The marketing of melatonin-laced brownies to children was a just a local issue last week, but not anymore.
Sen. Dick Durbin (D-IL) Wednesday asked U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to see if she has the authority “to oversee the safety of foods containing dietary supplement additives.”
“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 said in a letter to Commissioner Hamburg. “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.
“The relaxing effect promoted by these products is due to the ingredient melatonin. According to scientific research there is no recommended dose for melatonin supplements, but according to the Natural Medicines Comprehensive Database the typical dose should be between 0.3 and 5 milligrams. Generally each brownie and cookie contains roughly 8 milligrams of melatonin — almost double the upper limit of a typical dose,” Durbin added.
It was only as recently as May 12 that Fall River, MA Mayor William Flanagan called for a local ordinance to ban selling brownies with melatonin. Other Massachusetts municipalities became interested and the issue has quickly spread across the country.
Durbin is not only one of the most powerful U.S. Senators, but he is also among a handful with a deep interest in and knowledge of federal food safety issues. He was instrumental in getting the Food Safety Modernization Act through the last Congress.
He raises important legal points – -like when is a brownie a food and when is it a supplement?
“The inclusion of melatonin in baked goods raises numerous health concerns. For instance, 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,” the letter to Hamburg continues.
“According to the Office of Dietary Supplements in the National Institutes of Health, after taking melatonin people should not drive or use machinery for four to five hours, and melatonin may interact with contraceptive drugs, diabetes medications, and depressants.
“These products are currently marketed as dietary supplements, therefore they do not need to establish evidence of their products’ safety and effectiveness or require pre-market approval. 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.”
The need to clarify the distinction between foods and supplements has been recognized by the federal government for a long time, and come up in reports by the U.S. General Accountability Office (GAO) twice in the past decade.
Last year, FDA told the manufacturer of a product called “Drank” that melatonin is not an approved food additive, but that case remains unresolved.