Are botanical dietary supplements standardized?
U.S. law does not require dietary supplements to be “standardized." Standardization is a process that manufacturers may use for their products to ensure all of their supplements under the same label are similar. The standardization process involves identifying and measuring specific chemicals to assure consistent amounts in each supplement batch. Ideally, the chemical markers chosen for standardization would also be the constituents that are responsible for a botanical’s effect in the body. If such chemical markers were used, each batch of the product would have the same health effects. However, the constituents responsible for the effects of most botanicals are not known.
Are botanical dietary supplements safe?
Some people believe that products labeled “natural” are safe and good for them. This belief is not necessarily correct 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, and the amount used.
The actions of botanicals range from mild to powerful. Some botanicals with mild action might need to be taken for weeks or months before their full effects are achieved. For example, valerian might help users sleep better after a few weeks of use, but just one dose is rarely effective. In contrast, a powerful botanical produces a fast result. Green tea, for example, can have strong and immediate stimulant effects. Also, different preparations have different amounts and concentrations of constituents extracted from whole botanicals. For example, peppermint tea is generally considered safe to drink, but peppermint oil is much more concentrated and can be toxic if used incorrectly.
TIP: Follow the manufacturer’s suggested directions for using a botanical and do not exceed the recommended dose unless your healthcare provider directs otherwise. You should always talk with your healthcare provider about botanical and other dietary supplements you are using or are thinking of using.
Does a label indicate the quality of a botanical dietary supplement product?
Determining the quality of a botanical dietary supplement product from its label is difficult. The degree of quality control depends on the manufacturer and others in the production process. The U.S. Food and Drug Administration (FDA) has established good manufacturing practices (GMPs) that dietary supplement manufacturers must follow to help ensure the identity, purity, strength, and composition of their dietary supplements. However, this is all done by self-reporting from the manufacturers, so there isn't an objective way to test for identity, purity, strength, and composition unless supplements are third party tested.
Several independent organizations offer quality testing and allow products that pass these tests to display a seal of quality assurance. These seals indicate that a product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. I always recommend purchasing from a manufacturer that third-party tests their supplement products. Organizations that offer quality testing include:
What methods are used to evaluate the health benefits and safety of a botanical dietary supplement?
Scientists may conduct laboratory studies of the botanical’s effects on cell or tissue cultures, or examine its effects in animals. However, studies with humans provide the most direct evidence of a botanical supplement’s effects on health. The amount of scientific evidence available on the health effects and safety of botanical ingredients varies widely. For example, scientists have conducted numerous studies (with mixed results) on some botanicals, but very little on others.
Unlike medicines that must be evaluated for safety and efficacy and receive FDA approval before they can be sold or marketed, dietary supplements, including botanicals, do not require FDA approval. This is why it's important to have third party testing for identity, purity, strength, and composition of a dietary supplement.
How can you choose a safe, pure and effective supplement?
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What are some additional sources of information on botanical dietary supplements?
This article was adapted from the National Institute of Health: Office of Dietary Supplements page on Botanical Supplements. To read the full article and to learn more about botanical supplements visit this website: https://ods.od.nih.gov/factsheets/BotanicalBackground-Consumer/
For information about the safety and effectiveness of botanical and other dietary supplement ingredients, see the ODS Dietary Supplement Fact Sheets and the Herbs at a Glance series from the National Center for Complementary and Integrative Health.
For regulatory information on dietary supplements, visit the FDA website