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Advocates push for regulation of supplements.

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.

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 ensure 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. For example, aristolochic acid is not produced in the United States and the federal government has in place an import ban on it.

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.
Dirty Dozen: 12 Supplements to Avoid

Name(s) Dangers Regulatory Actions

DEFINITELY HAZARDOUS: Documented organ failure or known carcinogenic

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

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

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

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

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

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

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

LIKELY HAZARDOUS: Adverse event reports or theoretical risks

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

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

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

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

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

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

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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Article Details
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Title Annotation:Consumers Union Analysis
Author:Perlstein, Steve
Publication:Internal Medicine News
Date:May 15, 2004
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