Letter: To Dr. Andrew von Eschenbach, Commissioner, Food and Drug Administration

Letter

Letter: To Dr. Andrew von Eschenbach, Commissioner, Food and Drug Administration

Dear Dr. von Eschenbach:

I am concerned about your recent comments regarding pending legislation that would give the Food and Drug Administration (FDA) regulatory authority over tobacco products. Given the FDA's public health and safety mission and the lead regulatory role assigned to the agency pursuant to the legislation, your suggestion that the FDA should not be in a position to determine the safety of cigarettes is very troubling.

The first Surgeon General's Report linking cigarette smoking to lung cancer was released 40 years ago, yet tobacco use still kills more than 400,000 Americans every year, accounting for more than 30 percent of all cancer deaths, and 80 percent of deaths from chronic obstructive pulmonary disease. One in five deaths from coronary heart disease are directly attributable to smoking. As you well know, it is the leading preventable cause of death and disease in the United States . However, despite all of these disturbing statistics, tobacco remains among the least regulated consumer products on the market today, and is exempt from ingredient disclosure requirements, safety testing and restrictions on marketing to children.

The Kennedy-Cornyn bill and the Waxman-Davis bill, of which I am a cosponsor, has wide bipartisan support that is based on the expectation of millions of Americans that it is time to reign in the tobacco industry and its century long assault on the public health. This is an industry that manufactures its product in a way that increases its addictive power, and manipulates consumers, particularly children, into believing smoking is glamorous rather than deadly.

I am mindful of the concerns you expressed in the media about FDA's ability to undertake the mission envisioned in the legislation. The issue of providing sufficient resources and expertise are areas in which we need to work together in order to recognize the overwhelming need to move forward.

I believe your concerns about the legislation may be based on a misunderstanding of its provisions. The bill in fact would create a new legal standard to require changes in a tobacco product if FDA concludes the change "is appropriate for the protection of public health." If a tobacco company objects to the new standard, it would have the burden to prove that the "proposed standard will not reduce or eliminate the risk of illness or injury." There is no doubt that the new legal standard will save lives. The assertion that manufacturers will claim an FDA "seal of approval" is an issue that could be resolved within the legislative process, and certainly does not warrant a categorical rejection of the bill.

This legislation also would: restrict advertising; restrict minors' access to cigarettes; and replace the ineffective warning labels. It would allow FDA to regulate nicotine and other dangerous components of tobacco and cigarette smoke, and to regulate flavorings and other alternations added as a way to attract young replacement smokers. This bill is supported by every major public health organization, leaders of the House and Senate and an overwhelming majority of the general public.

It is my hope that you will work with Congress in passing this legislation, and then implement the necessary regulatory structure at FDA, which is the appropriate agency for this task. I recognize that this will be a major effort requiring a significant commitment of time and resources, and that is why the time to begin is now.

You have devoted your life and career to serving the public health, and I know that you understand the scourge of tobacco. I also believe that you are very aware of the impact this bill will have in saving lives. I urge the administration's support, and hope that you will play a constructive role in moving it forward. I look forward to discussing this bill with you further.

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