FDA says melatonin brownies are unsafe

August 4, 2011

According to the Associated Press, the U.S. Food and Drug Administration (FDA) has warned the manufacturer of melatonin-laced brownies called "Lazy Larry" that the government considers them unsafe and could seize them from store shelves.

"Lazy Larry" was until July known as "Lazy Cakes," but the Memphis-Tenn. based company that makes them, HBB LLC, changed the name after some lawmakers and public officials expressed concerns about the brownies. Melatonin is a naturally occurring hormone that helps regulate the sleep-wake cycle. The brownies can make those who eat them sleepy, and the manufacturer advertises them as a stress reliever.

The FDA said it can seize the brownies if HBB continues to make and market them. The federal agency said that it does not consider melatonin to be a safe food additive and that the brownies are "adulterated" because they contain it. In calling the product unsafe, Michael Roosevelt of the FDA said in the letter that the agency is not aware of data that establishes the safety of melatonin for use as an ingredient in foods. He cited medical research that has shown concerns about potential reproductive, cardiovascular, ocular, and neurological issues as side effects of using the drug.

The company has so far marketed the brownies as a dietary supplement, saying they should be regulated similarly to melatonin sold in pill form. Packaging on the product says it should be consumed by adults only and should not be consumed before driving or operating heavy machinery.

AP article
FDA letter

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