WASHINGTON — The Food and Drug Administration has issued a warning letter to HBB, L.L.C. cautioning the Memphis-based company that it can seize its melatonin-laced brownies called Lazy Larry. The brownies up until July were marketed as Lazy Cakes, but HBB changed the name after some lawmakers and public officials expressed concern about the melatonin in the brownies.

Although HBB has marketed the product as a dietary supplement, which is largely unregulated under federal law, the F.D.A. in its July 28 warning letter said HBB’s use of the term “dietary supplement” in the statement of identity and use of a “Supplement Facts” panel for nutrition labeling do not make the product a dietary supplement because the Lazy Larry product is represented for use as a conventional food.

Among the examples of factors and information that establish that the product is represented as a conventional food are:

? the product is marketed alongside snack foods;
? the name of a URL, www.mylazycakes.com, directs people to a web site that refers to a conventional food (cake);
? the product is described on the company’s web site as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
? the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg and salt); and
? the appearance and packaging of the product as a brownie.

“We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to Jan. 1, 1958,” said Michael W. Roosevelt, acting director for the Office of Compliance of the Center for Food Safety and Applied Nutrition within the F.D.A. “Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders.”

He continued, “F.D.A. is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about the effects on blood glucose homeostasis, and effects on the reproductive/developmental, cardiovascular, ocular, and neurological systems. Therefore, the use of melatonin in your Lazy Larry product does not satisfy the criteria for GRAS status under 21 CFR 170.30.”

The F.D.A. has given HBB 15 days from the receipt of the warning letter to correct the violation and prevent future recurrence. Failure to do so may result in enforcement action, the F.D.A. said.
HBB has not commented on the F.D.A. warning.