Guide to Dietary Supplements

by Food and Drug Administration (FDA)

Set between a Chinese restaurant and a pizza and sub sandwich eatery, a Rockville health food store offers yet another brand of edible items: Bottled herbs like cat's claw, dandelion root, and blessed thistle. Vitamins and minerals in varying doses. Herbal and nutrient concoctions whose labels carry claims about relieving pain, "energizing" and "detoxifying" the body, or providing "guaranteed results."

This store sells dietary supplements, 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.

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 will be required on the labels of most dietary supplements.

Dietary supplements come in many forms, including tablets, capsules, powders, softgels, gelcaps, and liquids. Though commonly associated with health food stores, dietary supplements also are sold in grocery, drug and national discount chain stores, as well as through mail-order catalogs, TV programs, the Internet, and direct sales.

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.

Monitoring for Safety

As with food, federal law requires manufacturers of dietary supplements to ensure that the products they put on the market are safe. But supplement manufacturers do not have to provide information to FDA to get a product on the market, unlike the food additive process often required of new food ingredients. FDA review and approval of supplement ingredients and products is not required before marketing.

Food additives not generally recognized as safe must undergo FDA's premarket approval process for new food ingredients. This requires manufacturers to conduct safety studies and submit the results to FDA for review before the ingredient can be used in marketed products. Based on its review, FDA either authorizes or rejects the food additive.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.