Advocates push for regulation of supplements.
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 properties 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. serpentaria, 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. blackwort, bruisewort, consolidae 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 cholesterol. companies to stop 17-dione, andro, manufacturing, androstene) marketing, and distributing in March 2004. Banned by athletic associations. Chaparral (Larrea Abnormal liver function or FDA warning to divaricata, damage, often irreversible; consumers in December creosote bush, deaths reported. 1992. greasewood, hediondilla, jarilla, larreastat) Germander Abnormal liver function or Banned in France and (Teucrium damage, often irreversible; Germany. chamaedrys, wall deaths reported. germander, wild germander) 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, rauschpfeffer, sakau, tonga, wurzelstock, 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 Switzerland. 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 tobacco) 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. piliolerial, pudding grass, pulegium, run-by-the-ground, squaw balm, squawmint, stinking balm, tickweed) Scullcap Abnormal liver function or None (Scutellaria damage. lateriflora, blue pimpernel, helmet flower, hoodwort, mad weed, mad-dog herb, mad-dog weed, quaker bonnet, scutelluria, skullcap) 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.
For more information, go to www.consumerreports.org/co/supplements.
BY STEVE PERLSTEIN
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|Title Annotation:||Consumers Union Analysis|
|Publication:||Internal Medicine News|
|Date:||May 15, 2004|
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