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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the National Association of Attorneys General 2010 Summer Meeting

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at the
National Association of Attorneys General 2010 Summer Meeting
June 15, 2010


Good afternoon — and thank you Cheryl [Healton] for that generous introduction. It’s wonderful to be here in beautiful Seattle and a great honor to stand before you and deliver the Sorrell lecture.

There’s no better way to begin than by recognizing those of you here today who have made a real and continuing contribution to fighting one of the most dangerous public health threats of our time. Through the 1998 Master Settlement Agreement and four separate state settlements, state Attorneys General have worked to hold the tobacco industry accountable and protect our communities from the dangers of tobacco products for more than a decade.

Special thanks to Generals Sorrell, Edmondson, Miller, Blumenthal and McGraw — 12 years ago, they were already serving as AGs and each played a critical role in making the MSA a reality. Today, that landmark agreement remains the largest legal settlement in history of the world — which is quite a remarkable accomplishment.

Indeed, the MSA imposed sweeping changes in tobacco advertising and education efforts, and has led to great success by some important measures. Cigarette sales in the United States have fallen by more than 21 percent since 1998, and declines in youth smoking have been even more pronounced. The MSA helped fundamentally change the way our society views tobacco.

I also want to thank the National Association of Attorneys General, not only for inviting me here today, but also for the devotion you have shown for the past dozen years in maintaining and strengthening the MSA and carrying out its public health mission. Congratulations to the members of the Tobacco Committee and to Generals Bruning and Coakley for their leadership.

Of course, we all know that anytime we celebrate success over time, we must also look to the future. We have come a long way — between 1965 and 2004, for example, per capita annual consumption of cigarettes in the U.S. decreased by more than 40 percent — but, we can all agree, we have a long way to go.

You have heard the statistics before. Tobacco use remains the leading preventable cause of death in the U.S. — we know that cigarettes are the only consumer product that, when used as directed, kill their consumer. 443,000 Americans die each year from tobacco-related diseases — more than the deaths caused by HIV/AIDS, alcohol use, cocaine use, heroin use, homicides, suicides, motor vehicle crashes, and fires combined. Between 20 and 25 percent of high school students in this country use tobacco, and about 4,000 new kids begin smoking every single day.

Of great concern is the fact that the decline in youth smoking has reached a plateau. And more kids are using smokeless tobacco and cheap cigars. These dangers are clearly unacceptable. We must do more.

As you know, I’ve been invited to give this Sorrell Lecture because the FDA has undergone some major changes as of late. A year ago next week, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act — a historic piece of legislation that for the first time, has given an agency explicit and broad authority to regulate tobacco products and the practices of the tobacco industry.

And these changes have been a long time coming. Interestingly, almost no one smoked cigarettes before 1900. That was the year the technology changed, resulting in a slightly acidic tobacco that was milder and easier to inhale. Then, advertising democratized smoking, proclaiming, “You can smoke the same cigarette that even the most wealthy Americans smoke.”

Most of you I’m sure are aware of the fight that my recent predecessor, David Kessler, waged against tobacco products, but you may not know that this legacy stretches back to the very first FDA Commissioner, Harvey Wiley … who led the Bureau of Chemistry that would later become the modern Food and Drug Administration.

Wiley was widely viewed as a crusader against tobacco and was particularly outspoken about its effects on pregnant women and children. He claimed he never smoked himself — his mother wouldn’t have approved, he said — and, after resigning his post at the Bureau, he used the pages of Good Housekeeping magazine as his soapbox to continue the cause.

He presciently labeled nicotine as “the quickest and most deadly poison known” next to “prussic acid” but his outlook was, unfortunately, slightly too optimistic: “I predict,” Wiley said in 1911, “that within 12 years, smoking and tobacco chewing in public will have been obsolete.”

FDA’s recent involvement with tobacco dates back to 1995, when the agency under David Kessler determined that cigarettes and smokeless-tobacco products were nicotine-delivery devices that fell within the scope of the Federal Food, Drug, and Cosmetic Act. The Supreme Court disagreed, but the decision only fueled the campaign toward the Tobacco Control Act we have today.

Now, FDA has broad authority over the manufacture, marketing, distribution, sale and importation of tobacco products, along with the flexibility to monitor and respond to new information and developments.

We have been given the power to set and enforce tobacco product standards for nicotine yields and to reduce exposure to harmful constituents in order to protect the public health. This has a number of important implications.

FDA now has the authority to require companies to reveal certain ingredients in tobacco products — including the amount of nicotine — and to enforce the upcoming ban on the sale of tobacco products marketed as “light,” “mild,” or “low,” unless such marketing is authorized by an FDA order. We can also regulate tobacco advertising and require manufacturers to use more effective warning labels and to restrict the access of young people to their products. And we can assess and regulate modified risk products — taking into account, for example, the impact their availability and marketing has on initiation and cessation of tobacco use.

Of course, there are a number of specific limitations: the FDA cannot ban the sale of tobacco products in face-to-face transactions in a retail establishment, require that nicotine levels be reduced to zero, ban the sale of an entire category of tobacco products, and or disclose — beyond a certain point — trade secrets and confidential commercial information.

Still, FDA’s new mission is urgent and clear. We must act not only to curtail practices that promote tobacco use, but set standards to protect the public health and help ensure that Americans have the information they need to make informed choices about tobacco use. Which means FDA’s authority may be new, but it’s grounded in values that have guided public health — and the American people — for generations.

So today I’d like to speak about our approach to the new law and discuss some ways that we can work together to continue the fight against tobacco-related illness.

After all, when the National Association of Attorneys General was founded a little over a century ago, one of the stated purposes of this organization was to strengthen partnerships between Federal and State governments. And in discussing one of the most pressing public health threats we face today, I sincerely hope to summon the same spirit of shared aspiration, joint responsibility — and, above all, strong partnership — that this organization has been cultivating for more than a century.

I recently co-authored a piece in the New England Journal of Medicine with FDA’s Principal Deputy Commissioner, Josh Sharfstein, and the Director of our new Center for Tobacco Products, Lawrence Deyton, in which we laid out FDA’s big vision and specific tactics for implementing the Tobacco Control Act.

In it, we identified four key elements to the agency’s public health approach to tobacco regulation. They are: reducing the rate of initiation of tobacco use, educating the public, applying regulatory science to the control of tobacco products and engaging actively with public health partners and industry.

We hit the ground running with the ban on candy-flavored cigarettes, and we haven’t slowed down since. This month alone, FDA will begin implementing the Tobacco Control Act’s requirement for new, rotational warning labels for smokeless tobacco and its ban on “light,” “low,” or “mild” labeling unless authorized by an FDA order. FDA’s new rules restricting the sale and distribution of cigarettes and smokeless tobacco also take effect this month. FDA will be cracking down on stores that sell cigarettes and smokeless tobacco to kids younger than 18; pulling the plug on vending machines sales any place where kids can get to them; eliminating distribution of free samples of cigarettes and limiting distribution of free samples of smokeless tobacco products to places only adults can go; and banning brand name sponsorship of sports, concerts, and other events geared to kids.

And this is just a start.

As you can see, broad authority — broad oversight — is necessary to develop an effective regulatory program — especially a program targeted largely at preventing children and young people from initiating a lifetime of addiction and reducing the overall rates of tobacco-related disease, disability, and death.

The actions we are taking now, after all, have been designed to reverse decades of industry efforts to mislead the public about the safety of tobacco products. Our goal is to use the law’s power to substantially improve the health of the American people … and to save lives.

Of course, to do this effectively, our agency must be strong in pursuing and, hopefully, fulfilling our mandate — something that I know all of you will expect us to be. This mandate, after all, is the result of a law that was passed overwhelmingly by Congress and signed by the President. And it gives FDA the authority to bring advisory, administrative or judicial actions, including seizures, injunctions, civil money penalties and criminal prosecutions. And we will not hesitate to take these steps when warranted by the facts.

The law was passed to protect the public’s health — that’s what the American people expect and that’s what we will deliver.

But we cannot do it alone. Even though FDA is now the primary regulatory authority for the manufacture, marketing, and distribution of tobacco products, our agency does not bear the sole responsibility of reducing the tremendous toll of disease, disability, and death caused by tobacco use in America. Nor should we.

We know, just as you do, that the fight against tobacco is too big for any one agency — and it’s too important and too complex to be left to Washington alone.

FDA regulation isn’t intended to replace the efforts of state government. Instead we aim to bolster them. And that’s why so much of the work to assist us in enforcing the law is being contracted to state government.

I am happy to be able to announce that the first such contracts are being awarded today, to Massachusetts and to Maine. FDA will soon announce additional contract awards to other states, and we will continue to award contracts in a rolling fashion over the next 12-18 months. Ultimately every state or territory that wants to assist will have that opportunity. This is very important.

In addition, as you know, state and local governments may adopt and enforce most requirements relating to tobacco products that are in addition to, or even more stringent than the requirements under the Tobacco Control Act. Under the law, you can have tougher restrictions relating to or even prohibiting: the sale or distribution of tobacco products, the possession, exposure to, or access to tobacco products, the advertising and promotion of tobacco products and the use of tobacco products by individuals of any age.

You’re also empowered to impose specific bans or restrictions on the time, place and manner for advertising cigarettes and can prohibit or restrict distribution of free samples of smokeless tobacco in any location.

There are some state and local requirements that are preempted … but even here it may make sense for us to consult with you before you conclude that a state cannot take an action to protect the public health.

What all this adds up to is that there are many opportunities for cooperation and synergy between our agency and you, the state Attorneys General. So how can we work most effectively together?

First, enforcement. As I said earlier, we have strong penalties in this law and we will not hesitate to use them. We want to work with you to identify violations and address them quickly and effectively. Together, we can hold violators accountable. And I want to re-emphasize that we are putting our money where our mouth is — to the extent feasible, FDA will contract with the appropriate agency in each of your states to assist us in enforcement of key provisions of the Tobacco Control Act.

Second, special attention to smuggling and illicit sales. Our expertise is public health, but, on the state level, you are focused on both public health and tax evasion. This is an area where your knowledge and your resources would be particularly valuable to FDA.

And third, policy development. I am certain that all of you have great ideas on tobacco policies and by working with us and with state and local health departments, you can be important laboratories of policy development and implementation. We would very much value your ideas and your contributions.

Our efforts can complement each other. Together — and only together — can we accelerate progress against one of the most dangerous public health threats of our time.

We have a compelling common cause. Not simply because we like a good fight. Not simply because we have new tools and authorities. Not simply because we must continue what our predecessors started more than a century ago.

It comes down to why we’re here.

You serve as Attorneys General not simply because you love the law. You do it because you believe in the promise of justice. Nor am I leading the FDA simply because I love medicine. I do it because I believe in the promise of the public health.

Both law and medicine are means, not ends. They are different ways of looking at the world. But when we’re in the realm of public health or law enforcement, justice – and doing right by the people we serve-- is the end for both of us. Which means we share a vision for the future.

And that’s why, on this occasion, I’m reminded of words from Teddy Roosevelt — the man who signed the first major law in FDA’s history and who was president at the time when this Association was founded. He once said, “Justice consists not in being neutral between right and wrong, but in finding out the right and upholding it, wherever found, against the wrong.”

This is what we are trying to do.

Thank you so much for your time and attention, and, as always, for your partnership.