U.S. Water News Online
WASHINGTON -- Water laced with nicotine is billed as a
``refreshing break to the smoking habit,'' but the U.S. government's
Food and Drug Administration ruled 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
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
``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 for children's 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
``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
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
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