Generally Recognized as Safe

When drugs as marketed to foods, people get hurt.  That’s what the FDA concluded about  Lazy Cakes, a melatonin laced brownie sold as “adults only” but marketed to kids and teens.  Michael Roosevelt of the FDA send a warning letter last week to HBB, maker of Lazy Cakes, declaring the “relaxation brownie” violated the law by representing itself as a conventional food (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm266129.htmnote).

Now it’s time for the FDA consistently apply that law.  There are hundreds of other food and drinks containing melatonin and other drugs which require similar warnings – like Kush Cakes (http://www.huffingtonpost.com/2011/08/02/fda-melatonin-brownies_n_916552.html), and many of the 350 relaxation drinks stuffed with melatonin, kava, valerian, and dozens of other substances (http://www.fastcompany.com/magazine/156/liquid-snooze.)

What is Safe?

Foods have the presumption of safety; drugs do not.  A huge American loophole exists in the form of dietary supplements,  drugs effectively treated as “non-drugs” by the FDA.

Dietary supplements constitute a large part of the alternative medicine market.  They generally appear as pills, look like drugs, and are understood to function as drugs by most adults.  Yet many marketers have successfully packaged these “non-drug drugs” as food and drink.

One notorious example was Four Loko, a combination of alcohol and caffeine that allowed drinkers to not notice the sedating effects of alcohol, letting them drink more and more. Four Loko was banned by the FDA five years after it appeared following incidents of increased aggressiveness and near-deaths (http://en.wikipedia.org/wiki/Four_(energy_drink).

So what constitutes substance “generally recognized as safe?”  The FDA uses two criteria: 1. Published and unpublished  scientific studies establishing generally recognized safety 2. Common use as a food by many consumers, or regular use as a food prior to 1958.

Safety is thus:1. Scientifically proven through general scientific consensus or 2. Assumed by common cultural use as a food.  Under the latter distinction, potentially addictive drugs like caffeine and alcohol are not considered for regulation.

But what about Relaxation Drinks?

Not What They Seem

Relaxation drinks come in all kinds of flavors and sizes.  Some, like Mary Jane’s Relaxing Soda contain kava, a dietary supplement that has been reported to cause liver failure.  Others, like Unwind ™, sold off the mylazycakes.com website, contain melatonin.  Quite a few contain valerian, used as a drug from ancient times.

Often they do not contain what they claim.

Prevention’s August issue http://www.prevention.com/health/nutrition/smart-shopping/sleep-aids-do-relaxation-drinks-work/article/a489333924bf0310VgnVCM10000030281eac____) included studies of what was inside many Relaxation drinks.  RelaxZen ™ possessed none of its proferred valerian.   Others, like Unwind, had half the amount of melatonin (1.5 versus 3 mg) that they declared.

Do These Drinks Fit FDA criteria?

1. If melatonin is a drug and regulable neurohormone, what goes for melatonin laced Lazy Cakes should go for melatonin containing relaxation drinks.  And many relaxation drinks sold to “calm and chill” are marketed as antidotes to energy drinks.  Until very recently Lazy Cakes’ website sold Unwind ™  as the way to “Stop a Charging Bull,” complete with a  pictured can of a red bull.
2. What about kava?  Valerian?  They may have been used for centuries – but as drugs, not as foods. Few scientific studies can be used to demonstrate they are safe.
3. Many of the drinks put together groups of different substances.  If you don’t know what one does, how about four working in combination?
4. Relaxation drinks often contain substances that are hardly studied at all – let alone scientifically shown to be safe.
5. They may not contain what they purport to contain – which means they may include unknown substances that bring consumers back, but may prove harmful – as happened with ephedrine laced dietary supplements.

Drugs and Non-Drug Drugs – What Should We Do?

Some relaxation drinks fit FDA criteria without difficulty.  Drinks like ViB ® contain FDA accepted L theanine, another amino acid, and sugar.  Whether they work as advertised is an issue, but they will be legal.

However, many relaxation drinks will produce the same legal issues as Lazy Cakes.    They contain substances like melatonin that have multiple physiologic effects inappropriate for food or drink.

Equally significant are the public health issues.  Why can’t people relax in thethousands of different ways that don’t involve drugs?

Every culture has its culture of rest and relaxation techniques. There is meditation; paradoxical relaxation; deep breathing; yoga – and dozens of other major ways to actively rest.  Many can be accomplished in the time it takes to down a can.

And why promote youth to go “up and down” with energy drinks followed by relaxation drinks?  Caffeine lightens sleep, no help when there is massive sleep deprivation among adolescents.  And for young brains that are particularly vulnerable, what will using “legal” drugs to go up and down do to future use of illicit pharmaceuticals? (http://www.nytimes.com/2011/08/02/health/02abuse.html?ref=drugabuseandtraffic)  Putting drugs into cans and cakes confuses matters for kids when they don’t recognize how what they ingest can harm them.

The FDA should act on many relaxation drinks.  And the manufacturers should do what they have not done – perform clinical trials to show their drinks actually work – without unpleasant side effects.

If capitalism is about competition, it’s time for relaxation drinks to prove the do what they advertise.
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