Water laced with nicotine is billed as a "refreshing break to the smoking habit," but the Food and Drug Administration ruled Tuesday 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.
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 Tuesday -- meaning NicoWater can't sell.
"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said FDA acting commissioner Lester Crawford.
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.
Anti-smoking activists had pushed the FDA to issue the ruling, saying allowing nicotine-laced water would have set a dangerous precedent opening the way for nicotine to be added to lots of products, including ones children use.
"The FDA decision is important because it recognizes nicotine as a powerful drug that needs to be regulated," said Matthew Myers of the Campaign for Tobacco-Free Kids, co-author of a petition filed with FDA against the products.
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 a patchwork way, one at a time, after Myers' organization files complaints.
The agency does regulate nicotine-containing products marketed as drugs -- meaning 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 over the Internet and in retail stores later this month, was never intended as a smoking cessation aid but as a boost for smokers when they can't light up.
"From a practical standpoint, you're on a plane from New York to L.A., this is to keep you from clawing the seat in front of you," he said.
He contended users would absorb less nicotine from the water — 2 milligrams or 4 milligrams of nicotine per 16-ounce bottle — than from nicotine gum. At those levels, it was touted as having little aftertaste.
Haisha wondered why anti-smoking activists opposed a smokeless way of getting nicotine. "It's a way to keep Susie in the back seat from getting any secondhand smoke when mommy's driving her to school."
The FDA also has begun reviewing a Virginia company's nicotine lozenges, which pose a slightly different legal question because they're made with tobacco instead of just nicotine, Myers said.
He also wants the FDA to regulate so-called safer cigarettes, saying the claims that they're less toxic or cancer-causing are scientifically unproved.
"The Supreme Court limited FDA's jurisdiction over traditional tobacco products as usually marketed. Today's decision demonstrates FDA has the authority to act over novel nicotine devices and when manufacturers make health claims," Myers said.