Public health officials and politicians are debating the safety of a new snack on the market — sold as Lazy Cakes, Kush Cakes and Lulla Pies. They’re brownies laced with the sleep aid melatonin.
Like other compounds sold as dietary supplements, melatonin doesn’t need premarket approval by the Food and Drug Administration when sold in pill form. But used as a food additive, it would likely be subject to FDA regulation. That’s why the makers of the new melatonin-spiked brownies are marketing their products as dietary supplements — not food.
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“It sounds to me like they are trying to claim that the entire brownie is like a tablet, which is, of course, preposterous,” Dr. Charles Czeisler, head of sleep medicine Brigham and Women’s Hospital, told the New York Times.
Each brownie contains 8 mg of melatonin (the dietary supplements come in doses of 0.2 to 20 mg), and the package suggests that people take half a brownie twice a day to relax and combat stress. Though the product is intended for adults, some health officials take issue with the fact that its packaging is so kid- and teen-friendly: Lazy Cakes are emblazoned with a cartoon brownie called Lazy Larry, whose drugged-out smile alludes to the illegal, hash-enhanced version of the chocolatey dessert. It doesn’t help that they’re sold in head shops (as well as in 7-Eleven, Walgreens and the Harvard Coop), which also sell drug paraphernalia.
“Children are attracted to brownies,” Dr. Caroline Apovian, director of the Nutrition and Weight Management Center at Boston Medical Center told the Boston Herald. “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.”
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The question is, is melatonin dangerous? Many people say the sleep-inducing supplements, which contain a synthetic form of the endogenous hormone, are helpful for combating jet leg or sleeplessness. Our bodies naturally produce melatonin (in the pineal gland in the brain) as an essential part of our normal sleep-wake cycle; when that cycle is disrupted, it’s thought that taking the supplements helps get us back on track. The hormone is also being clinically tested as a potential treatment for a wide-range of ailments, including insomnia, seasonal affective disorder and chronic cluster headaches.
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).
Overdose of melatonin is rare but putting the compound in delicious brownies only invites trouble. Nothing on the brownies’ packaging indicates potential drug interactions or side effects, which points to a larger issue: there is very little reminder on the product itself that its contents are medicinal in nature and should be taken under a doctor’s supervision. And that is what concerns many public health officials.
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“The promoters of these are appealing to people who think it’s better to do things outside of the medical establishment,” Dr. David S. Seres, the director of medical nutrition at Columbia Medical Center, also told the Times. “The desire to help people is an extremely strong motivator, but so is money.”
The cakes retail for $2.50 to $4 — a high price, considering that a 60-count bottle of 8-mg melatonin tablets costs $11.
So far, two Massachusetts politicians — Fall River’s mayor William Flanagan and New Bedford’s mayor Scott W. Lang — have called to ban the cakes. Mayor Flanagan has already drafted an ordinance to that effect.