FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
 
T97-56                        Marian Segal:     301-827-6242
November 6, 1997              
                              Consumer Hotline: 800-532-4440
 
      FDA WARNS AGAINST DRUG PROMOTION OF "HERBAL FEN-PHEN"
 
	The FDA has become aware of the increasing promotion of
various dietary supplement-type products as "natural" herbal
alternatives to the prescription drug combination commonly known
as "fen-phen."
     So-called "herbal fen-phen" products are being marketed over
the internet and through weight loss clinics, print ads and
retail outlets as natural alternatives to the prescription drugs
phentermine and fenfluramine (commonly referred to as
"fen-phen").  FDA considers these products to be unapproved drugs
because their names reflect that they are intended for the same
use as the anti-obesity drugs, fenfluramine and phentermine. The
agency is warning consumers that these unapproved drugs have not
been shown to be safe or effective and may contain ingredients
that have been associated with injuries.
     Two anti-obesity drugs, fenfluramine (brand name Pondimin)
and dexfenfluramine (brand name Redux), have been withdrawn from
the marketplace because of safety concerns.  FDA believes the use
of unapproved alternative products may increase as a result of
the withdrawal.  Herbal fen-phen products contain none of these
prescription drugs.
     The main ingredient of most herbal fen-phen products is
ephedra, commonly known as Ma Huang.  Ephedra is an amphetamine
-like compound with potentially powerful stimulant effects on the
nervous system and heart.  FDA has received and investigated more
than 800 reports of adverse events associated with the use of
ephedrine alkaloid-containing products since 1994.  These events
ranged from episodes of high blood pressure, heart rate
irregularities, insomnia, nervousness, tremors and headaches to
seizures, heart attacks, strokes and death.
     Many ephedra-containing herbal fen-phen products also
contain Hypericum perforatum, an herb commonly known as St.
John's Wort and sometimes referred to as "herbal Prozac."  The
actions and possible side effects of St. John's Wort have not
been studied under carefully controlled trials either alone or in
combination with ephedra.
     Other herbal fen-phen products contain 5-hydroxy-tryptophan,
a compound closely related to L-tryptophan, a dietary supplement
widely used in this country until 1990.  Used primarily as a
sleep aid, L-tryptophan was pulled from the market after it was
found to be linked to more than 1,500 cases, including about 38
deaths, of a rare blood disorder known as eosinophilia myalgia
syndrome.
     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 agency
is taking appropriate regulatory action to remove such products
from the market.
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