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FDA Threatens to Pull “Sleepy Brownies” From Store Shelves

1 comment

I’m sure you can guess what "sleepy brownies" are–no, they aren’t those kind of brownies…but they do have somewhat of a similar effect. According to the Food and Drug Administration, the new brownies that are laced with Melatonin and go by the name "Lazy Larry" are dangerous for consumption. In fact, the FDA sent a warning letter to the manufacturer, HBB LLC, earlier this week stating that they would seize the product from store shelves if HBB continues to make and market them.

Melatonin is a naturally occuring hormone that helps to regulate the sleep-wake cycle. HBB advertises the brownies as a stress reliever and consumers can, indeed, become sleepy after eating one. The FDA does not consider Melatonin to be a safe food additive and argues that the brownies are "adulterated" because they contain it. Furthermore, in its warning letter, the FDA cited medical research that Melatonin can have potential reproductive, cardiovascular, ocular, and neurological side effects.

However, the FDA has less regulatory power over dietary supplements sold in pill form. According to federal laws, supplement manufacturers are responsible for the regulation of their own products. HBB maintains that the "Lazy Larry" brownies are a dietary supplement and that they should be regulated in a similar manner to pills. Similar products have not yet been cited by the FDA, including "Kush Cakes" that advertise on their website that their product is "baked with love and our proprietary blend of all natural ingredients, featuring Melatonin and Valerian root".

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  1. Jesse_EngAmer says:
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    Please stop wasting time and money.

    To quote the FDA:
    “Between 10% and 15% of all food consumed by United States (U.S.) households is imported from abroad. Nearly two- thirds of the fruits and vegetables–and 80% of seafood–eaten domestically come from outside the U.S. Half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.”

    And further according to the FDA: The safety of America’s food and medical products remains under serious threat. Imported vegetable protein contaminated with melamine has sickened and killed American pets, and milk tainted with melamine killed and injured children in China. Contaminated heparin, diverted and counterfeit glucose monitor test strips, glycerin contaminated with diethylene glycol (DEG), and low quality titanium destined for medical implants have all raised public health concerns. Peppers, eggs, peanut butter, pistachios, spinach, and cookie dough have all been associated with serious disease outbreaks in recent years. Many of the crises were due to, or exacerbated by, the regulatory challenges of globalization.”

    I don’t think Lazy Cakes should be our chief concern.