Regulate Ephedra, Other Supplements, U.S. Docs Say
Mon Mar 10,
By Jesse J. Logan
NEW YORK (Reuters Health) - The editors of a major medical journal are calling
for stringent regulation of dietary supplements, after a new study cited the
potentially dangerous effects of the weight-loss supplement ephedra.
The editors of the Journal of the American Medical Association (news - web
sites) published their proposal as an editorial in their March 26 issue.
Dietary supplements, the editorial said in part, "are widely promoted, often
with unsubstantiated claims of benefit and rarely with any mention of potential
hazards."
The editorial was spurred by the results of a RAND Corporation study that found
limited benefit from the use of ephedra and also found that the stimulant,
touted as a weight loss treatment and athletic performance enhancer, could have
a potentially life-threatening effect on the nervous system and heart.
The Food and Drug Administration (news - web sites) currently classifies ephedra
as a "dietary supplement." Under the Dietary Supplement Health and Education Act
of 1994, dietary supplements do not have to undergo pre-market safety
evaluations with the FDA.
However, Dr. Phil Fontanarosa, executive editor of JAMA, said the new study is
"sufficient evidence" to restrict the use of ephedra and regulate it with
similar oversight as over-the counter medications or prescription drugs.
While the FDA has reportedly sent warning letters to ephedra manufacturers
instructing them to remove unproven claims from their product labels and
proposed a "black box" warning--the strongest type of warning on a drug
label--indicating serious adverse effects and deaths, JAMA editors claim "major"
regulation changes are needed.
"The current system for regulation of dietary supplements is inadequate for
ensuring the protection of the health and safety of the public who choose to use
ephedra and other dietary supplements," Fontanarosa and colleagues write in a
JAMA editorial.
They suggest the FDA re-examine dietary supplements, subject products making
health claims to "rigorous" regulation, enforce "mandatory" reporting of adverse
events and ensure advertising "is accurate and not misleading."
"They're saying dietary supplements need to be regulated like drugs and we would
disagree with that," Wes Siegner, legal counsel for the Ephedra Education
Council, told Reuters Health. He argued that the Dietary Supplement Health and
Education Act of 1994, if enforced, would guarantee the safety of products. "Our
view is that (the law) hasn't been implemented yet. The FDA hasn't enforced it.
When that happens there won't be any issue."
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