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WASHINGTON, D.C. -- The Food and Drug Administration (FDA) has called the melatonin-laced Lazy Larry brownies unsafe in a letter to their manufacturer HBB LLC, according to an Associated Press report. The agency also warned it could seize the brownies from store shelves if they continue to be produced and marketed.
The brownies, formerly known as Lazy Cakes, contain melatonin, a naturally occurring hormone that helps regulate one's sleeping cycle. Melatonin is also sold in a pill form as a dietary supplement, which the FDA does not regulate. The Lazy Larry brownies have also been marketed as a dietary supplement and stress reliever, but the FDA stated it does not consider melatonin to be a safe food additive and that the brownies are an "adulterated" food product as a result.
FDA's Michael Roosevelt stated the agency is unaware of any data that establishes melatonin as safe to add to foods, according to the report. He also pointed to medical research that has brought up concerns about potential reproductive, cardiovascular, ocular and neurological issues that could occur as side effects of using melatonin.
In recent months, Sen. Dick Durbin (D-Ill.) has asked the FDA to clarify its stance on foods containing dietary supplements. "The sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin," Durbin said to FDA Commissioner Margaret Hamburg in May. "Furthermore, consumers eating these baked goods may not recognize they are consuming a neurohormone, that they should consult a doctor before eating it, and that it may not be appropriate for children, people with auto-immune diseases, or women who are pregnant or breast-feeding."
HBB CEO Terry Harris said, "We are surprised that this product continues to be singled out, as it contains the same ingredients as many edible relaxation products on store shelves; these are melatonin, Valerian Root Extract, Rose Hips Extract and Passion Flower." However, an HBB spokeswoman said the company is still reviewing the FDA's letter and will not yet comment on the warning.