U.S. Senator Dick Durbin (D-Illinois) is jumping into the fight over Lazy Cakes and other baked products containing high doses of melatonin. On May 18, the senator wrote a letter to the Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), urging the agency to issue guidance clarifying its authority to regulate foods containing dietary ingredients as 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 wrote. “The website for Lazy Cakes claims their product is, ‘a delicious, chocolate alternative to medication and harmful narcotics to help you safety 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.”
Durbin’s argument focuses on the fact that, because Lazy Cakes and other melatonin-laced products are marketed as dietary supplements, these products do not require FDA pre-market approval for safety and efficacy. “The FDA has not approved melatonin as an additive in foods,” Durbin writes. “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 (GRAS) or failing this, the FDA would have to approve or reject melatonin as a food additive.”
According to Attorney Marc Ullman, a partner at Ullman, Shapiro and Ullman, products such as Lazy Cakes are not dietary supplements—despite the fact that the manufacturers have slapped a Supplements Facts panel on their products. “They are an adulterated food and unapproved new drug,” Ullman says.
Cleary, this is not the last we are likely to hear about Lazy Cakes or the question of whether they are, indeed, legally labeled as dietary supplements. As Marion Nestle wrote in a May 15 Food Politics blog post: “Is melatonin a drug, a supplement, or in brownie form, a food? The FDA is going to have to decide this, and fast.”