WASHINGTON – 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.
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 sweet treats feature a logo of a smiling -- and clearly relaxed -- brownie that resembles the children's TV show character SpongeBob SquarePants. The company's website says they are sold in convenience stores in "a select but growing number of markets." They are also sold online through the company's website.
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.
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.
"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," said Terry Harris, CEO of HBB.
Sen. Dick Durbin, D-Ill., the No. 2 Democrat in the Senate, has pressured the FDA to clarify its policy on foods that contain dietary supplements, prompted by the sale of the melatonin treats.
"The sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin," Durbin wrote FDA commissioner Margaret Hamburg in May. "Furthermore, consumers eating these baked goods may not recognize they are consuming a neurohormone, that they should consult a doctor before eating it, and that it may not be appropriate for children, people with auto-immune diseases, or women who are pregnant or breast-feeding."
The product's marketing evokes images of illegal substances. On the Lazy Larry website, the company promises that the brownies will help customers relax. "All this magic is baked in to put a smile on your face," the site reads. "This is living, my friend."
On the official Lazy Larry Facebook page -- still operating under the "Lazy Cakes" name -- the company interacts with enthusiastic consumers. On Friday, the day the FDA sent the company its letter, the company posted this status update: "Thinking about putting on some tunes and relaxing with a Lazy Larry tonight ... what is your favorite music to chill to?"
On the website for another product, Kush Cakes, which does not appear to have been cited by the FDA, the manufacturers boast that they are "baked with love and our proprietary blend of all natural ingredients, featuring Melatonin and Valerian root" as active ingredients. It's not clear why the FDA did not warn the manufacturers of Kush Cakes.
"These are 100% LEGAL and have NO THC or Marijuana in them," the website for Kush Cakes reads. "They simply give you the same effects as being relaxed and really work!"