Nicotine Water Is Drug, FDA Ban Says
Product Requires Review, Agency Rules

By Marc Kaufman
Washington Post Staff Writer
Wednesday, July 3, 2002; Page A03

The Food and Drug Administration ruled yesterday that nicotine water -- advertised widely as an alternative to smoking -- is an unapproved drug and cannot be sold to consumers.

In announcing the ban, the FDA said that the company making Nico Water had improperly claimed that the product was a dietary supplement that didn't need approval by the agency.

Instead, the FDA said, nicotine water is a drug designed to treat the "disease" of "nicotine addiction," and so has to be reviewed like nicotine patches and gum. The agency's action follows an April decision to take nicotine-laced lollipops and lip balm off the market because of similar objections.

"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said Lester M. Crawford, deputy commissioner of the FDA.

Public health advocates applauded the decision, particularly because it described nicotine as a dangerous and powerfully addictive drug. According to Matthew Myers of the Campaign for Tobacco-Free Kids, the FDA conclusion that nicotine addiction is a disease and that products to treat it must be approved as new drugs "is brand new."

The agency said that the California company producing the water, QT5 Inc., was improperly promoting it as an aid to stop or limit smoking. But company spokesman Ed Haisha said the FDA had acted based on misleading information provided in a citizens' petition by public health advocates late last year.

"We have never marketed Nico Water as a cessation product," Haisha said. "We've always said it is simply a nicotine supplement to get people from point A to Z when they can't smoke."

He said the company was not given an opportunity to explain its product and its plans to the FDA after the citizens' petition was filed, adding that it hopes to "clear up" any misunderstandings in a meeting soon. He said company officials are "confident that our position will prevail."

Haisha defended the claim that Nico Water is a dietary supplement, saying nicotine is a naturally occurring substance that would be used only when people couldn't smoke. The company had planned to start selling the water in stores next month.

According to David Horowitz, head of the FDA's drug compliance office, the water can't be considered a dietary supplement -- which requires minimal regulation -- because it contains nicotine, an active ingredient that has already been approved as a drug for other products. He said that the decision does not mean that the FDA will approach tobacco issues differently in the future, but rather that the agency will decide all nicotine issues on a "case-by-case" basis.

The Supreme Court ruled in 2000 that the FDA did not have the authority to regulate tobacco products, as it had claimed under then-Commissioner David Kessler. Numerous bills have been introduced in Congress to give the agency that authority, but tobacco companies and legislators have not been able to reach agreement.

The citizens' petition urging the FDA to ban nicotine water was filed by the American Medical Association, the American Lung Association and the Campaign for Tobacco-Free Kids. Myers said the groups had petitioned the agency to ban other products claiming to reduce the harm done by tobacco products -- mint-flavored lozenges and some new cigarettes.

But Myers said the FDA ruling on nicotine water "points out the absurdity of current law that allows the FDA to regulate some nicotine-containing products while exempting cigarettes and other traditional tobacco products that kill more than 400,000 Americans every year."

On a Web site that advertises Nico Water, the manufacturer calls it "a healthy breather . . . that provides a refreshing break to the smoking habit and the craving for nicotine when not smoking for an hour, a day, a week or a lifetime." Nico Water would have been sold in 16-ounce plastic bottles, with either 2 or 4 milligrams of nicotine.


2002 The Washington Post Company