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

ArticleinNutrition Reviews 68(2):114-21 · February 2010with14 Reads
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.
    • "Nevertheless, food manufacturers must include a disclaimer on the indicate product indicating that the scientific evidence behind the health claim is weak [17, 18, 21]. In order to verify food claims, the FDA pays special attention to research involving the administration of food compounds (at specific dosages) to animals and humans [17, 19]. Claims must then be approved under ''Significant Scientific Agreement " after which FDA officials rank claims based on the strength of the scientific evidence behind them 17. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Functional food science has gained momentum recently in response to the changing health status of developed countries. As healthcare costs and average life expectancy rise, the public has sought ways to become healthier and develop higher qualities of life. The concept of “functional food” developed as a convenient and inexpensive solution to chronic health problems, and is becoming influential in numerous branches of science and policy. Since its conception in 1984, “functional food” changed its meaning per country and culture. The term migrated from Japan to the EU and the United States where it generated profit but bred confusion among experts and non-experts. In this chapter, we review how “functional food” has been defined and redefined over the past 30 years, as well as the benefits of our current definition. The goal of this new definition is to strengthen communication between nutrition scientists, the public, and other groups as well as legitimize functional food science around the world.
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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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    • "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]. In United States, companies are responsible for the safety of their products and food supplements, including those containing botanicals, which do not need approval from Food and Drug Administration (FDA) before commercialization. "
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