People who choose to supplement their diet with a wide range of vitamins, minerals and other substances may want to know more about the safety of these products.
The use of dietary supplements continues to increase. The "Nutrition Business Journal" estimated the total sales of dietary supplements at $17.8 billion in 2001. The frequency of use of supplements among the elderly is high compared with the general population, according to a May 2003 report from the National Institutes of Health’s Office of Dietary Supplements.
A dietary supplement is any product intended to supplement the diet which contains at least one of these ingredients: vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, glandulars, metabolites or a combination of these ingredients. To be designated as a supplement, the item must not be for use as the sole item of a meal or diet. The Dietary Supplement Health and Education Act, or DSHEA, of 1994 places dietary supplements in a special category under the general umbrella of "foods."
According to FDA regulations, information that must be on a dietary supplement label includes:
– A descriptive name of the product stating that it is a supplement.
– The name and address of the manufacturer, packer or distributor.
– A list of each ingredient contained in the product.
– The net contents of the product.
– A supplement facts panel. The manufacturer is responsible for ensuring that the supplement facts label and ingredient list are accurate, that the dietary ingredients are safe and that the content matches the amount declared on the label.
– Ingredients not listed on the supplement facts panel must be listed in the other ingredient statement beneath the panel. Other ingredients could include water, sweeteners, gelatin, starch, colors, stabilizers, preservatives and flavors.
There are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval. Consumers who want more detailed information than what is listed about a specific product may contact the manufacturer.
The manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label. No provisions exist in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. The FDA monitors safety after the product has been marketed.
The responsibility for ensuring the validity of claims for dietary supplements rests with the manufacturer, FDA and, in the case of advertising, with the Federal Trade Commission. Advertising and promotional material received in the mail are subject to regulation by the U.S. Postal Inspection Service.
If you or your health-care provider suspect that you have suffered an adverse effect from the use of a dietary supplement, you should report your concerns to the FDA’s MedWatch hotline at 1-800-FDA-1088. You can also submit a report by fax to 1-800-FDA-0178 or online at http://www.fda.gov/medwatch/report/hcp.htm.
Be aware that some supplements interfere with the action of medications, creating a variety of ill effects. Large doses of either single-nutrient supplements or high potency vitamin-mineral combinations may be harmful. Some supplements may produce undesirable effects such as fatigue, diarrhea and hair loss when taken in large amounts. Too much of one mineral can interfere with the absorption of other minerals you may need.
Before taking supplements, ask your doctor or a registered dietitian to evaluate your eating habits, recommend beneficial changes and determine whether a supplement is appropriate for you. If you wish to supplement your diet, a multi-vitamin/mineral product that does not exceed 100 percent of the Recommended Dietary Intake is the best strategy. This is not as a replacement, but a supplement. The elderly may need more vitamin B12, and the 1,500 mg recommendation for calcium for the elderly may indicate they need a calcium supplement.
The most cost-effective way to promote good health is to exercise regularly and eat a wide selection of foods. There simply is no substitute for the nutritional benefits of food.
Additional information about dietary supplements is available from these Internet resources:
– Cooperative Extension fact sheet 9.338 – Food vs. Pills, at www.ext.colostate.edu/pubs/foodnut.
– Center for Food Safety and Applied Nutrition, "Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information" at www.cfsan.fda.gov/~dms/ds-savvy.html.
– National Institutes of Health, Dietary Supplements: Background Information at http://ods.od.nih.gov/factsheets/generalbackground_pf.html.
Additional information on Healthy Aging can be found on the Colorado State Cooperative Extension Web site at www.ext.colostate.edu by going to Info Online, Consumer and Family, and selecting Healthy Aging.
by Kay Zimka, Family and Consumer Extension Agent, Colorado State University Cooperative Extension, Jefferson County