A FEW weeks ago, a strange bottled water began stacking up on the shelves of corner stores and supermarkets in the US. Designed to give you the same dose of nicotine as a cigarette but without the cancer or bad breath, Nico Water could be swigged harmlessly on planes or in the office. It looked like an uncontroversial addition to the world of cigarette replacement.
Well, no longer. After six months pondering the issue, the US Food and Drug Administration ruled last week that the bottles must come down from the shelves. Nicotine, they say, is a drug, so Nico Water has to be regulated as a drug too. Until safety and efficacy tests are done and submitted for scrutiny, the nicotine water isn鈥檛 legal. For now, Nico Water鈥檚 retail life is over before it even had a chance to become a talking point.
No one has any evidence that Nico Water is dangerous. So it is tempting to see the withdrawal as a knee-jerk government response to pressure groups like Tobacco-Free Kids, who view nicotine as a nasty addictive substance and petitioned the FDA to make this move. But scratch the surface and you see that the story is not that simple.
Advertisement
The case highlights what has become an embarrassingly grey area of product regulation in many countries. Unlike the patch or nicotine gum, Nico Water called itself an occasional substitute for smoking rather than a full-blown 鈥渃essation aid鈥�. So its Californian manufacturers QuickTest5 said it shouldn鈥檛 be regulated as a drug鈥� as the patch and gum are 鈥� but as a humble dietary supplement like Vitamin C or cod liver oil. The definition of 鈥渟upplement鈥� is amazingly vague, allowing almost anything to slip into the gap between foods and drugs if the government wants it to. What鈥檚 more, new supplements can pop up on shelves without anyone providing evidence about what the product does to the body, how it does it, or even how safe it is.
With something as apparently simple and useful as Nico Water, it might be hard to see the point of tough regulation. While nicotine clearly stimulates brain cells and is addictive, it is not the key ingredient in cigarettes that wrecks hearts and lungs. Researchers dismiss the idea that this nicotine water is dangerous to health. The consensus from animal experiments is that you鈥檇 have to drink more than your own body weight to die from nicotine poisoning. So why squander time and money scrutinising it, when it could be out there saving lives?
One reason is that if the FDA waved Nico Water through as a food supplement, the door would have been opened a chink for Nico-lollipops, chocolate bars and ice cream 鈥� sexier products that would appeal to kids. But there鈥檚 a more fundamental issue. We talked to experts about Nico Water and stumbled on a simple question that nobody seems willing or able to answer: what exactly is in it?
The bottle lists its ingredients as purified spring water plus 4 milligrams of nicotine polacrilex. A plastic-like substance developed for nicotine gum, polacrilex is one of the most studied forms of nicotine and one of the few approved by the FDA for over-the-counter drugs. It鈥檚 therefore highly attractive for those looking to pioneer new cigarette substitutes. Strangely, however, Europe鈥檚 largest manufacturer of nicotine polacrilex, SMS Biopharma, assures New 杏吧原创 that the powder won鈥檛 dissolve in water.
鈥淚 don鈥檛 know what鈥檚 in their water, but it isn鈥檛 polacrilex,鈥� the company鈥檚 chief chemist told us. Might they be extracting nicotine from the gum and dissolving that instead? Perhaps 鈥� but that would be a laborious and costly way to do it, when you could just use a readily available, soluble alkaloid form of nicotine.
Others are even more befuddled. However you make nicotine solutions, a second expert revealed, they usually don鈥檛 last: the nicotine settles out of solution. To get round this problem a Boston company called Addiction Therapies has been developing a straw coated on the inside with beads of sugar-nicotine crystals. You drink through the straw to get your fix. Why go to such lengths if nicotine can simply be dropped into a drink?
New 杏吧原创 took these points to QuickTest5. The company replied by saying that its product has a shelf life of 18 months, 鈥渄oesn鈥檛 have anything on the label that isn鈥檛 in the product鈥�, and is made by a 鈥減atented process鈥�, though the US version of the patent doesn鈥檛 mention polacrilex.
SMS Biopharma鈥檚 chemist is 鈥渞ight in certain circumstances鈥�, they said, but QuickTest5 definitely has 鈥渁 soluble system鈥�. What is it? They couldn鈥檛 say 鈥� the information is 鈥減roprietary鈥�. Nor could they give us any safety data: that too is 鈥減roprietary鈥�, though it will be posted on the Web once the patent has been approved in other countries. The company then added that it recently decided to make its product available in several formulas, including one using straight nicotine alkaloid instead of polacrilex. Very confusing.
The labelling on supplements has to truthful. But unless complaints are lodged against them, it seems impossible to extract information about exactly what鈥檚 in them or even how safe they are. Nobody is saying nicotine water is inherently evil. But it would be nice to know more about it. Now that the FDA has placed the product firmly in the world of 鈥渄rugs鈥�, that information should finally come to light.