Problems When Patients Hide Supplements – Part 2

Part 2 of 7 parts.

The United States has seen the use of dietary supplements steadily increase from less than 20 percent of the population in 1970 to approximately 50 percent at the time of the last survey in 2006. Individuals report using dietary supplements to increase energy, maintain strength, enhance performance, maintain health and immune system function, and prevent nutritional deficiencies. Only 33.4 percent of individuals, however, inform their doctors that they are taking herbal products and dietary supplements.

Most consumers aren't aware that the health claims on labels intended for marketing purposes may not be accurate. Although dietary supplements are regulated by the US Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and drugs.

Individuals who use dietary supplements believe that these products help them retain control of their own health. Patients typically believe that dietary supplements are not drugs and for that reason have fewer side effects than conventional medications.

Whether a product is classified as a dietary supplement, conventional food, or drug depends on its intended use. Classification as a dietary supplement is usually determined by the information provided by the manufacturer on the product label or in accompanying literature, although many food and dietary supplement product labels lack these details.

The term "dietary supplement" is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) as a product, intended to supplement the diet, that bears or contains one or more of the following dietary ingredients:

• Vitamin;
• Mineral;
• Herb or other botanical;
• Amino acid;
• Dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
• Concentrate, metabolite, constituent, extract, or combination of any ingredient described above.

A dietary supplement is intended for consuming as a tablet, capsule, powder, soft gel, gel cap, or liquid form. These products are not represented for use as conventional foods or as the sole item in a meal or diet and are labeled as "dietary supplements." Moreover, a dietary supplement may not contain a form or substance that is an approved drug or is authorized for investigation as a new drug, and for which substantial clinical investigations have been initiated and made public, unless that article was marketed as a food or a dietary supplement prior to its approval as a new drug or authorization as an investigational new drug. Vitamin D is an example of a dietary supplement that may soon begin to be marketed as a drug.

The FDA regulates dietary supplements under a different set of rules than those covering conventional foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994, the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement after it reaches the market. Generally, manufacturers do not need to register their products with the FDA or get FDA approval before producing or selling dietary supplements. However, manufacturers must make certain that product label information is truthful and not misleading.

The FDA's post-marketing responsibilities include monitoring safety (eg, voluntary dietary supplement adverse event reporting) and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates advertising for dietary supplements. Domestic and foreign facilities that also manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register their facilities with the FDA.