By Ashlee Dunston
Posted: Wednesday, May 8, 2002
Publication Date: May 8, 2002

The recent ban on nicotine lollipops and lip balm by the U.S. Food and Drug Administration is another ironic effect of the FDA's odd jurisdiction.

The FDA banned the lollipops for four main reasons: the lollipops were compounded and distributed without a doctor's prescription; online pharmacies were promoting them as smoking cessation treatments, or new drugs, that were not FDA-approved; the particular form of nicotine in the lollipops, nicotine salicylate, was not FDA-approved; and the package labeling did not contain adequate directions for usage or adequate warnings against use by children. These are all valid FDA mandates for the ban, and this does not mean that the nicotine lollipops and other similar products will fail to gain FDA approval in the future. Why is it, though, that the FDA can regulate the nicotine in such products as lollipops and smoking cessation devices but has no control over the nicotine in cigarettes?

This has been a battle for quite some time now, since the FDA has previously tried to bring tobacco and tobacco products under its regulatory wing. Not only do cigarettes contains hazardous chemicals and byproducts, they contain nicotine, and it might be argued that the nicotine content alone is reason for FDA to gain control or regulatory rights. However, the U.S. Supreme Court ruled, most recently in March 2000, that the FDA could not regulate tobacco products until Congress declared tobacco part of the FDA's jurisdiction.

The FDA as we know it today is a consumer protection group and has origins dating back to the nineteenth century, when physicians and scientists wanted to standardize drugs and prevent adulterated drugs from entering the U.S. from abroad. The Pure Food Movement, a trade movement in the 1870s, became the foundation for the Food and Drugs Act of 1906 — the first real attempt to regulate "adulterated" food, drink, and drugs. The enforcement group was originally the Bureau of Chemistry, but the bureau later delegated control to the newly formed Food, Drug, and Insecticide Administration, which was later renamed the Food and Drug Administration.

There have been many changes to this department and its regulations throughout its history, redefining the Agency's mission and jurisdiction. The Federal Food, Drug, and Cosmetic Act of 1938 accommodated technological advances in the production of foods, drugs, and medical practices. There were also the Pesticide Amendment (1954), the Food Additives Amendment (1958), and the Color Additive Amendments (1960). The Delaney Clause (1958) made animal testing mandatory for FDA approval of new chemicals and pesticides and issued a "zero tolerance" policy stating that any amount of any substance shown to cause cancer in animals could not be added to foods. Further, the 1962 Drug Amendments increased the regulation of prescription drugs, new drugs, and experimental drugs, and this act in particular has had a lasting impact on the drug development process and clinical trials. "Harm prevention" was the focus of the amendments introduced in 1976 to insure the safety of medical devices and technology, and harm prevention was the focus again in 1980 with the Infant Formula Act, designed to monitor the nutrients in manufactured baby foods. The FDA Modernization Act of 1997 strongly reaffirmed the Agency's long-term goal of increasing its control over the review of medical devices, clinical trials, the advertising and marketing of drugs, and health claims for foods. However, the Dietary Supplements Health and Education Act of 1994 effectively removed dietary supplements from FDA oversight.

Today, the FDA regulates almost everything that we put in or on our bodies except controlled substances (the DEA has authority over those), dietary supplements — and cigarettes.

Consider the wide range of things the FDA now regulates: food (foodborne illness, nutrition, dietary supplements, food additives), drugs (prescription, over-the-counter, generic, clinical trials), medical devices (pacemakers, contact lenses, hearing aids, surgical procedures), biologics (vaccines, blood and tissue products, gene therapy), animal feed and drugs (livestock, pets, animal testing, antibiotics), cosmetics (safety, labeling), radiation-emitting products (cellular phones, lasers, microwaves), and more. The FDA even regulates things such as tanning beds and anti-wrinkle botox injections.

In 1994, FDA Commissioner David Kessler announced that in the future the FDA might consider regulating the nicotine in cigarettes, and in 1995 the FDA deemed cigarettes "drug delivery devices" and proposed restrictions on marketing and sales in an attempt to reduce the prevalence of smoking among young people. However, their attempts at gaining control over tobacco and tobacco products were thwarted by the 2000 Supreme Court ruling. FDA had overstepped its bounds by, among other actions, imposing restrictions on advertising and sales to minors in 1996. It seems as though the issue has been settled for the time being. However, given FDA's mission "to promote the public health" and "to protect the public health" — and in light of the recent attention focused on nicotine lollipops — there is an odd inconsistency about those things FDA can regulate and those it cannot.

Nobody knows exactly what would happen if the FDA ever did add nicotine to its repertoire of controlled drugs. Could the FDA consider cigarettes "safe and effective"? That's unlikely for a product that contributes to more than 430,000 deaths each year in the U.S. alone. FDA regulation of cigarettes need not mean the total elimination of tobacco products, but it would at the least eliminate the irony in our current laws.

Ashlee Dunston is ACSH's assistant director of public health.

Responses: February 28, 2004 To me it is the most ludicrous thing I have ever heard that the FDA is banning the sale of nicotine lollipops. These are precisely what helped me the most during the seventy-two-hour physical withdrawal period. Of course, there is the behavioral aspect of it as well, but for the government to ban the sales is one of the most ridiculous things I have ever heard in my life. If they are worried about the children, I am sure the pharmacies would be more than willing to put up a warning sign stating what the nicotine lollipops are. I guess the FDA would rather have people die from cigarette smoking than allow something helpful to stay on the market. —Butterflydance16