Botanical Drug Approval Lower Efficacy Standard Endorsed By Purdue's Tyler
This article was originally published in The Tan Sheet
Executive Summary
FDA should require less stringent efficacy standards for OTC botanical drug products than are necessary for synthetic drugs, Purdue University's Varro Tyler, PhD, suggested at Nutracon 2001 in San Diego July 9.
You may also be interested in...
Herbal Medicines Expert Tyler Dies At Age 74
The dietary supplement industry has lost one of its staunchest supporters and most vocal critics with the death of Varro Tyler, PhD, on Aug. 22 at St. Elizabeth's Hospital in Lafayette, Ind. He was 74.
NSF International
Dietary supplement certification program standards published July 9, organization notes at Nutracon. Program standards include criteria to measure quality and quantity of supplement ingredients, acceptable levels of contaminants. Twelve supplement products currently are being tested by NSF, group says; more tests to follow soon. Supplements meeting program standards will be emblazoned with NSF certification seal (1"The Tan Sheet" Feb. 19, p. 18)
Botanical Drug Product Guidance Sets Foreign Marketing Data Requirements
Companies interested in submitting an IND to conduct clinical trials on a botanical that has only been extensively available abroad must supply the agency with sales data as well as information on consumer exposure and adverse events.