The Food and Drug Administration (FDA) has warned the company that makes Lazy Larry® brownies containing melatonin that they are adulterated under federal law. According to FDA, “Your ‘Lazy Larry’ product is represented for use as a conventional food, and accordingly is not a dietary supplement.” The company apparently uses the term “dietary supplement” in the product’s “statement of identity” and a “Supplement Facts” panel for its nutrition labeling. FDA contends that these statements do “not make your product a dietary supplement,” because it is marketed alongside snack foods, its Website refers to the product as a conventional food, and the appearance and packaging make the product look like a brownie.
Noting that the agency “is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods” and that “reports in the scientific literature have raised safety concerns about the use of melatonin,” FDA warns the company that failure to correct the violation could result in “seizure of the illegal products and injunctions against manufacturers and distributors of those products.” According to a news source, melatonin, a naturally occurring hormone, can make people who use it sleepy. The owner of a Florida smoke shop that sells the product to consumers older than 18 only reportedly objected to a outright ban on the product, noting that its label indicates that it is not suitable for children. “They restrict certain ages to buy alcohol so they should maybe do something like that with the Lazy Cakes,” he said. See cfnews13, August 2, 2011.