FDA faces tricky task in limiting damage inflicted by tobacco

The tobacco bill newly signed into law is a compromise that acknowledges a few hard political facts:

- More than 43 million Americans remain addicted to the nicotine in tobacco (indeed, 70 percent of smokers say they wish they could quit, and 40 percent try yearly).

- Taxes on the sale of tobacco products are a major source of revenue for states.

- Even without adding tobacco to its regulatory portfolio, the Food and Drug Administration is straining to carry out its other responsibilities, including the safety of the nation's food, drugs and medical devices. The law stipulates that the FDA's tobacco rules will be underwritten by user fees levied on the tobacco companies.

- Finally, regulating tobacco is a pretty tricky job for an agency given the task of protecting the nation's health.

Tobacco is simply not like the drugs, medical devices and foods the FDA regulates: There are no demonstrable health benefits to tobacco against which the FDA can weigh the risks that go along with its use.

In fact, some in Congress argued the FDA has no place in trying to merely limit the damage caused by a product that causes only addiction and harm. By giving its blessing to the sale of some tobacco products and denying others, they argue, the FDA may lead consumers to think those products are safe.

Rep. Henry Waxman, D-Calif., the champion of the tobacco law, acknowledges that this is an unusual role for the FDA. But short of tobacco prohibition — which, he says, “isn't going to work” — the FDA is the only agency equipped to limit the damage that tobacco does to the nation's health. He also looks for the agency to stem the recruitment of new smokers.

“The FDA is the exact agency that should have that authority — it's a scientific organization with regulatory powers,” Waxman said.

Here are some of the law's main points and the FDA's plans for carrying them out.

- What are the FDA's orders? The law grants the FDA broad authority to require changes in current and future tobacco products “appropriate for the protection of the public's health.”

That broad mandate would allow the FDA to reduce or remove from tobacco products ingredients and additives that it considers harmful.

Some of the items likely to come under scrutiny — such as ammonia and formaldehyde — are probably unfamiliar ingredients to many consumers. But the list also will include flavorings. Chocolate and cherry, which enhance the appeal of tobacco to young people, are banned by the new law.

Although menthol is not automatically banned, the FDA's new jurisdiction would allow it to limit or even ban this flavoring, which is favored by 27 percent of all smokers and three-quarters of black smokers.

The law gives the FDA responsibility for the pre-market approval of new tobacco products. Companies sponsoring such products will have to submit to the FDA studies detailing their health effects. And the secretary of health and human services can, on the FDA's recommendation, deny approval if the sponsoring company fails to show that the marketing of their product “would be appropriate for the protection of the public health.”

In short, new cigarettes, cigars or chewed or eaten tobacco products are unlikely to enter the market — and several current products are likely to be pulled — if it can't be shown they reduce dependence or limit the harm of tobacco use.

Significantly, that assessment can consider a product's ability to reduce harm to bystanders who are affected, for instance, by secondhand smoke. That may open the way for some “bridge” products, including smoke-free cigarettes or edible nicotine disks, to enter the market.

- What are the limits of the FDA's authority? The law prohibits the FDA from banning outright all tobacco products or any class of tobacco products — such as cigarettes, cigars or chew.

The agency may require the reduction of nicotine, tobacco's most potently addictive ingredient, but is not permitted to require the chemical's elimination. Experts agree there are nicotine levels greater than zero that are not addictive but may provide some of the chemical's pleasurable and energizing effects. But plunging more than 45 million Americans into nicotine withdrawal with the stroke of a pen was not considered a viable option.

- What limits can the FDA place on tobacco advertising? The law gives the FDA broad authority to restrict marketing and promotion “to the fullest extent permissible” under the First Amendment — a limit that is certain to be tested in future court cases.

- How can the FDA regulate the sale or marketing of tobacco to kids beyond the age restrictions on purchase of tobacco products that are already in place? The FDA can limit the advertising of tobacco products anywhere it believes that children and teens are the intended or the unintended audience for their pitches.

As for selling tobacco to minors, that would now be a federal offense, enforced directly by federal authorities instead of states.

- Does the FDA have other powers to influence tobacco use? Yes, it has two. First, the law leaves to the FDA the decision of what future tobacco packaging will look like. That authority is likely to set up a debate about the effectiveness of messages that scare or horrify in helping smokers quit.

The FDA's other intriguing new power is the right to demand of tobacco companies details of research they have conducted on the contents and health effects of products — and, potentially, to release those findings.