Senator Durbin Questions FDA on Melatonin Baked Goods

U.S. Senator Dick Durbin (D-IL) today sent a letter to FDA questioning the agency’s policy on foods containing dietary ingredients as additives-and specifically for baked goods containing 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,” Durbin wrote in the letter. “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.

Sen. Durbin also took issue with the fact that these baked goods typically contain melatonin doses far higher than recommended levels. The letter notes that while the Natural Medicines Comprehensive Database says that a typical melatonin supplement dose should be between 0.3 and 5 mg, that brownies and cookies containing melatonin contain roughly 8 mg, which Durbin’s letter says is almost double the upper limit of a typical dose.

“The sweet, chocolaty taste [of these baked goods] may encourage consumers to eat well over a recommended quantity of melatonin,” he pointed out.

The letter asks that FDA clarify its position on regulating additives in foods. “The distinction between dietary supplements and foods with dietary ingredient additives is not always clear, leaving room for some food products to be marketed as dietary supplements in order to circumvent the safety standards required for food additives,” he stated.

Nutritional Outlook thanks Ullman, Shapiro & Ullman LLP for the tip.