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Dietary supplements may not be as they appear

March 24, 2004|by LYNN F. LITTLE

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.

A dietary supplement is any product that is intended to supplement the diet and 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 of 1994 places dietary supplements in a special category under the general umbrella of "foods."

According to U.S. Food and Drug Administration regulations, information that must be on a dietary supplement label includes:

  • a descriptive name stating that it is a supplement

  • the name and address of the manufacturer, packer or distributor

  • a list of each ingredient

  • 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.

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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, the 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 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 also can submit a report by fax to 1-800-FDA-0178 or online at the FDA MedWatch Web site: 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. Do not take self-prescribed single nutrient supplements without first consulting a physician or registered dietitian.

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 multivitamin/mineral product that does not exceed 100 percent of the recommended dietary intake for your age and gender is the best strategy.

Healthy people can obtain all the vitamins and minerals they need from eating a variety of foods. Taking supplements does not guarantee protection against disease.

The most cost-effective way to promote good health is to exercise regularly and eat a broad selection of foods. There simply is no substitute for the nutritional benefits of food. Our food supply provides a unique balance that cannot be duplicated by taking any combination of supplements. In addition, eating is one of life's pleasures. However, it is evident by supplement sales totaling over $3 billion a year that we are investing much in the hope that supplements will help.

Additional information about dietary supplements is available from these Internet resources:



Lynn F. Little is a family and consumer sciences educator with Maryland Cooperative Extension in Washington County.

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