How the US Food and Drug Administration evaluates the scientific evidence for health claims

Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, USA.
Nutrition Reviews (Impact Factor: 6.08). 02/2010; 68(2):114-21. DOI: 10.1111/j.1753-4887.2009.00267.x
Source: PubMed


Health claims describe the relationship between a substance (food or component of food) and a disease or health-related condition. They were first authorized through the Nutrition Labeling and Education Act of 1990. The standard set by the US Congress for the scientific evidence required to authorize a claim was the significant scientific agreement standard. This strong standard was challenged by several manufacturers of dietary supplements. Several court decisions directed the US Food and Drug Administration (FDA) to provide for dietary supplement claims not meeting the significant scientific agreement standard by adding a disclaimer to the claim that would eliminate the claim's potential to be misleading. In December 2002, the FDA announced a major new initiative, "The Consumer Health Information for Better Nutrition Initiative," which, among other things, provided for the use of qualified health claims for both conventional foods and dietary supplements. The process for reviewing the scientific evidence for a claim reaching significant scientific agreement and for those that require qualifying language is the same. In January 2009, the FDA issued a guidance document entitled "Evidence-Based Review System for the Scientific Evaluation of Health Claims." The process used by the FDA to review the scientific evidence for health claims and qualified health claims are described in this article.

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    • "without bias to both conventional foods and dietary supplements . Enforcement of the SSA standard is intended to achieve the following qualities: objectivity, which entails reliance on a body of sound and relevant scientific evidence; flexibility , which is cognizance of the fact that there are variabilities in both the amounts and type of data required to support the credibility of different substanceedisease relationships , and sound response, via recognition of the need to reassess data over time as research questions emerge and research methodologies are refined (Ellwood et al., 2010). It is well known that some already approved US FDA health claims do not show uniformity and consistency in the number of studies used to achieve their approval. "
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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.
    Full-text · Article · Apr 2013 · Trends in Food Science & Technology
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    • "The FDA exerts its oversight in determining, by means of the following Acts, which nutrient content claims may be used on a label or in labeling: (a) the Nutrition Labeling and Education Act (NLEA) of 1990, by issuing a regulation authorizing a nutrient content claim, and (b) the FDA Modernization Act of 1997, by prohibiting or modifying by regulation a nutrient content claim. The NLEA required that the FDA issue regulations for authorizing the use of a health claim about a substance/disease relationship only when the significant scientific agreement standard was met [23]. "
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    ABSTRACT: Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU) and United States (US) policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.
    Full-text · Article · Mar 2013 · Evidence-based Complementary and Alternative Medicine
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    • "Commerce, information, and safety were of concern before this time, but societal goals such as decreasing the incidence of dietaryinduced disease were just appearing, further complicating the food choice landscape and the breadth of regulatory possibility (Golan et al. 2001). Regulatory intervention occurred to guide consumer behavior toward healthier choices (Caswell et al. 2003; Ellwood, Trumbo, and Kavanaugh 2009). A 1969 White House Conference on Food, Nutrition, and Health paved the way for nutrition labeling (Lenahan et al. 1973). "
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    ABSTRACT: Food labeling in the United States has been a topic of public debate and conflict for almost two centuries. Legislative activity has involved consumer–industry–government battles over both mandated requirements for food labeling, industry’s freedom of speech in messaging, and consumers’ struggle to make informed choices in a complex food environment. Information asymmetries have been attributed to the failure of government in terms of enough legislation, industry’s noncompliance with existing regulations, lack of consumer attention to the information available, and industry marketing practices. This overview of food labeling legislation combined with a discussion of contemporary labeling issues makes the case that information asymmetry is likely to persist. The food environment is changing quickly, regulatory authorities are not nimble, regulators often clash with themselves and industry, business has been unable to look far beyond its bottom line, and consumers are unwilling or unable to comprehend and use label information to make choices that maintain and/or improve their health.
    Full-text · Article · Jun 2012 · Journal of Macromarketing
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