The Facts of Dietary Supplements

What information is required on a dietary supplement label?

FDA requires that certain information appear on the dietary supplement label:

General information

Supplement Facts panel

Other ingredients

The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean that no adverse effects are associated with the product.

A label for a fictitious botanical product is available at http://vm.cfsan.fda.gov/~acrobat/fdsuppla.pdf.

Does a label indicate the quality of a dietary supplement product?

It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.

FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.

Are dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements. Because of this, the term “standardization” may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word “standardized” on a supplement label does not necessarily indicate product quality.

General Safety Advisory

Disclaimer

Reasonable care has been taken in preparing this document and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations.

What are some additional sources of information on dietary supplements?

Medical libraries are one source of information about dietary supplements. Others include Web-based resources such as:

• PubMed
• FDA

Related Resources

_{Source: Dietary Supplements: Background Information, Office of Dietary Supplements, National Institutes of Health}

Go Back To Part 1 --- Facts Of Dietary Supplements --->