City and County of San Francisco Department of Public Health

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1 City and County of San Francisco Department of Public Health Population Health and Prevention TOBACCO FREE PROJECT Community Health Education Section Community Health Promotion & Prevention Branch November 10, 2011 To: Steven Tierney, Ed.D. and Members of the San Francisco Health Commission Thru: Barbara Garcia, MPA Director of Health From: Mele Lau Smith, Health Program Coordinator Re: Menthol in Tobacco Products Thank you for your consideration of resolution to ban menthol in tobacco products. I have provided information below about the San Francisco Tobacco Free Coalition and the importance of a Health Commission resolution in support of the Food & Drug Administration issuing regulations to ban menthol flavorings in tobacco products. San Francisco Tobacco Free Coalition Menthol Resolution Campaign The San Francisco Tobacco Free Coalition is a grassroots coalition of health, environmental and youth serving organizations and individuals concerned with tobacco control. The Coalition has focused on protecting nonsmokers from second hand smoke, reducing youth access to tobacco products, fighting tobacco industry marketing and advertising, and educating the community on international issues in tobacco control policies. Since 1990, the Coalition has successfully advocated for over a dozen tobacco control policies including ordinances that created smoke free worksites, prohibited self service tobacco sales, required a tobacco permit for the sale of tobacco, and most recently an ordinance, endorsed by the Health Commission, that expanded protections to secondhand smoke to common areas of apartment buildings, outdoor dining areas, farmers markets, and more. Family Smoking Prevention and Tobacco Control Act In 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act giving the Food and Drug Administration authority to regulate the tobacco industry. The FDA was granted regulatory powers through the Family Smoking Prevention and Tobacco Control Act of This historical act gives the FDA unprecedented authority over the manufacture and distribution of tobacco products as well as the marketing, labeling, advertising and promotion of cigarettes. Many of the restrictions adopted by the FDA in their new regulations have been in effect in San Francisco and California for many years, such as prohibiting the sale of cigarettes in vending machines, prohibiting tobacco brand name sponsorship of any athletic, musical, or other social or cultural event, and prohibiting gifts or other items in exchange for buying cigarettes or smokeless tobacco products. The Exclusion of Menthol in the Original Regulations When the act was signed into law, all candy and fruit flavorings, such as such as chocolate, vanilla, berry, and liquorices, were banned in manufacture of cigarette products. The notable exception to this list of flavorings was menthol. Flavored cigarettes are very appealing to young people and are generally recognized to be an enticing starter product for youth. Menthol was exempted when the other flavors were banned largely because of tobacco industry pressure to leave it in. The exclusion of a ban on menthol prompted seven former Secretaries of Health, including Drs. Joseph Califano and Louis Sullivan to write a joint letter vehemently 30 Van Ness Avenue, Suite San Francisco, CA Phone: (415) Fax: (415)

2 opposing the exclusion of menthol from the banned flavors. With Califano going on to say that the Family Smoking Prevention and Tobacco Control Act as written relegated, Black children to the back of the [public health] bus. As a last minute compromise, an amendment was introduced to the Act that required the newly formed FDA Tobacco Product Scientific Advisory Committee (TPSAC) to issue a report on menthol by March Report of the Tobacco Product Scientific Advisory Committee & the FDA response After months of hearings and public testimony, on March 22, 2011, TPSAC issued its report stating that the removal of menthol cigarettes from the marketplace would benefit public health in the United States. The FDA responded that it would undergo its own review process and release a progress report sometime in the future. The FDA s progress report could 1) issue draft rules around menthol flavoring or 2) conclude the issue needs further study. FDA Regulation Process and the importance of Public Health: The Tobacco Control Act provides a broad set of restrictions to reduce youth access and attractiveness to cigarettes and smokeless tobacco. The Act gives the FDA authority to set standards for new tobacco products and those marketed as having reduced risk. More importantly, the Act directs the FDA to use a public health/population health standard when regulating tobacco products. Once proposed regulations have been issued, there is a public comment period, generally of 60 days or more, specified in the announcement. The FDA reads and addresses all significant comments prior to issuing a final rule. Because the FDA is directed to use a public health/population health standard when regulating tobacco products, comments from public health entities can significantly contribute to this dynamic process and influence the direction of the FDA. The Health Commissions adoption of a resolution in support of a ban on menthol and commitment for DPH to submit comments during the public comment period is critical in the development of meaningful regulations that counter the Tobacco Industry s opposition to such a ban. The federal rulemaking process gives the American public an opportunity to influence federal regulations, but the chance to do so is brief. To make sure communities voices and opinions are heard, participation and preparation are key. Opposition to a Ban on Menthol Flavoring The most vocal opponent to a ban on menthol flavoring is the Tobacco Industry. Due to their lobbying efforts, a ban on menthol flavoring was not included in the original Act. During the TPSAC hearings, tobacco industry representatives provided two days of testimony challenging the public health and scientific findings that support a ban on menthol. Specifically, the tobacco industry challenged both the survey methodology of youth tobacco surveys that measure mentholated smoking prevalence and whether mentholated cigarettes were more harmful, more addictive, or harder to quit than nonmentholated. Additionally the tobacco industry denied engaging in predatory targeting of mentholated tobacco products to African Americans and other marginalized communities

3 Other opposition groups include groups with tobacco industry ties or corporate sponsorship. These groups include convenience store retailer s associations and of note (3) African American organizations who have historically benefited from tobacco industry corporate sponsorship. One of these groups, the Congress on Racial Equality is framing the issue as a violation of African American s civil rights that the cigarette taste preference of African Americans be singled out and banned. These groups have also voiced concerns that the ban could increase smuggling or black market cigarettes which is an argument used to counter every proposed cigarette excise tax increase. Organizations supporting Ban on Menthol: The following organizations are in support of the Coalition s resolution to ban menthol: The National African American Tobacco Prevention Network NAACP Educational and Defense Fund African American Tobacco Control Leadership Council American Heart Association, Western Affiliate SF Lesbian Gay Bisexual Transgender Community Center Dolores Street Community Services Asian Pacific Partners for Empowerment and Leadership (APPEAL) Sunset Russian Tobacco Education Project Youth Leadership Institute Breathe California Girls After School Academy American Cancer Society, Greater Bay Area Region Tobacco Free Project, Community Health Promotion and Prevention The Tobacco Free Project supports the Tobacco Free Coalition s request for the Health Commission to pass a resolution in support of the FDA banning menthol flavoring in cigarettes. The Board of Supervisors has passed a similar resolution. As the policy making body for the Department of Public Health, the Health Commission is in a unique position to adopt a position supporting a ban on menthol such that the Department of Public Health can submit comments based on the standard of public health/population health. Comments from respected and recognized public health entities will mitigate the influence of the Tobacco Industry and marginalize its role in making public health policy a role that antithetical to the business of selling cigarettes.

4 This report was prepared by reviewing and gathering information from a variety of local, state and national sources. As the newly created Federal Drug Administration-Tobacco Products Scientific Advisory Committee (TPSAC) continues to gather evidence regarding the regulation/banning of menthol in cigarettes the national debate has heated up considerably. Most notably is the recent TPSAC resignation of Gregory N. Connolly of the Harvard School of Public Health, a prominent and respected critic of the tobacco industry. The January 5 th, New York Times reported that Connolly resigned because he felt he could have more influence from the outside and said the committee was in effect acting as a tobacco industry scientist and has been too cautious in attacking menthol and nicotine. Dr. Connolly said he plans to testify at the TPSAC public hearing on Monday, January on a new Harvard study about menthol cigarettes. The study reported that menthol caused an increase in smoking initiation by women in Japan, from 4 per cent to 20 percent, and said menthol should be banned as a flavoring that makes it easier to start smoking. Dr. Connolly s stepping down from the TPSAC underscores the fact that time is of the essence in influencing the FDA process and that groups and individuals wishing to have meaningful impact need to understand the process and work across multiple fronts. The Tobacco Products Scientific Advisory Committee and Menthol Regulation TPSAC was created to advise and inform the FDA as it moves forward in implementing the Family Smoking and Prevention Act of This historic legislation gave the FDA unprecedented authority to: Create a tobacco control center within the FDA and gives the FDA authority to regulate the content, marketing and sale of tobacco products. Require tobacco companies and importers to reveal all product ingredients and seek FDA approval for any new tobacco products. Allow the FDA to change tobacco product content. o The ban on flavoring applies to any product meeting the definition of a "cigarette" according to section Family Smoking 3(1) of the Federal Cigarette Labeling and Advertising Act. This includes any tobacco that comes rolled such as cigarettes and cigars and added to this definition in the Family Smoking Prevention and Tobacco Control Act is any tobacco with the purpose to be rolled such as rolling tobacco. Call for new rules to prevent sales except through direct, face-to-face exchanges between a retailer and a consumer. Limit advertising that could attract young smokers. Require cigarette warning labels to cover 50 percent of the front and rear of each pack, with the word warning in capital letters. Ban the use of expressions such as "light, "mild" or "low" that give the impression that a particular tobacco product poses less of a health risk. The Tobacco Products Scientific Advisory Committee (TPSAC) advises the Commissioner or designee in discharging responsibilities as they relate to the regulation of tobacco products. TPSAC reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information and recommendations to the Commissioner of Food and Drugs. One of the first charges TPSAC is to study and collect information on the impact of the use of menthol in cigarettes on the public health, including such use among children, African Americans, Hispanics and other racial and ethnic minorities and to issue a 1

5 recommendation on whether or not the flavorant menthol should be banned in cigarettes. Though all other flavors were banned though the Family Smoking and Prevention Act, the flavor menthol was excluded. After a summer of protest from the public health community, an eleventh hour amendment was added directing the FDA to study and issue a recommendation on what should be done about menthol. As such a TPSAC sub-committee on menthol was established and they have been gathering information from public health officials, tobacco control experts, representatives from the tobacco industry, the media, community-based organizations, and members of the general public. Information is gathered in several ways; through public testimony at their hearings; through public submission of materials; and by the sub-committee requesting information (original and/or clarifying). All of the information gathered is contained in a docket and open to the public. Past meetings of TPSAC can be found on the FDA website and accessed through the following link, 2010 TPSAC Meeting Materials and Information. This webpage contains links to meeting agendas, minutes, transcripts, submissions, and archived webcasts. All meetings have live webcasts. Though this process sounds open and inclusive there is an inherent advantage to organizations that are well funded, well organized, see the big picture, have dedicated time to attend TPSAC meetings, follow the process and have the ability to respond to it in real time. The Technical Assistance Legal Center s (TALC) website has a wealth of information on the FDA process. Their materials are readily available, downloadable, and actually provide more practical information on how to influence the process than the FDA website. Of particular interest is the Timeline of FDA Tobacco Law Menthol Provisions. As the document below indicates the deadline for TPSAC to make its report and recommendation to the FDA on the 2

6 impact of menthol in cigarettes is March 23, After the March deadline the process becomes more fluid. The FDA may issue a draft rule based on committee recommendations, there is no deadline on when or if a draft rule will be issued. After the draft rule is issued there will be another public comment section lasting 60 to 90 days, after which the FDA will consider those public comments that were submitted before issuing (or not) a final rule which will have the effect of law. Those wishing to provide public comment to inform TPSAC s recommendation must do so now. TPSAC meets again on January 10 th and 11 th, they have not yet announced the deadline for input to their March 23 rd report. Those wishing to provide public comment on TPSAC s FDA recommendations must be prepared as once the window of input opens up there will be strict timelines on when it will close. This is important for those wishing to submit resolutions, since each municipality has its own process but it is also important for those wishing to refute or counter TPSAC s recommendations to the FDA. Further information on informing this process is contained in the TALC document Getting Your Voice Heard: Commenting on Federal Regulations. This document contains the following information which includes the four steps of how rules are created and how the public can get involved. Those steps are as follows: Step 1: Notice Issued Step 2: Comment Period Step 3: Agency Consideration Step 4: Final Rule Issued How Can the Public Get Involved? 3

7 During the comment period on a proposed regulation, anyone including local government officials, advocacy groups, and individuals can submit any relevant material to help educate the agency about a regulation s potential impact or convey the public s opinion on the issue. If you know an agency may be taking action, preparing materials in advance (including facts, statistics, and comments) will be useful. Local governments can also pass resolutions in support of (or opposition to) a particular issue. Resolutions are non-binding documents passed by a city council or board of supervisors, expressing a policy goal or intention. For example, communities may consider passing resolutions asking the FDA to ban mentholflavored cigarettes. When the FDA begins the rulemaking process on the subject, the resolutions can be submitted during the public comment period to illustrate the public s desire for further regulation of tobacco. Submitting public comments to an agency is not considered lobbying under federal law. TALC has also provided a model resolution complete with citations that can be tailored to individual municipalities. Here is a link to the TALC model menthol resolution: This model resolution was used as a template for the San Francisco draft resolution submitted with this report. In conferring with TALC they also reported that local governments can ban the sale of menthol products if they so choose, this is something to keep in mind should the FDA decide not to ban menthol. Santa Clara County just passed a tobacco retailer license law that includes a ban on all flavored tobacco products, the FDA has only banned flavored cigarettes, the Santa Clara law goes further to ban other types of flavored tobacco, but they exempted menthol just like the FDA did. TPSAC may also provide recommendations to the Secretary regarding any regulations to be promulgated under the act and may review any applications for new tobacco products or petitions for exemption under Section 906(e) of the Family Smoking Prevention and Tobacco Control Act. Lastly, they may consider and provide recommendations on any other matter as provided in the Family Smoking Prevention and Tobacco Control Act. The Bay Area s Response The counties of San Francisco, Contra Costa, San Mateo, Alameda and the city of Berkeley are all working to adopt resolutions encouraging the FDA to ban menthol in cigarettes. Thus far the counties of Contra Costa and Alameda have been successful and these counties are now working on different city councils within their counties to adopt resolutions as well. San Francisco, Berkeley and Oakland are at varying stages in the process, with the city of Oakland s resolution having been introduced to their city council at the end of last year. San Francisco and Berkeley are still gathering information and laying the groundwork for their respective resolutions. As mentioned, the Contra Costa County Board of Supervisors unanimously passed its menthol resolution on October 26, 2010, a link is provided to the archived video of that meeting to give an idea of the questions and responses of their supervisors. The supervisors discussed the importance of this resolution and talked about taking this matter up with other cities/counties and also using the resolution as a tool to strengthen tobacco control efforts in the schools. The supervisors were supportive of the resolution and seemed to be particularly concerned about youth uptake and the tobacco industry s historical targeting of minority groups with menthol products. Coordination and the sharing of information is a standard agenda item at the Bay Area Tobacco Staffers (BATS) meetings. All of these jurisdictions have expressed interest in having joint 4

8 activities/media around these resolutions and using them to build support in other areas of tobacco control. The Tobacco Industry s Response The tobacco industry has mounted a concerted push back on the FDA process. Two full days of testimony were reserved for them at the TPSAC meeting held February 16 th and 17 th. The industry s major argument is that there is no conclusive scientific evidence that mentholated cigarettes are any more harmful than non-mentholated. They are attempting to define harm in its most narrow scientific definition and stop the TPSAC from using broader definitions of harm that in their opinion don t stand up to scientific rigueur. Their scientist, executives and representatives who provided testimony are intent on slowing and confounding the process. Of particular note was an African American V.P. from Lorillard, he assertively denied that the makers of Newport cigarettes had used predatory tactics in marketing their brand to African Americans. He declared that the vast majority of African Americans who smoke Newport cigarettes did so simply because of a taste preference. Additionally, tobacco industry researchers refuted data regarding the high smoking prevalence of youth smoking menthol cigarettes as inaccurate, saying that the way the menthol survey question is worded is biased and leads to an over reporting of youth menthol smokers. They contend that when the menthol question is re-phrased youth report a lower consumption of menthol cigarettes. The industry also testified about the process of creating cigarette formulas, denying that the industry deliberately designs cigarettes to be more addictive instead they say their researchers focus on the flavor and taste preferences of their customers. Thus creating the tobacco blend and contents of their products similar to the way a chef creates a recipe. Lorillard who has the most to lose if menthol is banned has introduced a non-mentholated Newport cigarette. They have also recruited African American front groups to write letters to the FDA opposing the ban on menthol. A joint press release from the Legacy Foundation, the NAACP Legal and Educational Defense Fund, the National African American Tobacco Prevention Network, and the African American Tobacco Control Leadership Council denouncing the tobacco industry and these front groups has led to more media and public attention on the menthol issue. An October 2010 article in the Los Angeles Times, Much heated puffing among minority groups over menthol cigarette ban was one of many news articles that covered this story. Even more recently the Wall Street Journal published an article describing how Lorillard is fighting against the menthol ban. The article Lorillard Fights to Snuff Menthol Ban describes how Lorillard has purchased internet domains names that could be used to promote the proposed menthol ban. Lorillard has also created a website about menthol, This website purports to provide scientific information about menthol and cigarettes. 5

9 Menthol has been used without controversy as a characterizing flavor in cigarettes - a flavor that can be tasted and identified by the smoker - for more than eighty years in countries around the world. It is also one of the most widely studied ingredients in cigarettes. What have these studies found? The science is clear and compelling. The best available scientific evidence demonstrates that menthol cigarettes have the same health effects as non menthol cigarettes. Menthol neither causes people to smoke, nor deters them from quitting. A menthol cigarette is just another cigarette and should be treated no differently. Menthol cigarettes simply give adult smokers a taste choice. The evaluation of menthol provides an important opportunity for the FDA to follow sound science exclusively, and not pay heed to political or anti-tobacco influences. Regulators have a responsibility to understand the facts about menthol as they consider this important decision. The Public Health Arena Response The public health arena has responded by publishing supplemental journal articles on menthol, establishing websites to counter the tobacco industry, and making their public comment submissions to the FDA available to the general public. Menthol Cigarettes: Moving Toward a Broader Definition of Harm Volume 12 suppl 2 December

10 The Centers for Disease Control and Prevention s Office on Smoking and Health and Legacy are pleased to announce the publication of a special supplemental issue of Nicotine and Tobacco Research entitled Menthol Cigarettes: Moving Toward a Broader Definition of Harm. This supplement was published on December 21, 2010, and contains some of the proceedings from the Second Conference on Menthol Cigarettes that took place in Washington, D.C., on October 19 20, Overall findings from this supplement present a broader public health definition for the harmful effects of menthol cigarettes. These findings show that Menthol cigarettes are preferred by youth, women, and certain racial/ethnic minority groups. Menthol in cigarettes may increase smoking initiation, increase the addiction potential of tobacco, and make it harder to quit in certain subgroups. Menthol cigarettes may be perceived by some groups as being less harmful and providing health benefits due to the historical tobacco industry marketing practices of this product. The guest editors of this supplement are Drs. Bridgette E. Garrett, Phillip Gardiner, Pamela I. Clark, and Jennifer Unger. Below is the website that Legacy established to counter the Lorillard menthol website. 7

11 Recommendations As San Francisco moves forward with the resolution process it is recommended that they work closely with neighboring jurisdictions to educate the public and build support for the FDA s much debated ban on menthol. Local jurisdictions need to be empowered to understand that they can impact the final FDA decision. The egregious menthol targeting of African Americans as evidenced by the December 2010 Boston ruling against Lorillard in the Marie Evans estate lawsuit is a topical current event that can be used to garner support for a multitude of tobacco control endeavors. 8