FDA Threatens to Seize Melatonin Brownies, Says They’re ‘Unsafe’
The FDA has threatened to remove Lazy Larry brownies, which contain melatonin to induce relaxation, from store shelves if the manufacturer, HBB, LLC, doesn’t recall them willingly.
The warning came from the FDA, as the agency does not consider melatonin to be a safe additive to food. Typically sold as supplements—which are not regulated by the FDA—melatonin is a naturally occurring neurohormone in the body that decreases as we age. It is used to regulate the sleep cycle, and when taken in supplement form, has more of a sleep-inducing effect than one of stress relief as Lazy Larry promotes, says the FDA.
Sen. Dick Durbin (D-Ill.), has been urging the FDA to clarify its policy on dietary supplement infused foods, and said of the Lazy Larry products specifically in a letter to the FDA commissioner Margaret Hamburg, “The sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin,” stating that consumers “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.”
HBB CEO, Terry Harris, said the company will not remove the melatonin in question, but rather will make changes to the product packaging and marketing efforts to position the brownies as a dietary supplement, rather than as a food. “To be clear, there has never been any suggestion by anyone that the product itself is unsafe in any way. We look forward to continuing to work closely with the FDA to immediately remedy these concerns, and to ensure compliance with FDA’s dietary supplement regulations.”
Current FDA rules on supplements sold in the U.S. require that manufacturers make it clear that the products are not intended to “diagnose, treat, cure or prevent” any diseases.
Marketed to aid adults who lead stressful lifestyles, HBB has sold more than 2 million units of the Lazy Larry melatonin brownies in just over 6 months.
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Photo: Lazy Larry Brownies
