FDA Rules Nicotine Water Illegal

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FDA Rules Nicotine Water Illegal

WASHINGTON -- Water laced with nicotine is billed as a "refreshing break to the smoking habit," but the Food and Drug Administration ruled yesterday that it's also illegal -- ending a California company's bid to begin selling bottles later this month.

The crackdown had been expected since the FDA ordered nicotine-laced lollipops and lip balm off the market last April, calling them unapproved drugs that had enough nicotine to endanger children lured by the candy resemblance.

But NicoWater underwent additional scrutiny because its maker was promoting the bottled water as a dietary supplement, and the FDA isn't allowed to regulate supplements nearly as strictly as it does medications, according to the Associated Press.

Because nicotine is legally sold over-the-counter in FDA-approved smoking cessation aids, federal law prohibits it also being sold as a dietary supplement, FDA lawyers concluded -- meaning NicoWater can't sell.

Manufacturer QT5 Inc. remained confident that its water met the definition of a dietary supplement, but couldn't immediately say if it will challenge FDA's ruling, said spokesman Ed Haisha.

The FDA's attempt in the mid-1990s to regulate cigarettes was stopped by the Supreme Court. Now nicotine, the addictive ingredient in tobacco, is popping up in more and more novel products, and the FDA's reaction has been to deal with them in one at a time, the report said.

The agency does regulate nicotine-containing products marketed as drugs, such as smoking-cessation aids like nicotine gum and patches, which underwent rigorous scientific studies before their sales were allowed.

In April, the agency stopped pharmacists from brewing up their own nicotine-laced lollipops and lip balm as alternatives to those products, ruling they were unapproved drugs.

Haisha said NicoWater, which was to start selling in convenience stores later this month, was never intended as a smoking cessation aid but as a boost for smokers when they can't light up.

The FDA also has begun reviewing Star Tobacco's nicotine lozenges, which pose a slightly different legal question because they're made with tobacco instead of just nicotine.