Lazy Cakes Leaving You Wondering, ‘How are They Legal?’

In my search for food headlines I came across several stories about Lazy Cakes. Lazy Cakes are a sweet treat sold in gas stations and grocery stores that contains a small dose of melatonin, which purportedly aids sleep and encourages relaxation. Each Lazy Cake contains “eight milligrams of melatonin,”simply by adding two more milligrams and an adult would ”abruptly fall asleep,” according to Dr. Caroline Apovian, director of the Nutrition and Weight Management Center at Boston Medical Center. Anna Rouse Dulaney, a toxicologist with the Carolinas Poison Center, says that “eating the whole brownie would be about twice the recommended dose.”

Lazy Cakes markets itself as a dietary supplement and is careful in the packaging to warn “Lazy Cakes are recommended for adults only! Although perfectly safe for adults, these are NOT a snack for children.” This still raises the thorny question – how are they legal?

The lazy snack is legal because it claims to be a dietary supplement. In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This makes it much easier to get the product on the market. Under DSHEA a food company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed.

This doesn’t mean that the Food Safety Modernization Act won’t apply. If there are enough product complaints or the amount of melatonie exceeds healthy limits the product could still be subject to a recall. The brownie manfacturer also must comply with other components of FSMA such as tracing ingredients and having a recall plan ready.

The wisdom of separating out dietary supplements and the ease with which they enter the market emphasizes the massive role the FDA plays in our daily lives. It also shouts for a change to the system – a drug laced brownie should not be sold in gas stations and grocery stores within easy reach of children.

Click here to cancel reply.

Lazy Cakes Leaving You Wondering, ‘How are They Legal?’

Related posts

Leave a comment