Supplements

Dietary supplements are available widely through many commercial sources including health food stores, grocery stores, pharmacies, and by mail. Dietary supplements are provided in many forms including tablets, capsules, powders, geltabs, extracts, liquids, etc.

Historically in the United States, the most prevalent type of dietary supplement was a multivitamin/mineral tablet or capsule that was available in pharmacies by prescription or "over the counter." Supplements containing strictly herbal preparations were less widely available. Currently in the United States, a wide array of supplement products are available and they include vitamin, mineral, other nutrients, and botanical supplements as well as ingredients and extracts of animal and plant origin.

Concerning the manufacturer of the supplement

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, FDA has identified several problems where 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.

To help protect themselves, consumers should:

• Look for ingredients in products with the U.S.P. notation, which indicates the manufacturer followed standards established by the U.S. Pharmacopoeia.
• Realize that the label term "natural" doesn't guarantee that a product is safe. "Think of poisonous mushrooms," says Elizabeth Yetley, Ph.D., director of FDA's Office of Special Nutritionals. "They're natural."
• Consider the name of the manufacturer or distributor. Supplements made by a nationally known food and drug manufacturer, for example, have likely been made under tight controls because these companies already have in place manufacturing standards for their other products.
• Write to the supplement manufacturer for more information. Ask the company about the conditions under which its products were made.

How are dietary supplements regulated?

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Dietary Supplements Include The Following:

• a vitamin
• a mineral
• an herb or other botanical
• an amino acid
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake
• a concentrate, metabolite, constituent, extract, or combination of any of the above ingredients

Safety Tips

Consult a doctor or dietitian about the supplement.

Do some research concerning the supplement including:

• Use
• Dosage
• Benefits
• Adverse side effects
• Toxicity
• When it should not be taken because of disease processes
• What medications and other supplements that it should not be taken with