Dietary supplements are some of the hottest selling items on the market today. Surveys show that more than half of the U.S. adult population uses these products. In 1996 alone, consumers spent more than $6.5 billion on dietary supplements, according to Packaged Facts Inc., a market research firm in New York City.

But even with all the business they generate, consumers still ask questions about dietary supplements: Can their claims be trusted? Are they safe? Does the Food and Drug Administration approve them?

Many of these questions come in the wake of the 1994 Dietary Supplement Health and Education Act, or DSHEA, which set up a new framework for FDA regulation of dietary supplements. It also created an office in the National Institutes of Health to coordinate research on dietary supplements, and it called on President Clinton to set up an independent dietary supplement commission to report on the use of claims in dietary supplement labeling.

In passing DSHEA, Congress recognized first, that many people believe dietary supplements offer health benefits and second, that consumers want a greater opportunity to determine whether supplements may help them. The law essentially gives dietary supplement manufacturers freedom to market more products as dietary supplements and provide information about their products' benefits--for example, in product labeling.

The Council for Responsible Nutrition, an organization of manufacturers of dietary supplements and their suppliers, welcomes the change. "Our philosophy has been ... to maintain consumer access to products and access to information [so that consumers can] make informed choices," says John Cordaro, the group's president and chief executive officer.

But in choosing whether to use dietary supplements, FDA answers consumers' questions by noting that under DSHEA, FDA's requirement for premarket review of dietary supplements is less than that over other products it regulates, such as drugs and many additives used in conventional foods.

This means that consumers and manufacturers have responsibility for checking the safety of dietary supplements and determining the truthfulness of label claims.

Anatomy of the Requirements for Dietary Supplement Labels

Information that will be required on the labels of dietary supplements includes:

• Statement of identity (e.g., "ginseng")
• Net quantity of contents (e.g., "60 capsules")
• Structure-function claim and the statement "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."
• Directions for use (e.g., "Take one capsule daily.")
• Supplement Facts panel (lists serving size, amount, and active ingredient)
• Other ingredients in descending order of predominance and by common name or proprietary blend.
• Name and place of business of manufacturer, packer or distributor. This is the address to write for more product information.

For more info, see link, dietary supplement labels in PDF format.

What Is a Dietary Supplement?

Traditionally, dietary supplements referred to products made of one or more of the essential nutrients, such as vitamins, minerals, and protein. But DSHEA broadens the definition to include, with some exceptions, any product intended for ingestion as a supplement to the diet. This includes vitamins; minerals; herbs, botanicals, and other plant-derived substances; and amino acids (the individual building blocks of protein) and concentrates, metabolites, constituents and extracts of these substances.

It's easy to spot a supplement because DSHEA requires manufacturers to include the words "dietary supplement" on product labels. Also, starting in March 1999, a "Supplement Facts" panel has been required on the labels of most dietary supplements.

FDA oversees safety, manufacturing and product information, such as claims, in a product's labeling, package inserts, and accompanying literature. The Federal Trade Commission regulates the advertising of dietary supplements.

One thing dietary supplements are not is drugs. A drug, which sometimes can be derived from plants used as traditional medicines, is an article that, among other things, is intended to diagnose, cure, mitigate, treat, or prevent diseases. Before marketing, drugs must undergo clinical studies to determine their effectiveness, safety, possible interactions with other substances, and appropriate dosages, and FDA must review these data and authorize the drugs' use before they are marketed. FDA does not authorize or test dietary supplements.

A product sold as a dietary supplement and touted in its labeling as a new treatment or cure for a specific disease or condition would be considered an unauthorized--and thus illegal--drug. Labeling changes consistent with the provisions in DSHEA would be required to maintain the product's status as a dietary supplement.

Another thing dietary supplements are not are replacements for conventional diets, nutritionists say. Supplements do not provide all the known--and perhaps unknown--nutritional benefits of conventional food.

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