Deregulating Prescription Nicotine: An Open Letter to the FDA Commissioner David Kessler

Reprinted with Permission from The Pittsburgh Tribune-Review, October 28, 1995

Recently members of a U.S. Food and Drug Administration advisory panel unanimously recommended that the nation's 46 million smokers be given access to nicotine gum without prescription. In making this recommendation, the advisory panel recognized that nicotine gum helps smokers quit and that it has a margin of safety that would allow its use by smokers without supervision by a physician. The FDA usually follows the recommendations of its advisory panels; it is imperative that the agency do so in this case.

The release of nicotine substitution from prescription status would be a cause for celebration, because it represents a major step toward an important national health objective: to reduce the devastating health effects of cigarette smoking. But thus far the reaction by individuals and groups who so loudly cried for FDA regulation of tobacco a few weeks ago is decidedly -- well, nonexistent. Smoking cessation professionals across the nation must endorse the ready availability of nicotine gum. The change in status of nicotine substitution is important for two distinct reasons.

First, nicotine gum will be available immediately to millions of smokers who have not had access to prescriptions because they do not have ready access to physicians. Even with a prescription, obtaining the gum has been expensive for many smokers. In fact, some media releases have already warned that the price of the non-prescription gum will remain artificially high to discourage abuse. This is not only unnecessarily elitist but would be counterproductive to the objective of improving access. Following the precedent set by other drugs that become available over-the-counter, the price of nicotine gum should drop to a level that is within the financial reach of all smokers.

Second, the recommendation by the advisory panel heralds a subtle but extremely important shift in thinking about tobacco use, because it distinguishes between two separate but related issues: smoking-related health effects and nicotine addiction. The advisory panel recognizes that nicotine is the reason people smoke but not the reason that smokers die. Smokers develop cancers, heart attacks, and emphysema from many of the 3000 toxic products of tobacco combustion, but not from nicotine. In other words, quitting smoking -- without necessarily quitting nicotine -- is the key to reducing health risks.

Only 10% to 25% of smokers who try nicotine gum are successful. For smokers who are unsuccessful we are obligated to extend the strategy of nicotine substitution to an alternative that is inexpensive and already available without prescription: smokeless tobacco. Newer smokeless tobacco products efficiently deliver the nicotine spike smokers crave. Statistics from the Centers for Disease Control and Prevention show that 1.5 to 2 million former smokers have used smokeless tobacco to quit smoking on their own.

But a switch to smokeless tobacco is more than convenient, it's far healthier than smoking. The national toll from smoking is 419,000 deaths each year. In contrast, if all 46 million American smokers had instead used smokeless tobacco, annual tobacco-related deaths would number 6,000 from a small risk of oral cancer. In other words, smokeless tobacco use is 98% safer than cigarette smoking; smokers who switch reduce their risk for all smoking-related illnesses. Research shows that the average lifelong smoker lives almost eight years less than nonusers of tobacco, while smokeless tobacco use has a negligible impact on life expectancy.

Fundamentally a health issue, tobacco use has been increasingly portrayed as an emotional -- even a moral -- issue by ardent anti-tobacco crusaders. By endorsing nicotine substitution through safer delivery systems, the FDA will correctly refocus the issue on the health effects of smoking. This returns tobacco control to those who benefit most from these measures -- smokers.