WASHINGTON — Senator Richard Durbin of Illinois has raised concerns with the Food and Drug Administration about baked goods containing neurohormone melatonin that, because they are marketed as dietary supplements, do not require approval by the F.D.A. for use as additives in food. In a May 18 letter to Margaret Hamburg, commissioner of the F.D.A., Mr. Durbin asked the F.D.A. to clarify its authority to regulate foods that contain additives, such as baked foods that contain high doses of melatonin.
The action taken by Mr. Durbin comes as media attention in recent weeks has grown surrounding Lazy Cakes, a product made by Memphis-based HBB, L.L.C. and marketed as a “relaxation brownie” that contains 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,” Mr. Durbin wrote. “The web site 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 mg 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,” Mr. Durbin said. “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.”
In addition to Mr. Durbin’s call to the F.D.A. to regulate additives in food, the Arkansas Department of Health on May 19 recalled all Lazy Cakes, saying the product contains melatonin, “which has not been approved for general food use.”
“The A.D.H. is prohibiting the sale of this product in Arkansas and will be working with food vendors to recall Lazy Cakes,” the A.D.H. said.
The A.D.H. said it believes the product “poses a potential health risk to consumers, especially young children,” and has received complaints about the product being sold in food stores (mainly convenience stores) “without prominent labeling and easily accessible to children.”
Mayors in several other cities in which Lazy Cakes are sold also are trying to get the product removed from shelves.
On its web site, HBB, L.L.C. notes that Lazy Cakes “are recommended for adults only!”
“Although perfectly safe for adults, these are NOT a snack for children,” the web site said. “These are meant as a dietary supplement to aid adults who lead a stressful, energy drink fueled lifestyle to wind down and relax. As with any product, it is highly recommended that you read the labels.”
Mr. Durbin said this is not the first time the F.D.A. has been asked to clarify its authority to regulate certain dietary supplements and food additives. In January 2000, the F.D.A. 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 reports in July 11, 2000, and Jan. 29, 2009, recommended the F.D.A. clarify the boundary.