Chapter 12: Dietary Supplements and Over-the-Counter Drugs

Dietary supplements and over-the-counter drugs may look the same to consumers on the drugstore shelves, but they are regulated in very different ways.  A drug is defined as a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  Over-the-counter drugs must be proven to be safe, effective, pure, and accurately labeled as well as approved by the US Food and Drug Administration before they go on the market.

In contrast, dietary supplements are regulated much more like food products. They must be safe and pure but they are not required to show that they are effective or provide any benefit.  In terms of safety, the burden of proof is on the FDA to show that a product presents a significant risk of illness or injury. For example, in the case of the stimulant ephedra, it took the FDA about 10 years from initial reports of problems to compile evidence to get ephedra banned.  Dietary supplements may include vitamins, minerals, herbs, amino acids, and enzymes in a variety of forms.

The labels of dietary supplements look like the labels for food products and include basic information about the content of the product.  The FDA authorizes a small number of health claims that food and supplement manufacturers can use if their products meet certain requirements. Supplements can also make claims about improving the structure or function of the body or overall well-being.  These structure/function claims are not regulated or approved by the FDA and they must carry a disclaimer stating that the product is not designed to treat or prevent a disease.

The differences in the regulation of supplements and drugs mean that many more dietary supplements have become available, giving consumers more options.  However, much less research is available about the safety and effectiveness of supplements compared to over-the-counter drugs.  Even popular products such as Saint-John's-Wort and ginkgo biloba have relatively little research about their actions, safety and effectiveness. Supplements also can interact dangerously with drugs and other supplements, and consumers need to use caution.

Over-the-counter drugs include ingredients that have been evaluated by the FDA and determined to be generally recognized as safe, effective, and accurately labeled.  Uniform labels for over-the-counter drugs help consumers compare products, follow the instructions for safe and effective use and understand key cautions and warnings.

For a given category of over-the-counter drug, most brands contain the same few ingredients.

For example, over-the-counter stimulants all contain caffeine, while over-the-counter sleep aids contain antihistamines.  The widely used category of pain-killing drugs, also known as analgesics, includes aspirin, acetaminophen, and ibuprofen.  Aspirin has analgesic, antipyretic, and anti-inflammatory actions. Acetaminophen, ibruprofen, and other so-called nonsteroidal anti-inflammatory drugs have related effects.  Overuse of any of the over-the-counter analgesics carries the risk of stomach or liver damage.

Cold and allergy remedies are also widely used.  Cold remedies often contain some combination of an antihistamine, an analgesic and a decongestant. Because many over-the-counter remedies are based on a small number of approved ingredients, an informed consumer can understand a large proportion of these products by being familiar with only a few drugs.