Regulation of Tobacco Products in the United States

The U.S. federal government regulates all consumer products except cigarettes and other tobacco products. Products from foods and drugs to cars and car seats are all subject to rigorous regulation to ensure that they are safe and that they work as consumers expect. But with the exception of a program to ensure the collection of taxes from their sale, there is virtually no regulation of tobacco products. In fact, tobacco is expressly exempted from regulation under a number of consumer product statutes, such as the Federal Consumer Product Safety Act.

The most logical agency in the federal government to regulate tobacco products is the U.S. Food and Drug Administration (FDA). The FDA regulates food, drugs, cosmetics, and medical devices like X-ray machines and surgical instruments. Indeed, about 25 cents worth of every dollar spent on consumer products goes to a product regulated by FDA. In the 1990s the FDA did attempt to regulate tobacco products but, as will be explained, the agency's efforts were overturned in court.

Other federal agencies have tobacco-related responsibilities that do not involve product regulation. Some are involved in studying the health effects of tobacco products, while others inform the public of the risks of tobacco products and how to quit. The work of these other agencies also will be described.

Why Regulate Tobacco Products?

A logical first question many people ask is why tobacco products should be regulated at all. Some people believe that the public is already aware of the risks associated with tobacco products and that regulation is not needed. Others question why they are permitted to be sold at all. If tobacco products are so dangerous, so this argument goes, why not ban tobacco products entirely?

Many experts believe that the answer to this very sensible question is that prohibition would not work. Almost 50 million adults smoke. Most of these tobacco users are addicted to the nicotine in tobacco. These people would still be dependent on nicotine if tobacco sales were made illegal. Experts fear that, as was the case when alcohol sales were made illegal in the early twentieth century, a black market for tobacco products would quickly come into existence.

A black market is a system of illegal sales of prohibited products. One concern is that black market tobacco products could be more dangerous than the products available today because of even more questionable ingredient quality and product purity. The tens of millions of smokers who might seek out cigarettes in a black market could thus be exposing themselves to even greater risks than they would under a system in which sales are lawful.

What Would Tobacco Product Regulation Include?

Traditional regulation of consumer products is designed to ensure that ingredients or components are safe and that the products will work as promised. FDA regulation of health claims for food and drug products is a good example of a regulatory approach that might work for tobacco products.

Food and drug manufacturers have to first demonstrate to the FDA that there is scientific support for the claims they make about their products. Most importantly, they have to submit their evidence to the FDA before they can make a claim on a product label or package. The FDA then decides if there is adequate scientific evidence to support the claim. For example, a breakfast cereal company that wants to claim that its new high-fiber cereal will reduce the risk of cancer must first prove it to the FDA. If the FDA is not satisfied that there is sufficient clinical or epidemiological data from the scientific studies to support the claim, the company cannot make the claim. This important consumer protection system prevents the public from being exposed to unproven claims.

By contrast, in the current unregulated marketplace for tobacco products, cigarette manufacturers are free to make any claims about their products. Smokers, especially those concerned about their health and interested in quitting, have no way of knowing whether claims promising to reduce exposure to cancer-causing chemicals in smoke are actually true (see sidebar, p. 493).

Other features from the food and drug regulatory system could be applicable to the regulation of tobacco products. One would be to evaluate the safety of new ingredients before they can be added to a tobacco product already on the market. Another would be to reduce the risk of tobacco products by restricting the level of harmful compounds to which tobacco users are exposed. Yet another would be to monitor the marketplace to make sure products are being used as intended. This task is particularly important to ensure that children and adolescents are not using tobacco products.

The FDA's Attempt to Regulate Tobacco Products in the 1990s

In 1994, under then-Commissioner David Kessler, the FDA announced that it would investigate the role of nicotine in the design and manufacture of tobacco products. If there was sufficient evidence that tobacco companies deliberately designed their products to create and sustain an addiction to nicotine, the FDA claimed that it should assert jurisdiction and begin to regulate those products.

From 1994 to 1996, the FDA gathered evidence from public health experts, current and former tobacco industry scientists, and tobacco industry documents. Some of the most important evidence proving what the tobacco industry knew about nicotine's role in causing addiction came from the industry itself in admissions contained within internal documents (see sidebar p. 494).

Unregulated Health Claims for Tobacco Products

A new generation of tobacco products has entered the marketplace in the last decade. These products offer promises of reduced exposure to dangerous chemicals in tobacco smoke, and even make claims to reduce the risk of cancer and other diseases.

The products take various forms. Some burn tobacco, or use special methods to burn or heat tobacco. Others are tobacco-based but do not burn. The products that burn tobacco include Omni and Advance. Omni, manufactured by a company called Vector, invested $40 million in an advertising campaign prominently featuring the claim "Reduced Carcinogens. Premium Taste." Two-page ads for Omni bearing that claim appeared regularly in Parade magazine in 2002. The products that use novel methods to burn or heat tobacco include Eclipse and Accord. Their claims are similar to Omni's. The non-combusting products include Ariva, Revel, and Exalt; these promise tobacco satisfaction in situations where smoking is not possible (e.g., at work or at home.

Whether they burn or not, all of these products are aimed squarely at the health-concerned smoker. They have entered the marketplace in the absence of any independent scientific evaluation of their claims, and without any governmental scrutiny of the products or their claims.

From a public health perspective, these products may pose a significant threat to efforts to help smokers quit. Health-concerned smokers who see these products may now think that a safer cigarette genuinely exists. This may make them less inclined to try to quit.

There is the added concern that former smokers may start smoking again, thinking they can now safely consume tobacco products. Likewise, those who never smoked may light up for the first time, using one of these new products under the assumption that a safe cigarette exists.

In the absence of public health–based regulation of these products, there is no way to know whether this new generation of products will actually reduce exposure and risk. The great fear held by some public health experts is that these new products may be nothing more than a scientifically sophisticated version of the "light" cigarette. We now know, many decades too late to help smokers who switched to "light" cigarettes over the last 30 years, that "lights" were deliberately designed so as not to reduce tar and nicotine deliveries when smoked by human beings. Back then, well-intentioned public health officials encouraged health-concerned smokers to switch to "lights." Experts urge that we avoid repeating the same mistakes with today's products.

In 1996 the FDA gathered all the evidence from its nicotine investigation and made a two-part determination under the Federal Food, Drug, and Cosmetic Act: 1) that the nicotine in tobacco products was a drug; and 2) that the products (i.e., cigarettes and other tobacco products) were devices for the delivery of the drug nicotine.

Simultaneously, the FDA issued a final rule designed to reduce the numbers of children and adolescents who start smoking. The 1996 regulation made it illegal for retailers to sell cigarettes to minors. Other provisions were designed to make tobacco advertising less appealing to young people. For example, ads that children might see in magazines, other publications, or in stores would have been limited to a black-and-white, text-only format. This would have preserved the industry's ability to advertise to adults, but in a format that experts said would have been less attractive to youngsters.

Shortly thereafter, the FDA was sued by tobacco manufacturers, growers, retailers, and advertisers. They claimed that the agency's actions were illegal. The case made it all the way to the U.S. Supreme Court. While the case was being heard in the federal courts, the FDA began enforcing a few provisions of the 1996 final rule. From 1997 to 2000, the FDA worked with the states to conduct over 200,000 inspections of retailers to enforce the rule prohibiting the sale of tobacco products to minors. Over $1 million in fines was collected from retailers who illegally sold cigarettes to minors more than once.

What the Tobacco Industry Said Privately About Nicotine and Addiction

T hroughout the mid-1990s, thousands of previously secret internal tobacco industry documents were made available to the public. These documents were particularly helpful to the FDA during its investigation of the role of nicotine in the design and manufacture of cigarettes. Here are a few of the most revealing statements about nicotine and addiction from the industry's own documents, which helped the FDA to determine that tobacco products are drug delivery devices.

Nicotine is addictive. We are, then, in the business of selling nicotine—an addictive drug effective in the release of stress mechanisms.

▌ (ADDISION YEAMAN, BROWN & WILLIAMSON, 1963)

In a sense, the tobacco industry may be thought of as being a specialized, highly ritualized and stylized segment of the pharmaceutical industry. Tobacco products, uniquely, contain and deliver nicotine, a potent drug with a variety of physiological effects.

▌ (CLAUDE TEAGUE JR., R.J. REYNOLDS, 1972)

The cigarette should be conceived not as a product but as a package. The product is nicotine. . . . Think of the cigarette pack as a storage container for a day's supply of nicotine. . . . Think of a cigarette as a dispenser for a dose unit of nicotine. Think of a puff of smoke as the vehicle of nicotine. . . . Smoke is beyond question the most optimized vehicle of nicotine and the cigarette the most optimized dispenser of smoke.

▌ (WILLIAM L. DUNN, PHILIP MORRIS, 1972)

In 2000 the U.S. Supreme Court issued a 5–4 decision that stripped the FDA of legal authority over tobacco products. The Court ruled that Congress never intended for the FDA to have regulatory powers over these products under federal law. In order for the FDA to regain these powers, Congress would have to pass a new law granting the FDA that authority.

Other Federal Agencies

Other federal agencies are involved in tobacco-related work that is not directly tied to product regulation. Here is a brief description of what some of them do.

• The National Cancer Institute (NCI) funds important research into such questions as how tobacco causes cancer and what can be done to make tobacco products less harmful. The NCI issues reports that summarize research findings.
• The Office on Smoking and Health within the Centers for Disease Control and Prevention (CDC) provides critical guidance to the states on which programs work best to prevent young people from starting to use tobacco and on how to help addicted smokers who want to quit. The CDC also works with governments around the world to share advances in prevention and treatment efforts.
• The Office of the Surgeon General releases regular reports on smoking and health issues. The Surgeon General reports are important summaries of what is known about tobacco-related disease and what can be done to reduce the death and disease toll caused by tobacco. The first-ever Surgeon General's report on smoking and health, published in 1964, was a landmark publication in the history of public health.

The Federal Trade Commission also compiles and releases an annual report on the tar and nicotine levels for all marketed cigarettes in the United States, as well as a report on the annual marketing expenditures of the tobacco industry.

The Future of U.S. Tobacco Regulation

The World Health Organization is leading a global effort to enact a treaty known as the Framework Convention on Tobacco Control. One of the key provisions of this treaty calls for all countries to begin to regulate tobacco products as drug delivery devices. Such regulation could consist of advertising and marketing restrictions, as well as limits on permissible levels of toxins in tobacco smoke. At the time of this writing, it is unclear whether the United States will ratify this treaty. Public health experts continue to hope that the U.S. Congress will enact new legislation granting the FDA regulatory authority over tobacco products.

See Also Additives; Advertising Restrictions; Politics; Product Design; Prohibitions; State Tobacco Monopolies; Taxation; Warning Labels; Youth Marketing; Youth Tobacco Use.

▌ MITCHELL ZELLER

BIBLIOGRAPHY

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epidemiological pertaining to epidemiology, that is, to seeking the causes of disease.

tar a residue of tobacco smoke, composed of many chemical substances that are collectively known by this term.