Skip to content

FDA Threatens to Pull “Sleepy Brownies” From Store Shelves

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…

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".

David Mittleman

David Mittleman

A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.

All articles
Tags: Health

More in Health

See all
Fall Sports Safety Tips

Fall Sports Safety Tips

/
Heart Attack Symptoms & Medical Malpractice

Heart Attack Symptoms & Medical Malpractice

/
Recall of Popular Baby Formula Prompted by Bacteria

Recall of Popular Baby Formula Prompted by Bacteria

/

More from David Mittleman

See all