Supplement regulation pushed by advocates: like pharmaceuticals.
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 properties 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. ginger) 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. bruisewort, 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 associations. Chaparral (Larrea Abnormal liver FDA warning to divaricata, creosote function or damage, consumers in December bush, greasewood, often irreversible; 1992. hediondilla, jarilla, deaths reported. larreastat) 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 Switzerland. 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 tobacco) 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, skullcap) Yohimbe Change in blood None (Pausinystalia pressure, heart yohimbe, johimbi, arrythmias, yohimbehe, yohimbine) 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.
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|Comment:||Supplement regulation pushed by advocates: like pharmaceuticals.(Rx)|
|Publication:||Family Practice News|
|Date:||May 1, 2004|
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