Nutrition News & Views

September 1, 2000
Dietary Supplements: Use and Current Regulations-September 2000/No. 1

According to information from the U.S. Food and Drug Administration, there are approximately 29,000 varieties of dietary supplements that are available for consumer use. This number is rapidly increasing as roughly 1000 new products join the marketplace annually. The Dietary Supplement Health and Education Act (DSHEA) of 1994 allowed for a greater number of products to be designated as dietary supplements and enabled manufacturers to supply information about the supposed benefits of their products. As a result, there has been a considerable increase in the use of nonvitamin, nonmineral (NVNM) supplements.

The DSHEA defines dietary supplements as "a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following ingredients: a) a vitamin; b) a mineral; c) an herb or other botanical; d) an amino acid; e) a supplement used by man to supplement the diet by increasing the total dietary intake; or f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (a-e). The law provides that a dietary supplement is a product that is labeled as a dietary supplement and is not represented for use as a conventional food or as a sole item of a meal or the diet. These products can be ingested as a capsule, powder, gelcap, tablet, liquid, or other form."

As the number of dietary supplements and supplement usage steadily increase, the importance of understanding the impact of supplement regulation increases concurrently. Since the DSHEA distinguishes dietary supplements from drugs and food additives, they are not subject to the same regulations.

Under the DSHEA regulations, the words "dietary supplement" and a "Supplement Facts" panel must appear on all supplement labels. Manufacturers are also required to ensure that their products are safe, but are not required to provide this information to the U.S. Food and Drug Administration (FDA) to get a product on the market. Unlike supplements, which do not undergo testing, drugs and food additives must undergo clinical or safety studies to receive FDA approval.

Although many manufacturers seem to follow good manufacturing practices and ensure product safety, others do not. Good manufacturing practices specific for supplements have not yet been established. The FDA is authorized by the DSHEA to establish such guidelines and is currently working with trade organizations to do so.

Manufacturers of new dietary supplement products can submit to FDA, at least 75 days before marketing, information backing their claim that the supplement is expected to be safe and does not present a health risk. The FDA does not evaluate these products for safety and effectiveness or monitor the product contents to see if content claims on labels are accurate. Once a product is on the market, the FDA must demonstrate it is unsafe before restricting its use.

Structure/function claims can be made about a dietary supplement on the product label. These are claims that refer to the effect of the product on the structure or function of the body, including its effect on well-being. They must be reported to FDA within 30 days of marketing the claim. While the manufacturer must support these claims with scientifically valid evidence, submission of such evidence is not required. Because the FDA does not authorize or test dietary supplements in relation to manufacturer's claims, labels must have the following disclaimer, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Without additional funding the FDA has limited monitoring capabilities and is unable to test the contents and safety of dietary supplements prior to their placement on the market. Thus, potential risks may exist for some of the supplements. Consumers need to be aware of the current regulations on dietary supplements so that they may make educated choices regarding supplement use.

Submitted by Allison Randolph, Diane Allen, and Kay Hoss, MSU Dietetic Interns
Distributed by Barbara McLaurin, PhD., R.D., L.D., Human Nutrition Specialist, MSU Extension Service, September 2000

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