Earlier this month the House passed a landmark bill allowing the Food and Drug Administration to regulate tobacco products, granting the agency broad authority in controlling the manufacture, marketing and sale of cigarettes and other tobacco-based goods. This legislation, called the Family Smoking Prevention and Tobacco Control Act (H.R. 1256) , is now awaiting a vote in the Senate where it is expected to be approved “expeditiously” according to Senator Edward Kennedy, one of the bill’s sponsors.  Senator Harry Reid, the majority leader, recently told Congressional Quarterly that he thought the bill will be taken up before the current session ends at the end of May.

A year ago, with the Bush Administration opposing similar legislation, sponsors of the Senate bill worried that they would not be able to muster the 60 votes needed to override the expected Presidential veto and never voted on the measure. This year, with a strengthened Senate Democratic majority and implicit support from President Obama and Kathleen Sebelius, his Health and Human Services secretary-designate, there appears to be much more optimism that the bill will pass with the two-thirds majority needed to overcome a possible filibuster from Senator Richard M. Burr, Republican of North Carolina, the nation’s leading tobacco producing state, and home to R.J. Reynolds.

It’s about time Congress acted on legislation that would finally provide a framework for a national policy on tobacco. Cigarettes kill 400,000 people each year and smoking is associated with $96 billion in medical costs each year. Efforts to limit teenage smoking have recently stalled—in 2008 some 23% of high-school students were smokers, up 1% from the year before.

In a perfect world, tobacco would enjoy the same status as marijuana, cocaine or other illicit drugs—it would be illegal or at the very least, tightly controlled.  According to the National Institute on Drug Abuse, “Smoking harms nearly every organ of the body, causing many diseases and compromising smokers’ health in general. Nicotine, a component of tobacco, is the primary reason that tobacco is addictive, although cigarette smoke contains many other dangerous chemicals, including tar, carbon monoxide, acetaldehyde, nitrosamines, and more.”

Nicotine addiction occurs quickly and the habit is notoriously difficult to kick. Tobacco companies have used this to their advantage; they have admitted to manipulating nicotine levels to increase addiction and continue to make false claims about “low-tar” and “light” cigarettes that would appear less harmful. Nearly 35 million people say they want to quit smoking every year, but only 6% of them are actually successful for more than a month.

The FDA’s mission is to protect public health by assuring the safety and efficacy of a wide range of products that include drugs, cosmetics and foods. The question that begs an answer is why would an agency charged with enforcing product safety take on tobacco—a substance that is clearly harmful to human health and has no health benefits?

The reality is that banning tobacco outright is not a workable policy. For one, there are 45 million addicted smokers in the U.S. Although in many states they’ve been kicked out of bars, restaurants and their workplaces, forced to stand huddled outside to get their fix, smokers remain a significant portion of our population. Their seven-dollar packs of Marlboros and Camels also provide a necessary source of funding for state coffers. Tobacco taxes and punitive fees that were levied to settle state lawsuits, provided over $8 billion in funding last year for programs like the State Children’s Health Insurance Program (SCHIP), state smoking cessation efforts and other non-health related state initiatives. The tobacco companies have been hobbled by their legal troubles, but they retain lobbying power—especially when combined with the interests of tobacco-producing states like Kentucky, North Carolina and Virginia.

The Family Smoking Prevention and Tobacco Control Act has been years in the making. It offers the best chance for achieving a national policy on tobacco by enforcing strict limits on marketing and requiring full disclosure from companies on everything that goes into their products.  Under the legislation, the FDA will open a new Center for Tobacco Products that will reportedly be directly overseen by Margaret Hamburg, the President’s choice for FDA commissioner. Tobacco products will not be regulated under the “safe and effective” standard currently used for other products (like pharmaceuticals) under the agency’s control, but rather under a new standard—“appropriate for the protection of the public health.”

The Center, and all the FDA’s tobacco efforts, will be self-funded through industry fees that might actually provide ample resources to do the job effectively.  The Congressional Budget Office estimates the cost for the FDA to administer the new regulatory activities associated with the legislation at $5.3 billion over the next 10 years, financed by fees assessed on importers and manufacturers of tobacco products.  (This in contrast to the agency’s shortcomings in collecting sufficient fees from pharmaceutical companies to assuring the safety and effectiveness of drugs once they have been approved for marketing…)

Details of the legislation can be found on the website of Campaign for Tobacco-Free Kids, the advocacy group most involved in helping craft and lobby for H.R. 1256.

But the highlights—along with probable timetable implementation –are as follows:

1. Within one year of enactment of the legislation, the FDA would implement comprehensive restrictions on sales and marketing of tobacco products to children.
2. Within three months, candy and fruit-flavored cigarettes would be banned.
3. Within one year, warning labels that take up 30% of cigarette packaging would be required and could be increased to 50% by the FDA
4. Within three months the FDA will create the Center for Tobacco Products, whose role will be to regulate tobacco. Tobacco manufacturers will have to submit to the Center a list of all ingredients in their products within six months
5. By 12 months after enactment, terms like "light", "mild" and "low-tar" will be banned 

The disclosure component of the legislation is a key part of the agency’s role in reducing the harm associated with smoking. For the first time, tobacco companies would have to make public which ingredients are used in each brand of cigarette they market and their exact levels. They would also have to provide this information about the hundreds of chemicals that make up cigarette smoke. Eventually, the FDA will be able to mandate reductions of certain components—like nicotine levels—in cigarettes and other tobacco products, although they will not be able to mandate the complete removal of nicotine or ban tobacco outright. Therefore the goal is clearly not to ban cigarettes altogether, but to lead to “safer” products that either have most of their harmful ingredients removed or at least greatly reduced.

The worry for critics like Dr. Michael Siegel, professor at Boston University’s School of Public Health who writes a blog called “The Rest of the Story: Tobacco News Analysis and Commentary”  is that these “safer” products will be seen as being sanctioned by the FDA, making them even more attractive to potential smokers:

"One of the major criticisms I have leveled against the proposed legislation is that it would give cigarettes an FDA seal of approval, thus undermining the public's appreciation of the hazards of smoking and providing the tobacco companies with a golden marketing opportunity. The companies could start boasting that their products are officially approved by the U.S. Food and Drug Administration and that they comply with all federal regulations and requirements regarding the safety of tobacco products.”

He goes on to say;“Can you imagine statements on cigarette packages, advertisements, and web sites which state: ‘Our products are strictly regulated by the United States Food and Drug Administration. The FDA has approved this product for sale in the U.S. It meets all regulatory safety standards promulgated by the FDA.’”

In fact, in response to worries from Siegel and others, the bill now has a section that prohibits tobacco companies from describing their products as “FDA-approved,” “safe” or “made to government standards.” Whether or not those restrictions would stand up to a First Amendment challenge—as Siegel suggests is unlikely— is still debatable.

Critics also worry about the FDA’s ability to adequately regulate tobacco, especially in light of the key role Philip Morris had in helping craft the legislation. Philip Morris, which represents 50% of the tobacco market in the U.S. worked with advocates on drafting particulars of the legislation and will have a (albeit, non-voting) seat on the FDA advisory committee that will oversee regulation. The legislation contains some concessions that might be construed as pandering to Phillip Morris’s interests: For example, although candy and fruit flavors are banned from cigarettes, menthol is not. Menthol-flavored cigarettes make up 28% of the U.S. market and are used by 75% of black smokers. Also, the legal age for purchasing tobacco products will remain at 18, and the industry has assurances that tobacco will not be outlawed.

Writing in the Huffington Post, Howard Wolinsky, an adjunct professor at Medill Graduate School of Journalism at Northwestern University and Dr. Alan Blum, the director of the Center for the Study of Tobacco and Society at the University of Alabama offer their take on the tobacco industry’s impact:

“In effect the new FDA legislation would serve as a Marlboro Preservation Act. It used to be said that what's good for General Motors is good for the USA. In the new business calculation, where GM=USA, what's good for Philip Morris apparently is good for the FDA, and vice versa.”

It’s clear that submitting to FDA regulation will remove some of the threat of lawsuits for tobacco companies. And there is the potential for the industry to come up with new products to satisfy the smoking cravings of current addicts. There is some thought that reducing nicotine levels in cigarettes might actually cause people to smoke more to get their fix.

For an interesting take on why Phillip Morris threw their support behind tobacco legislation—in contrast to other tobacco manufacturers like R.J. Reynolds who remain opposed to FDA regulation of tobacco—take a look at this piece by Joe Nocera that ran in the New York Times Magazine:
“If It’s Good for Philip Morris, Can It Also Be Good for Public Health?” by Joe Nocera

In the end, the current tobacco legislation is a major shift away from what the Institute of Medicine in its 2007 report, “Ending the Tobacco Problem: A Blueprint for the Nation,” has called an incrementalist approach that has traditionally left anti-tobacco strategies to the states and local legislatures.

California, for example, is one of only two states that have instituted complete smoking bans in all public places (including offices, restaurants and bars), in cars occupied by children; and has strict limitations on the location of billboard advertisements and vending machines. The net result: Overall adult smoking rates in California have decreased 41 percent, from 22.7 percent in 1988 to 13.3 percent in 2008. In 2008, the youth smoking rate in California declined to 14.6 percent, one of the lowest rates in the nation.

In Kentucky, meanwhile, smoking is banned only in the city of Louisville (excepting Churchill Downs…) and in that tobacco-producing state where local anti-smoking ordinances are often not enforced, some 28.3% of adults smoke, as well as 24.5% of high school students.

The new legislation will not effect how states decide to deal with smoking bans or impact what kinds of additional taxes they choose to levy on cigarettes. And projections of H.R. 1256’s effect on smoking rates might seem modest in the short-term. The Congressional Budget Office, in what the Campaign for Tobacco-free Kids calls a “conservative estimate” predicts that implementation of H.R. 1265 will lead to an 11% reduction in the number of underage tobacco users by 2019 and a further decline by 2% in adult smoking after 10 years.

But combined with the new, federal, $1.01 fee assessed on cigarettes as part of the Children’s Health Insurance Program expansion, this bill that gives FDA regulatory power over tobacco will play a major role in helping form a national strategy to deal with an unquestionably harmful product.