FDA: Nicotine Lollipops Illegal
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."