Education Key to Proper Supplement Use
By Kimberly Beauchamp, ND
Healthnotes Newswire (December 30, 2004)—In a November 4, 2004, press release, the US Food and Drug Administration (FDA) discussed initiatives to aid in the execution of the Dietary Supplement Health and Education Act (DSHEA), which will benefit the public by introducing measures to ensure product safety and by standardizing manufacturing and labeling of supplement products. The FDA has a unique opportunity through these new initiatives to heighten public awareness as to the proper use of nutritional supplements. Standardization of manufacturing and labeling practices should result in higher quality supplements being made available to a better-informed public—a step in the right direction for manufacturers and consumers of nutritional supplements.
The DSHEA was introduced in 1994 to help establish manufacturing, labeling, and safety standards for dietary supplements. The new initiatives set forth by the FDA were made in an attempt to ensure product consistency, improve the process of supplement safety evaluation, and further define how and when regulatory actions should be taken to protect consumers against unsafe or mislabeled nutritional supplements.
The first initiative is a regulatory strategy whereby the FDA will pool its resources with other groups to expand the base of information available to make safety and regulatory decisions about dietary supplements. Regulatory actions taken in other countries, adverse event reports, and consultation with experts will help determine the need for further investigation by the FDA to address supplement safety concerns.
The second initiative will help to ensure the safety of nutritional supplements by setting industry-wide standards for purity, quality, strength, and composition. One way the FDA plans to enforce good manufacturing procedures and accurate labeling practices is by analyzing samples of products for verification of the labeled ingredients. Appropriate action will be taken against manufacturers of unsafe or mislabeled products by a process similar to that used for other over-the-counter remedies and prescription drugs.
The third initiative is designed to help determine the amount, type, and quality of evidence needed for a manufacturer to substantiate claims made in the marketing of nutritional supplements. Currently under DSHEA, these claims must be substantiated; however, the term “substantiate” is not defined. Manufacturers are allowed to make few claims regarding nutrients, despite sound scientific evidence of the health-promoting properties of many of these substances, such as the use of calcium for osteoporosis prevention, folic acid for the prevention of brain and spinal cord defects in infants, potassium for stroke and high blood pressure prevention, and omega-3 fatty acids for heart disease prevention.
The steps announced by the FDA represent important advances in ensuring the consistency of nutritional supplements. For example, studies have shown that the antioxidant activity of gingko preparations varies considerably between products from different manufacturers. Standardization of manufacturing processes will assure consumers that the quality and activity of nutritional supplements is consistent, regardless of the maker. As safety is of paramount concern to all consumers of nutritional supplements, by appropriately addressing safety concerns, consumer awareness of and confidence in natural remedies should increase.
A possible area of concern regarding these initiatives is that the FDA may try to set maximum dosages of supplement ingredients. Often, higher dosages of certain nutritional ingredients are used to have a therapeutic, or healing, effect on the body. If maximum dosages are set, it will limit the consumers’ access to therapeutic dosages of nutritional supplement ingredients. Multivitamin preparations that contain the US Recommended Dietary Allowances for vitamins and minerals, for instance, are likely only to prevent certain deficiency syndromes (such as scurvy). The amounts of vitamins and minerals in these preparations are unlikely to be great enough to have a therapeutic effect in the treatment of many health conditions. Were the FDA to use these initiatives to set maximum allowable ingredient dosages, it could prove detrimental to the health of the American public.
Hopefully, the FDA will also use these strategies to compare the safety and efficacy of other over-the-counter remedies with the natural remedies used to treat the same conditions. For example, dextromethorphan, the active ingredient in many cough suppressants such as Robitussin Pediatric™, commonly causes dizziness and nausea. If a safety concern should arise regarding a natural cough suppressant, the natural remedy should be evaluated in the context of the over-the-counter alternatives. In addition, the FDA should use its expanded base of information regarding nutritional supplement ingredients to increase the number of health claims allowed to be made by manufacturers so that consumers can make more informed decisions about which supplements to take and why.
Kimberly Beauchamp, ND, received her bachelor’s degree from the University of Rhode Island and her Doctorate of Naturopathic Medicine from Bastyr University in Kenmore, WA. She is a co-founder and practicing physician at South County Naturopaths, Inc., in Wakefield, RI. Dr. Beauchamp teaches holistic medicine classes and provides consultations focusing on detoxification and whole-foods nutrition.
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