Label Claims for Foods and Supplements: A Review of the Regulations

Food Science and Human Nutrition Department, University of Florida, PO Box 110370, Gainesville, FL 32611-0370, USA.
Nutrition in Clinical Practice (Impact Factor: 2.4). 03/2005; 20(1):21-32. DOI: 10.1177/011542650502000121
Source: PubMed


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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    • "Both nutrient content and structure/function claims do not need the US FDA preapproval in order to be used on labels; however, such claims must be accompanied by a disclaimer statement that the claim has not been evaluated by the FDA, and is not intended to diagnose , treat, cure or prevent any disease. Health claims, which form the basis for this review, describe the relationship of consuming a food and its inherent components, or dietary supplement with the reduction of risk of a disease or health condition (Turner et al., 2005). For example, the health claim for soy protein states that the 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. "
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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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    • "The manufacturer is responsible for the truthfulness of its claims, and, although the DSHEA requires the manufacturer to have evidence to support them, there is no requirement that such evidence be provided to the FDA for its review before marketing the product [8] [10]. Turner and colleagues [8] questioned the degree to which the FDA has enforced misleading claims regulations, stating that because of its limited resources it has made product safety a higher priority. Their article is an excellent review of label claims for supplements. "
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    ABSTRACT: Ergogenic dietary supplement use is highly prevalent among adolescent and collegiate athletes, and use is increasing. To make appropriate recommendations for or against use by individual athletes, physicians who work with adolescent athletes should be knowledgeable about the most commonly used supplements and be able to access high-quality information about others. This article first discusses the legal and regulatory environment of dietary supplements. Several of the most commonly used supplements are then discussed in detail, including creatine, beta-hydroxy-beta-methylbutyrate, protein, amino acids, stimulants, alkalotic agents, glycerol, vitamins, and minerals. Finally, the "Gateway Theory" as it may relate to adolescent supplement and other drug use is discussed.
    Pediatric Clinics of North America 09/2007; 54(4):735-60, xi. DOI:10.1016/j.pcl.2007.04.009 · 2.12 Impact Factor
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    ABSTRACT: Plants are one of the most important resources of human foods and medicines. Rapidly increasing knowledge on nutrition, medicine, and plant biotechnology has dramatically changed the concepts about food, health and agriculture, and brought in a revolution on them. Nutritional therapy and phytotherapy have emerged as new concepts and healing systems have quickly and widely spread in recent years. Strong recommendations for consumption of nutraceuticals, natural plant foods, and the use of nutritional therapy and phytotherapy have become progressively popular to improve health, and to prevent and treat diseases. With these trends, improving the dietary nutritional values of fruits, vegetables and other crops or even bioactive components in folk herbals has become targets of the blooming plant biotechnology industry. This review attempts to display and remark on these aspects. It summarizes the progress made on nutraceuticals, nutritional therapy, phytonutrients, phytotherapy, and their related epidemiological investigations and clinical studies. It also covers markets of these health-promoting products and disease-preventing or healing systems, as well as regulations behind them that direct the development of biotechnology study and application. Finally, related patents are listed and briefly analyzed, regarding of plant biotechnological research and progress on transgenic crops to improve nutritional value, phytotherapy efficiency, or to produce pharmaceutically important secondary metabolites or high-valued protein medicines such as vaccines and antibodies.
    02/2007; 1(1):75-97. DOI:10.2174/187220807779813893
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