By Thomas J. Glynn, PhD
The discussion around whether the U.S. Food and Drug Administration (FDA) should keep or ban menthol-flavored cigarettes has produced a number of news headlines in recent weeks, because in July the agency released a report reviewing current science around these cigarettes. This science will inform many of the decisions the agency may make about menthol cigarettes, and the millions of current and potential smokers who will be affected by those decisions. But the menthol story goes back much further than just the past few weeks.
Menthol and cigarettes: a brief history
Menthol is an organic compound which can be made in a laboratory or derived from mint oils, and has a distinctive and, for most people, pleasant odor and taste. It is used to enhance the flavor, popularity, and ease-of-use of many food products, candies, and medications.
As a medication, it can be used as a mild local anesthetic, counter-irritant, and, more specifically, for the relief of minor throat irritation. That is why menthol was first introduced in cigarettes in the 1920's and gained broader popularity with the introduction of a filtered menthol brand, Salem, in the mid-1950's.
Over the years, largely because they mask the harsh taste and/or throat-irritating properties of inhaled tobacco smoke, mentholated cigarettes have gained a wide audience, such that about 30% of all 44 million smokers in the U.S. now identify menthols as their preferred cigarette. This is especially true among African American smokers, about 80% of whom are menthol users.
FDA and flavored cigarettes
As one of its first actions after being given the authority to regulate tobacco through the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, the FDA announced that it would ban all flavorings in cigarettes (e.g. strawberry, cinnamon, chocolate, clove) as required by the new law. The flavorings are widely viewed as being especially attractive to children and youth, and banning them is one way to help keep kids from taking up the habit. This ban went into effect in September 2009.
The one exception to the flavorings ban under the law, however, was menthol. Menthol was exempted from the ban for a variety of reasons, including the size of the market, political calculations by members of Congress, and insufficient and sometimes conflicting scientific data. But the law required the FDA to task its newly created outside advisory group - the Tobacco Products Scientific Advisory Committee (TPSAC) - with the preparation of a report reviewing all of the scientific literature on menthol cigarettes. The TPSAC report was delivered in March 2011, and its concluding recommendation was that "...removal of menthol cigarettes from the marketplace would benefit public health in the U.S."
The FDA noted, however, that the TPSAC recommendation was just that, a recommendation, and then proceeded to conduct its own scientific review of the menthol issue. That is the report released in July, with the assumption that it will soon lead to definitive FDA action on menthol cigarettes.
FDA report findings
The 2013 FDA report on menthol reinforced the findings of the 2011 TPSAC report, and it was able to update the data by including a range of scientific studies that had been conducted in the period between the two reports. The major findings of the July report are:
- There is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than non-menthol cigarettes;
- Adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults;
- The data indicate that menthol in cigarettes is likely associated with greater addiction; and
- Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking
Although the report concluded, as have previous reports and studies, that it is not menthol itself that increases the risk of heart disease and cancer, among other diseases, the remaining conclusions - that youth and young adults are more likely to start smoking due to menthol, that menthol smokers are more addicted, and that they are less likely to successfully quit smoking - are serious indictments of menthol cigarettes and support the TPSAC conclusion that the public health of the U.S. would benefit by removing menthol cigarettes from the marketplace.
Once its report came out, the FDA opened up a 60-day period for public comment. [Ed. note: the public has until September 23, 2013, to comment.] The FDA will then consider all comments, data, research, and other information submitted about menthol in cigarettes and determine what, if any, regulatory action is appropriate. If the FDA decides to issue new requirements, or rules, about menthol cigarettes, the first step in that process would be a Notice of Proposed Rulemaking, which would give the public another opportunity to weigh in on the specifics of the proposed rule, followed by FDA action based upon all of this input. This process is expected to continue well into 2014.
The FDA will have a range of actions available to it when completing this process. There could be, for example, a total ban on menthol additives in cigarettes after say, one year from the issuance of a new rule; there could be an order for a reduction in the amounts of menthol allowed in cigarettes; there could be a new rule about product standards for menthol cigarettes, regarding, for example, their chemical makeup or how they are actually constructed or engineered; or the FDA could decide to take no action, saying it needs more scientific studies.
And, despite the clear data that menthol cigarettes are a danger to public health, there are also other considerations the FDA will need to take into account before taking any action. Given the large number of menthol users in the U.S. - 12-15 million smokers - an illicit market for menthol cigarettes could develop if a complete menthol ban is proposed. African American menthol users could feel that a ban on menthol would be discriminatory, given that community's overwhelming preference for menthol cigarettes. The tobacco industry, and particularly those companies which are heavily dependent upon menthol product sales, could (and likely will) go to court immediately to fight any rule banning or changing menthol levels. The tobacco industry could also develop menthol substitutes, which would undermine any rule banning or adjusting menthol levels.
The FDA, therefore, is being properly cautious and thorough in considering the science behind menthol cigarettes and the other considerations noted above. Nevertheless, the process is now in place for decisions to be made in 2014.
The American Cancer Society and American Cancer Society Cancer Action Network position on menthol
The American Cancer Society and the American Cancer Society Cancer Action Network have carefully examined the detailed scientific reports of both the FDA and its Tobacco Products Scientific Advisory Committee. As a result, they have concluded that the science is clear and that menthol cigarettes pose a threat to public health. Therefore, they urge the FDA, after taking into consideration the scientific evidence and input from the current public comment period, to take swift action to ban menthol cigarettes from the marketplace. The result will be a healthier America.
Dr. Glynn is director of cancer science and trends for the American Cancer Society.