Nicotine lollipops licked

With the U.S. Food and Drug Administration cracking down on national sales of nicotine-laced lollipops Wednesday, two Inland Northwest pharmacies say they take precautions to prevent children mistaking the lollipops for candy.

The potential risk to children is one of the FDA's main concerns about the lollipops, which are sold to people who want to kick the tobacco habit.

The Medicine Shoppe on Northwest Boulevard in Spokane sells nicotine lollipops by prescription to smokers who want to quit. The multiflavored pops go home in a child-proof vial if the smoker has children, said pharmacist Wayne Clemens.

The Moses Lake Professional Pharmacy puts a warning label on its lollipops.

"I have not received one report (of a child tasting the lollipops)," said pharmacist Shawn Needham, owner of the pharmacy. "I do not know of anybody who has received one report."

The FDA on Wednesday declared lollipops containing nicotine salicylate illegal and ordered three pharmacies in Mississippi, Illinois and Massachusetts to stop sales immediately.

The lollipops pose a risk to children because they look like regular candy, the FDA warned.

"The quantity of nicotine could be potentially dangerous to a small child," said FDA attorney David Horowitz.

The FDA determined that the lollipops - and also nicotine-laced lip balm - are being promoted as smoking-cessation aids, which under federal law renders them drugs. That means the agency must approve them before they can be sold.

Pharmacists can compound drugs, mixing up medications in different forms to make them easier for patients to use. But the lollipops and lip balm contain a form of nicotine never tested for safety and thus is not legal to compound, the FDA said.

Needham, the Moses Lake pharmacist, said his lollipops contain an FDA-approved form of nicotine. They contain no nicotine salicylate, he said, but instead are laced with nicotine polacrilex, the same type used in FDA-approved smoking cessation products.

A promotional brochure from Needham's pharmacy, however, states the pops contain the nonapproved form. Needham said Wednesday his promotional materials are wrong because he based them on materials from other pharmacies.

"I'll be honest with you. We've always used nicotine polacrilex," he said. "Those materials are wrong."

Spokane's Medicine Shoppe does use nicotine salicylate, the nonapproved form. Clemens said the form is "therapeutically equivalent" to the approved form. The FDA is overstepping its bounds when it tries to regulate the practice of medicine, said the Spokane pharmacist, who plans to continue selling the product for now.

The three pharmacies targeted in Wednesday's FDA crackdown also wrongly dispensed the products without a doctor's prescription, both in stores and over the Internet, the agency said.

The Moses Lake pharmacy is working with a doctor under a "prescribing protocol" it has pending with the state. Once approved, the protocol will allow the pharmacy to legally dispense the lollipops under supervision from the doctor, but without a prescription from each patient's doctor.

For now, the Moses Lake pharmacists carefully question patients who call a toll-free number to order the lollipops, Needham said.

"We try to work with patients' physicians because that is the best way," Needham said. "Most physicians don't have a problem with the lollipops. They like any tool that will help their patients quit because smoking is such a health issue."

The FDA's Horowitz urged smokers who bought the products to switch to FDA-approved nicotine gum, patches or other smoking-cessation aids, which contain a different form of nicotine.

The FDA couldn't say if the lollipops posed a health risk to adult smokers because there is no data on the safety or effectiveness of this nicotine salt, called nicotine salicylate.

The FDA gave the three pharmacies 15 days to tell the government they're stopping sales or risk further legal action. Ashland Drugs in Ashland, Miss., and The Compounding Pharmacy in Aurora, Ill., said they immediately ended sales. The third, Bird's Hill Pharmacy in Needham, Mass., did not return a phone call.

The FDA is hunting other sellers of nicotine lollipops. It is reviewing other unconventional nicotine products - such as a Virginia company's nicotine lozenges and a California company's nicotine- laced water - to determine if they, too, must come off the market.

The Supreme Court ended the FDA's drive in the mid-1990s to regulate the nicotine in cigarettes, but the agency does normally regulate the chemical when it is sold in other forms.

The makers of the lollipops, sold in a variety of fruit flavors for $2 to $2.50 apiece, claim that one lollipop can get a smoker through four or five episodes of cigarette craving. The idea: Suck on it just until the craving passes, then put it back in the wrapper until the next attack.

Proponents said that, unlike gum or patches, the lollipop gives smokers something to do with hands that itch to cradle a cigarette. That habit, the makers said, is as important to address as the actual nicotine craving.

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