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FDA Warns Brownie Melatonin Is Unsafe

Getty(MEMPHIS, Tenn.) -- Melatonin is not safe as a food ingredient, says the Food and Drug Administration in a warning to the makers of Lazy Larry brownies, formerly known as Lazy Cakes, which contain the sleep-inducing hormone.

The agency sent a letter last week to HBB, the Memphis, Tenn.-based manufacturer, warning that if it continues to manufacture and sell the brownies, the products could be seized and removed from store shelves.

Melatonin in pill form is considered a dietary supplement, and the FDA doesn't regulate supplements as strictly as it regulates food and other drug products.

Experts say they support the agency's action against Lazy Cakes, and expressed concern over the brownies because of their appeal to children. The packaging features a dozy cartoon brownie character on a bright purple background. Lazy Cakes provoked controversy back in May when young children reportedly became ill after eating them. At the time, two Massachusetts towns considered banning the brownies.

Melatonin is a brain hormone that controls the body's sleep-wake cycle. It's relatively safe for adults, but children who consume too much of it can fall into an extremely deep sleep.

What's more, Lazy Cakes contain a startling amount of the substance. Experts say each treat has about 8 milligrams of melatonin in it. Experts say if children do take melatonin, it should be no more than .3 milligrams per day. Even adults who use melatonin don't generally consume as much as is found in the brownies.

The makers of Lazy Cakes must inform the FDA of the actions they've taken to correct the violation within 15 days of receiving the warning letter.

Terry Harris, the CEO of HBB LLC, issued a statement in response to the FDA's warning.

"We are taking immediate steps to address the concerns expressed in the letter -- all of which stem from the way the product is packaged, labeled and marketed," Harris said.

Copyright 2011 ABC News Radio

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