Nicotine Lollipops: Sweet, Addictive, and Illegal

By Rep. Henry A. Waxman, U.S. House of Representatives (D-CA).

On April 3, 2002, I wrote to Secretary of Health and Human Services Tommy Thompson to express my concern about nicotine lollipops. These products - known by trade names like NicoPop and LikatineÑwere manufactured and marketed by compounding pharmacies in violation of the federal law. I urged Secretary Thompson to take immediate action to pull these candies from the market. One week later, on April 10, the Food and Drug Administration (FDA) sent warning letters to three pharmacies, halting sales of the lollipops. This was a welcome first step towards increased regulation of the many products on the market containing nicotine and making unproven health claims.

Although I support innovative strategies for smoking cessation, there were three problems with nicotine lollipops. First, these products pose serious risks to children. Nicotine lollipops are new, so there are no studies that examine the use of these products by children. Nevertheless, the potential for use by children is obvious. Just consider the list of available flavors, which include Blueberry, Bubble Gum, Cherry, Cinnamon Apple, Grape, Green Apple, Hawaiian Coconut, Lemon, Lemon-Lime, Licorice, Orange, Orange-Pineapple, Peach, Peppermint, Pina Colada, Pineapple Splash, Raspberry, Root Beer, Strawberry, Strawberry-Banana, Spearmint, Sweet Citrus, Tangerine, Tequila Sunrise, Tropical Punch, Tutti Fruitti, Very Berry, and Watermelon.

Moreover, pharmacists created and marketed the products in ways that might attract children. For example, one Washington State pharmacist said, ÒWe do a good job of flavoring and masking any taste of the drug.Ó And a pharmacy employee in Indiana said, ÒThey taste just like Dum Dum suckers

. . . you canÕt even taste the nicotine at all.Ó

To prevent use by children, an addictive drug should not be masked by sweeteners and sold as a lollipop without a thorough review by the FDA and strict safeguards. Yet no such review had been conducted. Several pharmacies even sold the lollipops over the internet without requiring a prescription.

Second, the active ingredient in nicotine lollipops is a potentially unsafe drug, nicotine salicylate. The salicylate in nicotine salicylate has been associated with a devastating brain and liver disorder in children, ReyeÕs Syndrome. Moreover, unlike the forms of nicotine in FDA-approved nicotine patches and nicotine gums, the safety of nicotine salicylate has not been established by the FDA.

The section of federal law regulating pharmacy compounding permitted pharmacies to produce small quantities of unapproved drugs only if the bulk drug substance is a component of an approved drug, and is found in the United States Pharmacopeia or National Formulary monograph, or is named by the FDA in a separate list. Nicotine salicylate, however, does not meet any of these criteria.

Third, nicotine lollipops were being marketed on the basis of health claims that had not been approved by the FDA or substantiated scientifically. Pharmacies advertised that nicotine lollipops are a treatment for nicotine withdrawal symptoms in the same way as nicotine gum and nicotine patches, two FDA approved products are. One pharmacy tried to convince customers that nicotine lollipops were better than other smoking cessation products. Another pharmacy even claimed nicotine sugar-free lollipops are Òideal for persons with diabetes.Ó

Such health claims are not supported by evidence. In contrast to the many studies establishing the effectiveness of the nicotine patch, gum, and inhaler, I am not aware of a single published study on nicotine lollipops. Unproven claims may deceive consumers and promote a potentially unsafe drug. Under the law, it is simply illegal to market a drug with health claims that have not been approved by the FDA.

At the same time that the FDA issued warning letters to stop the sale of nicotine lollipops, it also barred the sale of nicotine lip balm. According to advertisements, nicotine lip balm Òlooks like a plastic ÔChapstickÕ but it contains a dose of nicotine in a sweet flavored base.Ó Each tube allegedly Òprovides hundreds of small dosesÑequivalent to approximately 100 cigarette breaks.Ó

Other products not covered by the FDAÕs recent warning letter also raise similar concerns. Advertisements for nicotine water can still be seen on the internet. Described as a smoking cessation aid and sold as a dietary supplement, this product promises, Òall you will taste is the water.Ó I believe the FDA should take the unequivocal position that any product containing nicotine and making health claims must be found safe and effective by the agency before it can be lawfully marketed. The FDA should build on the precedent of its action against nicotine lollipops and bring other products making health claims under its jurisdiction. At the same time, Congress must also take action to bring all tobacco products under the agencyÕs authority to protect the public health.