Tough Times for Vampires
It’s been difficult recently for vampires.
October 9th was World Vampire Day. Only two days following this celebratory occasion, Toronto vampires filming the latest “Resident Evil” were struck by a construction accident, with multiple injuries and broken bones.
Yet we all know that are vampires are very resilient.
One potential vampire is Lazy Cakes – melatonin stuffed brownies that bring children to the emergency room and put neurohormones and other wonderful stuff into a tiny, expensive chocolate cake. But though the FDA ran them off the shelves, the “nearest equivalent to a hash brownie” may soon rise again in your local convenience store.
The “banning letter” came from the FDA on August 17th, . The response of the president of the “Lazy Larry” Corporation making Lazy Cakes was insouciance itself:
“Lets clear up the rumors on the street and in the press: we are in receipt of a letter from the FDA and are taking immediate steps to address their concerns – all of which stem from the way the product is packaged, labeled and marketed. To be clear, there has never been any suggestion that the product itself is unsafe in any way. We look forward to continuing to work closely with the FDA to immediately remedy these concerns, and to ensure compliance with FDA’s dietary supplement regulations.”
Never any suggestion that the product itself is unsafe in any way? Really?
Here’s what the FDA did say in their letter:
” – the product is marketed alongside snack foods;
– the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);
– the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
– the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);
– the appearance and packaging of the product as a brownie.
Then they go further:
We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. ”
That’s FDA speak for you’re putting a drug in a food – and that’s illegal.
For that is what is inside Lazy Cakes – high dose melatonin, plus valerian and a bunch of other drug-supplements not studied in combination, mapped into a brownie.
However, the president of Lazy Larry is sure they will “find a way” to make Lazy Cakes come back again. And the way regulation works, he’s probably right.
The Canadian Challenge
Canada sees the issues of drugs masquerading as food a bit differently. Recently their regulators banned “energy beverages” that contained more than 180 mg of caffeine.
Their our scientific body suggested 80 mg as the top level – precisely what is found in the most common form of Red Bull – coincidence? A normal cup of coffee may provide 40 mg of caffeine.
However, Canada did recognize that energy drinks are foods, and need be regulated as foods; that they should not be sold to children, pregnant or lactating women; that they be labeled high caffeine beverages; that they not be used with alcohol; and that limits be placed on the “other substances” like amino acids, that can be added to the mix.
In present circumstances, that is progress.
Caffeine, Melatonin and the US
Presently a bill has been introduced in the US Senate to regulate drugs in food. It would ask the National Institute of Medicine to provide a list of drugs deemed safe, which can then be put into foods at will.
With our present Congress, chances of passage are pretty dim.
But public concern with food-drugs is growing. Some worries are sparked by the high number of dangerous drugs used by young people to get high that presently fit around the laws. As reported in the Economist, many of these drugs are not entirely unknown to science or industry, but were dumped by pharmaceutical companies because of their nasty side effects.
They do not provoke much fear however, among intrepid psychoactive drug users who claim a right to self-experimentation. The situation is so crazy and fluid that one London clinic has been set up to treat the kids who are addicted because the kids seem to have much knowledge than clinicians of the new drugs they’re using.
Caffeine and alcohol have been around too long to achieve much regulation. They are drugs long considered foods – and with their own pharmaceutical advantages, particularly caffeine in tea and coffee.
Yet melatonin brownies should not be allowed to get back on the shelves – any more than we should market alcohol-laden pop tarts. Sometimes the public health has to be assertively protected.
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