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.
"We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food," the letter says. Since the company sold Lazy Cakes alongside other foods and referred to them as cakes and brownies, the FDA does not allow the use of an additive such as melatonin.
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 said they support FDA's action against Lazy Cakes, and expressed concern over the brownies because of their appeal to children. The packaging features a cartoon brownie 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.
Lazy Cakes contain about 8 milligrams of melatonin, and 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.
"Most melatonin overdoses in children are not necessarily life-threatening, but they are associated with not only deep sleep but also with nausea, gastrointestinal problems, changes in mood, headaches and other effects," said Dr. Steven Lipshultz, executive dean for children's health at the University of Miami's Miller School of Medicine.
Although the brownies usually aren't harmful to adults, Bruce Goldberger, professor and director of toxicology at the University of Florida College of Medicine in Gainesville, said there's no reason to eat them at all.
"There is no need for this product," he said. "If people want to take melatonin, they should just take it in its pure form."
There are other similar foods that contain melatonin, such as Kush Cakes, but so far, the FDA has not issued any warnings to their manufacturer.
A number of drinks also contain melatonin, including Drank and Unwind. The FDA sent a warning letter to Innovative Beverage Group, the manufacturer of Drank, in January 2010. The agency did not say whether there's been any further action in that case.
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. "We look forward to continuing to work closely with the FDA to immediately remedy these concerns, and to ensure compliance with FDA's dietary supplement regulations."