Nicotine water sales stalled

The makers say their product is a "smoking alternative"

US authorities have ruled that a bottled water product with added nicotine to help smokers quit cigarettes is a drug, and therefore cannot be sold legally without proper regulatory clearance.

Pressure groups voiced concern children could become addicted or poison themselves

The US Food and Drug Administration (FDA) said the makers of Nico Water will not be able to sell its product - which has not yet been launched - until the agency can establish that it is safe and effective.

The agency made its decision after a petition from anti-smoking groups and health associations who had expressed concern about the safety of such a product being promoted on the internet.

The product makers must now submit a new drug application to the agency for review if it wants to sell it to consumers.

'Smoking alternative'

The product was deemed an unapproved drug by the agency because it was used to treat nicotine addiction, which the agency views as a disease.

The FDA decision recognizes that nicotine is a powerful drug that must be regulated because of its dangers and addictiveness

President of Campaign for Tobacco-Free Kids Matt Myers

The FDA requires additional safety and effectiveness data if a product claims to treat a disease.

"(The) FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," FDA deputy commissioner Lester Crawford said in a statement.

However the makers of Nico Water, California-based firm QT5 Incorporated, disagreed with the FDA's decision, arguing that the product was not something to help people to give up smoking but a "smoking alternative" for when people cannot have cigarette - such as on an airplane.

"We are confident our position, which has the support of consumers, will prevail," said company spokesman Ed Haisha.

Pressure groups

The FDA had previously ruled in April this year that nicotine lollipops sold to help smokers over the internet were also illegal, Reuters news agency reported.

Anti-smoking groups have frequently fought against the possible marketing of such nicotine products, citing concerns that children may become addicted or poison themselves with the substance.

"The FDA decision recognises that nicotine is a powerful drug that must be regulated because of its dangers and addictiveness," President of pressure group Campaign for Tobacco-Free Kids Matt Myers said.