A small Westlake Village company's bid to put the first nicotine-laced drinking water on drugstore shelves this summer was rejected Tuesday by the Food and Drug Administration, making it the third smokeless nicotine product the agency has blocked this year.
Quick Test 5 Inc., a three-year-old, 25-employee firm, had planned to have its NICO Water available for consumers this month as a "nicotine supplement" and a "convenient beverage when you can't or don't want to smoke."
One advertisement would have read "Out of Smokes? Grab a Bottle!"
The FDA said Tuesday that it had "determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement."
The agency added that nicotine-laced water also could not be marketed as a smoking cessation product without undergoing the same testing demanded of the manufacturers of other products, such as Nicoderm CQ, Prostep, Habitrol, and Nicorette.
"The decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said FDA Deputy Commissioner Lester M. Crawford.
A spokesman for Quick Test 5, Ed Haisha, said the FDA had confused the company with an earlier and now-defunct effort to sell nicotine-laced water. Quick Test 5 bought the rights to the nicotine water patent in April.
Haisha added that the company was confident it would be able to convince the federal agency that it ought to be able to market the product.
Quick Test 5 manufactures drug- and disease-testing kits, Haisha said.
Haisha added that it was hypocritical of anti-smoking groups to fight against a product that eliminates the health risks associated with secondhand smoke.
About 20 anti-smoking groups, including Washington-based Campaign for Tobacco Free Kids, petitioned the FDA in December to step in before nicotine-laced water hit the market.
The group argued, among other things, that the water would serve only as a hook to create more nicotine cravings and eventual smokers.
A spokesman for Campaign for Tobacco Free Kids also said nicotine water served as another example of why Congress should give the FDA the authority to regulate tobacco products.
The Campaign for Tobacco Free Kids said it also has requested that the FDA take action against a nicotine mint and against two cigarette brands whose manufacturers claim to have removed at least some cancer causing ingredients.
In April, the FDA called on pharmacists around the nation to pull two other nicotine products from their Internet sales lists: nicotine-laced lollipops billed as a way to quit smoking and nicotine lip balm.
In a separate action Tuesday, the FDA rejected New York-based Forest Laboratories Inc.'s application to sell an alcoholism drug with Germany-based partner Merck KgaA.
The drug, which is called acamprosate, is designed to calm the cravings of recovering alcoholics. The FDA said it expected one more safety test and more analysis of studies already conducted on the drug.