Lazy Cakes Ordered Off Shelves, Deemed Unsafe by FDA
The melatonin-enhanced brownie "Lazy Larry," formerly known as "Lazy Cakes," is in danger of being seized from shelves if their manufacturer, HBB LLC, does not recall the product.
Last week, the FDA sent a letter to the company ordering the removal of the brownies from store shelves after the melatonin content of the brownies was deemed unsafe.
Melatonin is a naturally occurring hormone that is associated with sleep-wake cycles. It is commonly sold in pill form and is oftentimes an ingredient in sleeping aids. The most immediate side effect of melatonin as well as the melatonin-laced brownie is that they cause drowsiness.
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Manufacturer HBB LLC previously marketed the brownies under the name “Lazy Cakes.” The name was changed recently in order for the company to continue advertising the brownies as a dietary supplement as opposed to food.
The FDA however, does not recognize melatonin as safe additive for food; and “Lazy Larry” can be found among snack foods in many convenience stores.
FDA representative Michael Roosevelt stated that the letter sent to HBB LLC references research that shows melatonin as a drug could have adverse side effects to the reproductive and cardiovascular systems as well as cause ocular and neurological problems.
HHB LLC has yet to respond to the FDA’s order. Representatives state that the letter is still being reviewed.
“We are surprised that this product continues to be singled out as it contains the same ingredients as many edible relaxation products on store shelves; these are melatonin, Valerian Root Extract, Rose Hips Extract, and Passion Flower,” CEO of HBB Terry Harris said.
Nevertheless, medical professionals and state representatives alike have concerns about the marketing of “Lazy Larry” as a healthy dietary aid.
Illinois Senator Dick Durbin has called upon the FDA to make clearer, the guidelines for dietary supplements in foods.
“The sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin,” Durbin said in a written statement to FDA commissioner Margaret Hamburg.
Carolinas Poison Center toxicologist Anna Rouse Dulaney told NPR that an entire brownie provides almost twice the recommended dose of melatonin. A single serving for a “Lazy Larry” is half a brownie.
There is also concern among parents about children abusing and overdosing on melatonin by consuming the brownie. For a child, the brownie contains 40 times the recommended dosage Dr. John Ringwood told Fox News Charlotte.
Despite warnings that the brownie is only suitable for adults and should not be consumed while operating heavy machinery, drinking alcohol or while pregnant or breastfeeding on the “Lazy Larry” website, the packaging has no such disclaimer.
“It looks like a normal brownie so there doesn’t seem to be anything to lead me to think, it should at least be packaged or marketed to show there’s sleeping aid in it,” Daniel Stoffler, father of two, told Fox News Charlotte.
“I think it’s pretty dangerous if you get it in the wrong hands or too many kids eat it, there could be prolonged effect parents aren’t even aware of.”
“Lazy Larry” has been banned in Arkansas and two towns in Massachusetts are looking to establish bans.
