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Supplement regulation pushed by advocates: like pharmaceuticals.

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 share 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.

The only supplement listed as "Definitely Hazardous," aristolochic acid, often is marketed as a premenstrual syndrome remedy or a heart disease treatment under such names as PMS-Ease and Cardioflex. It is banned in at least 10 countries, and the FDA issued a warning in 2001 that the product was associated with permanent kidney damage and cancers of the urinary tract.

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.

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.
Dirty Dozen: 12 Supplements to Avoid

Name(s)                 Dangers                 Regulatory Actions

DEFINITELY HAZARDOUS: Documented organ failure or known carcinogenic

Aristolochic acid       Potent human            FDA warning to
(Aristolochia,          carcinogen; kidney      consumers and
birthwort, snakeroot,   failure, sometimes      industry and import
snakeweed, sangree      requiring transplant;   alert in April 2001.
root, sangrel,          deaths reported.        Banned in seven
serpentary,                                     European countries
serpentaria, asarum                             and Egypt, Japan, and
canadense, wild                                 Venezuela.

VERY LIKELY HAZARDOUS: Banned in other countries, FDA warning,
or adverse effects in studies

Comfrey (Symphytum      Abnormal liver          FDA advised industry
officinale, ass ear,    function or damage,     to remove from market
black root,             often irreversible;     in July 2001.
blackwort,              deaths reported.
consolidae radix,
consound, gum plant,
healing herb,
knitback, knitbone,
salsify, slippery
root, symphytum
radix, wallwort)

Androstenedione         Increased cancer        FDA warned 23
(4-androstene-3,        risk, decrease in HDL   companies to stop
17-dione, andro,        cholesterol.            manufacturing,
androstene)                                     marketing, and
                                                distributing in
                                                March 2004. Banned
                                                by athletic

Chaparral (Larrea       Abnormal liver          FDA warning to
divaricata, creosote    function or damage,     consumers in December
bush, greasewood,       often irreversible;     1992.
hediondilla, jarilla,   deaths reported.

Germander (Teucrium     Abnormal liver          Banned in France and
chamaedrys, wall        function or damage,     Germany.
germander, wild         often irreversible;
germander)              deaths reported.

Kava (Piper             Abnormal liver          FDA warning to
methysticum, ava,       function or damage,     consumers in
awa, gea, gi,           occasionally            March 2002. Banned
intoxicating pepper,    irreversible; deaths    in Canada, Germany,
kao, kavain,            reported.               Singapore,
kawa-pfeffer, kew,                              South Africa, and
long pepper, malohu,                            Switzerland.
maluk, meruk, milik,
rauschpfeffer, sakau,
tonga, wurzelstock,
yagona, yangona)

LIKELY HAZARDOUS: Adverse event reports or theoretical risks

Bitter Orange (Citrus   High blood pressure;    None
aurantium, green        increased risk of
orange, kijitsu,        heart arrythmias,
neroli oil, Seville     heart attack, stroke.
orange, shangzhou
zhiqiao, sour orange,
zhi, oiao, zhi xhi)

Organ/glandular         Theoretical risk of     FDA banned high-risk
extracts (brain/        mad cow disease,        bovine materials from
adrenal/pituitary/      particularly from       older cows in foods
placenta/other gland    brain extracts.         and supplements in
"substance" or                                  January 2004.
"concentrate")                                  (High-risk parts from
                                                cows under 30 months
                                                still permitted.)
                                                Banned in France and

Lobelia (Lobelia        Breathing difficulty,   Banned in Bangladesh
inflata, asthma weed,   rapid heartbeat, low    and Italy.
bladderpod, emetic      blood pressure,
herb, gagroot,          diarrhea, dizziness,
lobelie, Indian         tremors; possible
tobacco, pukeweed,      deaths reported.
vomit wort, wild

Pennyroyal oil          Liver and kidney        None
(Hedeoma pulegioides,   failure, nerve
lurk-in-the-ditch,      damage, convulsions,
mosquito plant,         abdominal tenderness,
piliolerial, pudding    burning of the
grass, pulegium,        throat; deaths
run-by-the-ground,      reported.
squaw balm,
squawmint, stinking
balm, tickweed)

Scullcap (Scutellaria   Abnormal liver          None
lateriflora, blue       function or damage.
pimpernel, helmet
flower, hoodwort, mad
weed, mad-dog herb,
mad-dog weed, quaker
bonnet, scutelluria,

Yohimbe                 Change in blood         None
(Pausinystalia          pressure, heart
yohimbe, johimbi,       arrythmias,
yohimbehe, yohimbine)   respiratory
                        depression, heart
                        attack; deaths

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

Source: Consumer Reports, May 2004

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Comment:Supplement regulation pushed by advocates: like pharmaceuticals.(Rx)
Author:Perlstein, Steve
Publication:Family Practice News
Geographic Code:1USA
Date:May 1, 2004
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