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HUNDREDS OF INDEPENDENT druggists across the country are producing
suckers under brand names such as NicoStop, NicoPop and Likatine—all
spiked with nicotine, and all produced off the radar screen of the Food
and Drug Administration. The high-octane pops, in flavors such as cherry,
grape, apricot, and tequila sunrise, are the latest attempt to quench
America’s craving for nicotine and the dopamine buzz it provides. “Trying
to stop smoking? It’s as easy as having a lollipop!!!” exclaims Tom Jones
Drug in Garner, N.C., on a Web site advertising nicotine lollipops.
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No one is tallying sales in this cottage industry, but it’s clear
that they are growing fast. One supplier to pharmacists says sales of the
nicotine used in lollipops increased 20-fold from 2000 to 2001. Many
pharmacists also are concocting nicotine-spiked hard candy, gummy lozenges
and even lip balm, selling them in stores and on the Internet.
The lollipops are drawing fire from critics and
putting druggists into the crosshairs of regulators. Congressman Henry
Waxman, a California Democrat, says he is writing a letter to Health
Secretary Tommy G. Thompson asking him to halt sales of nicotine lollipops
and similar products immediately until they are tested. “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,” Mr. Waxman says.
FDA LOOKING INTO
LEGALITY
An FDA spokesman, Brad
Stone, said the agency “is looking into” the legality of the lollipops and
declined to elaborate.
Tobacco-control
activists say the suckers are dangerous because children can easily get
their hands on them and end up hooked on nicotine. It is possible to buy
the lollipops online with no prescription or proof of age required.
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Pharmacists including Mr. Holgate say the chances of children buying
the lollipops are remote. For one thing, they are expensive, selling for
$2 or $3 a pop. Mr. Holgate and many others say they sell the pops only to
customers who have a doctor’s prescription. Mr. Holgate packages his pops
in a clear plastic bag that makes them look like police evidence. The
Compounder, an Aurora, Ill., pharmacy, labels its lollipops, “This is NOT
candy. NOT FOR CHILDREN.”
Underage use isn’t
the only concern, however. Nicorette gum, nicotine patches, nasal sprays
and other smoking-cessation products from big drug companies have received
FDA approval only after rigorous testing to prove they are safe and also
effective in helping people overcome cigarette addiction. The lollipops
haven’t passed such tests. Nicotine is addictive, but it doesn’t cause the
diseases associated with smoking. |
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‘We wanted to
mimic smoking as much as we could.’
— JOHN
VOLIVA
Pharmacist who sells nicotine lollipops |
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Still, many pharmacists say their concoctions are superior to
patches and gums. “We wanted to mimic smoking as much as we could,” says
John Voliva, a pharmacist at Hooks Apothecary in Evansville, Ind., which
sells 200 to 300 lollipops a week. Mr. Voliva says the suckers give users
a spike of nicotine that more closely mimics the one they would get from
inhaling cigarette smoke.
One reason is that
smokers put the lollipop in the mouth, get a hit of nicotine and remove
it, just as they do with a cigarette. Another reason, pharmacists say, is
that the nicotine compound used in the lollipops, known as nicotine
salicylate, is more readily absorbed, with a taste that is more easily
masked than the nicotine found in gums and patches, known as nicotine
polacrilex.
NOT PROVED SAFE AND
EFFECTIVE
But nicotine salicylate
hasn’t been proved safe and effective for use as a medicine and isn’t
approved by the FDA, Rep. Waxman says. Nor is it listed in the U.S.
Pharmacopoeia, a compendium of recognized drugs and ingredients used in
the pharmaceutical industry.
Mr. Holgate
says he isn’t doing anything wrong. “I’ve never had anyone even question
that before,” he says. He has applied for a patent on his lollipop
formulation and wants to apply for FDA approval, but can’t afford the
money required for testing, he says. He says he is simply trying to help
patients by doing what “compounding” pharmacists have always done-mixing
medicine into ointments, suppositories and even candy to make them easier
to use. |
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David Sparks, president of Professional Compounding Centers of
America, a Houston supplier to pharmacists, agrees. He says druggists can
use nicotine salicylate because the FDA has said it “is permissible” to
use active ingredients, such as nicotine, in different salt
forms.
Mr. Holgate says he got the idea for
a nicotine lollipop while listening to Rush Limbaugh on the radio talk
about the high price of cigarettes and the flood of lawsuits against
tobacco companies. He presented his idea, along with a recipe, to other
compounding pharmacists at a trade show, and it caught on. “I’m not the
smartest guy. But I was gifted with common sense,” he says.
Betty Jones, a 64-year-old Augusta homemaker, is
counting on the lollipops to help her kick a four-pack-a-day habit. She
has tried the gum, the patch and even hypnosis without success. Earlier
this year, she went to her doctor and declared: “I just can’t smoke
anymore. I’m coughing my head off.” The physician handed her one of Mr.
Holgate’s lollipops, and she’s been sucking on them ever since. “I’ve
tried it all. And this is the best,” Ms. Jones says, leaning back in her
big, brown recliner and licking a strawberry pop. She says she has stopped
smoking completely. “It’s taking me a lot of lollipops,” she adds,
pointing to the pile of white sticks next to her now-spotless
ashtray.
AVOID TASTING TOO
GOOD
The FDA has insisted that
makers of smoking-cessation aids avoid making their products taste too
good so they aren’t abused. When GlaxoSmithKline PLC wanted to make
Nicorette gum more minty, the FDA at first refused. “They were worried
about introducing anything that tasted better,” says Kenneth R. Strahs,
head of smoking-control research and development for the company. “They
were worried about abuse, especially by young people.” Glaxo had to
conduct a lengthy “abuse liability” study to show the FDA that the new
flavor wouldn’t make it more likely to be addictive.
Jed Rose, a Duke University scientist and one of the
inventors of the nicotine patch, says he thinks the FDA should thoroughly
review and approve smoking cessation lollipops and other products. “The
nicotine pharmaceutical products should be made more palatable so they
will be more effective” in helping people stop smoking, he says. He, too,
has been working with a colleague on a new invention: A
nicotine-impregnated straw that delivers the drug as a person sips on a
drink. A Massachusetts company has licensed the patent and is now doing
the safety and efficacy tests required for FDA approval.
Copyright © 2002 Dow Jones
& Company, Inc.
All Rights Reserved.
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U.S., Andersen
weighing settlement
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