Supplement regulation pushed by advocates.
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
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|Title Annotation:||Practice Trends|
|Publication:||Clinical Psychiatry News|
|Date:||May 1, 2004|
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