Label claims for foods and supplements: a review of the regulations.
ABSTRACT Consumers are confronted with a vast array of food and dietary supplement products claiming to improve health, manage conditions, and reduce disease risks. Most consumers are unaware of the legal requirements, regulatory processes, and scientific evaluation that underlie these label statements. Labeling for foods and dietary supplements is regulated by the US Food and Drug Administration (FDA). Regulations cover 3 main types of health-related statements: health claims, structure/function claims, and nutrient content claims. Health claims must be supported by "significant scientific agreement" among experts that the claimed benefit of a food or food component on a disease or health-related condition is true. When significant scientific agreement is lacking, qualifying statements may be required on the label to describe the strength of the evidence that supports the claim. Structure/function claims describe an effect of a product on body structure or function, and whereas these claims must be truthful and not misleading, they are not subject to premarket scientific review and approval. Nutrient content claims describe the level of a nutrient in a food or supplement and require FDA approval. By understanding the regulatory framework behind label statements and claims, health care professionals can better assist their patients and clients in making informed decisions.
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ABSTRACT: In 1999, the United States Food and Drug Administration (FDA) approved a soy protein health claim (category 'A') which states that "consumption of 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies grams of soy protein". Shortly after the approval, emerging results showed only modest (2-7%) to no effect on heart disease risk factors. One objective of this review is to highlight some studies that were key evidence in the soy protein health claim approval, comparing these to emerging divergent scientific data, indicating modest lipid-lowering effects from soy proteins. Furthermore, the current US FDA health claim ranking system is reviewed, with a suggestion to use our modified ranking transient scale that will assist in appropriate ranking of all future health claims.Trends in Food Science & Technology 04/2013; 30(30):121-32. DOI:10.1016/j.tifs.2012.12.003 · 4.65 Impact Factor
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ABSTRACT: This article describes the Dietary Supplements Labels Database, a new resource from the National Library of Medicine that integrates information from dietary supplement manufacturers, government agencies, and clinical research into an easy-to-use interface. This database contains information on more than 2,000 brands of dietary supplement and more than 800 active ingredients. This resource will greatly assist consumers and health care providers in evaluating the safety, efficacy, and quality of dietary supplements. Features of the resource will be described as well as the browse and search methods used to access the information.
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ABSTRACT: Background Knowledge regarding the possible health benefits of probiotic preparations has been increasing, but clinical trials have largely produced non-significant results. In contrast, the open market for probiotics is expanding worldwide despite little research of consumer characteristics.