Perspective_vanBreemen_2015-rev.pdf (892.36 kB)
Development of Safe and Effective Botanical Dietary Supplements
journal contribution
posted on 2016-07-14, 00:00 authored by R.B. Van BreemenRegulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug-botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements.
Funding
Grant P50 AT000155 from the NIH Office of Dietary Supplements and the National Center for Complementary and Integrative Health
History
Publisher Statement
© 2015 American Chemical Society.Publisher
American Chemical SocietyLanguage
- en_US
issn
0022-2623Issue date
2015-06-01Usage metrics
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