Unlike global warming and the environment, there is little if any debate over the adverse effects of smoking on health. As a result, more stringent government regulation of tobacco products is inevitable. A bill for regulation by the Food and Drug Administration passed in the U.S. House last year, and its supporters in the House this year stand a good chance for victory there and in the Senate. Sens. Richard Burr of Winston-Salem and Kay Hagan of Greensboro have crossed party lines to introduce an alternative bill that, while far from perfect, could lead to reasonable FDA regulation.
Burr and Hagan propose that a new agency be created to regulate tobacco. We believe that would be unnecessary and unwise. This is not the time to be growing government, and the agency that Burr and Hagan propose would have less power than the FDA. While the FDA may not have the best track record, it is the appropriate agency for regulating the manufacture and sale of tobacco, a legal, but habit-forming and deadly product.
As with our endorsement last month of a bill in the state House to ban smoking in virtually all enclosed workplaces and buildings open to the public in North Carolina, our support of FDA regulation of tobacco products is a break from the past. We have long opposed regulation. Tobacco has for generations supported farmers, factory workers and many others throughout our region. That picture is changing as we transform from a manufacturing to a high-tech economy, but tobacco still holds a strong place in the region.
We opposed FDA regulation out of concern that its marketing restrictions would cement Philip Morris as the nation's No. 1 cigarette maker, to the detriment of Winston-Salem's Reynolds American Inc., the nation's No. 2 manufacturer. That's been Reynolds' argument as well. But Reynolds has had years to catch up with Philip Morris in an unregulated environment. Instead, it has continued to lose cigarette market share.
We also saw FDA regulation as government intervention. But the health effects of smoking are broad and significant. These dangers, which include cancer and heart disease and contribute to almost 14,000 deaths a year in North Carolina alone, have come to outweigh our concerns about the marketplace and government intervention. The FDA is charged with regulating prescription drugs and monitoring our food supply to protect us from harm. It should do the same concerning the harmful substances in cigarettes. The highly addictive nicotine in cigarettes is a drug.
Adult smokers have the right to use a legal product, and neither bill seeks to ban tobacco or regulate tobacco farmers. But the government has the right, and the duty, to protect its citizens from harm -- especially when all Americans are affected by the health-care costs of a product. Tobacco costs the state of North Carolina $2.5 billion in health-care bills each year, according to the Campaign for Tobacco Free Kids.
Burr and Hagan's opposition to FDA regulation is understandable. Under the FDA's watch, at least eight people have died in recent months from eating tainted peanut products. As Time magazine noted earlier this month, that's "the latest in a series of black eyes for the FDA over unsafe foods, dangerous medicines such as Vioxx and allegedly cozy ties with the pharmacy industry it regulates."
President Obama has pledged to reform the FDA. His expected choice to lead the agency, Margaret Hamburg, is a results-driven public-health expert. The FDA has the needed experience to regulate tobacco and should do the job well if managed properly.
In contrast, Burr and Hagan's bill would create a new body, the Tobacco Regulatory Agency. It would be under the Department of Health and Human Services. The senators want to protect the tobacco industry. Their proposal would submit it to regulation that would be far less stringent than the FDA's under the bill proposed by Rep. Henry Waxman, a California Democrat.
The Burr/Hagan bill is "a step in the right direction," said Maura Payne, a spokeswoman for Reynolds American. "It increases the likelihood that there will be some science-based discussion about what methods of regulating the tobacco industry might be most effective at making substantial improvements in public health. It is a much better place to start that discussion than the Waxman legislation."
Both bills impose fees on tobacco companies to pay for the regulation. The Burr/Hagan bill estimates the proposed new agency would cost about $100 million a year, the Raleigh News & Observer reported recently. FDA regulation would ultimately cost several times that amount. The latter would be a heavy price, but critics say the cost estimate of the proposed new agency is not enough to support effective regulation.
The Burr/Hagan bill does eliminate most tobacco advertising, as does the FDA bill, and it requires disclosure to the Tobacco Regulatory Agency of all ingredients. It requires consultation with the FDA and the national Centers for Disease Control and Prevention on products that claim to be safer. But it gives tobacco companies much influence in the regulatory process.
And most important, though the Burr/Hagan bill limits the amount of tar in cigarettes, it makes no further regulation of content. "We are interested in providing full disclosure to consumers and giving them the list of ingredients in the product, but we are not interested in the government changing what the definition of a cigarette is," said Caitlin Legacki, a spokeswoman for Hagan.
The Waxman bill would allow regulation of amounts of nicotine and other toxic ingredients, as well as the elimination of ingredients. That's a crucial provision.
The Burr/Hagan bill could lead to meaningful compromise on FDA tobacco regulation. Supporters of this bill and the Waxman bill could start the process by agreeing on maximum levels of toxic ingredients that will be allowed in cigarettes. Perhaps the regulation could begin with cigarettes, and phase in other tobacco products gradually.
The human and financial costs of smoking are undeniable. More stringent oversight of tobacco products is needed. It's time for FDA regulation.
Advertisement