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FDA releases draft of Guidance for Industry Botanical Drug Products

Published August 10, the guidance details when a botanical drug may be marketed under an over-the-counter drug monograph or a new drug application and includes guidelines for "submitting investigational new drug applications (INDs) for botanical drug products, including those...currently... marketed as foods and dietary supplements." The guidance also allows manufacturers to "submit reduced documentation of preclinical safety and of chemistry, manufacturing, and controls (CMC) to support an IND for initial clinical studies of botanicals that have been legally marketed in the United States as dietary supplements or cosmetics." Comments on the draft must be submitted by October 9. To view the draft, visit www.fda.gov/cder/guidance/ 1221dft.pdf. FDA website, August 11, 2000; www.naturalproductsinsider.com

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