They’ve now been covered in the New York Times, the Los Angeles Times, NPR and numerous other news outlets; their strong effects are being discussed on message boards carrying names such as Grasscity.com; and now they’re even being considered worthy of banishment by at least two Massachusetts towns.

They are Lazy Cakes, a product sold in “head” shops, adult bookstores and some food shops, under the label: “The official relaxation brownie.”

Along with containing more than two grams of trans fat per brownie, one Lazy Cake packs 8 mg of melatonin to, as the company says, “create a sense of relaxation.” Other ingredients include valerian root extract, rose hips extract and passion flower.

When used properly and at recommended dosages (which, for an adult, is typically 1 mg to 3 mg), melatonin can serve as a useful sleep aid. But at the level baked into one Lazy Cake, this natural hormone can be dangerous—especially for children and teens, who are likely to eat more than the one-half brownie recommended on the Lazy Cakes label. In fact, reports are already surfacing of young children who have required medical attention after eating melatonin-laced food.

Terry Harris, the CEO of HBB LLC, the company that makes Lazy Cakes, stresses the product is not intended for kids. “We created Lazy Cakes to provide adults with a great-tasting way to combat stress associated with our fast paced lives,” Harris said in a statement. “Each brownie is clearly labeled to indicate that we recommend that Lazy Cakes be enjoyed by adults only.”

Yet, as the growing legion of Lazy Cakes opponents are quick to point out, the product may be labeled for adults but it is clearly designed to appeal to young people.

"Children are attracted to brownies," Caroline Apovian, MD, director of the Nutrition and Weight Management Center at Boston Medical Center told the Boston Herald. "I don't think it's appropriate to put herbal things that are actually drugs in brownies or food items that are attractive to children. I think that's heinous."

The mayors of two Massachusetts towns agree and are working to ban the products from the state. "It's clear to me that a young child would find it attractive and tasty, and it's got chemicals in it that aren't appropriate for kids," New Bedford Mayor Scott Lang told Reuters.

 

 

Not a dietary supplement

Although the Lazy Cakes label carries a Supplement Facts panel, the product is not a dietary supplement, according to Attorney Marc Ullman, a partner at New York City-based Ullman, Shapiro and Ullman. “They are an adulterated food and unapproved new drug,” Ullman says.

The Lazy Cakes product is not the only food- or beverage-based product on the market to include strong dosages of melatonin and carry a dietary supplement label. Others include Kush Cakes, Lulla Pies and Mary J’s Relaxation Brownies. Melatonin can be legally used in supplements, but it has not been approved as a food additive by the U.S. Food and Drug Administration (FDA), nor has it received generally recognized as safe (GRAS) status—one of which is required to be legally used in food and beverage products.

By slapping a Supplement Facts panel on the label, the manufacturers of Lazy Cakes and other melatonin-laced products are hoping to get around the FDA’s food labeling laws.

"It sounds to me like they are trying to claim that the entire brownie is like a tablet, which is, of course, preposterous," Charles Czeisler, MD, head of sleep medicine at Harvard’s Brigham and Women's Hospital, told the New York Times.

 

Drawing FDA ire

All of the negative publicity generated by Lazy Cakes and other “relaxation” foods and beverages is drawing the attention of the FDA. In fact, a spokesperson for the agency, Stephanie Yao, wrote in an e-mail to the New York Times that any food product containing melatonin “as an additive may be subject to regulatory action.”

The FDA also recently issued a letter to food and beverage manufacturers outlining its rules for the use of novel ingredients in food and beverage products. According to the letter, “food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition, ordinarily by the producer. A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, among other reasons, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use.”

The agency said it issued the communiqué because of trepidation over the growing number of food and beverage products containing novel ingredients, such as herbal extracts, that have not been used as food additives in the past.

“The FDA is concerned that some of the herbal and other botanical ingredients that are being added to conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use,” the agency wrote.

Do we need stronger rules separating supplements and foods?

Over the last several years, the FDA has worked to clarify what it considers to be supplements and foods and beverages.

In December 2009, the agency issued draft guidance on how it would distinguish between liquid dietary supplements and beverages. In that document, FDA cites factors such as packaging type, serving size and use of terms drink and beverage as qualifications that cause many consumers to view a product as a beverage rather than a dietary supplement.

Regulatory experts say that, if enforced, this draft guidance could cause a number of liquid dietary supplements on the market now to require reformulation or risk being deemed an adulterated beverage product by the FDA.

As NewHope360 has reported, many in the dietary supplement industry believe the FDA's draft guidance on liquid dietary supplements is too broad and restrictive. And yet, such guidance could help address products such as Lazy Cakes, which is clearly not a dietary supplement despite its labeling.

In the end, as Ullman notes, the supplement industry is likely to take the heat for products like Lazy Cakes—especially if they are connected to adverse event reports or health safety incidents. “When some kid eats three of these and then wraps his/her car around a light pole on the way home from the prom," Ullman says, "the Congressional hearing will focus on the ‘irresponsible’ dietary supplement industry.”