While nicotine-laced lollipops are becoming more popular as a means of quitting smoking, critics are concerned that the products hold appeal for children and have urged a ban until studies prove they are safe and effective.
Sold in flavours such as apricot, eggnog and watermelon, the lollipops are available at some US pharmacies and over the Internet. Unlike gums and patches to kick the tobacco habit, the lollipops do not have US Food and Drug Administration approval.
Pharmacists said they can sell the confectionery under rules that permit them to prepare medicines using bulk ingredients to make them easier to take, a practice known as compounding. For example, pharmacists can take a drug tablet and make it into a liquid for a child.
The nicotine lollipops, sold under names such as NicoPop and Likatine, are causing controversy because critics view them as unapproved drugs.
Rep. Henry Waxman, a California Democrat, said the lollipops contain nicotine salicylate, an unapproved form of nicotine that he said may harm children's livers in rare cases.
"An addictive drug should not be masked by sweeteners and sold as a lollipop without a thorough review by FDA and strict safeguards to prevent inappropriate underage use," Waxman wrote in a letter to Health and Human Services Secretary Tommy Thompson.
Waxman urged the government to halt the manufacture and sale of the lollipops and require the extensive safety and effectiveness testing needed for medicines.
An FDA spokesman said the agency was looking into the lollipops but declined to comment further.
David Sparks, president of Professional Compounding Centers of America, which supplies drug ingredients to pharmacists, defended the lollipops. He said various salt forms of nicotine, including nicotine salicylate, are permitted in compounding.
The lollipops are promoted as a tasty way to wean oneself off cigarettes, or a means for smokers to get a nicotine fix in places where they cannot light up a cigarette. Some lollipops require a prescription, but those with lower nicotine strengths are sold without a doctor's note.
Pat Frieders, a pharmacist and co-founder of The Compounder Pharmacy, which sells nicotine pops over the Internet and at its store, said the products have grown in popularity over the past two years. The lollipops come with warnings to keep them out of children's reach. The company also makes a nicotine lip balm.
"I think people should have some freedom" to buy the lollipops, Frieders said in an interview, adding that the lollipops are "much safer" than cigarettes.