FDA says sleepy brownies are unsafe
Monday, August 1, 2011
WASHINGTON (AP) — The Food and Drug Administration has warned the manufacturer of melatonin-laced brownies called “Lazy Larry” that the government considers them unsafe and could seize them from store shelves.
The warning letter obtained by The Associated Press was sent to the company last week. “Lazy Larry” was until July known as “Lazy Cakes,” but the Memphis-based company that makes them, HBB LLC, changed the name after some lawmakers and public officials expressed concerns about the brownies.
Sold in many convenience stores, the sweet treats feature a logo of a smiling — and clearly relaxed — brownie that resembles the children’s TV show character SpongeBob SquarePants.
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, a hormone that helps regulate the sleep-wake cycle, to be a safe food additive and that the brownies are “adulterated” because they contain it.
The agency has less authority over melatonin that is sold in pill form as a dietary supplement because supplements are largely unregulated. Under federal law, supplement manufacturers are responsible for making sure their own products are safe.
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.
A spokeswoman for HBB said Monday that executives are still reviewing the letter with lawyers and are not yet commenting on the FDA warning.
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.