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Lloyd I. Sederer, MD

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Brownies Your Mother Never Made: FDA Issues Warning

Posted: 08/05/11 07:40 PM ET

The Food and Drug Administration has issued a warning letter to Baked World, a Memphis, Tenn., company marketing brownies laced with melatonin. The FDA notified this company that their product, first called "Lazy Cakes" then renamed "Lazy Larry," is in violation of the law for its production of brownies with this food additive while representing the brownie as just a brownie, and not something that contains a food additive, namely melatonin.

Melatonin is a naturally occurring compound that the FDA described as "... a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders." Their letter went on to say:

"You should take prompt action to correct this violation and prevent its future recurrence. Failure to do so may result in enforcement action without further notice."

Clearly, the FDA is not happy with this company's loading brownies with melatonin and not even saying so.

For good reason. Melatonin has side effects that include nightmares and sleepwalking, daytime sleepiness and confusion, and headaches. It also can interact with medications taken commonly, like birth control pills, anti-coagulants and drugs used to treat diabetes and suppress immunity (taken for conditions like rheumatoid arthritis, colitis and lupus). And who knows what doses of melatonin a person might ingest from a "Lazy Cake" or "Lazy Larry"?

Melatonin can be a helpful supplement, used thoughtfully, with careful dosing and mindfulness of its side effects and interactions with medications. The issue is not melatonin, it is slipping it into a brownie that lures youth into yet another promised state of mental alteration and makes no mention of how.

These are not your mother's brownies. Let your kids and friends know about these "lazy" products. You might want to remind them that old-fashioned brownies are really good with milk or coffee -- and are a lot safer.

The opinions expressed here are solely my own as a psychiatrist and public health advocate. I receive no support from any pharmaceutical or device company. Visit Dr. Sederer's website at for questions you want answered, reviews, commentary and stories: www.askdrlloyd.com