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26.04.2004 » US consumer group names "dirty dozen" dietary supplements

BMJ 2004;328:975 (24 April)

US consumer group names "dirty dozen" dietary supplements

Janice Hopkins Tanne

New York

Americans can easily buy 12 dangerous dietary supplements over the counter or from the internet, the latest (May) issue of Consumer Reports magazine says. At least five of these supplements are banned in Asia, Europe, or Canada.

Consumer Reports (accessible at www.consumerreports.org) is published by the non-profit Consumers Union, which tests products and services and aims to protect the public through information and advocacy.

The revelation came in the same week that a federal judge finally upheld the US Food and Drug Administration's ban on ephedra, the stimulant that has been linked to more than 100 deaths, including that of a major league baseball player.

Aristolochic acid is categorised as a carcinogen by the World Health Organization. Its inclusion in a Chinese herbal product for weight loss caused an outbreak of kidney failure and cancers of the kidney, ureter, and bladder in patients in Belgium ( New England Journal of Medicine 2000;342: 1686-92). Consumer Report investigators were able to purchase products labelled as containing aristolochia.

The "very likely hazardous" supplements on the list include comfrey, androstenedione, chaparral, germander, and kava. Supplements in the "likely hazardous" category include bitter orange, organ/glandular extracts, lobelia, pennyroyal oil, skullcap, and yohimbe. Products containing androstenedione, kava, and yohimbe supplements produced sales of $76m (42m; 63m) in 2002 in the United States.

In March the administration wrote to manufacturers of androstenedione, saying that it considered the supplement unsafe and asking distributors to stop marketing it. "Andro," as it is known, is a precursor to sex hormones. Athletes use it instead of banned steroid hormones.

Last December the UK Medicines Control Agency linked kava to liver toxicity and said, "There is no evidence to support a safe dose of kava."

Supplements are not subject to the same regulations and safety checks as prescription drugs. Instead, to impose a ban the administration has to prove that a supplement is unsafe under the terms of the 1994 Dietary Supplement Health and Education Act.

Although supplement manufacturers can't claim that a product prevents or treats a disease or disorder, they can say their product affects structure or function or supports healthy function. Labels of supplementary medicines are supposed to list ingredients and their quantity, but labelling varies widely, and some ingredients have confusing and different names.

A national poll showed that customers mistakenly thought that supplements had been approved by a government agency, that products were required to carry warning labels about possible side effects, and that supplement makers could not make safety claims without scientific support.


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