WashPost.com

Smoke and Water
Tuesday, July 18, 2006; HE02

The Complaint Two consumer groups -- the Campaign for Tobacco-Free Kids and Public Citizen's Health Research Group -- have asked the Food and Drug Administration (FDA) to stop online sales of Nic Lite, a lemon-flavored, nicotine-infused water made by Nico Worldwide, a company based in Oxnard, Calif. Nicotine is an addictive chemical that makes tobacco habit-forming. In 2002 the FDA forced two other companies to stop selling their nicotine-laced waters after finding that the products were untested drugs, not dietary supplements, as claimed. Dietary supplements do not require safety and efficacy testing and are only loosely regulated by the FDA.
The Product Nic Lite is said to contain 2 milligrams of nicotine (about two cigarettes' worth). But its exact contents can't be confirmed, says Matt Barry, director of policy research for the Campaign for Tobacco-Free Kids, because the product has never gone through formal testing. Barry said he drank a bottle of Nic Lite that he ordered online and felt no effects -- ill or otherwise. But he argues that consumers "should have an assurance that they aren't going to get sick from it."
Nico Worldwide CEO J. Robert Knight said Nic Lite is safe and effective in helping adult smokers cut back or quit. Knight called the water "an alternative method of delivering nicotine," ideal for smokers who can't get through a flight without lighting up.
The Upshot In a late June letter to Nico Worldwide, the FDA ruled that Nic Lite is not a dietary supplement, but an unapproved new drug that requires safety and effectiveness testing. Knight said the letter was a surprise to him because the company has a certificate from the FDA granting it the right to sell the product. The company's Washington-based attorney, Paul Hyman, said the matter is under negotiation. "We hope to work it out with the FDA," he said.
-- Alicia Ault