FDA: Nicotine Lollipops Illegal

[Guest guest]

I quit smoking cigarettes almost ten years ago!

 

*Smile*

Chris (list mom)

http://www.alittleolfactory.com

 

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FDA: Nicotine Lollipops Illegal

http://content.health.msn.com/content/article/3606.1464

 

Pharmacies Warned to Stop Sales of Hot-Selling Suckers

By Daniel DeNoon

 

 

April 10, 2002 -- Drop that sucker! The FDA today declared nicotine

lollipops illegal.

 

 

The hot-selling candies are made by individual pharmacies. Sold as aids

for those who wish to quit smoking, the lollipops contain up to 4 mg of

nicotine salicylate.

 

 

The FDA has warned pharmacies selling the product through the Internet

that it considers the lollipops to be unapproved drugs. It's threatened

seizure or injunction actions if the pharmacies don't prove to the FDA

that they have stopped selling the products.

 

 

The pharmacies already stopped selling them without prescription -- but

the FDA says that even a doctor's orders won't make the loaded lollipops

legal.

 

 

" Nicotine salicylate is not an approved drug, " FDA spokeswoman Kathleen

Kolar tells WebMD. " Even with a doctor's prescription, it would be

illegal for them to sell it. "

 

 

Tom Jones Drug Health and Wellness Center in Garner, N.C., makes its own

nicotine lollipops. Pharmacist Tom Jones, RPh, has been selling his

trademark NicoStop-Pops to people with a doctor's prescription -- if

they sign a waiver saying they will keep them away from children and pets.

 

 

" Right now we are not now filling any prescriptions, " Jones tells WebMD.

" I am surprised they have taken this stance, but I will abide by all the

things the FDA brings forth. Actually, it has been a great help to a lot

of people who have quit smoking. That has been our whole goal. I'm real

disappointed for the people who won't be able to get this help any more. "

 

 

The FDA action comes none too soon for John F. Banzhaf III, JD,

executive director of the antismoking group Action on Smoking and Health

(ASH). Speaking only hours before the warning was issued, Banzhaf

accused the agency of not doing its job.

 

 

" Nicotine is an addictive drug, but suddenly it's OK to put it in

lollipops? " Banzhaf tells WebMD. " There are several problems with these

products. One is that they haven't been tested, and we don't know if

they are safe or effective. They may be dangerous in the sense of giving

too much nicotine or giving it too fast -- and they may be ineffective

and actually discourage people from using legitimate nicotine

replacement therapies. And lollipops are things that do attract kids --

they come in flavors that appeal to kids. Unlike that awful-tasting

nicotine gum, they are something kids might like and start using. "

 

 

The FDA action also answers questions raised by Jed E. Rose, PhD, chief

inventor of the nicotine patch. The patch gained FDA approval only after

safety and efficacy testing.

 

 

" I don't know of any studies that have demonstrated safety and efficacy

for the so-called nicotine lollipops, " Rose tells WebMD. " It seems they

are proceeding without FDA supervision or approval. Even if they require

a prescription, it would still seem strange for a doctor to prescribe

where there is no safety, efficacy, or pharmacological data. "

 

 

Rose is developing a nicotine drinking straw for people trying to quit

cigarettes. This product, he says, is being developed as a new drug

according to FDA guidelines.

 

 

The FDA action also applies to nicotine-laced lip balm. It does not

apply to the tobacco lozenges now being sold as Ariva by Star

Scientific. Why? The melt-in-the-mouth lozenges are made from specially

formulated tobacco and not from nicotine extract. That seems like an

awfully fine distinction to both Rose and Banzhaf.

 

 

" Where something stops being a tobacco product and starts being a

nicotine delivery system is a question mark, " Rose says. " But for

tobacco and all other products that deliver nicotine, it would be nice

if they were all viewed in a comprehensive way. "

 

 

Banzhaf is even more emphatic.

 

 

" With the lozenge you have the same problem as with the lollipop, " he

says. " You have a substance everybody agrees is both deadly and

addictive. They are being put on the market without any oversight or

supervision whatever. If I came out with any other addictive product and

tried to do that, they'd throw me in jail. "