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Action on Smoking and Health
A National Legal-Action Antismoking Organization Entirely Supported by Tax-Deductible Contributions
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FDA Will Not Regulate Nicotine Lozenges [09/02-4]
Excerpts from: Eating Cigarettes
Washington
Post [08/31/03]
Friday the Food and Drug Administration issued a remarkable opinion announcing that it had no jurisdiction to regulate a product known as Ariva -- a small minty lozenge for use by smokers "when you can't smoke." An Ariva "cigalett," like nicotine gum, patches and inhalers, delivers a dose of nicotine; as its manufacturer puts it, the product is designed for "adult smokers who increasingly find themselves in situations when they can't smoke." Yet, unlike smoking cessation products marketed by drug companies, which are regulated as the drugs and medical devices that they are, the FDA has found that Ariva is beyond its regulatory power. The reason? The product is 60 percent tobacco, and tobacco products marketed for pleasure, the Supreme Court has said, are beyond the FDA's jurisdiction.
Of course, most people don't eat cigarettes, and it seems fairly obvious -- to us, anyway -- that a tobacco product ingested orally and ultimately swallowed in order to consume the drug with which it is laced should be regulated either as a food or a drug. But Ariva's marketing cleverly avoids mentioning nicotine delivery as its purpose -- though that is what makes it work. So Ariva, the FDA announced, "meets the definition of 'smokeless tobacco' . . . because it is made of powdered tobacco 'intended to be placed in the oral cavity.' "
There are two big problems with this state of affairs. The first is that no highly addictive and harmful drug should be marketed without substantial regulatory oversight. It is bad enough that cigarettes themselves should go unregulated by a public health-oriented agency, but it is simply inexcusable that their constituent chemical compounds would be sold in drugstores without triggering the jurisdiction of the agency that supposedly regulates drugs. Moreover, the situation is grossly unfair to drug companies that spend significant time and resources to bring to market traditional nicotine-replacement products under the usual rules of drug and medical device development. Why would smokers buy a heavily regulated and consequently expensive nicotine lozenge when the same nicotine in water is available for far less as a homeopathic formula?
The FDA's current impotence concerning tobacco products in general is indefensible -- a situation Congress desperately needs to correct. Yet the FDA does not need to make current law worse than it already is by interpreting its way out of the oversight of nicotine that it is able to perform.
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