NEW YORK (MainStreet) —  The Food and Drug Administration has formally taken issue with Lazy Larry, a brownie marketed as a way to reduce stress and facilitate relaxation.

In a warning letter issued late last week, the FDA calls attention to the product’s use of melatonin, a neurohormone that has not been approved as a food additive. 

Based on current laws, melatonin, a naturally-occurring compound that is often used as a sleep aid for the treatment of sleep-related disorders, can be sold as a dietary supplement with little regulation from the FDA. But that may change.

Earlier this year legislators urged the FDA to look into products sold as baked goods the contained melatonin, believing that they posed a health risk. 

“The sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin,” Sen. Dick Durbin (R-Ill.) said in written statement in May that mentions Lazy Larry (under its original name Lazy Cakes) and other similar products, Kush Cakes and Lulla Pies. “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 scrutiny led Lazy Larry manufacturer HBB LLC to change the product’s name and make adjustments to its packaging, but the FDA letter indicates that these changes haven’t adequately addressed the problem.

“Your use of the term ‘dietary supplement’ in the statement of identity and your use of a ‘Supplement Facts’ panel for nutrition labeling do not make your product a dietary supplement, because your ‘Lazy Larry’ product is represented for use as a conventional food,” Michael W. Roosevelt, Acting Director of the FDA’s Office of Compliance, wrote in the letter.

Roosevelt cites in the letter that the Lazy Larry products are sold alongside other snack foods, still available for distribution through a website with the “cakes” in the url and have the appearance and packaging consistent with other brownies not considered supplements, but rather as regular food products.
The letter states that the FDA could seize the products if HBB continues to make and market them.

HBB told MainStreet that the warning letter does not indicate that the product itself is unsafe for consumption and that they plan on making additional changes in response to the FDA’s concerns.

“We are taking immediate steps to address the concerns expressed in the letter, all of which stem from the way the product is packaged, labeled and marketed,” says Terry Harris, CEO of HBB.

Whether or not melatonin actually poses a health risk is still up for debate; the warning letter cites that while the FDA has not officially concluded that melatonin is dangerous, several reports in the scientific literature have raised safety concerns about its use. Among these are concerns about effects on blood glucose homeostasis, reproductive/developmental health and the cardiovascular, ocular and neurological systems.

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