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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. The FDA oversees safety, manufacturing and product information, such as claims, in a product's labeling, package inserts, and accompanying literature. One thing dietary supplements are not is drugs. 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. Dietary supplements are also not to be mistaken as replacements for conventional diets, nutritionists say. Supplements do not provide all the known--and perhaps unknown--nutritional benefits of conventional food. Surveys show that more than half of the U.S. adult population uses dietary supplements. In 1996 alone, consumers spent more than $6.5 billion on dietary supplements. 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? FDA Regulation The 1994 Dietary Supplement Health and Education Act, or DSHEA set up a new framework for FDA regulation of dietary supplements. 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. It also created an office in the National Institutes of Health (NIH) to coordinate research on dietary supplements calling on President Clinton to set up an independent dietary supplement commission to report on the use of claims in dietary supplement labeling. FDA answers consumers' questions by noting that under DSHEA, FDA's requirement for pre-market 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.
Dietary supplement labels will be required to include the following information.
An FDA Guide to Dietary Supplements Fraudulent Products
Fraudulent products often can be identified by the types of claims made in their labeling, advertising, and promotional literature. Some possible indicators of fraud are:
Though often more difficult to do, consumers also can protect themselves from economic fraud, a practice in which the manufacturer substitutes part or all of a product with an inferior, cheaper ingredient and then passes off the fake product as the real thing but at a lower cost. Consumers should avoid products sold for considerably less money than competing brands. If it's too cheap, the product is probably not what it's supposed to be. If shoppers find dietary supplements whose labels state or imply that the product can help diagnose, treat, cure, or prevent a disease (for example, "cures cancer" or "treats arthritis"), they should realize that the product is being marketed illegally as a drug and as such has not been evaluated for safety or effectiveness. Quality Products
To help protect themselves, consumers should:
Reading and Reporting Consumers who use dietary supplements should always read product labels, follow directions, and heed all warnings. Supplement users who suffer a serious harmful effect or illness that they think is related to supplement use should call a doctor or other health-care provider. He or she in turn can report it to FDA MedWatch by calling 1-800-FDA-1088 or going to the MedWatch Website. Patients' names are kept confidential. To get the skinny on dietary supplements from the U.S. Food and Drug Administration click here: An FDA Guide to Dietary Supplements Heed this advice from the FDA before beginning any dietary supplement program: Before starting a dietary supplement, it's always wise to check with a medical doctor. It is especially important for people who are:
Certain supplements can boost blood levels of certain drugs to dangerous levels. Varro Tyler, Ph.D., Sc.D., distinguished professor emeritus of pharmacognosy at Purdue University, cites as examples garlic and the supplement ginkgo biloba. Both can thin the blood, which can be hazardous, he says, for people taking prescription medicines that also thin the blood. In addition to medical doctors, other health-care professionals, such as registered pharmacists, registered dietitians and nutritionists, can also be sources of information about dietary supplements. For more information check out USACHPPM's Dietary Supplements page and Potential Dangers and Guidance - Dietary Supplements & Performance Enhancers. Source: US Food and Drug Administration: FDA Guide to Dietary Supplements
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Traditionally, dietary supplements refer to products made of one or more of the essential nutrients, such as vitamins, minerals, and protein; and may also include any product intended for ingestion as a supplement to the diet. This includes vitamins; minerals; herbs, botanicals, and other plant-derived substances; amino acids (the individual building blocks of protein); and concentrates, metabolites, constituents and extracts of these substances.
Consumers need to be on the lookout for fraudulent products. These are products that don't do what they say they can or don't contain what they say they contain. At the very least, they waste consumers' money, and they may cause physical harm.
Poor manufacturing practices are not unique to dietary supplements, but the growing market for supplements in a less restrictive regulatory environment creates the potential for supplements to be prone to quality-control problems. For example, some manufacturers were buying herbs, plants and other ingredients without first adequately testing them to determine whether the product they ordered was actually what they received or whether the ingredients were free from contaminants.
