Months after a controversy erupted over melatonin-laced brownies, the U.S. Food and Drug Administration has warned one company that its product is “adulterated” because melatonin is an unapproved dietary supplement.

lazycake-inside.jpgIn a July 28 warning letter to HBB LLC, doing business as Baked World, the FDA told the Memphis, TN-based company that while its Lazy Larry (formerly Lazy Cakes) package says the “relaxation brownies” are a dietary supplement, the company is marketing the brownies as conventional food.

The FDA letter gave these examples:

– the product is marketed alongside snack foods;

– the name of a URL, (accessed 7-14-11), that directs people to the product website, refers to a conventional food (cake);

– the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;

– the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);

– the appearance and packaging of the product as a brownie.

Any ingredient added to a conventional food must be used in accordance with a food additive regulation or be GRAS (generally recognized as safe). Melatonin, FDA pointed out in the letter, is not a food additive nor considered GRAS.

Melatonin is a neurohormone primarily used as a sleep aid, FDA said, adding reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns are effects on blood glucose homeostasis, and effects on the reproductive/developmental, cardiovascular, ocular and neurological systems.

 “Therefore, the use of melatonin in your ‘Lazy Larry’ product does not satisfy the criteria for GRAS status under 21 CFR 170.30,” FDA wrote.

The FDA told NBB to “take prompt action to correct this violation” and gave the company 15 days of receipt of the warning letter to identify whatever steps it has taken.  The agency said it can seize the products and prevent further manufacture or distribution.