December 11, 2013 (Washington, DC)–Recently, IPCPR President Finnie Helmuth, 1st Vice President Craig Cass, and others met with the Office of Management and Budget Office of Information and Regulatory Affairs (OIRA) to discuss the FDA’s proposal to regulate premium cigars under the Tobacco Control Act. While we do not know what the rule contains, we remain vigilant to any provision that has implications on how you conduct business as a premium cigar retailer.
As a follow-up to that meeting, IPCPR’s counsel for FDA affairs, Dave Clissold of Hyman Phelps, prepared the letter below for IPCPR’s Federal Affairs Committee in conjunction with CRA and sent it to the Administrator of OIRA, Howard Shelanski. This letter outlines the argument why premium cigars do not fit the scope of the Tobacco Control Act because they are not habitual and are not desirable, affordable, or accessible to America’s youth.
IPCPR is continuing the fight to keep the FDA out of your humidor. If you have not already, please contact your Member of Congress to urge support of H.R. 792 & S. 772. More information can be found at www.ipcpr.org.
If you have any questions, please contact Senior Director of Federal Legislative Affairs, Kip Talley (email@example.com), for more information.
December 10, 2013
Administrator Howard Shelanski
Office of Information and Regulatory Affairs The Office of Management and Budget
725 17th Street, NW
Washington, DC 20503
￼Dear Administrator Shelanski:
As the Office of Management and Budget (“OMB”) considers the Food and Drug Administration’s (“FDA’s”) proposed rules deeming certain tobacco products to be subject to The Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), we believe it is important to emphasize the guiding principal that regulatory policy must be based on objective science of the highest quality. In particular, FDA’s proposed regulations must comport withThe Information Quality Act and Executive Order 12866. As explained below, when examined under those standards, there is no public health basis to conclude that premium cigars should be regulated by FDA under the Tobacco Control Act.
A. The Information Quality Act
The Information Quality Act (“IQA,” sometimes referred to as the “Data Quality Act”1), and IQA guidelines promulgated by OMB,2 Department of Health and Human Services (“HHS”),3 and FDA4 explain the standards of quality for disseminations of agency information. Among other things, such disseminations must meet the standard of “objectivity.” According to the HHS Guidelines:
￼‘Objectivity’ involves two distinct elements, presentation and substance. ‘Objectivity’ includes whether disseminated information is being presented in an accurate, clear, complete, and unbiased manner. This involves whether the information is presented within a proper context. Sometimes, in disseminating certain types of information to the public, other information must also be disseminated in order to ensure an accurate, clear, complete, and unbiased presentation. Also, the agency needs to identify the sources of the disseminated information (to the extent possible, consistent with confidentiality protections) and, in a scientific, financial, or statistical context, the supporting data and models, so that the public can assess for itself whether there may be some reason to question the objectivity of the sources. Where appropriate, data should have full, accurate, transparent documentation, and error sources affecting data quality should be identified and disclosed to users.
As acknowledged in the FDA Guidelines, the Agency disseminates public health and safety information in many forms, including in the Federal Register as proposed rules.6 FDA claims that it will strive to “ensure that the information we disseminate is presented in an accurate, clear, and unbiased manner,” and assures the public that the Agency “take[s]steps to ensure that our regulatory decisions are based on objective information.”7 As the FDA Guidelines note:
￼The OMB Guidelines, however, apply special quality standards to the dissemination of information that is considered influential. Such information must meet high standards of transparency of the data and methods used to facilitate the reproducibility of such information by third parties.8 ￼
The FDA Guidelines define “influential information” as:
￼Disseminated information that results from or is used in support of agency actions that are expected to have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities.9
￼￼The FDA Guidelines then identify two rulemaking procedures as examples of “influential information.”10 Clearly, any rules proposed by FDA to regulate tobacco products will meet this standard of influential information, and thus the heightened proscriptions of the Information Quality Act and the implementing guidelines will apply: “When we disseminate information, but particularly in those cases involving influential information, we strive to ensure that the information is accurate and unbiased, as well as substantially reproducible and replicable.”11 In particular, the proposed rule must be based on scientific information that is presented in an accurate, clear, complete, unbiased, and transparent manner.
￼B. Executive Order 12866
In additionto the IQA, Executive Order 12866 instructs administrative agencies promulgating regulations, to adhere to certain standards. These standards include:
- Each agency shallidentify the problem that it intends to address (including, where applicable, the failures of private markets or public institutions that warrant new agency action) as well as assess the significance of that problem.
- In setting regulatory priorities, each agency shall consider, to the extent reasonable, the degree and nature of the risks posed by various substances or activities within its jurisdiction.12
Thus, in order to be in compliance with Executive Order 12866, before FDA can issue any proposed regulations affecting premium cigars, it must first determine the public health “risk” of premium cigars, and then place that risk in the context of other tobacco products, notably cigarettes. As explained below, premium cigars do not pose any type of public health risk that would warrant costly or punitive regulation by FDA. The relatively higher retail costs of premium cigars, along with State and local regulation, have proven more than adequate to minimize youth access to premium cigars, and FDA should direct its scarce resources to tobacco products of greater public health concern.
C. The Data Used by FDA in a Proposed Rule to Regulate Tobacco Products Must Meet the Standards of the Information Quality Act and Executive Order 12866
￼The most comprehensive compilation of epidemiology, toxicology, and other studies pertaining to the health effects of cigars is known as “Monograph 9.”13 We believe that if FDA attempts to regulate premium cigars, Monograph 9 (or the studies cited therein) will be the primary basis for such regulation. Therefore, it is important to critically analyze all assertions made about Monograph 9 so that those assertions can be placed in the proper context. As will be explained below, when Monograph 9 is examined completely, accurately, and in an unbiased manner, the studies cited in Monograph 9 do not provide the necessary public health basis to support the regulation of premium cigars.
￼1. What is a Premium Cigar? ￼
A premium cigar does not have a legal or regulatory definition. However, “cigars” or “little cigars” are defined in the Tobacco Control Act,14 Federal Cigarette Labeling and Advertising Act(“Cigarette Labeling Act”),15 and Internal Revenue Code.16 The ￼Tobacco Control Act uses the same definition of a “little cigar” as the Cigarette Labeling Act, which is based on the type of wrapper and weight of the product:
￼The term “little cigar” means any roll of tobacco wrapped in leaf tobacco or any substance containing tobacco (other than any roll of tobacco which is a cigarette within the meaning of subsection (1)) and as to which one thousand units weigh not more than three pounds.17
￼Several bills have been proposed that attempt to define “premium cigar.” Generally, the bills define a “premium cigar” as: A roll of tobacco weighing at least 6 pounds per 1,000 count that is wrapped wholly in 100% leaf tobacco and bunched with 100% tobacco filler; does not contain a filter, tip or non-tobacco mouthpiece; is made by hand and has a tobacco binder, or is made using human hands to lay the wrapper onto only one machine; and is not a “cigarette” or “little cigar” as these products are defined in the Tobacco Control Act.18
￼2. The Studies Discussed in Monograph 9 do Not Support the Regulation of Premium Cigars
￼The first limitation of the studies discussed in Monograph 9 is that they do not differentiate between the many different types of cigars on the market: “Few surveys have questioned cigar smokers about the quantity and type of cigars typically consumed.”19 Instead all cigar products are most often, and inappropriately, lumped together as “cigars.” As a public health matter, this aggregation is inappropriate since it fails to account for the different demographics of premium cigar users, or the differences in inhalation patterns between the various types of “cigars.” FDA must recognize that the risk to the public health depends on the type of cigar at issue, and that broad policy decisions based on generalizations regarding the alleged public health risks of “cigars” is not a complete or unbiased representation of the available science. For example, it would be misleading for FDA to speak of prevalence and rate changes in “cigar” consumption ￼￼within any age group, especially among adolescents, without also considering the type of cigar at issue. As another example, generalizations regarding a potential for the development of “dependence” in cigar smokers, without critical analysis of the basis for such statements, would also raise concerns under both the IQA and Executive Order 12866. In short, FDA should not arbitrarily regulate all types of cigars together, but should instead define the types of cigars it deems worth regulating.
￼3. Executive Order 12866: What Premium Cigar “Issue” is FDA Trying to Address?
The Tobacco Control Act provides that its purpose is to grant FDA “the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco” while at the same time “to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure they are not sold or accessible to underage purchasers.”20 Assuming that these are the “issues” that FDA is attempting to address, an unbiased examination of all of the data shows that premium cigars are not used to a significant extent by young people, and that dependence on premium cigars is not a significant public health issue.
￼￼￼￼￼￼a. Premium Cigars are Not Used by Young People
￼In 1996, the first time that FDA attempted to assert regulatory authority over cigarettes and smokeless tobacco, cigars were expressly exempted. FDA rejected regulating cigars ￼stating: “There is insufficient evidence of cigar or pipe tobacco use by children and adolescents to support the inclusion of cigar[s] . . . within the scope of the final rule.”21 Since that time, there has been no evidence showing that children or adolescents use premium cigars in significant quantities.22 In fact, the most recent data from HHS shows that “cigar” use (all types of cigars) in youths aged 12 to 17 fell significantly between 2009 and 2010, which are the most recent HHS data available.23 Primarily because of the relatively higher cost of premium cigars, premium cigar use by youths aged 12 to 17 likely represents a very small fraction of the total “cigar” use in this population. As recently as July 2012, the House Appropriations Committee reminded FDA that “premium cigars have unique characteristics and cost-prohibitive price points and are not marketed to kids” and that “[a]ny effort to regulate cigars should take these items into consideration.”24 In sum, when all of the data is analyzed accurately and in an unbiased manner as required under the IQA and Executive Order 12866, there is no evidence to suggest that the use of premium cigar by children and adolescents is a public ￼health issue. Because this lack of evidence was exactly the same rationale used by the FDA in 1996 to exempt cigars from regulation, the same rationale should be applied again today to exempt premium cigars from FDA regulation.
b. Premium Cigars do Not Cause Dependence
￼Physical dependence is not an issue for premium cigar smokers because consumers do not absorb nicotine by smoking premium cigars. While cigars contain nicotine, nicotine absorption is effectively absent, primarily because the smoke is not inhaled or absorbed into the buccal cavity. Two recent studies that measured the metabolite of nicotine (cotinine) confirm that nicotine absorption (by either the inhalation or oral route) is effectively absent in cigar smokers.25 If consumers do not absorb nicotine from cigars, dependence cannot result. Monograph 9 does not contain any studies showing a direct effect of cigars on dependence, because “studies to document the frequency or intensity of nicotine dependence in cigar smokers have not been conducted.”26 But Monograph 9 ￼notes that the majority of “cigar” smokers are “occasional” users (e.g., less than one per week, or only on some days, depending on the survey instrument used), or smoke only one cigar per day.27 Even Monograph 9 concedes that “[T]here would be little basis to expect that substantial levels of physical dependence would be observed in people who rarely smoked on two or more consecutive days.”28 A complete and unbiased examination of all of the data regarding the alleged development of “dependence” in smokers of premium cigars must consider and address all of these facts to the contrary. That is the standard required under the IQA and Executive Order 12866. When examined in that light, there is no evidence to suggest that premium cigar smokers are “dependent.”
￼c. Premium Cigars do Not Pose a Public Health Risk
The majority of premium cigar smokers smoke less than 1 cigar per day.29 In a 2007 ￼￼survey conducted by Cigar Aficionado magazine, 36.37% of respondents reported smoking 1 cigar or less per week over the previous year, 33.12% reported smoking 2-3 cigars per week, and 14.22% of respondents reported smoking 4-5 cigars per week.30 Monograph 9 confirms this low level of cigar consumption in the majority of cigar smokers, and highlights the relationship between frequency of exposure and public health risk, stating: ￼
Most cigarette smokers smoke every day. In contrast, as many as three- quarters of cigar smokers smoke only occasionally, and some may only smoke a few cigars per year. This difference in frequency of exposure translates into lower disease risks.31 ￼￼￼
Despite the acknowledgement that 75% of cigar users are “occasional” users, another limitation of the mortality and morbidity studies cited in Monograph 9 is that the lowest level of exposure for which data are presented is 1-2 cigars per day. However, even if it is assumed that the health risks to cigar smokers who smoke 1 to 2 cigars per day is the same as that of cigar smokers of 1 to 2 per week (i.e., the average premium cigar smoker), no increased risk of disease or mortality can be measured in these individuals. Monograph 9 shows that cigar smokers who smoke 1 to 2 cigars per day have a mortality rate of 1.02, which is indistinguishable from non-smokers.32 Furthermore, these cigar smokers are at no greater risk of disease compared to non-smokers, including risks of ￼￼￼￼lung cancer,33 buccal and pharyngeal cancer,34 cancer of the larynx,35 cancer of the esophagus,36 pancreatic cancer,37 coronary heart disease,38 COPD,39 or cerebrovascular disease.40 While the morbidity and mortality tables in Monograph 9 show some increase in risk as a result of higher levels of consumption, these rates are not representative of premium cigar smokers since premium cigar smokers do not consume cigars at that higher frequency of use. Thus, should FDA’s proposed regulations discuss health risks associated with cigars generally, that would not be an accurate, unbiased, or complete analysis of the information that is required under both the IQA and Executive Order 12866 because FDA must take these different exposure levels into account.
￼￼4. Executive Order 12866: What is the Degree and Nature of the Risks Posed by Various Tobacco Products Within FDA’s Jurisdiction?
In 2012, taxable removals of cigarettes were 279.8 billion.41 Total large cigars were 9.4 billion,42 however premium cigars are a small fraction of the total number of large cigars. ￼￼A recent report estimated that the number of premium cigars (“hand-made/hand-finished large cigars”) in the United States ranged from 259-305 million units annually in 2005- 2012.43 Thus, premium cigars represent a miniscule fraction of the tobacco products available, especially when compared to cigarettes (300 million premium cigars / 279.8 billion cigarettes = 0.1%). When the totality of the data for premium cigars is examined in the context of all tobacco products, as required under the IQA and Executive Order 12866, the unbiased conclusion must be that if premium cigars pose any degree of risk at all, it is far less than the risk of cigarette smoking. In contrast to cigarette smokers, premium cigar smokers are at no increased risks of morbidity or mortality. Even using the most conservative standard of 1 to 2 cigars per day, Monograph 9 shows that there is no increased risk of morbidity or mortality in these individuals, compared to significantly ￼elevated risks for cigarette smokers.44 The suggested risks are likely even lower for the vast majority of premium cigar smokers who smoke but 1 to 2 cigars per week. In addition, compared to other tobacco products, neither youth access nor dependence are “risks” that would warrant FDA regulation of premium cigars. Therefore, FDA should focus their scarce resources on the tobacco products posing significant public health risks and not premium cigars, which are enjoyed as a celebratory product by adult consumers.
If FDA proposes to regulate premium cigars, we will be closely examining the proposal to ensure that the data and science that FDA alleges would support such regulation complies with the IQA and Executive Order 12866. When examined under those standards, there is no basis to conclude that premium cigars should be regulated under the Tobacco Control Act. ￼
Finnie P. Helmuth
Cc: Director Mitch Zeller, FDA Center for Tobacco Products Andrew Perraut, Office of Management and Budget ￼
- 44 U.S.C. §§ 3504(d)(1), 3516.
- 67 Fed. Reg. 8,452 (Feb. 22, 2002).
- HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Dessiminated to the Public (“HHS Guidelines”), available at http://aspe.hhs.gov/infoquality/guidelines/index.shtml.
- FDA, Guidelines for Ensuring the Quality of Information Disseminated to the Public (“FDA Guidelines”), available at http://aspe.hhs.gov/infoquality/guidelines/fda.shtml.
- HHS Guidelines, § D(2)(c).
- FDA Guidelines, § IV. As noted in the FDA Guidelines, these standards of quality and objectivity apply to disseminations of information that are included in both proposed rules (“Substances Affirmed as Generally Recognized as Safe: Menhaden Oil; a proposed rule that published on February 26, 2002”) and final rules (“Hazard Analysis and Critical Control Point (HACCP): Procedures for the Safe and Sanitary Processing and Importing of Juice; a final rule that published on January 19, 2001”). Id. § III(B).
- Id. § V(B).
- Id. § VII.
- Id. § VII.A.
- 11 12 Id. FDA cited both the Quality Mammography Standards regulations (62 Fed. Reg. 55,852 (Oct 28, 1997)) and the Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice regulations (66 Fed. Reg. 6,138 (Jan. 19, 2001)) as examples of regulations containing “influential information” subject to “higher standards of transparency.”
- Id. § VII(B).
- 58 Fed. Reg. 51,735 (Oct. 4, 1993) (emphasis added).
- Smoking and Tobacco Control Monograph 9: Cigars: Health Effects and Trends, National Cancer Institute, Bethesda, MD (1998), available at http://www.cancercontrol.cancer.gov/tcrb/monographs/9/index.html.
- 21 U.S.C. § 900(11).
- 15 U.S.C. § 1332.
- “Cigar” means “any roll of tobacco wrapped in leaf tobacco or in any substance containing tobacco (other than any roll of tobacco which is a cigarette).” 26 U.S.C. § 5702. For purposes of taxation, “cigars” are classified as “small cigars,” defined as cigars “weighing not more than 3 pounds per thousand,” and large cigars, “weighing more than 3 pounds per thousand.” 26 U.S.C. § 5701.
- 15 U.S.C. § 1332.
- 18 H.R. 792, 113th Cong. (2013) (introduced); S. 772, 113th Cong. (2013) (introduced). For example, H.R. 792 defines a “traditional large and premium cigar” as:
any roll of tobacco that is wrapped in 100 percent leaf tobacco, bunched with 100 percent tobacco filler, contains no filter, tip or non-tobacco mouthpiece, weighs at least 6 pounds per 1,000 count, and─ (I) has a 100 percent leaf tobacco binder and is hand rolled; (II) has a 100 percent leaftobacco binder and is made using human hands to lay the leaf tobacco wrapper or binder onto only one machine that bunches, wraps, and caps each individual cigar; or (III) has a homogenized tobacco leaf binder and is made in the United States using human hands to lay the 100 percent leaf tobacco wrapper onto only one machine that bunches, wraps, and caps each individual cigar; and (ii) does not include a cigarette (as such term is defined by section 900(3)) or a little cigar (as such term is defined by section 900(11)).
- Monograph 9 at 27 (emphasis added).
- Tobacco Control Act, §§ 3(2), 3(7) (emphasis added).
- Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44369, 44421-22 (Aug. 28, 1996).
- In 1999, the Department of Health and Human Services issued a report stating: “Manufactured cigars, rather than premium cigars, are most commonly used by teens due to their ease of purchase, low cost . . . ” DHHS, Youth Use of Cigars: Patterns of Use and Perceptions of Risk, Office of Inspector General, Washington, D.C., OEI-06-98-00030 (1999).
- SAMSHA, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, Figure 4.2, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658, 2011, Substance Abuse and Mental Health Services Administration, Rockville, MD.
- H.R. Rep. No. 112-542, at 46 (2012).
- Rodriguez, J., et al., The association of pipe and cigar use with cotinine levels, lung function, and airflow obstruction: a cross-sectional study, Annals of Internal Medicine 152(4):201-10 (2010); Funck-Brentano, C., et al., Effects of type of smoking (pipe, cigars or cigarettes) on biological indices of tobacco exposure and toxicity, Lung Cancer 54(1):11-18 (2006).
- Monograph 9 at 191.
- Id. at iii.
- Id. at 190.
- 2007 Survey by Cigar Aficionado, data on file.
- Monograph 9 at iii (emphasis added).
- Id. at Chapter 4, Table 3.
- Id. at Chapter 4, Table 7.
- Id. at Chapter 4, Table 11.
- Id. at Chapter 4, Table 18.
- Id. at Chapter 4, Table 21.
- Id. at Chapter 4, Table 27.
- Id. at Chapter 4, Table 31.
- Id. at Chapter 4, Table 35.
- Id. at Chapter 4, Table 39.
- Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau, Statistical Report-Tobacco, December, 2012 Report Symbol: TTB 5210-12-2012 (Feb. 12, 2013).
- Cigar Association of America, Inc., CAA Import Report February 2013 (Apr. 11, 2013).
- See, e.g., Monograph 9 at Chapter 4, Table 3.