An American nicotine drink being marketed as a cigarette substitute
would only be sold with a prescription if it hit the shelves in
Canada, according to Health Canada.
Health Canada spokeswoman Nathalie Lalonde said it had previously
stated that Nic Lite would fall under the definition of a natural
health product because nicotine is a natural chemical substance
derived from tobacco plants. Products containing nicotine with a dose
equal or lower than four milligrams per serving - equivalent to the
amount found in Nic Lite - are regulated as over the counter natural
health products.
"However, this only applies to certain dosage forms, such as gums and
lozenges, and not products in liquid form (such as Nic Lite)," Lalonde
wrote in an e-mail to The Canadian Press.
Lalonde said all health products must also undergo a thorough
pre-market review by Health Canada before they're approved for sale.
"Only where there is sufficient evidence supporting the safe and
effective use of a product will the product be authorized for sale in
Canada," Lalonde wrote.
Nic Lite is a lemon-flavoured drink that contains organic nicotine
equivalent to the amount found in two cigarettes.
Joseph Knight, CEO of California-based Nico Worldwide Inc., the makers
of Nic Lite, said that his company has filed an application to Health
Canada to bring the product to Canada.
"We're hoping that in the next two to three months we would have our
clearances in place," Knight told The Canadian Press in a phone
interview last week from Oxnard, Calif.
Knight said Nic Lite was designed to be used by smokers to help them
when they can't smoke.
The product is also being touted as a way to cope with smoking bans.
In a statement released in June, the makers of Nic Lite said they plan
to roll out the product in more than 50 U.S. airports, targeting
nicotine-addicted airline passengers facing smoke-free flights and
long periods where they may be unable to light up.
But Nico Worldwide Inc. may have been dealt a blow in distributing the
product in the United States. The U.S. Food and Drug Administration
told the company in June that Nic Lite doesn't meet the definition of
a dietary supplement.
"The product is considered an unapproved new drug," FDA spokeswoman
Laura Alvey wrote in an e-mail to The Canadian Press. "The company is
in violation of the (Food Drug and Cosmetic) Act in continuing to
market the product as a dietary supplement."
Nico Worldwide had cited a 1993 New England Journal of Medicine
article which stated that nicotine is a naturally occurring compound
in many vegetables including cauliflower, eggplant and tomatoes, to
support its dietary supplement claim.
Knight has said the FDA originally approved Nic Lite in 2004 and that
his company's lawyers plan to meet with the government agency in
Washington.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
# posted by Network @ 9:22 AM
