March 12, 2001

The Honorable Robert Pitofsky
Chairman
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580

Dear Chairman Pitofsky:

In light of the newly released report by the Institute of Medicine (IOM) of the National Academy of Sciences, and the continued marketing of Eclipse by the RJ Reynolds Tobacco Company (RJRTC), we the undersigned urge the Federal Trade Commission (FTC) to act on our previous request for action against RJRTC pursuant to section 5 of the Federal Trade Commission Act (15 U.S.C. 45) concerning RJRTC’s advertising for its Eclipse product. We first brought this matter to your attention in an August 1, 2000 letter - see attachment.

On February 22, 2001, the Institute of Medicine released its long anticipated study, "Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction." The U.S. Food and Drug Administration (FDA) had requested this study to give them a sound scientific basis for evaluating how to regulate and review new tobacco products that were marketed with explicit or implicit claims that they present a reduced risk of tobacco caused disease than products already on the market.

After more than a year of study and examination, the IOM concluded the following:

• Potential reduced-exposure products (PREPs) – including Eclipse - have not yet been evaluated comprehensively enough (including for a sufficient time) to provide a scientific basis for concluding that they are associated with a reduced risk of disease compared to conventional tobacco use.

• The public health impact of PREPs is unknown. While the IOM concluded that it is feasible to make a product that will reduce the risk of tobacco caused disease, the impact of those products now on the market is unknown and depending on how they are marketed, the net impact on the health of the population as a whole could, in fact, be negative.

The implications for Eclipse in light of the IOM’s conclusions are important:

1. RJ Reynolds fails to possess adequate substantiation (i.e., lacks a scientific basis) required under Section 5 of the FTC Act for the health related claims that it is making for Eclipse according to experts explicitly asked by the FDA to address this vitally important scientific question;
2. If the FTC fails to act to stop RJ Reynolds from making health related claims in light of the findings of the IOM, it is tantamount to a license to Reynolds and other tobacco companies to make unsubstantiated and unproven health claims with impunity and without fear of federal oversight.

The IOM report makes it clear that, absent effective federal regulation of tobacco, the tobacco industry’s introduction of these products with unsubstantiated claims of "reduced risk" leaves Americans unprotected from new deceptions that would cost even more lives.

The tobacco industry has repeatedly made claims of reduced risk that later proved to be unfounded, deceptive and, in far too many cases, lethal. "Light" cigarettes that boasted lower levels of tar in cigarette smoke were introduced in the 1960’s with claims of less risk to smokers. In fact, because smokers of "lights" tend to compensate by smoking more, inhaling more deeply or blocking ventilation holes, and other studies have shown that the marketing of "lights" has probably led fewer smokers to quit, we now know that the introduction of "lights" did not improve the public health and may in fact have resulted in an increase in the incidence of disease.

Today we face an increase in the introduction of an entire new generation of products that promise to give smokers a safer alternative to quitting or not starting. In light of the IOM report, we now know that there is inadequate evidence to support these conclusions, just as there was for "light" and "low tar" product promises a generation ago. Other tobacco companies, including Philip Morris, Vector Group Ltd. (parent company of Liggett Group), Brown & Williamson and Star Scientific, are all developing or already selling allegedly "reduced risk" products. The IOM report sounds a loud and clear warning that, without effective federal regulation of these products and the claims made about them, we could repeat the mistake we made with "low tar" products once again with equally tragic consequences.

As articulated in our August 1, 2000 letter and re-iterated here, there is more than sufficient legal ground, bolstered by the conclusions of the IOM report, to warrant FTC taking action against the unsubstantiated claims made by the RJ Reynolds Tobacco Company in its advertising for its Eclipse product.

We urge you to act promptly.

Sincerely,

Alliance for Lung Cancer Advocacy, Support and Education
American College of Cardiology
American College of Chest Physicians
American College of Preventive Medicine
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American School Health Association
American Society of Addiction Medicine
Campaign for Tobacco-Free Kids
Community Anti-Drug Coalitions of America (CADCA)
Federation of Behavorial, Psychological and Cognitive Sciences
Latino Council for Alcohol and Tobacco
National Association of County and City Health Officials
National Association of Local Boards of Health
National Center for Policy Research for Women and Families
Oral Health America
Partnership for Prevention

Attachment

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March 12, 2001

Bernard A. Schwetz, D.V.M., Ph.D.
Acting Principal Deputy Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

In light of the newly released report by the Institute of Medicine of the National Academy of Sciences, and the continued marketing of Eclipse by the RJ Reynolds Tobacco Company, we the undersigned urge the Food and Drug Administration (FDA) to act on our previous request to the FDA to assert jurisdiction over and regulate, under the Federal Food, Drug, and Cosmetic Act (FTCA), the marketing, sale and distribution by the RJ Reynolds Tobacco Company (RJRTC) of its Eclipse product. We first brought this matter to the FDA’s attention in an August 1, 2000 letter to FDA Commissioner Jane Henney - see attachment.

On February 22, 2001, the Institute of Medicine (IOM) released its long anticipated study, "Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction." The FDA requested this study to give the agency a sound scientific basis for evaluating how to regulate and review new tobacco products that were marketed with explicit or implicit claims that they present a reduced risk of tobacco caused disease than products already on the market. Despite the fact that the Supreme Court struck down the FDA’s assertion of jurisdiction over tobacco products generally, the nature of Eclipse and manner in which Eclipse is being marketed as well as the emergence of an ever growing number of products that are being represented as reduced risks makes it clear (1) that the FDA does currently have the authority to act to stop these claims, and (2) the need for FDA to act is growing.

After more than a year of study and examination, the IOM concluded the following:

• Potential reduced-exposure products (PREPs) – including Eclipse - have not yet been evaluated comprehensively enough (including for a sufficient time) to provide a scientific basis for concluding that they are associated with a reduced risk of disease compared to conventional tobacco use.

• The public health impact of PREPs is unknown. While the IOM concluded that it is feasible to make a product that will reduce the risk of tobacco caused disease, the impact of those products now on the market is unknown and depending on how they are marketed, the net impact on the health of the population as a whole could, in fact, be negative.

The implications for Eclipse in light of the IOM’s conclusions are important:

1. RJ Reynolds lacks a scientific basis for the health related claims that it is making for Eclipse according to experts explicitly asked by the FDA to address this vitally important scientific question;
2. If the FDA fails to act to stop RJ Reynolds from making health related claims in light of the findings of the IOM, it is tantamount to a license to Reynolds and other tobacco companies to make unsubstantiated and unproven health claims with impunity and without fear of federal oversight.

The IOM report makes it clear that, absent effective federal regulation of tobacco, the tobacco industry’s introduction of allegedly "reduced risk" products leaves Americans unprotected from new deceptions that would cost even more lives.

The tobacco industry has repeatedly made claims of reduced risk that later proved to be unfounded, deceptive and, in far too many cases, lethal. "Light" cigarettes that boasted lower levels of tar in cigarette smoke were introduced in the 1960’s with claims of less risk to smokers. In fact, because smokers of "lights" tend to compensate by smoking more, inhaling more deeply or blocking ventilation holes, and other studies have shown that the marketing of "lights" has probably led fewer smokers to quit, we now know that the introduction of "lights" did not improve the public health and may in fact have resulted in an increase in the incidence of disease.

Today we face an increase in the introduction of an entire new generation of products that promise to give smokers a safer alternative to quitting or not starting. In light of the IOM report, we now know that there is inadequate evidence to support these conclusions, just as there was for "light" and "low tar" product promises a generation ago. Other tobacco companies, including Philip Morris, Vector Group Ltd. (parent company of Liggett Group), Brown & Williamson and Star Scientific, are all developing or already selling allegedly "reduced risk" products. The IOM report sounds a loud and clear warning that, without effective federal regulation of these products and the claims made about them, we could repeat the mistake we made with "low tar" products once again with equally tragic consequences.

The ultimate answer to the issue of FDA authority to regulate all tobacco products resides with Congress. However, there is more than sufficient legal ground (as described in detail in our August 1, 2000 letter), and bolstered by the conclusions of the FDA-funded IOM report, to warrant FDA asserting jurisdiction in the case of Eclipse under current law.

We urge you to act promptly.

Sincerely,

Alliance for Lung Cancer Advocacy, Support and Education
American College of Cardiology
American College of Chest Physicians
American College of Preventive Medicine
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American School Health Association
American Society of Addiction Medicine
Campaign for Tobacco-Free Kids
Community Anti-Drug Coalitions of America (CADCA)
Federation of Behavorial, Psychological and Cognitive Sciences
Latino Council for Alcohol and Tobacco
National Association of County and City Health Officials
National Association of Local Boards of Health
National Center for Policy Research for Women and Families
Oral Health America
Partnership for Prevention

Attachment

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March 13, 2001

Tommy Thompson
Secretary
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

This week we have renewed our request to the Food and Drug Administration asking the FDA to assert jurisdiction over "Eclipse," a tobacco product being marketed by the RJ Reynolds Tobacco Company as a reduced risk product. Our original petition was filed August 1, 2000 and a copy is attached.

This petition raises two critical public health issues. The first concerns the ability of the FDA to protect the public health when a tobacco manufacturer, like RJ Reynolds, markets a new product with unsubstantiated health claims. The second concerns the larger question of the need for the FDA to have broad and effective jurisdiction over all tobacco products in order to protect the public health. These are critically important public health issues, which we hope that you will address as a high priority.

We have renewed our call for prompt and decisive action now because of the findings from the newly released report by the Institute of Medicine (IOM) of the National Academy of Sciences. On February 22, 2001, the IOM released its long anticipated study, "Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction." The FDA requested this study to give the agency a sound scientific basis for evaluating how to regulate and review new tobacco products that were marketed with explicit or implicit claims that they present a reduced risk of tobacco caused disease than products already on the market.

After more than a year of study and examination, the IOM concluded the following:

• Potential reduced-exposure products (PREPs) – including Eclipse - have not yet been evaluated comprehensively enough (including for a sufficient time) to provide a scientific basis for concluding that they are associated with a reduced risk of disease compared to conventional tobacco use.

• The public health impact of PREPs is unknown. While the IOM concluded that it is feasible to make a product that will reduce the risk of tobacco caused disease, the impact of those products now on the market is unknown and depending on how they are marketed, the net impact on the health of the population as a whole could, in fact, be negative.

The implications for Eclipse of the IOM’s conclusions are important:

1. RJ Reynolds lacks a scientific basis for the health related claims that it is making for Eclipse according to experts explicitly asked by the FDA to address this vitally important scientific question;
2. If the FDA fails to act to stop RJ Reynolds from making health related claims in light of the findings of the IOM, it is tantamount to a license to Reynolds and other tobacco companies to make unsubstantiated and unproven health claims with impunity and without fear of federal oversight.

The IOM report makes it clear that, absent effective federal regulation of tobacco, the tobacco industry’s introduction of allegedly "reduced risk" products leaves Americans unprotected from new deceptions that could cost even more lives.

The tobacco industry has repeatedly made claims of reduced risk that later proved to be unfounded, deceptive and, in far too many cases, lethal. "Light" cigarettes that boasted lower levels of tar in cigarette smoke were introduced in the 1960’s with claims of less risk to smokers. In fact, because smokers of "lights" tend to compensate by smoking more, inhaling more deeply or blocking ventilation holes, we now know that the introduction of "lights" did not improve the public health and may in fact have resulted in an increase in the incidence of disease.

Today we face the introduction of an entire new generation of products that will promise to give smokers a safer alternative to quitting or not starting. In light of the IOM report, we now know that there is inadequate evidence to support these conclusions, just as there was for "light" and "low tar" product promises a generation ago. Other tobacco companies, including Philip Morris, Vector Group Ltd. (parent company of Liggett Group), Brown & Williamson and Star Scientific, are all developing or already selling allegedly "reduced risk" products. The IOM report sounds a loud and clear warning that, without effective federal regulation of these products and the claims made about them, we could repeat the mistake we made with "low tar" products once again with equally tragic consequences.

While the ultimate answer to the issue of FDA authority to regulate all tobacco products resides with Congress, we believe there is more than sufficient legal ground to warrant FDA asserting jurisdiction over Eclipse under current law. These are critically important public health issues on which we hope you will work closely with us.

Sincerely,

Matthew L. Myers
President

Attachment