Baked brownie-like treats laced with melatonin, marketed as "relaxation treats" and sold over the counter in convenience stores and online, are causing anxiety among federal regulators. One such product, previously marketed as “Lazy Cakes,” is now known as “Lazy Larry.” Last Thursday, the Food and Drug Administration (FDA) sent a warning letter to a manufacturer of the products, Baked World/HBB, advising that “there is no food additive regulation that authorizes the use of melatonin.” In the letter, the FDA described melatonin as a “neurohormone used for medicinal purposes, primarily as a sleep aid,” and said that reports in the scientific literature have raised safety concerns about its use. The FDA gave Baked World 15 days to respond with a plan for addressing the violation.
Consumers may be turning to these "relaxation treats" when they suffer from insomnia. Read Psychiatric News to learn why is is crucial that sleep problems be evaluated and treated by a sleep-medicine specialist at http://pn.psychiatryonline.org/content/46/2/27.full.
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