NICOTINE-LACED WATER IS A DRUG, F.D.A. RULES

Federal regulators said yesterday that nicotine-laced bottled water, which
is being marketed as a dietary supplement, is an unapproved drug and cannot
be sold in the United States without federal clearance.

The product, Nico Water, fell squarely in the middle of the debate about
whether substances that contain nicotine, but do not make drug claims,
should be classified as dietary supplements or drugs. In April, the Food
and Drug Administration ordered nicotine lollipops and nicotine lip balm
off the market.

"This product clearly cannot be marketed as a dietary supplement because it
contains ingredients that do not meet the definition of a dietary
supplement," said David J. Horowitz, the F.D.A.'s head of drug compliance.
"Secondly, the product is marketed as a smoking cessation product, which
rendered the product an unapproved drug under the law."

Mr. Horowitz said products could not be considered dietary supplements if
they contained an ingredient that is already in an approved drug. The
active ingredient in Nico Water is nicotine polacrilex, the same form of
nicotine that the F.D.A. has approved for use as a drug in the nicotine
patch and in nicotine gum.

Nicotine-laced water came to federal regulators' attention in December,
when anti-tobacco groups including the Campaign for Tobacco-Free Kids and
the American Cancer Society asked the F.D.A. to regulate the product as a
drug. At the time, another company owned the product and sold it over the
Internet. In April, Quick Test 5, based in Westlake Village, Calif., bought
the patent for nicotine water, renamed it Nico Water and begin marketing it
for release this summer.

The company said it had not yet shipped any cases of water, but had taken
orders from retailers in other countries, including Japan. American retail
outlets, it said, had not placed orders, largely because they were awaiting
the F.D.A. decision.

Executives maintained yesterday that they had never said the water would
help people stop smoking. They have said their product is a "healthier"
alternative to smoking "without the side effects associated with other
nicotine alternatives."

A spokesman, Ed Haisha, said, "The F.D.A. is under some misunderstanding
about the product, so we need to open some communication or dialogue with
the F.D.A. to see if we can clear it up or at the very least come to a
mutual agreement."