U.S. Senator Dick Durbin (D-Ill.) has asked the Food and Drug Administration (FDA) “to clarify its authority to regulate foods that contain additives, such as baked goods that contain high doses of melatonin,” after media reports drew attention to so-called “relaxation brownies” touted for allegedly alleviating stress and easing sleep deprivation.
In a May 18, 2011, letter to FDA Commissioner Margaret Hamburg, Durbin argues that melatonin-laced sweets “with names such as Lazy Cakes, Kush Cakes and Lulla Pies” could raise health concerns for consumers who “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.” He notes that these products contain “roughly 8 milligrams of melatonin—almost double the upper limit of a typical dose” set by the Natural Medicines Comprehensive Database, which advises consumers to avoid driving or using machinery for four to five hours after taking melatonin, and warns that melatonin “may interact with contraceptive drugs, diabetes medications, and depressants.”
Durbin questions whether FDA should continue to classify “relaxation brownies” as dietary supplements that do not require pre-market approval, noting that some of these baked goods “appear to be promoting themselves as therapeutic alternatives to medications,” and, as such, “may be marketed in ways that are inconsistent with federal law.” As his letter concludes, “The FDA has not approved melatonin as an additive in foods. If the FDA makes a determination that these products are foods containing a dietary ingredient additive, the manufacturers would be responsible for determining that melatonin is generally regarded as safe or failing this, the FDA would have to approve or reject melatonin as a food additive.”
Meanwhile, the Arkansas Department of Health (ADH) has already recalled Lazy Cakes, and two Massachusetts towns—New Bedford and Fall River—are reportedly seeking to ban similar products. ADH has advised consumers to discard the product and prohibited its sale in the state, claiming that melatonin “has not been approved for general food use” and that its side effects are not fully known. “ADH believes this product poses a potential health risk to consumers, especially young children,” states a May 19, 2011, press release. “The ADH has received complaints about this product being sold in food stores (mainly convenience stores) without prominent labeling and easily accessible to children.” See The New York Times, May 14, 2011; Reuters, May 18, 2011; Law360, May 19, 2011.