Echinacea Extract GRAS Status For Binding Agent In Drugs Requested
This article was originally published in The Tan Sheet
Executive Summary
An Israeli pharmaceutical firm is seeking GRAS status for use of echinacea extract as a binding agent in certain solid-dosage form OTC and Rx drugs intended for short-term use.
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CTS Chemical Industries
Company withdraws citizen petition requesting GRAS status for use of echinacea extract as binding agent in certain solid-dosage form drugs, FDA acknowledges in Oct. 3 letter to Israeli pharmaceutical firm's New Jersey-based consultant. CTS filed a petition in September 2000 proposing use of the extract, in amounts of 3 mg-30 mg per dosage unit, in cough/cold remedies, antidiarrheal agents, analgesics, antibiotics (1"The Tan Sheet" Sept. 18, 2000, p. 3)
CTS Chemical Industries
Company withdraws citizen petition requesting GRAS status for use of echinacea extract as binding agent in certain solid-dosage form drugs, FDA acknowledges in Oct. 3 letter to Israeli pharmaceutical firm's New Jersey-based consultant. CTS filed a petition in September 2000 proposing use of the extract, in amounts of 3 mg-30 mg per dosage unit, in cough/cold remedies, antidiarrheal agents, analgesics, antibiotics (1"The Tan Sheet" Sept. 18, 2000, p. 3)
CTS Chemical Industries
Company withdraws citizen petition requesting GRAS status for use of echinacea extract as binding agent in certain solid-dosage form drugs, FDA acknowledges in Oct. 3 letter to Israeli pharmaceutical firm's New Jersey-based consultant. CTS filed a petition in September 2000 proposing use of the extract, in amounts of 3 mg-30 mg per dosage unit, in cough/cold remedies, antidiarrheal agents, analgesics, antibiotics (1"The Tan Sheet" Sept. 18, 2000, p. 3)