Tag Archives: cigarettes

NCHR Testimony on Low Nicotine Cigarette Claim

Nina Zeldes, National Center for Health Research, February 14, 2020


Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here as a senior fellow speaking on behalf of the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies or tobacco companies, so I have no conflicts of interest.

We strongly oppose the approval of this modified risk application by the 22nd Century Group for their low-nicotine combusted filtered cigarette tobacco products. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. Unfortunately, evidence is lacking to support the claim that this product significantly reduces harm for smokers. At the same time, it is likely to entice people who have never smoked, especially adolescents, to start smoking.

As the applicant has pointed out, this low nicotine cigarette poses similar risks of tobacco-related disease as conventional cigarettes. Its only advantage is that it contains much less nicotine, and could therefore be less addictive. However, the claims of reduced harm seem to be based entirely on the assumption that people would smoke less often – an assumption that was not adequately supported by the applicant’s data. For example, this product was rated as less satisfying than smokers’ usual brand of cigarettes and less likely to be used again compared to nicotine gum, raising questions about whether smokers would switch completely to this product and ultimately quit smoking.

The FDA briefing document points out that nicotine is often perceived as causing smoking-related health risks. That means that a claim of a product having “95% less nicotine” will be misunderstood as being less likely to cause cancer, when in fact it just means potentially less addictive. Although the applicant provided a voluntary warning that “less nicotine does NOT mean safer”, study participants who were shown this warning still perceived this product as safer than conventional cigarettes. Additionally, the applicant only tested the claims on packaging and not how they would be used in ads and social media. We’ve all learned that the context and imagery in these ads can vastly alter how these claims are interpreted. Tobacco companies have learned how to make very persuasive ads that go beyond the specific claims that they make.

And as we all know, smoking is a habit that is very difficult to break, and addiction to nicotine is only one of the reasons that quitting is so difficult.

Most smokers start smoking as children and adolescents, and yet adolescents were not included in any of the studies provided by the applicant. Previous studies have demonstrated that this group is likely to perceive products with a risk-mitigation claim as less harmful, but that is not proven in this case.

In conclusion, while the claim that this product contains 95% less nicotine may be factually correct, the company’s claims of health benefits are based on the implied assumption that this product would help smokers quit. If that is supposed to be the benefit, their product should have sought to market this product as a cessation aid. Moreover, the packaging does not explain how to achieve this health benefit. Because of such claims, smokers interested in reducing smoking-related health risks might start using this product, instead of quitting or using available FDA-approved cessation products. Meanwhile, non-smokers, particularly adolescents, might start using this product, thinking it is a safe alternative to other tobacco products.

If we’ve learned anything from the vaping epidemic, it is that adolescents are easy to influence, and once they start a habit like smoking or vaping, they are unlikely to stop. We encourage you to let the FDA know that you do not believe that would be an acceptable outcome.

Thank you.

Comment for Proposed Rulemaking, Menthol in Cigarettes, Tobacco Products; Docket No. FDA-2013-N-0521

November 2013

We write today to urge the FDA to remove menthol cigarettes from the market as quickly as possible.

Tobacco use is responsible for more than 400,000 deaths each year in the United States and is the leading preventable cause of death. A quarter of all cigarettes sold are menthol cigarettes, which studies show are preferred by younger smokers and new smokers. Since almost 9 out of 10 (88%) adult smokers began smoking before age 18, it will save lives to make smoking as unappealing as possible for teenagers and young adults. Menthol’s “cooling effect” does the opposite: it makes smoking as palatable (perhaps more palatable) to young people and nonsmokers as candy flavoring, which was banned in 2009 under the Family Smoking Prevention and Tobacco Control Act. According to the FDA’s Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes, “the weight of the evidence supports the conclusion that menthol in cigarettes is likely associated with increased initiation and progression to regular cigarette smoking.”

Not only are menthol cigarettes a starter product for youth, they are harder to quit because they are likely associated with: 1) “increased dependence,” and 2) “reduced success in smoking cessation, especially among African American menthol smokers.”  For these reasons, we strongly agree with the FDA conclusions that “menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes.”

The Tobacco Products Scientific Advisory Committee (TPSAC), before which we testified, concluded over two years ago that “removal of menthol cigarettes from the marketplace would benefit public health in the United States.” A conservative modeling scenario published in a peer-reviewed medical journal estimated that over 320,000 deaths—most of them among African Americans—could be averted by 2050 had menthol been banned in 2011 as recommended.1 The FDA must not drag its feet any longer. The decision to extend the comment period an additional two months itself cost thousands of lives.

The Cancer Prevention and Treatment Fund represents the millions of American families whose lives have been touched by cancer, and our mission is to gather and scrutinize research to determine how programs and policies can reduce the incidence of cancer and improve treatment options for cancer patients.  Our scientific analysis indicates that hundreds of thousands of lives will be saved when the FDA removes menthol cigarettes from the market, and we strongly urge the FDA to protect the public health by implementing a final rule to do so.

Sincerely,

Cancer Prevention and Treatment Fund