. It can be distinguished from primary legislation on the one hand and judge-made law on the other...
by the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
in the public interest
Public interest
The public interest refers to the "common well-being" or "general welfare." The public interest is central to policy debates, politics, democracy and the nature of government itself...
. See 21 Code of Federal Regulations § 101.14.
On July 10, 2003, the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
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
Uncertainty
Uncertainty is a term used in subtly different ways in a number of fields, including physics, philosophy, statistics, economics, finance, insurance, psychology, sociology, engineering, and information science...
:
- 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.
European Laws
In the United KingdomUnited Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, 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 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
International Life Sciences Institute
The International Life Sciences Institute is a nonprofit [501c3] science organization founded in 1978 and headquartered in Washington, DC. It is a member organization whose members are primarily food and beverage, agricultural, chemical, and pharmaceutical companies...
-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
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
website: http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm.
External links
- 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