Two Massachusetts towns are moving to ban sales of a "relaxation" brownie named Lazy Cakes, laced with melatonin and sold in food markets, after children who ate them required hospitalisation.
The mellowing chocolate treats, which sell for $3 (about R21) to $5 (about R35) at food stores and some night clubs, are legal but contain nearly 8mg of the supplemental sleep aid, which is about 25 times the usual amount prescribed for adults.
Standard doses in the Unites States, where it is available over the counter, and in Europe, where a prescription is typically required, range from 0.3 mg to 3 mg.
Considered a dietary supplement rather than a drug, melatonin is not regulated by the Food and Drug Administration. Doctors say an adult dosage could be dangerous to a child, effectively acting as a strong drug akin to diazepam (Valium).
Reports have emerged of youngsters who sampled Lazy Cakes and were rushed to hospital emergency rooms, where it was extremely difficult to wake them up. In Arizona, a two-year-old boy given a few bites of a relative's treat was hospitalised after becoming withdrawn and falling deeply asleep.
In the Massachusetts cities of New Bedford and nearby Fall River, efforts are underway to ban their sales, largely because of their appeal to children. Purple packaging features Lazy Larry, a cartoonish brownie with a big grin on its face.
New Bedford Mayor Scott Lang said he supports a statewide ban, at least until such products are federally regulated.
Not appropriate for children
"It's clear to me that a young child would find it attractive and tasty, and it's got chemicals in it that aren't appropriate for kids," Lang said.
National poison control centres receive more calls regarding melatonin than for any other herbal supplement - about 5,000 calls in 2009, said William Flanagan, mayor of Fall River, Mass., in a press conference about his ordinance to ban Lazy Cakes in the city.
Baked World/HBB, the Memphis-based maker of Lazy Cakes, says it clearly labels each brownie to show it advises consumption by adults only.
"We encourage stores to place these products alongside the energy shots or with other dietary supplements that are also produced for adults," Chief Executive Terry Harris said.
Lazy Cakes are the latest snacks marketed as an antidote to energy-boosting products and everyday stress. Another is DRANK, a carbonated beverage made with "natural calming agents including melatonin, rose hips, and valerian root."
The FDA sent DRANK's manufacturer, Houston-based Innovative Beverage Group, a warning letter citing concerns that melatonin can cause a drop in blood pressure or have hormonal effects on women who are pregnant or trying to conceive.
(Reuters Health, Zach Howard, May 2011)