After Durbin Raises Concerns About Melatonin in Baked Goods, FDA Declares "Lazy Cakes" Unsafe

Product marketed as a dietary supplement is clearly a food containing the unapproved additive melatonin

[WASHINGTON, D.C.] – U.S. Senator Dick Durbin (D-IL) praised the decision by the Food and Drug Administration (FDA) to declare “Lazy Larry” brownies – formerly known as “Lazy Cakes” – unsafe because although the product is marketed as a dietary supplement, it is clearly a conventional food containing the unapproved food additive melatonin. The manufacturer has 15 days to send FDA a response indicating what steps they have taken to correct the violation.


Today’s announcement comes after Durbin raised concerns in a May 2011 letter to the FDA about baked goods containing neurohormone melatonin that, because they are marketed as dietary supplements, do not require approval by the FDA for use as additives in food. 


“The FDA has taken a hard look at relaxation brownies containing melatonin and determined today that they are marketing themselves as dietary supplements in a way that is inconsistent with federal law,” said Durbin.  “When top health and government officials began publicly questioning the safety of ‘Lazy Cakes’, the manufacturer simply changed the name.  Clearly, the maker of this product is more concerned with their bottom line than the safety of the consumers. 


“I am encouraged by the FDA’s action today and will continue to work with Senator Blumenthal to see that the agency has clear authority to regulate drinks and foods circumventing FDA regulation by marketing themselves as dietary supplements.”


In June, Durbin was joined by Senator Richard Blumenthal (D-CT) in introducing legislation that would ensure that consumers have the information they need to distinguish between products that are safe and others that contain potentially dangerous ingredients.  The Dietary Supplement Labeling Act would improve the information available to consumers, and curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the FDA.