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2015 ; 58
(21
): 8360-72
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Development of Safe and Effective Botanical Dietary Supplements
#MMPMID26125082
van Breemen RB
J Med Chem
2015[Nov]; 58
(21
): 8360-72
PMID26125082
show ga
Regulated 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.