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Supplement regulation pushed by advocates.

The lack of federal regulation requiring safety and efficacy testing means that millions of Americans are unwittingly spending billions of dollars every year on dietary supplements that are at least dangerous and at worst deadly, Consumers Union officials said at a news conference.

A decade after Congress passed the Dietary Supplement Health and Education Act (DSHEA), which allows supplements to be marketed without any of the testing required of pharmaceuticals, the public is woefully uninformed about the lack of safety and efficacy information available for products on which it spends $19.4 billion a year, said Nancy Metcalf, author of a report on supplements published in the organization's magazine, Consumer Reports.

Under DSHEA, the burden of proof is on the Food and Drug Administration to prove a supplement is unsafe before it can be pulled from the market, and manufacturers are not required to pass on any data regarding adverse events.

"Most consumers have no clue that their products have not been tested for safety," Ms. Metcalf said. "We found one supplement (Thermorexin, marketed as a fat-burning supplement) containing 30 mg of theophylline. This stuff you can now buy completely unregulated in a pill."

Consumers Union has named its "Dirty Dozen," 12 dietary supplements deemed either "Definitely Hazardous" (documented organ failure or known carcinogenic properties), "Very Likely Hazardous" (banned in other countries, FDA warning, or adverse effects in studies), or "Likely Hazardous" (adverse event reports or theoretical risks). A Consumers Union researcher was able to buy all 12 substances either online or at retail outlets.

Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition, a supplement industry trade group, disagrees with the premise of the report.

"They basically are not correct in their assumption that the current situation requires that DSHEA be changed," Dr. Dickinson told this newspaper. "The law has not been fully implemented and enforced."

While supplement manufacturers are not required to test their products prior to marketing, the burden of proof of safety still falls on the manufacturers to assure the product is safe, Dr. Dickinson said. "In general, these products, like all foods, are considered safe based on a long history of use."

She acknowledged that at least some of the products analyzed in the report "certainly raise concerns," but that current laws should guard against the sale of them.

Chuck Bell, Consumers Union programs director, dismissed the industry's claims and said his organization is fighting for legislation currently pending on Capitol Hill that would supplant DSHEA and require the supplement industry to follow at least some of the rules pharmaceutical manufacturers must live by.

Physicians need to be acutely aware of the dangers posed by these 12 and other potentially dangerous dietary supplements, Dr. Marvin Lipman, Consumers Union chief medical advisor, told this newspaper. Because many supplements react adversely with prescription medications and affect patients in other ways, clinicians need to make questions about supplements a regular part of their patient interviews.

Forty percent of patients are using supplements, whether their physicians know it or not, Dr. Lipman said. "If you don't ask, you won't be told."
Dirty Dozen: 12 Supplements to Avoid

Name(s) Dangers Regulatory Actions

DEFINITELY HAZARDOUS: Documented organ failure or known carcinogenic
properties
Aristolochic acid Potent human carcinogen; FDA warning to
(Aristolochia, birthwort, kidney failure, consumers and
snakeroot, snakeweed, sometimes requiring industry and import
sangree root, sangrel, transplant; deaths alert in April
serpentary, serpentaria, reported. 2001. Banned in
asarum canadense, wild seven European
ginger) countries and
 Egypt, Japan, and
 Venezuela.
VERY LIKELY HAZARDOUS: Banned in other countries, FDA warning, or
adverse effects in studies
Comfrey (Symphytum Abnormal liver function FDA advised
officinale, ass ear, or damage, often industry to remove
black root, blackwort, irreversible; deaths from market in July
bruisewort, consolidae reported. 2001.
radix, consound, gum
plant, healing herb,
knitback, knitbone,
salsify, slippery root,
symphytum radix,
wallwort)
Androstenedione Increased cancer risk, FDA warned 23
(4-androstene-3, decrease in HDL companies to stop
17-dione, andro, cholesterol. manufacturing,
androstene) marketing, and
 distributing in
 March 2004. Banned
 by athletic
 associations.
Chaparral (Larrea Abnormal liver function FDA warning to
divaricata, creosote or damage, often consumers in
bush, greasewood, irreversible; deaths December 1992.
hediondilla, jarilla, reported.
larreastat)
Germander (Teucrium Abnormal liver function Banned in France
chamaedrys, wall or damage, often and Germany.
germander, wild irreversible; deaths
germander) reported.
Kava (Piper methysticum, Abnormal liver function FDA warning to
ava, awa, gea, gi, or damage, occasionally consumers in March
intoxicating pepper, kao, irreversible; deaths 2002. Banned in
kavain, kawa-pfeffer, reported. Canada, Germany,
kew, long pepper, malohu, Singapore, South
maluk, meruk, milik, Africa, and
rauschpfeffer, sakau, Switzerland.
tonga, wurzelstock,
yagona, yangona)
LIKELY HAZARDOUS: Adverse event reports or theoretical risks
Bitter Orange (Citrus High blood pressure; None
aurantium, green orange, increased risk of heart
kijitsu, neroli oil, arrythmias, heart
Seville orange, shangzhou attack, stroke.
zhiqiao, sour orange,
zhi oiao, zhi xhi)
Organ/glandular extracts Theoretical risk of mad FDA banned high-
(brain/adrenal/pituitary/ cow disease, risk bovine
placenta/other gland particularly from brain materials from
"substance" or extracts. older cows in foods
"concentrate") and supplements in
 January 2004.
 (High-risk parts
 from cows under 30
 months still
 permitted.) Banned
 in France and
 Switzerland.
Lobelia (Lobelia inflata, Breathing difficulty, Banned in
asthma weed, bladderpod, rapid heartbeat, low Bangladesh and
emetic herb, gagroot, blood pressure, Italy.
lobelie, indian tobacco, diarrhea, dizziness,
pukeweed, vomit wort, tremors; possible deaths
wild tobacco) reported.
Pennyroyal oil (Hedeoma Liver and kidney None
pulegioides, lurk-in-the- failure, nerve damage,
ditch, mosquito plant, convulsions, abdominal
piliolerial, pudding tenderness, burning of
grass, pulegium, run-by- the throat; deaths
the-ground, squaw balm, reported.
squawmint, stinking balm,
tickweed)
Scullcap (Scutellaria Abnormal liver function None
lateriflora, blue or damage.
pimpernel, helmet flower,
hoodwort, mad weed, mad-
dog herb, mad-dog weed,
quaker bonnet,
scutelluria, skullcap)
Yohimbe (Pausinystalia Change in blood None
yohimbe, johimbi, pressure, heart
yohimbehe, yohimbine) arrythmias, respiratory
 depression, heart
 attack; deaths reported.

Note: Based on data from Natural Medicines Comprehensive Database 2004
and Consumers Union's medical and research consultants.
Source: Consumer Reports, May 2004


For more information, go to www.consumerreports.org/co/supplements.

BY STEVE PERLSTEIN

Midwest Bureau
COPYRIGHT 2004 International Medical News Group
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004 Gale, Cengage Learning. All rights reserved.

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Title Annotation:Practice Trends
Author:Perlstein, Steve
Publication:Clinical Psychiatry News
Geographic Code:1USA
Date:May 1, 2004
Words:1006
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