June 18, 2013

Stanton A. Glantz, PhD

FDA should ban menthol as an additive not as an undefined "characterizing flavor"

I just submitted the following public comment to the FDA

COMMENT ON CITIZEN PETITION ASKING THE U.S. FOOD AND DRUG ADMINISTRATION TO
PROHIBIT MENTHOL AS ACHARACTERIZING FLAVOR IN CIGARETTES[*]

Docket ID: FDA-2013-P-0435
June 19, 2013

            Rather than prohibiting the use of menthol “as a characterizing flavor” are requested in the Citizen Petition, the FDA should simply prohibit the use of menthol (and menthol analogs) in cigarettes and, as it asserts jurisdiction over other tobacco products, those products as well.

            There are two reasons for pursuing a prohibition.

            First, “characterizing flavor” is not defined in the Family Smoking Prevention and Tobacco Control Act and the de facto definition of “characterizing flavor” that the FDA has applied to other additives (such as chocolate, licorice, and strawberry) that are included in the Act is that products containing these additives not be advertised using words as containing these additives.  The FDA has taken no action to limit the actual use of these additives in cigarettes (or any other tobacco products).  Thus, if the FDA applies the same de facto definition for menthol “as a characterizing flavor,” cigarette companies could keep using menthol at the same levels in cigarettes as they are today, simply drop the word “menthol” from the packaging and advertising, and keep selling the cigarettes in color coded green packages.[†]

            Second, should the FDA decide to prohibit the use of menthol above a certain concentration as a “characterizing flavor” the Agency would have to develop a methodology for setting the level of menthol that constituted a “characterizing flavor.”  Because of the complex effects of menthol on the sensation of smoking as well as its complex interaction with nicotine (documented in the TPSAC report on menthol, the Citizen Petition, as well as the broader scientific literature) there is a good chance that it would be impossible to define an absolute level of menthol that smokers would “taste” that would be independent of all the other ingredients and additives in cigarettes (and other tobacco products).   Such a process could take years, during which time the cigarette companies could continue making and promoting menthol cigarettes despite the fact that, as TPSAC noted, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”[‡]

            The FDA should simply use the information in the TPSAC report, the Citizen Petition, and the scientific evidence that continues to accumulate that menthol is more than just a “flavor,” but serves a wide range of functions to recruit youth to smoking and discourage quitting,[§] not just among one or another “target” group but among broad elements of the population. 

            Based on the available scientific evidence, a decision to prohibit the use of menthol and menthol analogs in cigarettes (and, when the FDA takes jurisdiction, other tobacco products) is clearly justified and easier to defend than trying to set an absolute level of menthol at which it becomes a “characterizing flavor.”    

            Stanton A. Glantz, PhD
            Professor of Medicine
            American Legacy Foundation Distinguished Professor of Tobacco Control
            Director, Center for Tobacco Control Research and Education

 
This comment is also available in www.regulations.gov with comment identifier1jx-85zp-r17p here.
  

[*] In addition to in the FDA docket, the petition is available at http://www.publichealthlawcenter.org/sites/tobacco.ucsf.edu/files/tclc-fdacitizenpetition-menthol-2013.pdf

[†] As detailed in my Comment on Docket No. FDA-2012-D-0071, Draft Guidance for Industry: Modified Risk Tobacco Product Applications, the FDA has taken no action to stop the companies from replacing the prohibited terms “light” and “mild” with color coded packages transmitting the same information, so there is no reason to expect that the FDA would treat menthol any differently.

[‡] Tobacco Products Scientific Advisory Comm., U.S. Food & Drug Admin., Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations 220 (2011), available at  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterial/TobaccoProductsScientificAdvisoryCommittee/UCM269697.pdf  (final as reviewed and approved by the TPSAC on July 21, 2011) , page 225.

[§] See, for example, Levy, et al., Quit attempts and quit rates among menthol and nonmenthol smokers in the United States.  Am J Public Health. 2011;101(7):1241-7 and Levy, et al, Modeling the Future Effects of a Menthol Ban on Smoking Prevalence and Smoking-Attributable Deaths in the United States.  Am J Pub Health 2011;101(7):1236-40.

Comments

Comment: 

Several people have emailed me agreeing with my recommendation that the simplest and most effective thing for the FDA to do would be to simply prohibit the use of menthol (and menthol analogs) in cigarettes.
While it is gratifying to hear from people, what we really need if for you to <strong;tell the FDA</strong;.&nbsp;
You don't need to write a long scientific discourse; you can just type a brief comment into the regulations.gov website by clicking http://www.regulations.gov/#%21documentDetail;D=FDA-2013-P-0435-0001" target="_blank";here.
Comments from outside the USA are welcome, too.

Comment: 

In my comment for a complete ban I cited Brazil’s National Health Surveillance Agency decision to do just that.
However ridiculous it seems to have to re-submit comments on this issue given the extensive public comment period for the original TPSAC investigation on this topic, taking 10 minutes to comment again, or for the first time, is necessary.&nbsp; This decision will be a political one and a menthol ban will not happen unless political pressure is brought to bear on the FDA.&nbsp; Public comment is one way to exert this pressure.
Kim Klausner
Industry Documents Digital Library Manager
University of California, San Francisco

Comment: 

I submitted the following comment - MG
<strong;RE:&nbsp; Citizen Petition Asking the U.S. Food and Drug Administration to Prohibit Menthol as a Characterizing Flavor (</strong;<strong;Docket ID: FDA-2013-P-0435)</strong;
Date:&nbsp; June 20, 2013
&nbsp;
<strong;<em;The US is obligated to ban menthol cigarettes under its International Covenant on Civil and Political Rights and Convention on the Elimination of All Forms of Racial Discrimination human rights obligations</em;</strong;
It has been well established the menthol cigarettes pose a population level harm to the US public as they increase smoking initiation and are target at vulnerable populations [1].&nbsp; Prior to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) 2009 cigarettes identified as containing menthol were the most popular type of cigarettes, representing 20% of the market in 2006,[2] and menthol is added to over 90% of cigarettes produced in the United States.[3] &nbsp;Historically these cigarettes have been used to target African Americans,[4-7] women,[8] and youth.[8, 9]&nbsp; More recently they have been used to target other racial and ethnic minorities such as Hispanic.[10] &nbsp;As a result of this targeting, menthol-identified cigarettes remain the preferred product for most African American smokers,[2, 11] and are most likely to be the starter cigarette for adolescents.[12]&nbsp; Furthermore, adolescents who started smoking menthol cigarettes are more likely to become regular smokers than those who start out with non-mentholated cigarettes.[12, 13]&nbsp; Menthol smokers are also more likely to be women than men, and African American than Hispanic or non-Hispanic Whites.[14]&nbsp; The disproportionate consumption of menthol cigarettes by women and African Americans is a tobacco-induced health disparity in the US that continues because the FDA has not banned menthol cigarettes.&nbsp; By failing to ban menthol cigarettes, the FDA has not taken all steps possible to lower youth and young adult smoking initiation rates.&nbsp;
&nbsp;
As a party to both the International Covenant on Civil and Political Rights and Convention on the Elimination of All Forms of Racial Discrimination the United States has accepted the duty to ensure its citizens have the right to life and that racial and ethnic minorities have equality before the law with respect to public health.&nbsp; By failing to ban menthol in cigarettes, the FDA has placed the US in violation of its duties under these two international human rights treaties that the US has ratified.
&nbsp;
&nbsp;
<strong;<em;Failure to ban the sale of menthol cigarettes violates the right to life</em;</strong;
Ratifiers, including the United States, of the International Covenant on Civil and Political Rights (CCPR) acknowledge the right to life in article 6 of the treaty, stating:
<em;Every human being has the inherent right to life. This right shall be protected by law...[15]</em;
This right, as interpreted by the treaty body of the CCPR is a positive right,[16] which means that parties must not only refrain from violating the right, but that they take steps to ensure that right.&nbsp; In particular, General Comment 6, which provides guidance on the interpretation of the CCPR states, “the protection of this right [to life] requires that States adopt positive measures. In this connection, the Committee considers that it would be desirable for States parties to take all possible measures to reduce infant mortality and to increase life expectancy, especially in adopting measures to eliminate malnutrition and epidemics…”[16]&nbsp; The preventable death and disease caused by tobacco consumption in the United States represents such an epidemic.&nbsp; By failing to address menthol, the “flavor” with the largest market share, the FSPTCA of 2009 failed in its attempt to decrease initiation by banning flavored cigarettes and to decrease industry targeting of women, young adults, and racial/ethnic minorities.&nbsp; As a result, the United States has failed in its duty to “adopt measures to eliminate…epidemics.”&nbsp; Fortunately, the FSPTCA granted the FDA the authority to regulate menthol . The FDA should exercise that authority and ban menthol cigarettes..
&nbsp;
<strong;<em;Failure to ban menthol cigarettes violates racial/ethnic equality before the law with respect to public health</em;</strong;
Article 5 of the Convention on the Elimination of All Forms of Racial Discrimination (CERD) acknowledges the right to equality before the law with respect to public health stating:
<em;In compliance with the fundamental obligations laid down in article 2 of this Convention, States Parties undertake to prohibit and to eliminate racial discrimination in all its forms and to guarantee the right of everyone, without distinction as to race, colour, or national or ethnic origin, to equality before the law, notably in the enjoyment of the following rights:</em;
<em;&nbsp;…(e) Economic, social and cultural rights, in particular:</em;
<em;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; …(iv) The right to public health, medical care, social security and social services….</em;[17]
As noted above, by failing to ban the one flavor of cigarette which has historically been used to target African Americans, and which is preferred by African Americans, the FSPTCA of 2009 is a discriminatory bill.&nbsp; As a result, six former U.S. Secretaries of Health and Human Services, a former U.S. Secretary of Health, Education and Welfare, former Surgeon General, and the Executive Director, National African American Tobacco Prevention Network have stated that the FSPTCA discriminates against African Americans and sent a letter to the US Senate stating that the bill “sends a message that African American youngsters are valued less than white youngsters.”[18]&nbsp; In general comment 29, the Committee on the Elimination of Racial Discrimination urged parties to CERD to “[e]laborate, adopt and implement plans and programmes of economic and social development on an equal and non-discriminatory basis…”[19]&nbsp; By banning menthol cigarettes the FDA would ensure that the FSPTCA of 2009, which is a major public health law in the United States, is implemented on a non-discriminatory basis.
&nbsp;
<strong;<em;The United States should ban menthol in order to comply with its human rights duties under the</em;</strong;<em;<strong;International Covenant on Civil and Political Rights and Convention on the Elimination of All Forms of Racial Discrimination</strong;</em;
By failing to ban menthol cigarettes, the United States FSPTCA of 2009 has placed the United States in violation of its duties under two international human rights treaties that it has ratified.&nbsp; By banning menthol flavored cigarettes, the US would not only be in compliance with its international obligations, but it would significantly decrease youth initiation and the targeting of women, racial/ethnic minorities, and young adults with this product.&nbsp;
While the FDA should take steps to ban menthol cigarettes in compliance with its international duties, as noted by others (Comment 1jx-85zp-r17p) the FDA has not defined what constitutes a cigarette with a “characterizing flavor.”&nbsp; In particular, Dr. Stanton A. Glantz noted:
…should the FDA decide to prohibit the use of menthol above a certain concentration as a “characterizing flavor” the Agency would have to develop a methodology for setting the level of menthol that constituted a “characterizing flavor.”&nbsp;&nbsp;Because of the complex effects of menthol on the sensation of smoking as well as its complex interaction with nicotine (documented in the TPSAC report on menthol, the Citizen Petition, as well as the broader scientific literature) there is a good chance that it would be impossible to define an absolute level of menthol that smokers would “taste” that would be independent of all the other ingredients and additives in cigarettes (and other tobacco products).&nbsp;&nbsp;&nbsp;Such a process could take years, during which time the cigarette companies could continue making and promoting menthol cigarettes despite the fact that, as TPSAC noted, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.
As a result, the only practical way for the FDA to ban menthol flavored cigarettes is to ban the use of menthol in cigarettes in general.
Works Cited
&nbsp;
1. Gardiner PS, Clark PI. Menthol cigarettes: moving toward a broader definition of harm. Nicotine Tob Res. 2010 Dec;12 Suppl 2:S85-93.
2. Lawrence D, Rose A, Fagan P, Moolchan E, Gibson J, Backinger C. National patterns and correlates of mentholated cigarette use in the United States. Addiction. 2010 105(Suppl. 1):13-31.
3. Anderson SJ. Marketing of menthol cigarettes and consumer perceptions:&nbsp; A review of tobacco industry documents Tob Control. 2011;20(Suppl. 2):ii20–ii8.
4. Yerger VB, Przewoznik J, Malone RE. Racialized geography, corporate activity, and health disparities: tobacco industry targeting of inner cities. J Health Care Poor Underserved. 2007;18(Suppl. 4):10–38.
5. Gardiner PS. The African Americanization of menthol cigarette use in the United States. Nicotine Tob Res. 2004 Feb;6 Suppl 1:S55-65.
6. Balbach ED, Gasior RJ, Barbeau EM. R.J. Reynolds' targeting of African Americans: 1988–2000. Am J Public Health. 2003;93:822–7.
7. Cruz T, Wright L, G C. The menthol marketing mix: targeted promotions for focus communities in the United States. Nicotine Tob Res. 2010;12(Suppl. 2):S147-53.
8. Sutton CD, Robinson RG. The marketing of menthol cigarettes in the United States: populations, messages, and channels. Nicotine Tob Res. 2004 Feb;6 Suppl 1:S83-91.
9. Kreslake JM, Wayne GF, Alpert HR, Koh HK, Connolly GN. Tobacco industry control of menthol in cigarettes and targeting of adolescents and young adults. Am J Public Health. 2008 Sep;98(9):1685-92.
10. Landrine H, Klonoff EA, Fernandez S, Hickman N, Kashima K, Parekh B, et al. Cigarette advertising in Black, Latino, and White magazines, 1998-2002: an exploratory investigation. Ethn Dis. 2005 Winter;15(1):63-7.
11. Substance Abuse and Mental Health Services Administration, Office of Applied Studies. The NSDUH Report: Use of Menthol Cigarettes. Rockville, MD: November 19, 2009.&nbsp; Available at:&nbsp; http://oas.samhsa.gov/2k9/134/134MentholCigarettes.htm. Accessed:&nbsp; June, &nbsp;2013.
12. Hersey JC, Ng SW, Nonnemaker JM, Mowery P, Thomas KY, Vilsaint MC, et al. Are menthol cigarettes a starter product for youth? Nicotine Tob Res. 2006 Jun;8(3):403-13.
13. Nonnemaker J, Hersey J, Homsi G, Busey A, Allen J, Vallone D. Initiation with menthol cigarettes and youth smoking uptake. Addiction. 2013 Jan;108(1):171-8.
14. Cubbin C, Soobader M-J, LeClere FB. The intersection of gender and race/ethnicity in smoking behaviors among menthol and non-menthol smokers in the United States. Addiction. 2010;105(Suppl. 1):32–8.
15. UN General Assembly. International Covenant on Civil and Political Rights.&nbsp; United Nations, Treaty Series. 9991966. p. 171.
16. UN Human Rights Committee (HRC). CCPR General Comment No. 6: Article 6 (Right to Life), 30 April 1982: Office of the United Nations High Commissioner for Human Rights;&nbsp; [June 2013]. Available from: http://www.unhchr.ch/tbs/doc.nsf/%28Symbol%29/84ab9690ccd81fc7c12563ed00.... &nbsp;Accessed:&nbsp; June, 2013.
17. UN General Assembly. International Convention on the Elimination of All Forms of Racial Discrimination.&nbsp; United Nations, Treaty Series. 6601965. p. 195.
18. Califano Jr. JA, Sullivan LW, Shalala DE, Thompson TG, Bowen OR, Schweiker RS, et al. Text of Letter to Senators on Menthol Exemption for Cigarettes [dated June 4, 2008]. New York Times. 2008. Available from:&nbsp; http://www.nytimes.com/2008/06/05/business/05TobaccoLetter.html?_r=0. " title="http://www.nytimes.com/2008/06/05/business/05TobaccoLetter.html?_r=0. ";http://www.nytimes.com/2008/06/05/business/05TobaccoLetter.html?_r=0.  Accessed:&nbsp; June, 2013.
19. UN Committee on the Elimination of Racial Discrimination (CERD). CERD General Recommendation XXIX on Article 1, Paragraph 1, of the Convention (Descent), 1 November 2002: Office of the United Nations High Commissioner for Human Rights;&nbsp; [June 2013]. Available from: http://www.unhchr.ch/tbs/doc.nsf/%28Symbol%29/f0902ff29d93de59c1256c6a00.... Accessed:&nbsp; June, 2013.

Comment: 

She is a postdoctoral fellow at UCSF.

Comment: 

I agree
Dear Dr Glanz,
This write up is extraordinary. Incidentally I did not know that US had ratified the following two treaties. I should admit my ignorance and also ask for forgiveness for always saying that US has not ratified any convention.
Having said that is it only the business which is making US (FDA) not to comply or is there any research which indicates that addition of menthol lessens the harm due to tobacco?. It cannot be just the taste for they can introduce something else.
I wait to hear from you.
mira aghi, New Delhi, India
&nbsp;
&nbsp;
--&nbsp;
Mira Aghi, Ph.D.
Behavioral Scientist
Communication Expert

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