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133:, "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.
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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
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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
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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
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Verhagen, Hans; Tuijtelaars, Sandra; Rechkemmer, Gerhard; Pijls, Loek T. J.; Persin, Christoph; MĂĽller, Detlef J. G.; Howlett, John; Cummings, John H.; Contor, Laura; Bellisle, France; Asp, Nils-Georg; Antoine, Jean-Michel; Aggett, Peter J. (June 2005). "Passclaim".
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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.
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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
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Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health.
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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
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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.
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The rule in place before 2003 required "significant scientific consensus" before a claim could be made, applying characterization of a hierarchy of
144:. The authorized health claim must be written in a way that helps consumers understand the importance of including the element in their daily diet.
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D: "Very limited and preliminary scientific research suggests . The FDA concludes that there is little scientific evidence supporting this claim."
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funded by manufacturers or marketers has been criticized to result in more favorable results than those from independently funded research.
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69:. Vague health claims include that the food inside is "healthy," "organic," "low fat," "non-GMO," "no sugar added," or "natural".
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275:. The final consensus paper, comprising the final set of criteria, has been published in June 2005 in the
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Lenard I. Lesser; Cara B. Ebbeling; Merrill
Goozner; David Wypij; David S. Ludwig (January 9, 2007).
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463:"Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles"
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This article is about health claims made about foods. For the labeling of food products, see
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B: "Although there is some scientific evidence supporting , the evidence is not conclusive."
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330:"Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard"
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provides regulations on food labeling to address the quality of possible health foods.
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New York Times article, "Looser Rules
Proposed for Health Claims on Food Labels"
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Based on scientific evidence, such claims may be used for marketing on foods or
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523:"21 Code of Federal Regulations § 101.14 Health claims: general requirements"
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https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/
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The FDA has guidelines for what is considered a misleading label, and also
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Office of
Nutrition, Labeling, and Dietary Supplements (January 2013).
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http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm
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https://web.archive.org/web/20090822045739/http://europe.ilsi.org/
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or condition. For example, it is claimed by the manufacturers of
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are regulated as a separate type of consumer item from food or
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relationship between the element and the disease is valid.
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359:"Questions and Answers on Health Claims in Food Labeling"
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http://www.ilsi.org/Europe/Pages/PASSCLAIM_Pubs.aspx
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A: "There is significant scientific agreement for ."
361:. US Food and Drug Administration. 13 December 2017
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332:. U.S. Food and Drug Administration. 7 March 2022
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301:Labels Unwrapped | Learn How to Read Food Labels
525:. US Food and Drug Administration. 1 April 2015
442:. US Food and Drug Administration. 7 March 2022
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401:: CS1 maint: multiple names: authors list (
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418:"Warning letter: Carol Bond Health Foods"
220:for a description of current FDA policy.
42:products that their food will reduce the
16:Claim by a manufacturer of food products
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547:. European Food Safety Authority. 2017
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545:"Nutrition and health claims"
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100:are regulated by the U.S.
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106:Federal Trade Commission
640:European Union food law
382:"A Food Labeling Guide"
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224:Health claims in Canada
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159:supporting the claim.
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63:cholesterol
61:can reduce
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306:2021-09-23
283:References
268:scientific
32:food label
665:Packaging
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262:-Europe (
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