FDA censures sale of nicotine lollipops

The US Food and Drug Administration (FDA) has clamped down on the sale of nicotine lollipops via pharmacies and the Internet, warning that the products could easily be consumed by children.

The lollipops pose a risk to children because they look like regular sweets, 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, as well as a nicotine lip balm, are being promoted as smoking-cessation aids, which under federal law renders them drugs - and the agency must approve drugs before they sell.

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 not legal to compound, the FDA explained.

The three pharmacies singled out by the FDA this week - Ashland Drugs, The Compounding Pharmacy and Bird's Hill Pharmacy - were also guilty of wrongly dispensing the products without a doctor's prescription, both in stores and over the Internet. The FDA gave the three pharmacies 15 days to stop sales or risk further legal action.

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 problem facing the FDA is that there is simply no data available on the safety, or indeed the effectiveness, of the nicotine salt - nicotine salicylate used in the lollipops.

The quest does not stop there, however. The FDA is hunting other sellers of nicotine lollipops, as well as 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 are also illegal.

"This is an important first step in regulating a whole range of new nicotine-laced products that have recently been brought to the market,"​ Matthew Myers of the Campaign for Tobacco-Free Kids told the Associated Press​. The organisation petitioned the FDA last November to end sales of Triax Nicotine Water but so far without success. "The entire situation points out a major gap in the regulation of nicotine,"​ Myers said.

The makers of the lollipops, sold in a variety of fruit flavours for $2 to $2.50 apiece, claim that one lollipop can get a smoker through four or five episodes of cigarette craving.

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.