FDA rules against nicotine water

The US Food & Drug Administration (FDA) has ruled that the product called Nico Water is an unapproved drug and that it cannot therefore be legally marketed as a cure for nicotine addiction or as a dietary supplement.

The FDA was responding to a petition by various groups including the National Center for Tobacco-Free Kids, the American Medical Association and the American Lung Association, and based its decision on a number of factors, including statements contained in the labelling of the product and other evidence of intended use.

"The 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, FDA deputy commissioner.

The petition was submitted in December of 2001 and called for the FDA to classify Nico Water, made by Californian firm QT5, as a drug or as a food containing an unapproved food additive. The FDA took the latter option, stating that because the water was intended to treat or mitigate nicotine addiction, which the FDA classifies as a disease, it was required to provide sufficient data to support its claims.

The FDA reviewed these claims - which were posted on the Nico Water website - and ruled that there was insufficient evidence to support them. This effectively makes the water an unapproved drug, which in turn means it cannot legally be sold in the United States until the manufacturer submits a new drug application to the agency and the agency approves the application.

The FDA also determined that Nico Water cannot be legally marketed as a dietary supplement. Nico Water is promoted by QT5 as a dietary supplement, but the FDA said that it does not meet the statutory definition of a dietary supplement because it contains an active ingredient which is already approved as a drug by the FDA - namely nicotine and nicotine polacrilex. These ingredients have been approved by the FDA in drugs such as Nicoderm CQ and Nicorette.

This is not necessarily the end of the line for Nico Water, which could still be marketed as a product designed to help consumers quit smoking providing it can prove its efficacy to the FDA and win approval, although this will not be a rapid or indeed an easy process. Whatever happens now, the anti-tobacco groups which filed the original petition will clearly be pleased at the ruling, as it should make it far harder to gain access to Nico Water, a product which they viewed primarily as promoting rather than preventing nicotine intake.