Food and Drug Administration cracks down on previously unregulated dietary supplement. .

Since March the FDA has demanded greater accountability of dietary supplement manufacturers, which derive their compounds from roots, leaves and animals. They had belonged to a category in between "food" and "drugs," and therefore existed outside the FDA's regulatory jurisdiction. Examples of formerly self-policed supplements include St. John's wort, ginseng, ginkgo biloba and even vitamin C.

While many people supplement safely for nutrition or enhanced athletic performance, problems with some of the lesser known manufacturers have ranged from finding contaminants like pesticides, bacteria and glass in their products, to labels wildly misrepresenting the amount of active ingredients within. The FDA rules will help ensure that the contents of a supplement are fully disclosed and the amounts accurately listed on the pill's package. Notably, the FDA has not taken steps yet to force manufacturers to state whether an ingredient is potentially harmful, or to show that it is effective. www.consumerlab.com makes an excellent resource for anyone interested in supplements and their manufacturers.

The FDA is one step closer to calling for warning labels on products containing ephedra, however. In a press release dated a week before the March announcement, the FDA assured the public it was aggressively pursuing warnings for ephedra and seeking information to possibly warrant a ban on its use in all dietary products.

The most recent spate of attacks on the substance began in February when Baltimore Orioles pitcher Steve Bechler died of heatstroke during spring training. The medical examiner implicated ephedra in the 23-year-old's death. In March the baseball players union warned its members against using the drug, and Senator Jackie Speier of California began lobbying for a statewide ban on diet pills containing it.

Ephedra, also known as ma huang, stimulates the sympathomimetic and central nervous systems and suppresses appetite. An independent analysis of 140 adverse events reported to the FDA between June 1997 and March 1999 found that 47% involved the cardiovascular system and 18% involved the central nervous system. Over 60 more serious adverse events-- including suicide, psychotic episodes, seizure and stroke--have been reported in Canada, and the list of such incidents is ever-growing in the U.S. as well. Other recognized adverse effects include anxiety, tremors, headaches, insomnia, hypertension and myocardial infarction (heart attack).

The effects of ephedra are like those of amphetamines. The drug's impact on the central nervous system can lead to mind-altering effects. People who are being treated for psychiatric problems or who may be at risk for mental illness are warned not to take it. It can have effects similar to bipolar disorder. The drug is best avoided, particularly in preparations that also contain caffeine or other stimulating herbs such as guarana. These combination products may compound ephedra's adverse effects and should never be used.

(U.S. Food & Drug Admin., February 28 and March 7, 2003 News Releases, www.fda.gov; American Journal of Psychiatry, 2002, Vol. 159, No. 2, pp. 318a-319a; Canadian Medical Assoc. Journal, 2002, Vol. 166, No. 5, p. 633; Psychosomatics, 2000, Vol. 41, No. 1, pp. 58-62)

RELATED ARTICLE: Buyer Beware: Herbal Remedies Don't Fair Well For Hot Flashes

Several studies have found most herbal supplements are ineffectual in the relief of menopausal symptoms, regardless of their popularity. Ginseng, red clover, dong quai and evening primrose oil have little or no effect.

Although in some studies phytoestrogens (estrogen-like molecules found in plants) provided some relief, in many cases women receiving a placebo fared just as well. Only black cohosh showed true promise. In three of the four studies, reviewed, it appeared to diminish hot flash frequency and intensity. Though widely used in Germany and available in the U.S. in a product called RemiFemin, its precise mechanism of action is unknown. Visit www.clinicaltrials.gov for further studies underway on black cohosh.

(Harvard Women's Health Watch, 2003, Vol. 10, No. 6, p. 3)