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Remarks at the International Tobacco Regulators Conference

Remarks as Delivered by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Washington, DC
November 14, 2011

It is a pleasure to be here today, and I want to thank you all for coming from around the world for this important effort to help enable a vibrant international community of tobacco regulators.

We’re actually a unique group, in that we’re science-based regulators with a public health mission that drives our work. And few actions provide as great an opportunity to promote and protect the public health as robust tobacco regulation.  It’s an excellent example of the power of regulation to enhance the common good. 

I’ve no doubt that our frank and open discussion over the next three days…a dialogue about our experiences and the challenges that lie ahead—where we are and where we need to go…will help us enhance the common good by helping to chart a common course in our common cause.

This conference—the culmination of a long process of increasing regulatory engagement in tobacco control—is taking place on an oddly appropriate anniversary.  In 1492, Italian explorer Christopher Columbus noted in his journal that on November 15th he observed an interesting custom among the native people of the New World:  He witnessed them using tobacco.  It’s believed to be the first written mention of tobacco in world history…and the beginning of the plant’s worldwide journey.  

Today, we know that tobacco use circles the globe—and its burden of disease spares no corner of the global community.  We are all familiar with the statistics.  According to WHO, tobacco kills nearly six million people every year—including 600,000 non-smokers exposed to second hand smoke.  And unless urgent action is taken, the annual death toll could rise to more than eight million by 2030.

This terrible human burden—which we’ll be hearing more about over the next three days—is the real reason we gather here today.   It should also remind us that a global problem requires a global solution.  And I think this means that together we must address several broad challenges: We must learn from one another.  We must envision our international regulatory efforts as an interconnected system across borders and boundaries.  And we must work together to support ongoing, forward movement from this meeting.  Let me say a little about each.

First, learning from each other.  In the U.S., the Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products.   This represented an historic opportunity—one that many had long awaited. 

But let me note that we recognized the definitive challenges on many levels—but particularly to having tobacco fall under an agency that, otherwise, regulates products that are designed to be beneficial—or at least not harmful.  Certainly, there was criticism about this approach.  But those voices are quieter now as the enormous potential of tobacco regulation in the U.S. has become apparent to all.

Our Tobacco Control Act—and its ongoing implementation—has been very much informed by international experiences….experiences that you’ll all be discussing in more detail over the course of our discussions.  Whether it was health warning labels in Australia or Brazil….or the reporting of ingredients in Canada and the European Union…we’ve learned from what others had already been doing in the international community. 

We know that our efforts in the U.S. to regulate tobacco are new compared to many of the countries represented in this room.  And that’s why we look forward to sitting with you around the table, as we continue to learn from your experiences. 

But all of us—those who are further along the path to tobacco control—and those who are taking the first steps…those who are leaders in tobacco regulation and those who are anxious to get started—must listen and, ultimately, learn from one another.  We must share our ideas and information.  And we must always engage, not in a monologue—but in a dialogue, because we know that collaborative actions will likely yield the greatest benefit.

As we do, we must remember our second challenge: Envisioning our international regulatory efforts as an interconnected system.  Thanks to ever-increasing globalization, we live in a world where people are more interconnected…nations more interdependent…and humanity less separated.  Local products can quickly become global. Television advertisements “leak” across national boundaries…and the Internet provides additional opportunities for the promotion of tobacco products – often beyond the reach of national authorities. Counterfeit and illicit tobacco products pose still further challenges. 

In such a world, problems, solutions—and, perhaps most important for those of us in this room, regulation—cannot be viewed in national isolation. That’s the thinking behind the FDA’s “Pathway to Global Product Safety and Quality” strategy—announced in June of this year.  This new initiative, which is designed to ensure import safety and quality in our globalized world, recognizes that, since the year 2000, global imports of FDA regulated products have more than quadrupled.  These substantial increases represent an enormous strain on our current regulatory system.  To ensure the safety and quality of imported products—and the health and welfare of the people in the U.S.—a new approach is essential. 

Such an approach requires us to think and act globally—specifically, to act in close collaboration with our sister regulatory authorities and other stakeholders around the world.  I mention this because it’s the exact same approach this conference is trying to catalyze with tobacco control.

Two key elements of our new initiative are particularly instructive to our work at this meeting. First, the FDA—in close partnership with our international counterparts—is committed to joining a global coalition of regulators dedicated to building and strengthening the regulatory safety net around the world.

And, second, working with these coalitions, we will develop global data information systems and networks in which regulators, worldwide, can regularly and proactively share real-time information and resources with one another.

These two elements also provide excellent guidance for our regulatory engagement with tobacco…for our work to ensure that our children’s futures are no longer clouded by tobacco smoke or plagued by pouches and pinches of smokeless tobacco.

Of course, to successfully do that, we must meet our third challenge:  We must keep the momentum of this meeting going into the future.  At the end of this conference, I will be very interested in hearing your ideas on what we should do next…on what actions to take…on what initiatives to consider…and on what opportunities for further collaboration we should pursue.  This conference is a truly great step—but it is a step to build on.

So let us take the next step… and let us begin this morning, with our dialogue and discussion on how to remove the burden of tobacco from the headlines, and consign it to the history books.

Thank you.