Health claim#FDA guidelines
{{Short description|Claim by a manufacturer of food products}}
{{About|health claims made about foods|the labeling of food products|food labeling regulations}}
A health claim on a food label and in food marketing is a claim by a manufacturer 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. 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 procedures, and medical devices, 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 (FDA), while advertising is regulated by the Federal Trade Commission.{{Cite web|title=Labels 101|url=https://labelsunwrapped.org/labels-101|access-date=2021-09-23|website=Labels Unwrapped {{!}} Learn How to Read Food Labels}} Dietary supplements are regulated as a separate type of consumer item from food or over-the-counter drugs.{{cn|date=August 2023}}
=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."{{cite web|date=7 March 2022|title=Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard|url=https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard|archive-url=https://web.archive.org/web/20190915020051/https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard|url-status=dead|archive-date=September 15, 2019|access-date=20 December 2022|publisher=U.S. Food and Drug Administration}}{{cite web |title=Questions and Answers on Health Claims in Food Labeling |url=https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling |archive-url=https://web.archive.org/web/20190926093326/https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling |url-status=dead |archive-date=September 26, 2019 |publisher=US Food and Drug Administration |access-date=20 December 2022 |date=13 December 2017}} 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 supplements. 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,{{Cite web|url=https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM265446.pdf|archive-url=https://web.archive.org/web/20171114122649/https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM265446.pdf|url-status=dead|archive-date=November 14, 2017|title=A Food Labeling Guide|last=Office of Nutrition, Labeling, and Dietary Supplements|date=January 2013|website=FDA.gov}} 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.{{cite web|author1=Edmundo Garcia Jr.|date=9 March 2018|title=Warning letter: Carol Bond Health Foods|url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600398.htm|archive-url=https://web.archive.org/web/20180424093726/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600398.htm|url-status=dead|archive-date=April 24, 2018|access-date=15 April 2018|publisher=US Food and Drug Administration}}
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.{{cite web |title=Qualified health claim |url=https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims |archive-url=https://web.archive.org/web/20190925233144/https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims |url-status=dead |archive-date=September 25, 2019 |publisher=US Food and Drug Administration |access-date=20 December 2022 |date=7 March 2022}}
==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.{{cite journal|author=Lenard I. Lesser|author2=Cara B. Ebbeling|author3=Merrill Goozner|author4=David Wypij|author5=David S. Ludwig|date=January 9, 2007|title=Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles|journal=PLOS Medicine|volume=4|issue=1|pages=e5|doi=10.1371/journal.pmed.0040005|pmc=1764435|pmid=17214504|quote=Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health. |doi-access=free }} {{open access}}
=Dietary supplements=
In the United States, these claims, usually referred to as "qualified health claims", are regulated by the Food and Drug Administration (FDA) in the public interest.{{cite web|url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.14|archive-url=https://web.archive.org/web/20030914054812/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=101.14|url-status=dead|archive-date=September 14, 2003|title=21 Code of Federal Regulations § 101.14 Health claims: general requirements|publisher=US Food and Drug Administration|date=1 April 2015|access-date=15 January 2016}}
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 [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 FDA has determined that this evidence is limited and not conclusive."
- D: "Very limited and preliminary scientific research suggests [the 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
{{main|Canadian health claims for food}}
Health claims in Europe
In the European Union, the European Food Safety Authority provides regulations on food labeling to address the quality of possible health foods.{{cite web|date=2017|title=Nutrition and health claims|url=https://www.efsa.europa.eu/en/topics/topic/nutrition-and-health-claims|access-date=15 April 2018|publisher=European Food Safety Authority}}
In the United Kingdom 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.{{cn|date=August 2023}}
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.{{cite journal |title= Passclaim|journal=European Journal of Nutrition |volume=44 |issue=1 |pages=i5–i30 |doi=10.1007/s00394-005-1104-3 |pmid=15933809 |date=June 2005 |last1=Verhagen |first1=Hans |last2=Tuijtelaars |first2=Sandra |last3=Rechkemmer |first3=Gerhard |last4=Pijls |first4=Loek T. J. |last5=Persin |first5=Christoph |last6=Müller |first6=Detlef J. G. |last7=Howlett |first7=John |last8=Cummings |first8=John H. |last9=Contor |first9=Laura |last10=Bellisle |first10=France |last11=Asp |first11=Nils-Georg |last12=Antoine |first12=Jean-Michel |last13=Aggett |first13=Peter J. }}
References
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External links
- [https://www.nytimes.com/2003/07/11/national/11FOOD.html?ex=1058925526&ei=1&en=5a840bc5a0a4e167 New York Times article, "Looser Rules Proposed for Health Claims on Food Labels"]
- {{UK SI|year=1996|number=1499|title=UK Food Labelling Regulations 1996}}
- https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/
- http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm.
{{Authority control}}
{{DEFAULTSORT:Health Claims On Food Labels}}
Category:European Union food law