Excerpted from ABC News, Wednesday, 5 November 1997.

FDA Frowns on Herbal Diet Drug

Says 'Phooey' to Fen-Phen

Washington -- The Food and Drug Administration warned consumers Thursday against diet supplements known as "herbal fen-phen" and said it will work to get these drugs off the market.

"These unapproved drugs have not been shown to be safe or effective and may contain ingredients that have been associated with injuries," the FDA said in a statement.

These herbal supplements are considered unapproved because they are being promoted as "natural" alternatives to the prescription anti-obesity drug combination phentermine and fenfluramine—collectively called fen-phen—which have been withdrawn from the market due to safety concerns.

The FDA said the use of the alternative, herbal products could increase following the withdrawal of fen-phen.

"FDA regards any over-the-counter product commercially promoted as an alternative to prescription anti-obesity drugs (such as phentermine and fenfluramine) to be a drug," the statement said. "The agency is taking appropriate regulatory action to remove such products from the market."

The main ingredient of most herbal fen-phen is ephedra, commonly known as Ma Huang, a stimulant associated with more than 800 reports since 1994 of conditions such as high blood pressure, heart rate irregularities, insomnia, nervousness, tremors, headaches, seizures, heart attacks, strokes and death, the FDA said.

Many herbal fen-phen products that contain ephedra also contain hypericum perforatum, an herb known as St. John's Wort, which the FDA said had not been studied adequately on its own or in combination with ephedra.

Another ingredient in some of these products is 5-hydroxy-tryptophan, a compound related to L-tryptophan, a diet aid widely used in the United States until 1990. It was withdrawn from the market after it was linked to more than 1,500 cases of a rare blood disorder, including 38 deaths.

Excerpted from ABC News, Wednesday, 5 November 1997.