As if we didn’t have enough reasons why dietary supplements need better regulation

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.

3 Responses to As if we didn’t have enough reasons why dietary supplements need better regulation

  1. Really, it’s not a matter of lax regulation of supplements so much as it is a matter of the indiscriminate mixing of food and drugs. I work in a natural food store, and when I controlled what products came into my store, I never allowed foods that had medicinal herbs or large doses of supplements on to the shelves (like kava laced corn chips, for instance). That is irresponsible marketing.

    Personally, I don’t want to have to go to a doc to get a Vitamin C prescription, or a even a melatonin or GABA prescription. If I have done the research and want to try it, I want that to be MY choice, not some pharma-beholden gatekeeper’s choice. When herbs are outlawed, only outlaws will have herbs.

  2. ashartus says:

    Better regulation does not mean banning, or even requiring a prescription. There are lots of drugs, whether herbal or chemical in origin, available over the counter or even on the shelves as it stands, and I don’t have a problem with that. Most medicinal herbs and supplements are probably safer than Tylenol, which is pretty readily available. Where regulation is needed is restricting the addition of active substances to foods, particularly at levels that can be potentially harmful.

    I also think there needs to be better regulation with respect to health claims and demonstration of safety (and clear labeling to show maximum safe amounts), and actually providing evidence of both efficacy and safety. I’m willing to accept different standards of evidence for some of these products than pharmaceuticals – I recognize that no one can spend the money required to meet current drug testing standards on something they won’t be able to patent. There also needs to be better information about possible drug interactions involving medicinal herbs – some of these can be pretty serious. Several countries are starting to move more this way, but there’s a long way to go.

    Unfortunately not everyone in natural food stores is as responsible as you.

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