A health claim on a
food label
The packaging and labeling of food is subject to regulation in most regions/jurisdictions, both to prevent false advertising and to promote food safety.
Regulations by type
Multi-faceted
* Codex Alimentarius (international voluntary standard) ...
and in
food marketing is a claim by a manufacturer of
food
Food is any substance consumed by an organism for nutritional support. Food is usually of plant, animal, or fungal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is in ...
products that their food will reduce the
risk
In simple terms, risk is the possibility of something bad happening. Risk involves uncertainty about the effects/implications of an activity with respect to something that humans value (such as health, well-being, wealth, property or the environm ...
of developing a
disease
A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that a ...
or condition. For example, it is claimed by the manufacturers of
oat cereal
A cereal is any grass cultivated for the edible components of its grain (botanically, a type of fruit called a caryopsis), composed of the endosperm, germ, and bran. Cereal grain crops are grown in greater quantities and provide more food ...
s that
oat bran can reduce
cholesterol
Cholesterol is any of a class of certain organic molecules called lipids. It is a sterol (or modified steroid), a type of lipid. Cholesterol is biosynthesized by all animal cells and is an essential structural component of animal cell memb ...
, which will lower the chances of developing serious
heart conditions. Vague health claims include that the food inside is "healthy," "organic," "low fat," "non-GMO," "no sugar added," or "natural".
Health claims are also made for
over-the-counter drugs and
prescription drugs,
medical procedure
A medical procedure is a course of action intended to achieve a result in the delivery of healthcare.
A medical procedure with the intention of determining, measuring, or diagnosing a patient condition or parameter is also called a medical test. ...
s, and
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s, but these generally have a separate, much more stringent set of regulations.
Health claims in the United States
In the United States, health claims on
nutrition facts labels are regulated by the U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA), while advertising is regulated by the
Federal Trade Commission
The Federal Trade Commission (FTC) is an independent agency of the United States government whose principal mission is the enforcement of civil (non-criminal) antitrust law and the promotion of consumer protection. The FTC shares jurisdiction o ...
.
Dietary supplement
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order ...
s are regulated as a separate type of consumer item from food or
over-the-counter drugs.
Food
FDA guidelines
According to the
FDA, "Authorized health claims in food labeling are claims that have been reviewed by FDA and are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or a health-related condition."
An authorized health claim is limited to evidence for reducing the risk of a disease, and does not apply to the diagnosis, cure, mitigation, or treatment of disease.
[ It must be reviewed, evaluated, and publicly-announced by the FDA prior to use.][
Approval of a health claim by the FDA requires significant scientific agreement (SSA) among reputable scientists that the claim is based on publicly-available evidence that a relationship exists between an element and a disease.][ The SSA standard provides a high degree of confidence that the relationship between the element and the disease is valid.][
Based on scientific evidence, such claims may be used for marketing on foods or ]dietary supplement
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order ...
s.[ The authorized health claim must be written in a way that helps consumers understand the importance of including the element in their daily diet.][
The FDA has guidelines for what is considered a misleading label,] and also monitors and warns food manufacturers against labeling foods as having specific health effects when no evidence exists to support such statements, such as for one manufacturer in 2018.
A ''qualified health claim'' is supported by some scientific evidence, but does not meet the significant scientific standard of evidence required for an authorized health claim. Qualified health claims must be accompanied by a disclaimer or other qualifying language to accurately communicate the level of scientific evidence supporting the claim.
Consumer advocacy
The use of the label “Healthy” on a variety of foods has been a particular issue for many food quality advocacy groups. In general, claims of health benefits for specific foodstuffs are not supported by scientific evidence and are not evaluated by national regulatory agencies. Additionally, research funded by manufacturers or marketers has been criticized to result in more favorable results than those from independently funded research.[ ]
Dietary supplements
In the United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...
, these claims, usually referred to as "qualified health claims", are regulated
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. ...
by the Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) in the public interest
The public interest is "the welfare or well-being of the general public" and society.
Overview
Economist Lok Sang Ho in his ''Public Policy and the Public Interest'' argues that the public interest must be assessed impartially and, therefor ...
.
The rule in place before 2003 required "significant scientific consensus" before a claim could be made, applying characterization of a hierarchy of degrees of certainty:
* A: "There is significant scientific agreement for he claim"
* B: "Although there is some scientific evidence supporting he claim the evidence is not conclusive."
* C: "Some scientific evidence suggests he claim However, the FDA has determined that this evidence is limited and not conclusive."
* D: "Very limited and preliminary scientific research suggests he claim The FDA concludes that there is little scientific evidence supporting this claim."
See the Wikipedia article on dietary supplements for a description of current FDA policy.
Health claims in Canada
Health claims in Europe
In the European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are located primarily in Europe, Europe. The union has a total area of ...
, the European Food Safety Authority provides regulations on food labeling to address the quality of possible health foods.
In the United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and ...
by law 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 (https://web.archive.org/web/20090822045739/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
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body ...
website: http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm.
All approved EU health claims translated into various European language are available at https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/
References
External links
New York Times article, "Looser Rules Proposed for Health Claims on Food Labels"
*
{{DEFAULTSORT:Health Claims On Food Labels
European Union food law
Food safety
Food labelling
Food retailing
Product certification
Packaging
European Union consumer protection law