The Facts of Botanical Dietary Supplements

Many people believe that products labeled "natural" are safe and good for them. This is not necessarily true because the safety of a botanical depends on many things, such as:

• its chemical makeup
• how it works in the body
• how it is prepared
• the dose used

The action of botanicals range from mild to powerful (potent). A botanical with mild action may have subtle effects. Chamomile and peppermint, both mild botanicals, are usually taken as teas to aid digestion and are generally considered safe for self-administration. Some mild botanicals may have to be taken for weeks or months before their full effects are achieved. For example, valerian may be effective as a sleep aid after 14 days of use but it is rarely effective after just one dose. In contrast a powerful botanical produces a fast result. Kava, as one example, is reported to have an immediate and powerful action affecting anxiety and muscle relaxation.

The dose and form of a botanical preparation also play important roles in its safety. Teas, tinctures, and extracts have different strengths. The same amount of a botanical may be contained in a cup of tea, a few teaspoons of tincture, or an even smaller quantity of an extract. Also, different preparations vary in the relative amounts and concentrations of chemical removed from the whole botanical. For example, peppermint tea is generally considered safe to drink but peppermint oil is much more concentrated and can be toxic if used incorrectly.

It is important to follow the manufacturer's suggested directions for using a botanical and not exceed the recommended dose without the advice of a health care provider.

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

It is difficult to determine the quality of a botanical 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.

What methods are used to evaluate the health benefits and safety of a botanical dietary supplement?

Scientists use several approaches to evaluate botanical dietary supplements for their potential health benefits and safety risks, including their history of use and laboratory studies using cell or animal models.

Studies involving people (individual case reports, observational studies, and clinical trials) can provide information that is relevant to how botanical dietary supplements are used. Researchers may conduct a systematic review to summarize and evaluate a group of clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis of data combined from many studies.

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 botanical dietary supplements?

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

• PubMed
• FDA

Related Resources

_{Source: Botanical Dietary Supplements: Background Information, Office of Dietary Supplements, NIH}

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