Dietary supplements are used by about 75% of Americans. They are the most common therapies included among integrative medicine and health (IMH) and complementary and alternative medicine (CAM) Overview of Integrative, Complementary, and Alternative Medicine Integrative medicine and health (IMH) and complementary and alternative medicine (CAM) include a variety of healing approaches and therapies that historically have not been included in conventional... read more , which include healing approaches and therapies that historically have not been included in conventional, mainstream Western medicine. Dietary supplements include medicinal herbs and nutraceuticals (products derived from food sources that claim to provide health benefits). Because the use of dietary supplements is widespread, the United States government passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. It defines a dietary supplement as any product (besides tobacco) that contains a vitamin, mineral, herb or other plant product, or amino acid and that is intended as a supplement to the normal diet. Certain hormones, such as dehydroepiandrosterone Dehydroepiandrosterone (DHEA) Dehydroepiandrosterone (DHEA) is a steroid produced in the adrenal glands and converted into sex hormones (estrogens and androgens). DHEA’s effects on the body are similar to those of testosterone... read more (DHEA) and melatonin Melatonin Melatonin, a hormone produced by the pineal gland (located in the middle of the brain), regulates the sleep-wake cycle. Melatonin used in supplements can be derived from animals, but most is... read more , also are considered dietary supplements.
The DSHEA requires that the label of a dietary supplement identify it as such. The label must state that the claims for the dietary supplement have not been evaluated by the US Food and Drug Administration (FDA). The label must also list each ingredient by name, quantity, and total weight and must identify the plant parts from which each ingredient is derived. Manufacturers are permitted to make claims about the product's structure and function (for example, good for urinary tract health), but they cannot make or imply claims for the product as a drug or therapy (for example, treats urinary tract infections). Expiration dates are often included on the standardized product labels.
Most dietary supplements used in alternative medicine are derived from plants, and some are derived from animals. Because such dietary supplements are natural, some people assume that they are safe to use. However, a substance is not necessarily safe just because it is natural. For example, many potent poisons, such as hemlock, are derived from plants, and some, such as snake venoms, are derived from animals. Furthermore, almost all substances that affect the body, whether dietary supplements or drugs approved for medical use by the FDA, can have unwanted side effects.
Safety and Effectiveness
Because dietary supplements are not regulated as drugs by the FDA, their manufacturers are not required to prove that supplements are safe and effective (although they must have a history of safety). Consequently, few supplements have been studied rigorously for safety and effectiveness. Furthermore, because the need to evaluate supplements in humans has been recognized only recently, much of the available information has not been gathered systematically or scientifically and so is difficult to evaluate. Manufacturers must now report serious adverse events to the FDA through the FDA MedWatch system. However, a few supplements (for example, fish oil Fish Oil Fish oil is derived from the tissues of oily fish, such as mackerel, herring, tuna, and salmon. Fish oil supplements contain oil that is extracted directly or concentrated and put in capsule... read more , chondroitin Chondroitin Sulfate Chondroitin sulfate is a natural component of cartilage. It is extracted from shark or cow cartilage or manufactured synthetically. It is frequently combined with glucosamine. Chondroitin sulfate... read more , glucosamine Glucosamine Glucosamine is extracted from a material (chitin) present in the shells of crabs, oysters, and shrimp. Glucosamine can be applied topically in a cream or salve or taken in tablet or capsule... read more ) are proven to be safe and useful additions to standard drugs.
In contrast, both prescription and nonprescription (over-the-counter) drugs have been extensively and systematically studied by researchers and reviewed for safety and effectiveness Drug Effectiveness and Safety The main goals of drug development are demonstrating the effectiveness and safety of the drug. Because all drugs can harm as well as help, safety is relative. The difference between the usual... read more by the FDA. These include studies in animals to detect the development of cancer and organ damage and studies in humans to detect any signs of toxicity.
The amount and quality of evidence supporting the effectiveness of supplements vary greatly. For some supplements, evidence supporting their effectiveness is convincing. However, for most, scientific studies have not been designed well enough to provide clear, reliable answers. For some supplements, the only evidence suggesting effectiveness is reports about small numbers of people or studies conducted in animals.
Evidence about the safety and effectiveness of dietary supplements is increasing rapidly as more and more clinical studies are being done. Information about such studies is available from the National Institutes of Health's National Center for Complementary and Integrative Health (NCCIH).
Purity and Standardization
Other areas of concern are the purity and standardization of supplements. Supplements, unlike drugs, are not regulated to ensure that they are pure or that they contain the ingredients or the amount of active ingredient they claim to contain. As a result, the supplement may contain other substances that may be inert or harmful, including, in some cases, prescription or nonprescription drugs, natural toxins, bacteria, pesticides, unapproved dyes, and even dangerous substances such as heavy metals, including lead and mercury.
The amount of active ingredient in a dose of a supplement may vary, especially when whole herbs are ground or made into extracts to produce a tablet, capsule, or solution. The buyer is at risk of getting less, more, or, in some cases, none of the active ingredient in a supplement. Standardization requires that each individual dosage form of the product contain a precise amount of its active ingredient or ingredients. However, most herbal products are mixtures of several substances, and which ingredient is the most active is not always known. Therefore, determining which ingredient or ingredients should be considered active and thus subject to standardization can be difficult. Some supplements, particularly those produced in Europe, have been standardized and may include a designation of standardization on the label.
Advice on how to choose a pure, standardized product varies from expert to expert. Most experts recommend buying from a well-known manufacturer, and many recommend buying products made in Germany because oversight of supplements is stricter there than in the United States.
Although the content of a supplement is not standardized, the way in which it is manufactured has been standardized. In 2007, the Food and Drug Administration (FDA) created current good manufacturing practices (GMPs) that standardize the manufacturing, packaging, labeling, and storing of dietary supplements. These GMPs help ensure the quality of dietary supplements and help protect the public health.
Interactions With Drugs
Supplements can interact with prescription and nonprescription drugs. Such interactions may intensify or reduce the effectiveness of a drug or cause a serious side effect. Before taking supplements, people should consult their doctor, so that such interactions can be avoided. Few well-designed studies have been conducted to investigate supplement-drug interactions, so most information about these interactions comes from sporadic individual reports of interactions.
Other Concerns
In addition to drug interactions, there are other potential issues with using dietary supplements:
Supplements (especially herbal products) may not be stable once manufactured and may, as a result, yield inconsistent benefits or no benefit at all.
Unlike with prescription drugs, there is often little evidence about the best dose of supplements.
People may use dietary supplements instead of conventional drugs prescribed by their doctor.
Supplements may be toxic and cause harm.
Supplement use may contribute to incorrect diagnosis of a medical problem because placebo effects can simulate true benefits, particularly if the person and/or doctor strongly believe in the supplement. Therapeutic responses to supplements, placebo-mediated or otherwise, could be mistaken as evidence that confirms a particular, possibly incorrect, diagnosis.
To avoid or manage these potential issues, it is important that people disclose their use of all dietary supplements to their doctor.
More Information
The following are some English-language resources that may be useful. Please note that THE MANUAL is not responsible for the content of these resources.
