U.S. Senator Dick Durbin (D-IL) has raised concerns with FDA about baked goods containing neurohormone melatonin that, because they are marketed as dietary supplements, do not require approval by the agency for use as additives in food. Sen. Durbin asked FDA to clarify its authority to regulate foods that contain additives, such as baked goods that contain high doses of melatonin.

“Products with names such as Lazy Cakes, Kush Cakes, and Lulla Pies are marketed as dietary supplements that claim to provide a harmless way to promote relaxation, alleviate stress and ease sleep deprivation,” Sen. Durbin wrote. “The website for Lazy Cakes claims their product is, ‘a delicious, chocolate alternative to medication and harmful narcotics to help you safely relax and fall asleep.’ These products appear to be promoting themselves as therapeutic alternatives to medications. As such, the products may be marketed in ways that are inconsistent with federal law.”

There is currently no recommended dose for melatonin supplements, but according to the Natural Medicines Comprehensive Database the typical dose should be between 0.3 and 5 mg. Generally, each brownie and cookie contains roughly 8 mg of melatonin—almost double the upper limit of a typical dose.

“The inclusion of melatonin in baked goods raises numerous health concerns,” Sen. Durbin noted. “The sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin. 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.”

This is not the first time FDA has been asked to clarify its authority to regulate certain dietary supplements and food additives. In January 2000, FDA issued a 10-year plan to implement the Dietary Supplement Health and Education Act of 1994 (DSHEA), which identified the need to clarify the distinction between conventional foods and dietary supplements. Moreover, U.S. General Accountability Office (GAO) reports in July 11, 2000 and January 29, 2009 recommended FDA clarify the boundary.