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Symposium: Evidence-Based Public Nutrition: An Evolving Concept

FDA's Review of Scientific Evidence for Health Claims¹

Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD

^* To whom correspondence should be addressed. E-mail: barbara.schneeman{at}fda.hhs.gov.

	ABSTRACT

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Under the Federal Food, Drug, and Cosmetic Act health claims on foods or dietary supplements must be authorized by the FDA. Health claims describe the relationship between a food, food component, or dietary supplement and reducing the risk of a disease or health-related condition. Under interim guidance and enforcement discretion, certain qualified health claims have been provided for on foods and dietary supplements; these claims contain language to qualify the quality and strength of scientific evidence to support the claim because they are not based on significant scientific agreement, which is the standard for health claims authorized by the Federal Food, Drug, and Cosmetic Act. In order to meet its statutory responsibility for evaluation of health claims, the agency has developed guidelines for review of scientific evidence in support of a health claim.

http://www.cfsan.fda.gov/dms/lab-qhc.html

Health claims for foods and dietary supplements are voluntary statements that characterize the relation between a substance and its ability to reduce the risk of disease or health-related condition in healthy populations. The intent of such claims is to provide information to consumers that will help reduce the risk of disease. Health claims on foods and dietary supplements are not for the treatment, cure, diagnosis, or mitigation of disease; such statements would be considered a drug claim. Based on the definitions provided in the Code of Federal Regulations, a "substance" can be a specific food or component of food, including a dietary supplement, and a "disease or health-related condition" refers to damage to an organ, part, structure, or system of the body such that it does not function properly or a state of health leading to such dysfunction (2).

In order to meet its statutory responsibility for evaluation of health claims, the Agency has developed guidelines for review of scientific evidence in support of a health claim. These guidelines include Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, which was published December 22, 1999 (http://www.cfsan.fda.gov/dms/ssaguide.html; accessed July 5, 2006), Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data as a part of the Consumer Health Information for Better Nutrition Initiative, which was published July 10, 2003. In addition, the letters of enforcement discretion for qualified health claims, which have been released since 2004, include an overview of the evidence-based review criteria (http://www.cfsan.fda.gov/dms/lab-qhc.html).

When NLEA was enacted in 1990, it allowed health claims that are based on "significant scientific agreement" (SSA). During the original implementation of NLEA, 7 claims were allowed based on monographs produced and reviewed by experts in the field. Subsequently 5 additional claims, as well as amendments to existing claims, that meet the standard of SSA have been authorized through petitions to the FDA (2).

The standard of SSA is based on a high level of confidence in the validity of the relation between the substance and the disease or health-related condition. If one considers the continuum between emerging evidence and scientific consensus, the evidence would be viewed as closer to scientific consensus about the relationship. In the original regulations implementing NLEA, the FDA denied 4 claims that did not meet the SSA standard. Subsequently, court decisions in the United States struck down the prohibition on manufacturers from providing claims about substance-disease relations when the science is still viewed as emerging and has not yet achieved the standard of SSA. Of special consideration in the United States is the right of free speech, including commercial speech, under the First Amendment. In particular, courts indicated that the FDA had not presented any data that potentially misleading claim language would not be cured by qualifying language enabling consumers to understand the nature of the evidence supporting a claim. As a consequence of these court decisions, the FDA developed a process to review qualified health claims, and enforcement discretion is used to provide for use of such claims on foods and dietary supplements. A QHC is distinguished from an SSA claim by language in the claim that characterizes the quality and strength of the scientific evidence because the claim is not based on significant scientific evidence.

As indicated in its guidance documents and enforcement discretion letters, the FDA goes through several steps to review scientific evidence in support of a claim. Once the Agency has defined the specific substance and disease or health-related condition that is the subject of the claim, it identifies the relevant studies that are suitable for an evidence-based review, classifies these studies, rates them for quality, and rates the strength of the body of evidence based on the quality of the studies plus their consistency and relevance to the asserted health claim relationship.

Evidence to support a health claim should be based on studies in humans. Animal and in vitro studies are useful but not sufficient on their own to substantiate a claim. Among studies in humans, the randomized, placebo-controlled, double-blind intervention study provides the strongest evidence. However, it is not always possible to conduct such intervention studies on food and food components; thus, the studies that are available must be reviewed for their quality and relevance to support the claims. Such a review examines whether the studies are controlled for confounders and bias, the appropriateness of the study population, and soundness of the experimental design and analysis, including the use of appropriate statistical analysis and estimates of intake. Observational data can be supportive of a claim but often are less persuasive scientifically based on the nature of the study and its design. Research syntheses such as meta-analysis or review articles are primarily useful for identifying studies for further examination. The FDA is in the process of developing a draft guidance document for its evidence-based review system; in the interim, examination of a letter of enforcement discretion for a qualified health claim will provide information on the criteria used and how the criteria are applied.

	FOOTNOTES

 
¹ Presented as part of the symposium "Evidence-Based Public Nutrition: An Evolving Concept" given at the 2006 Experimental Biology meeting on April 4, 2006, San Francisco, CA. The symposium was sponsored by the Dannon Institute and the Connecticut EXPORT Center of Excellence for Eliminating Health Disparities among Latinos (NIH-NCHMD grant 1P20MD001765-01). This supplement is the responsibility of the guest editors to whom the Editor of The Journal of Nutrition has delegated supervision of both technical conformity to the published regulations of The Journal of Nutrition and general oversight of the scientific merit of each article. The opinions expressed in this publication are those of the authors and are not attributable to the sponsors or the publisher, editor, or editorial board of The Journal of Nutrition. Guest editors for the symposium publication are Rafael Pérez-Escamilla, University of Connecticut, Storrs, CT, and Janet King, Children's Hospital Oakland Research Institute, Oakland, CA.

² Abbreviations used: FDCA, Federal Food, Drug, and Cosmetic Act; NLEA, Nutrition Labeling and Education Act; QHC; qualified health claim(s); SSA, significant scientific agreement.

	LITERATURE CITED

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1. Food, Drug, and Cosmetic Act; 21 USC 343, Section 403, U.S. Government Printing Office, Washington, DC, 2005.

2. Office of the Federal Register. Code of Federal Regulations. Food and Drugs, title 21, part 101. Food Labeling. U.S. Government Printing Office, Washington, DC.

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