News Briefs
News Briefs
NIH Panel Suggests More Oversight of Vitamin and Mineral Supplements
An independent panel convened by the National Institutes of Health Office of Medical Applications of Research and the Office of Dietary Supplements has concluded that more rigorous scientific research is needed before strong recommendations can be made regarding multivitamin/minerals (MVMs) use to prevent chronic diseases.
This conclusion followed two days of expert presentations, public discussion, and panel deliberations. The panel did recommend the combined use of calcium and vitamin D supplementation for postmenopausal women to protect bone health. The panel also advocated that antioxidants and zinc be considered for use by non-smoking adults with early-stage, age-related macular degeneration.
In addition, the panel supports previous recommendations by the Centers for Disease Control and Prevention in Atlanta that women of childbearing age take daily folate to prevent neural tube defects in infants. Conversely, it found no evidence to recommend beta carotene supplements, a form of vitamin A, for the general population, and strong evidence to caution smokers against taking them.
In looking specifically at MVMs for chronic disease prevention, however, the panel found that the available data are insufficient to make a firm recommendation for or against their use in the general population.
The panel identified several possible risks associated with MVM use. Among these is the potential for overconsumption of certain nutrients, with the resulting possibility of adverse effects. The combined effects of eating fortified foods, taking MVMs, and consuming single vitamins or minerals in large doses, may lead consumers to unwittingly exceed the Upper Levels of nutrients, which can be harmful.
The panel made several specific recommendations regarding future research, including but not limited to:
- Design and conduct rigorous randomized, controlled trials of the impact of individual supplements to test their efficacy and safety in prevention of chronic disease, using well-validated measures.
- Build new MVM databases that detail the exact composition of supplements, update them on a continuous basis, and assure their constant availability to the research community.
- Develop a strategy to support a better understanding of possible interactions between MVMs and prescribed or over-the-counter medications.
The panel's findings pertain to the generally healthy population, and do not include pregnant women, children, or those with disease. The full text of the panel's draft state-of-the-science statement is available at http://consensus.nih.gov. The final version should also be available at the same web site soon.
FDA Allows Qualified Health Claim that Barley Helps Reduce Risk of CHD
The FDA finalized a rule that allows foods containing whole grain barley to claim that they reduce the risk of coronary heart disease.
Specifically, whole barley and dry milled barley products such as flakes, grits, flour, meal, and barley meal, which provide at least 0.75 g soluble fiber per serving, may bear the following claim: "Soluble fiber from foods such as [name of food], 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 [x] grams of the soluble fiber necessary per day to have this effect."
Scientific evidence indicates that including barley in a healthy diet can help reduce the risk of coronary heart disease by lowering low density lipoprotein cholesterol and total cholesterol levels.
FDA began allowing the claim in December 2005 under an interim final rule, while at the same time accepting public comments on the rule for 75 days. During this time no comments were received that warranted changes to the interim final rule. To view the final rule, go to: www.fda.gov/ohrms/dockets/98FR/04p-0512-nfr0001.pdf.
FDA Denies Petition to Allow Qualified Health Claim for Green Tea
The FDA has concluded that there is no credible evidence to support qualified health claims for green tea or green tea extract and a reduction of a number of risk factors associated with cardiovascular disease (CVD).
In June 2005, Ito En, Ltd., and its American subsidiary Ito En (North America) petitioned FDA to authorize the qualified health claim that "daily consumption of at least 5 fluid ounces (150 mL) of green tea as a source of catechins may reduce a number of risk factors associated with cardiovascular disease." FDA denied the petition.
The petition cited 105 publications as evidence to substantiate the relationship for this claim. In addition to the studies included in the petition, FDA identified from a literature search one additional observational study and one additional intervention study that evaluated the relationship between green tea consumption and risk of CVD.
When it had evaluated the information included in the petition, FDA said that the totality of the scientific evidence in this case included four intervention studies on green tea that found no evidence of an effect on CVD; four observational studies on green tea, three of which (two cross-sectional studies and one hybrid design) reported a correlation between green tea and a reduced risk of CVD; and three intervention studies on green tea extract that found no evidence of an effect. Overall, FDA determined that this evidence is not credible to support the relationship between consumption of green tea or green tea extract and a reduced risk of CVD.
For a more in-depth discussion of the petition, see www.cfsan.fda.gov/~dms/qhcgtea2.html.
An independent panel ... has concluded that more rigorous scientific research is needed before strong recommendations can be made regarding multivitamin/minerals (MVMs) use to prevent chronic diseases.Subscribe Now for Access
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