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FDA: Nicotine-Laced Water Illegal
Agency Says Drug Can't Be Sold As Supplement
POSTED: 3:34 p.m. EDT July 2, 2002
WASHINGTON -- Americans won't be able to buy water laced
with nicotine -- at least not anytime soon.
The Food and Drug Administration has ruled that nicotine, the
addictive chemical in tobacco, is a drug and can't be sold as a
dietary supplement.
The distinction is important. The FDA can regulate drugs, but
it has less power to regulate supplements.
The FDA concluded "nicotine water" is an unapproved drug and may not be legally sold in the United States until the manufacturer submits a new drug application to the agency and the agency approves the application.
Because nicotine addiction is considered a disease, the FDA requires safety and efficacy data to support any claims intended to treat this disease.
"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said Dr. Lester M. Crawford, the agency's deputy commissioner.
California-based QT5 Inc. had planned to market NicoWater in
bottles beginning this month.
The company promotes the product as a way for smokers to get the nicotine
they crave without subjecting others to smoke.
The firm hasn't decided yet whether to appeal the ruling.
The FDA decision had been expected, since it had pulled
nicotine lip balm and lollipops off the market.
The Food and Drug Administration has ruled that nicotine, the
addictive chemical in tobacco, is a drug and can't be sold as a
dietary supplement.
The distinction is important. The FDA can regulate drugs, but
it has less power to regulate supplements.
The FDA concluded "nicotine water" is an unapproved drug and may not be legally sold in the United States until the manufacturer submits a new drug application to the agency and the agency approves the application.
Because nicotine addiction is considered a disease, the FDA requires safety and efficacy data to support any claims intended to treat this disease.
"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said Dr. Lester M. Crawford, the agency's deputy commissioner.
California-based QT5 Inc. had planned to market NicoWater in
bottles beginning this month.
The company promotes the product as a way for smokers to get the nicotine
they crave without subjecting others to smoke.
The firm hasn't decided yet whether to appeal the ruling.
The FDA decision had been expected, since it had pulled
nicotine lip balm and lollipops off the market.
Previous Stories:
- May 24, 2002: Drink Nicotine When You Can't Smoke
Copyright 2002 by KSBW.com. The Associated Press contributed to this report. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
