Manual of Nutritional Therapeutics by Alpers David H. & Taylor Beth E. & Bier Dennis M. & Klein Samuel

Author:Alpers, David H. & Taylor, Beth E. & Bier, Dennis M. & Klein, Samuel
Language: eng
Format: epub
Publisher: LWW
Published: 2015-01-20T16:00:00+00:00

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Dietary Supplements

A dietary supplement is a product or compound that is taken orally and meant to supplement the diet. A wide variety of dietary supplements include herbal products, vitamins, minerals, amino acids, and biochemical intermediates such as carnitine and creatine (1). In some countries, supplements are defined as foods, and in others as drugs or natural health products. No such distinction is made in the United States of America by the Food and Drug Administration (FDA). Dietary supplements are consumed widely in the United States and elsewhere; in the United States alone, many billions of dollars are spent on dietary supplements each year. A large percentage of the US population use supplements, accounting for a major proportion of the estimated average requirement (EAR) for many micronutrients (2).

For some dietary supplements, good scientific data are available to support safety and efficacy, whereas for others, no such data exist. Few large, controlled clinical trials have assessed the safety and efficacy of dietary supplements. In contrast, large, controlled trials are required by law for the approval of prescription drugs. For this reason, far less information is available to assess the safety and efficacy of dietary supplements than to assess prescription drugs. To address this lack of data, the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) has developed a website that serves as a clearing house for peer-reviewed information on dietary supplements, http://ods.od.nih.gov/publications/publications.html.

REGULATION OF DIETARY SUPPLEMENTS

The FDA requires that prescription drugs have been proved safe and effective for their labeled use before they are marketed; however, no such requirement applies to dietary supplements provided they are not marketed as a treatment for a specific disease. Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994. These regulations, which are largely favorable to the manufacturers of dietary supplements, were enacted by Congress in response to an effort by the FDA to remove some herbal products from the market. The negative public response to this effort caused the government to relax the regulations on dietary supplements.

Subsequent to the passage of the DSHEA, the FDA in 2007 implemented a policy to ensure that dietary supplements “are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled,” using current good manufacturing practices (GMPs) (3). Audits in 2011 and 2012, however, showed that approximately 70% of supplement manufacturers were currently not compliant with GMP, and also were under-reporting adverse events (4). To remove a product from the market, the FDA must prove that the product is unsafe, but the FDA is underfunded to test most of the products. The FDA’s final rule on GMPs means that the products must meet the conditions to prevent adulteration under the Federal Food, Drug, and Cosmetic Act (3). It is not surprising that contamination and false labeling are not uncommon (5). An attempt was made in 2010 to require enforcement of the DSHEA (Dietary Supplement Full Implementation and Enforcement Act, S3414), but it did not become law (6).

The FDA does

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