August 31, 1998 ~ Web posted at: 11:57 a.m. EST
Supplements immune from government regulation:
Industry giant disputes findings
LOS ANGELES (AP) -- Several of the nation's leading brands of
St. John's Wort, a popular herbal remedy for depression, are not as potent as advertised on their labels, the Los Angeles Times reported Monday. In an independent test commissioned by the Times, three of 10 brands of St. John's Wort had no more than about half the potency listed on the label.
Four other brands had less than 90 percent of the potency listed,
the Times reported. Health experts told
the newspaper that a significant number of depressed people may
be pinning hopes on products too weak to help them even when
taken at the recommended dosages.
"How is it possible to appropriately regulate a treatment regimen
if you can't even be sure of the dosage?" said Dr.
Norman Rosenthal, a research psychiatrist at the
National Institute of Mental Health, who believes in St.
John's Wort's mood-elevating properties.
"You're using this product for important reasons and you want to
know you're getting what you're supposed to be getting",
he said. "It's quite important that there should
be truth in advertising."
The findings raise concerns over the booming herbal market.
Sales of St. John's Wort and other botanical
remedies, including ginseng, ginkgo biloba,
echinacea and saw palmetto may reach $4.3 billion this
year, according to Nutrition Business Journal.
Sally Guthrie, a University of Michigan
pharmacy professor, said one concern is that,
unlike pharmaceutical drugs, herbal supplements do not
undergo government scrutiny before marketing. The
Food and Drug Administration can seize dietary supplements that
turn out to be harmful, fraudulent or improperly
promoted. So people taking St. John's Wort can't
be assured from batch to batch and manufacturer to manufacturer
that they're getting the same quality or amount", she
St. John's Wort, a weed also known as hypericum,
has a long record as a nerve tonic. The
golden flower, with its extract hypericin, has
long been used in folk medicine. In the study the
Times commissioned, 10 pills were sampled from each of
three containers of one lot of each product. The
products were identified only with a code, so the
laboratory would not know the brand being tested.
Five independent experts who reviewed the research procedures
said the approach was sound.
One of the lowest-scoring products sampled, with
about 20 percent of the labeled potency, was from
Sundown Herbals, a division of Rexall, the nation's No. 1 distributor of dietary supplements. (at that time, at least)
Deborah Shur Trinker, Sundown's vice
president of regulatory affairs, responded to the
findings by saying they were "false" and "misleading".
In a letter to the Times, Ms. Trinker
said the tests involved too few pills for the findings to be
significant. She said an independent lab hired by
Sundown had found the product to be 100 percent potent.
Two of the other low scoring companies,
Pure Source and Futurebiotics, declined to comment.
Officials of Trader's, a Southern
California market chain, said they would stop selling the
St. John's Wort brands that tested poorly.