Back in May, a “relaxation brownie” called Lazy Cakes caused a stir, when several politicians and public-health experts expressed concern about its safety. On Friday, the Food and Drug Administration (FDA) sent a letter to the maker of the baked good, deeming the product — which contains the sleep-inducing compound melatonin — unsafe and warning that it could be seized.
The FDA said that it considers the brownies “adulterated” because melatonin has not been determined to be a safe food additive. Although melatonin supplements are sold over the counter with little FDA regulation (safety of dietary supplements is the manufacturer’s responsibility by law), the agency said that it is not aware of any data suggesting the compound is safe as a food ingredient.
Melatonin is a naturally occurring hormone produced in the pineal gland of the brain that regulates the sleep-wake cycle. The synthetic form sold in supplements is popularly used as a treatment for jet lag or sleeplessness — conditions that result when the sleep-wake cycle is disrupted.
HBB LLC, the maker of Lazy Cakes, which renamed the product Lazy Larry in July, markets the brownies as a dietary supplement, rather than as a food. “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,” HBB CEO Terry Harris told the AP.
Still, HBB’s dietary supplement argument sounds a bit specious, the FDA says, given that the cakes are sold in convenience stores alongside other snack foods and contain the same ingredients as conventional brownies. And while Lazy Larry is intended for adults, its packaging features a cartoon icon of a brownie character that may appeal to children. That’s a concern to many public health officials.
“Children are attracted to brownies,” Dr. Caroline Apovian, director of the Nutrition and Weight Management Center at Boston Medical Center, told the Boston Herald in May. “I don’t think it’s appropriate to put herbal things that are actually drugs in brownies or food items that are attractive to children. I think that’s heinous.”
There’s also a potential problem with dosing: each brownie contains about 8 mg of melatonin and the package recommends that consumers “take” half a brownie twice a day to relax and combat stress. But given the cake’s small size and sweet taste, consumers may easily eat far more than that. (Overdose of melatonin is rare, however.)
The brownies’ packaging does not include side effects or possible drug interactions. In the FDA letter, Michael W. Roosevelt, the agency’s acting director of food compliance, cited studies linking the use of melatonin supplements to potential effects on reproductive and developmental functioning, heart health, ocular health and blood-sugar regulation.
In May, Healthland reported:
Obviously, since melatonin causes drowsiness and some grogginess, it shouldn’t be taken if you’re about to drive a car or otherwise need to be alert. Melatonin may also interfere with the effectiveness of prescription sedatives like clonazepam, birth control pills, anti-anxiety meds like fluvoxamine, and the anti-HIV drug atazanavir. And the FDA warns that pregnant women should not take it. In addition, some users report side effects like lower body temperature, changes in blood flow and “vivid” dreams (i.e., nightmares).
The FDA has given HBB has 15 days to respond to the agency’s concerns (that is, take the melatonin out of the brownies) or risk seizure. Harris said the company’s legal team was still reviewing the letter and did not yet have a response, the AP reported.
So far, the FDA has not gone after makers of other relaxation brownies like Kush Cakes or Lulla Pies.