There’s a controversy in Massachusetts right now regarding some brownies called “Lazy Cakes” that are being sold in various markets. These brownies are laced with melatonin, and are apparently marketed as a relaxation and calming aid. Melatonin is a naturally occurring hormone in humans and other animals, and is considered to be a dietary supplement rather than a pharmaceutical. As a result it is not subject to the same level of regulation as a pharmaceutical drug. As a result of this poor regulation, children have been hospitalized.
Melatonin has a lot of effects on the body, many of them beneficial. There are legitimate uses of this hormone, particularly related to sleeping disorders, with some suggestive evidence of benefits for a few other medical conditions. However, these Lazy Cakes reportedly have 8 mg of melatonin, which is far above the normal dose for medical purposes, and as seen in Massachusetts a potentially hazardous amount for children.
The problems stem from the false assumption that because melatonin is a natural substance it is safe and therefore doesn’t require extensive regulation. Melatonin acts as a drug, no different than any pharmaceutical product. It produces a pharmacological effect in the body, and it has doses at which it is effective, doses at which it is safe, and doses at which it is unsafe. In the case of Lazy Cakes (and possibly other consumer products containing melatonin) the dose is crossing into the unsafe level, particularly since there is nothing to stop people from consuming several of these brownies.
I strongly believe in better regulation of dietary supplements, and cases like this reinforce my belief. Any supplement that purportedly produces an effect on the body should need appropriate testing to demonstrate that it is both safe (at the dose present, including consideration of maximum likely doses) and effective prior to being marketed, and products with a clear pharmacological effect such as this should be treated just the same as any other drug. In fact in some countries, particularly in Europe, melatonin is available by prescription only – with good reason.