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."