How the US Food and Drug Administration evaluates the scientific evidence for health claims.
ABSTRACT 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.
- SourceAvailable from: Anel Schoonees[Show abstract] [Hide abstract]
ABSTRACT: Objective: Nutritional supplements are inadequately regulated in South Africa. These types of products are increasingly advertised and the advertisements frequently contain health claims. Because advertisements play a considerable role in informing potential consumers, it is crucial that information about supplements in advertisements is accurate. A survey was carried out to determine the extent to which health claims are made in nutritional supplement advertisements and to describe the appropriateness of the research cited within the advertisements in support of the health claims. Design: The design was a descriptive survey. Method: The five women’s magazines with the highest circulation figures in South Africa in July 2010 were identified by the Audit Bureau of Circulations of South Africa as Cosmopolitan, Finesse, Move!, Rooi Rose and Sarie. Issues of these magazines were obtained during the period from September 2010 to August 2011. Pre-specified eligibility criteria were used to identify suitable advertisements and to determine the percentage of nutritional supplements about which health claims were made. The percentage of these supplements for which research was cited in support of the claims was also determined, and the level and appropriateness of the cited research, described. Results: In total, 486 eligible advertisements were identified which referred to 158 nutritional supplements. Of these, 137 (86.7%) made health claims and 9 of the 137 (6.6%) cited research to support their claims. The cited research was judged to be largely inappropriate based on study design and/or the characteristics of the study. Conclusion: South Africans should be wary of advertisements that make claims about the health benefits and safety of nutritional supplements. Regulation of the advertising of nutritional supplements is urgently needed.South African Journal of Clinical Nutrition 01/2013; 26(2):12-18.
- [Show abstract] [Hide abstract]
ABSTRACT: Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. Newfoods/dietary supplements are often marketed by health claims or structure/ function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions. Expected final online publication date for the Annual Review of Nutrition Volume 34 is July 17, 2014. Please see http://www.annualreviews.org/catalog/pubdates.aspx for revised estimates.Annual Review of Nutrition 07/2013; · 10.46 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: ABSTRACT Tribulus terrestris (TT) is a dicotyledonous herbal plant of the Zygophyllaceae family. In ancient medicine, extracts of the aerial parts and fruits have been used for its diuretic, tonic, and aphrodisiac properties. Today, TT is widely used by athletes and bodybuilders based on the belief, fueled by claims in marketing information, that it can enhance testosterone concentrations. To assess TT's effect on testosterone levels in human and animals, an electronic literature search out using seven databases and the patent database up to August 2013 was carried out. Randomized control trials, which included healthy human subjects ingesting TT as sole or combined supplement, along with animal studies with TT as a sole treatment across a number of species were included. Eleven studies met the inclusion criteria, including one patent application. The results showed that trials varied in duration, dosage and supplementation with TT as sole or combined treatment, rendering meta-analysis impossible. A limited number of animal studies displayed a significant increase in serum testosterone levels after TT administration, but this effect was only noted in humans when TT was part of a combined supplement administration. Literature available for the effectiveness of TT on enhancing testosterone concentrations is limited. Evidence to date suggests that TT is ineffective for increasing testosterone levels in humans, thus marketing claims are unsubstantiated. The nitric oxide release effect of TT may offer a plausible explanation for the observed physiological responses to TT supplementation, independent of the testosterone level.Journal of Dietary Supplements 03/2014; 11(1):64-79.