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FDA can't assure safety of melatonin

melatonin

March 5, 1996
Web posted at: 9:30 a.m. EST

From Medical Correspondent Jeff Levine

WASHINGTON (CNN) -- The hormone melatonin is being touted as a potential treatment for everything from insomnia to aging.

But because the substance is not regulated by the U.S. Food and Drug Administration, some experts worry it could be misused.

For Alison Moseley, day and night were drastically out of sync.

"It's just like having jet lag every day, only you're not going anywhere," she says.



Alison Moseley

"It's just like having jet lag every day, only you're not going anywhere."

-- Alison Moseley


Moseley's condition was hindering her career as a trial lawyer until she began taking melatonin last August. (68K AIFF sound or 68K WAV sound)

"Melatonin has been -- I hesitate to use the word 'lifesaver' -- but it's enabled me to work at a job where I must be there at 8:15 (a.m.)."

The attorney has been taking low-dose melatonin under medical supervision. But many regular melatonin users are not or are taking it for benefits yet unproven.

Rosenthal

"Where melatonin is concerned, the hype has gone way ahead of the data, and many more claims have been made than have been substantiated," says Norman Rosenthal of the National Institute of Mental Health. (111K AIFF sound or 111K WAV sound)

Melatonin is a hormone that researchers believe regulates the body's natural clock, helping us to adjust to changes in darkness and light. And there is evidence it's useful for insomnia, as well as jet lag. Some people take it for cataracts, and others for conditions associated with aging.

But the doses available in health food stores may boost levels of the hormone up to hundreds of times above normal.

"There are reports of some people having depression, becoming much worse after taking melatonin. There are reports of people developing hallucinations, in particular hallucinatory dreams after taking melatonin," says Dr. Dan Oren, also from the mental health institute.

Since it qualifies as a dietary supplement, melatonin falls outside FDA's drug jurisdiction.

Is there a reason for the FDA to crack down on melatonin? Even if the answer is 'yes,' it's tougher for the agency to move against dietary supplements because of a law passed by Congress in 1994.

"If these products are in the marketplace, without claims on the label, and if we don't have reports of serious adverse reactions, what is the regulatory hook for us to intervene?" asks Mitch Zeller of the FDA.

The anti-regulatory atmosphere on Capitol Hill has weakened the agency, according to critics.

"FDA is no longer able to make the kinds of demands for scientific information and validation of safety that they used to, on people who are selling food supplements," says Dr. Sidney Wolfe of the advocacy group Public Citizen.

A trade group opposed to melatonin regulation says such action would simply force people to pay more for the same thing. Nonetheless, the group recommends that consumers take low doses, limit sleep treatment to no more than 30 days and avoid melatonin during pregnancy

In the meantime, the FDA says it can't vouch for the safety of melatonin.

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