TOBACCO 

PRODUCT 

REGULATION

Most FDA Spending 

Funded Public 

Education, Regulatory 

Science, and 

Compliance and 

Enforcement Activities

Report to Congressional Committees

June 2014

GAO-14-561

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-14-561, a report to 

congressional committees

June 2014

TOBACCO PRODUCT REGULATION

Most FDA Spending Funded Public Education, 

Regulatory Science, and Compliance and 

Enforcement Activities

Why GAO Did This Study

Tobacco use is the leading cause of 

preventable death and disease in the 

United States. In 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Tobacco Control Act) 

granted FDA, an agency within the 

Department of Health and Human 

Services (HHS), authority to regulate 

tobacco products, including marketing 

and distribution to youth. The act 

established CTP, which implements 

the act by educating the public on the 

dangers of tobacco use; developing 

the science needed for tobacco 

regulation; and developing and 

enforcing regulations on the 

manufacture, marketing, and 

distribution of tobacco products. The 

act authorized FDA to assess and 

collect user fees from tobacco 

manufacturers and importers.

The Tobacco Control Act mandated 

that GAO review the authority and 

resources provided to FDA for 

regulating the manufacture, marketing, 

and distribution of tobacco products. 

This report examines (1) how FDA 

spent tobacco user fees for key 

activities using its authorities granted in 

the act, and (2) any challenges FDA 

encountered in using its authorities. 

GAO analyzed data on tobacco user 

fees collected and spent on key 

activities by FDA as of March 31, 2014; 

reviewed documents related to FDA’s 

key activities, as well as relevant laws, 

regulations, and guidance; and 

interviewed CTP, public health, and 

tobacco industry officials.

HHS reviewed a draft of this report and 

agreed with GAO’s reiteration of its 

previous recommendation that 

performance measures for all tobacco 

product reviews are needed.

What GAO Found

As of March 31, 2014, the Food and Drug Administration (FDA) spent about 

$1.48 billion (79 percent) of the $1.88 billion in total tobacco user fees it collected 

since fiscal year 2009. FDA spent the majority of tobacco user fees on key 

activities led by the agency’s Center for Tobacco Products (CTP), which is 

funded solely by tobacco user fees. These included activities related to public 

education (including public education campaigns and communicating CTP 

activities); regulatory science (including research, product review, and developing 

the science to support regulations and guidance); and compliance and 

enforcement (including tobacco retailer inspections; manufacturer and import 

inspections and enforcement; promotion, advertising, and labeling surveillance; 

and outreach and small business assistance).

Proportion of FDA Tobacco User Fee Spending by Activity as of March 31, 2014

While FDA has taken steps to address some of the challenges it has faced, 

including challenges related to starting up a new center, it continues to face 

challenges, including setting and monitoring review time frames. Until recently, 

CTP has not had performance measures for making final decisions on new 

tobacco product submissions by which to assess its progress, as GAO previously 

recommended. FDA has announced performance measures for two of its new 

tobacco product review processes (to take effect in October 2014), but not for the 

type of new tobacco product submission that comprises the bulk of FDA’s review 

backlog. The agency has indicated that it intends to establish such performance 

measures, but until it does so, the agency’s ability to assess its efforts will be 

limited. This will be particularly pressing as FDA moves forward with plans to 

deem additional types of tobacco products to be subject to its regulatory 

authority.

View GAO-14-561. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov.
Page i GAO-14-561 FDA Tobacco Product Regulation

Letter 1 

Background 4

FDA Spent Nearly 80 Percent of User Fees Collected, Mostly for 

Public Education, Regulatory Science, and Compliance and 

Enforcement 10

FDA Encountered Challenges As It Established CTP, Including 

Setting Review Time Frames 35

Concluding Observations 42

Agency Comments 42

Appendix I Summary of Center for Tobacco Products Offices and Key Activities 44

Appendix II Examples of Tobacco-Related Research Projects Supported by 

Food and Drug Administration Spending 47

Appendix III Positions at the Center for Tobacco Products (CTP) at the End 

of Each Fiscal Year as of March 31, 2014 49

Appendix IV Comments from the Department of Health and Human Services 50

Appendix V GAO Contact and Staff Acknowledgments 53

Tables

Table 1: FDA Center for Tobacco Products (CTP) Offices 5

Table 2: Total Tobacco User Fee Amounts Authorized by the 

Tobacco Control Act, Fiscal Years 2009 through 2019 9

Table 3: FDA Spending on Tobacco-Related Research Projects 

as of March 31, 2014 20

Table 4: Status of FDA Review of Submissions Made Under 

Pathways to Market New Tobacco Products and 

Submissions for Modified Risk Tobacco Products (MRTP) 

as of March 31, 2014 24

Contents
Page ii GAO-14-561 FDA Tobacco Product Regulation

Table 5: State and Territorial Retail Inspection Contracts Awarded, 

Inspections Conducted, and Advisory and Enforcement 

Actions Taken by FDA as of March 31, 2014 31

Table 6: Summary of Center for Tobacco Products (CTP) Offices, 

Spending, and Key Activities as of March 31, 2014 44

Table 7: Examples of Tobacco-Related Research Projects 

Supported by FDA Spending and the Entity Conducting or 

Overseeing the Project as of March 31, 2014 47

Figures

Figure 1: Total Tobacco User Fees Spent and Not Spent by FDA 

as of March 31, 2014 11

Figure 2: FDA Spending by Center for Tobacco Products (CTP) 

Office as of March 31, 2014 12

Figure 3: Proportion of FDA Tobacco User Fee Spending by 

Activity as of March 31, 2014 14

Figure 4: Proportion of FDA Tobacco User Fee Spending on 

Public Education Activities as of March 31, 2014 15

Figure 5: Proportion of FDA Tobacco User Fee Spending on 

Regulatory Science Activities as of March 31, 2014 19

Figure 6: Proportion of FDA Tobacco User Fee Spending on 

Compliance and Enforcement Activities as of March 31, 

2014 29

Figure 7: Center for Tobacco Products (CTP) Office of Science 

(OS) Positions as of March 31, 2014 37
Page iii GAO-14-561 FDA Tobacco Product Regulation

Abbreviations

CDC Centers for Disease Control and Prevention

CTP Center for Tobacco Products

FDA Food and Drug Administration

HHS Department of Health and Human Services

HPHC harmful and potentially harmful constituent

MRTP modified risk tobacco product

NIH National Institutes of Health

OCE Office of Compliance and Enforcement 

OHCE Office of Health Communication and Education

ORA Office of Regulatory Affairs

OS Office of Science

PMTA Premarket Tobacco Product Application

SE Substantial Equivalence

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Page 1 GAO-14-561 FDA Tobacco Product Regulation

441 G St. N.W.

Washington, DC 20548

June 20, 2014

The Honorable Tom Harkin

Chairman

The Honorable Lamar Alexander

Ranking Member

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Fred Upton

Chairman

The Honorable Henry Waxman

Ranking Member

Committee on Energy and Commerce

House of Representatives

Tobacco use is the leading cause of preventable death, disease, and 

disability and is a significant contributor to health care costs in the United 

States. Smoking was responsible for more than 480,000 premature 

deaths annually between 2005 and 2009 among Americans 35 and older, 

according to the U.S. Surgeon General.1 The Surgeon General also 

reported that among adults who had ever smoked cigarettes daily, 

87 percent had tried their first cigarette by the time they were 18 years of 

age. In 2009, the Family Smoking Prevention and Tobacco Control Act 

(Tobacco Control Act) granted the Food and Drug Administration (FDA), 

an agency within the Department of Health and Human Services (HHS), 

authority to address concerns about tobacco use by young people and to 

regulate the manufacturing, marketing, and distribution of tobacco 

products using a public health standard.2

 

1

Department of Health and Human Services, The Health Consequences of Smoking— 

50 Years of Progress: A Report of the Surgeon General (Atlanta, Ga.: Jan. 17, 2014).

The act provides FDA with a 

range of authorities, such as restricting tobacco sales to minors and 

2

Pub. L. No. 111-31, div. A, 123 Stat. 1776 (2009). Tobacco products that FDA currently 

regulates include cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 

tobacco products. The Tobacco Control Act enables FDA to assert jurisdiction over other 

tobacco products through rulemaking. Under the public health standard, FDA regulates 

tobacco products for the protection of the public health, taking into account the risks and 

benefits of tobacco products on the population as a whole, including users and non-users.
 

Page 2 GAO-14-561 FDA Tobacco Product Regulation

setting tobacco product standards. The Tobacco Control Act represents 

the first time that FDA has had the authority to regulate tobacco products.

The Tobacco Control Act established the Center for Tobacco Products 

(CTP) within FDA as the entity responsible for implementing the act.3

CTP was formed in 2009—the first new center within FDA in 21 years— 

and it implements the act by educating the public on the dangers of 

tobacco use; developing the science needed for tobacco regulation; 

developing and enforcing regulations on the manufacture, marketing, and 

distribution of tobacco products; and performing other activities. To 

support FDA’s tobacco regulation activities, the Tobacco Control Act 

authorized FDA to assess and collect user fees—the sole source of 

funding for CTP’s activities— from each tobacco manufacturer and 

importer subject to FDA’s regulation.4

The Tobacco Control Act mandated that GAO review FDA’s authority and 

resources to regulate the manufacture, marketing, and distribution of 

tobacco products.

5

To examine how FDA spent tobacco user fees for its key activities using 

its authorities granted in the Tobacco Control Act, we analyzed data on 

tobacco user fees collected through March 31, 2014, such as the 

amounts collected by FDA and the amounts spent by CTP’s offices. We 

also interviewed agency officials and reviewed agency documents, 

including budget justifications, reports to Congress, performance reports, 

and agency documentation of CTP’s activities to identify the key activities 

the agency carried out. We analyzed spending data provided by FDA for 

these activities for fiscal years 2010 through the first half of fiscal year 

This report examines (1) how FDA spent tobacco user 

fees for key activities using its authorities granted in the Tobacco Control 

Act and (2) any challenges FDA encountered in using its authorities 

granted in the Tobacco Control Act.

 

3

§ 101(b), 123 Stat. at 1787 (codified at 21 U.S.C. § 387a(e)).

4

§ 101(b), 123 Stat. at 1826 (codified at 21 U.S.C. § 387s).

5

§ 106 (b), 123 Stat. at 1842 (codified at 21 U.S.C. § 387u(b)). 
 

Page 3 GAO-14-561 FDA Tobacco Product Regulation

2014 (March 31, 2014) and planned spending for fiscal year 2014.6

To examine any challenges FDA encountered in using its authorities 

granted in the Tobacco Control Act, including whether FDA faced 

limitations in its authority to regulate tobacco products, we reviewed 

relevant laws, tobacco-related regulations and guidance, and the key 

activities undertaken by FDA to carry out the Tobacco Control Act. We 

reviewed documents and interviewed agency officials, public health 

stakeholders, an association representing state and territorial health 

officials, and tobacco industry stakeholders—including representatives of 

tobacco manufacturers and tobacco retailers—to obtain information on 

any challenges FDA encountered, including any challenges associated 

with limitations in its authorities or resources.

Spending for key activities included actual spending and an estimated 

distribution, generated by FDA, of personnel costs across activities within 

each individual CTP office. For our analysis, we included spending for the 

tobacco-related work of FDA’s Office of Regulatory Affairs (ORA) with 

CTP’s compliance and enforcement activities, since ORA assists CTP by 

conducting select activities. Other tobacco-related spending by CTP and 

FDA, including spending on information technology infrastructure and 

centralized funding for, among other things, furniture, office equipment, 

and center-wide training; spending for rent and rent-related activities; and 

the tobacco-related spending of FDA headquarters, including the Office of 

the Commissioner was not included in our analysis of spending by key 

activity. We assessed the reliability of FDA data we received by reviewing 

related documentation, performing data reliability checks (such as 

examining the data for missing values and checking values against other 

documentation), and interviewing CTP officials. After taking these steps, 

we determined that the data we used were sufficiently reliable for our 

purposes.

We conducted this performance audit from September 2013 to June 2014 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

 

6

For the purposes of this report, spending means obligations, including those for which 

expenditures have been made. The term obligation refers to a definite commitment by a 

federal agency that creates a legal liability to make payments immediately or in the future. 

According to FDA, CTP spent $4.9 million in the fourth quarter of fiscal year 2009 for 

startup activities. The center, which was established in August 2009, did not report fiscal 

year 2009 spending by office or activity.
 

Page 4 GAO-14-561 FDA Tobacco Product Regulation

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.

The Tobacco Control Act provides FDA with the authority to regulate 

cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 

tobacco products, as well as the authority to deem other tobacco products 

to be subject to FDA’s regulatory authority.7 Under the act, FDA has the 

authority to issue regulations controlling the manufacture, marketing, and 

distribution of tobacco products. The act also places limitations on FDA’s 

regulatory authority over tobacco products. For example, the Tobacco 

Control Act prohibits FDA from banning all tobacco products in certain 

categories, lowering nicotine yields to zero, or raising the minimum age to 

purchase tobacco.8

FDA executes its regulatory authority under the Tobacco Control Act 

through CTP. CTP’s Office of Health Communication and Education 

The Tobacco Control Act includes provisions 

requiring FDA to regulate tobacco products using a public health 

standard, which takes into account the risks and benefits of tobacco 

products on both users and non-users of tobacco products. This standard 

is unique to FDA’s regulation of tobacco products, as other products 

regulated by FDA, such as drugs and medical devices, use a “safe and 

effective” standard.

 

7

§ 101(b), 123 Stat. at 1786 (codified at 21 U.S.C. § 387a). Tobacco products that FDA 

currently regulates include cigarettes, cigarette tobacco, roll-your-own tobacco, and 

smokeless tobacco products. The Tobacco Control Act enables FDA to deem other 

products that are made or derived from tobacco and intended for human consumption—

for example, cigars, pipe tobacco, hookah, and e-cigarettes—subject to its authority by 

rulemaking.

8

§ 101(b), 123 Stat. at 1796, 1803 (codified at 21 U.S.C. §§ 387f(d)(3), 387g(d)(3)). 

Section 104 of the act directs FDA to convene an expert panel to conduct a study on the 

public health implications of raising the minimum age to purchase tobacco and to submit a 

report to Congress by April 2015. According to CTP officials, FDA has contracted with the 

Institute of Medicine to empanel a committee of experts and develop a report for CTP by 

January 2015. The Institute of Medicine report will be used as a basis for FDA’s report to 

Congress.

Background

FDA’s Authority to 

Regulate Tobacco 

Products
 

Page 5 GAO-14-561 FDA Tobacco Product Regulation

(OHCE), Office of Science (OS), and Office of Compliance and 

Enforcement (OCE) have primary responsibility for developing the public 

education, regulatory science, and compliance and enforcement 

infrastructure for the tobacco program and carrying out the associated 

activities. CTP has additional offices that support the activities of these 

offices (see table 1). 

Table 1: FDA Center for Tobacco Products (CTP) Offices

Office Description

Office of the Center Director • Provides scientific, policy, and managerial 

leadership and direction to the other offices that 

constitute the center.

• Communicates agency initiatives and guidance to 

consumers and industry in support of public health.

Office of Compliance and 

Enforcement

• Advises center officials on compliance and 

enforcement issues, policies, and procedures 

relating to regulated tobacco products and industry.

• Ensures that regulated tobacco products and the 

manufacturers, distributors, retailers, and importers 

of those products are in compliance with the law.

Office of Health 

Communication and Education

• Leads CTP’s public education and communication 

activities.

Office of Management • Provides administrative services to support CTP’s 

business operations in the following areas: financial 

management, information technology, human 

resources, acquisitions, management analysis, and 

logistics.

Office of Policy • Develops and analyzes policy to implement the 

Tobacco Control Act.

a

Office of Regulations • Leads and coordinates the development and 

issuance of regulatory and policy documents.

Office of Science • Develops and implements CTP’s regulatory science 

framework and policies in tobacco regulatory 

development and tobacco product review.

• Implements a research agenda to meet regulatory 

science needs and to evaluate population and 

public health impact of tobacco products.

Source: GAO summary of FDA information. | GAO-14-561

a

According to CTP officials, as a result of an organizational review, entities within the Office of Policy 

were reassigned as of April 1, 2014, to the Office of the Center Director, the Office of Management, 

and the Office of Science.
 

Page 6 GAO-14-561 FDA Tobacco Product Regulation

In addition to establishing CTP, the Tobacco Control Act required FDA to 

reissue regulations originally published in 1996 that, among other things, 

banned cigarette sales to minors.9 The act also banned all flavors except 

tobacco and menthol in cigarettes and directed FDA to issue regulations 

requiring the display of graphic warning labels depicting the negative 

health consequences of smoking on cigarette packages and 

advertisements.10

The Tobacco Control Act also requires that manufacturers of new tobacco 

products submit information—for example, a statement of the product’s 

ingredients—to FDA and receive marketing authorization before 

introducing those new tobacco products into the U.S. market. The act 

established three pathways for FDA’s review of new tobacco product 

submissions: (1) the Substantial Equivalence (SE) pathway, which is for 

new tobacco products that have the same characteristics as a predicate 

tobacco product that is already legally marketed or has different 

characteristics that do not raise different questions of public health;11

 

9

§ 102(a), 123 Stat. at 1830 (codified at 21 U.S.C. § 387a-1(a)). FDA reissued this final 

rule in March 2010. 75 Fed. Reg. 13,225 (Mar. 19, 2010).

 

(2) the Exemption from SE pathway, which is for new tobacco products 

with minor modification of another product marketed by the same 

10§§ 101(b), 201(a), 123 Stat. at 1799, 1845 (codified at 21 U.S.C. § 387g(a)(1)(A) and 

15 U.S.C. § 1533(d)). While the Tobacco Control Act explicitly exempted menthol from the 

flavor ban, it required additional research on the public health impact of menthol in 

cigarettes and gave FDA the authority to ban menthol if it finds such a ban is appropriate 

for the protection of the public health. § 101(b), 123 Stat. at 1804 (codified at 21 U.S.C. 

§ 387g(e)). In June 2011, FDA issued a final rule specifying nine color graphic images to 

accompany new textual warnings for cigarette packages and advertisements. 76 Fed. 

Reg. 36,628 (June 22, 2011). In February 2012, however, a federal appeals court found 

that FDA failed to provide substantial evidence that the rule’s specific requirements would 

reduce the number of Americans who smoke and, therefore, that the rule 

unconstitutionally restricted cigarette manufacturers’ First Amendment rights. The court 

vacated the rule and remanded it to FDA. R.J. Reynolds Tobacco Co. v. F.D.A., 696 F.3d 

1205 (D.C. Cir. 2012). FDA did not appeal the court’s decision. As of April 25, 2014, FDA 

has not issued a revised rule, but indicated plans to conduct research in an effort to do so.

11A predicate tobacco product is a product commercially marketed in the United States on 

February 15, 2007, or previously found by FDA to be substantially equivalent, provided the 

product has not been removed from the market at FDA’s initiative or has not been 

determined by a judicial order to be misbranded or adulterated.
 

Page 7 GAO-14-561 FDA Tobacco Product Regulation

manufacturer;12 and (3) the Premarket Tobacco Product Application 

(PMTA) pathway, which is for new tobacco products that do not meet the 

criteria for the other two pathways.13 The act also required manufacturers 

to submit applications to FDA to market modified risk tobacco products 

(MRTP), which are products that are sold or distributed for use to reduce 

harm or the risk of tobacco-related disease associated with commercially 

marketed tobacco products.14

The Tobacco Control Act established several deadlines for FDA activities. 

For example, the act required FDA to establish, and periodically revise, a 

list of harmful and potentially harmful constituents (HPHC) by April 1, 

2012, and required manufactures to report HPHC data for each regulated 

tobacco product by April 1, 2013.

CTP is responsible for reviewing new 

tobacco product submissions and MRTP submissions and determining 

whether manufacturers may introduce the products in those submissions 

to the U.S. market.

15 In addition, FDA was required to 

publish HPHC information to the public in a format that is understandable 

and not misleading by April 1, 2013.16

 

12Manufacturers can make a submission under the Exemption from SE pathway if the 

product is modified by adding, deleting, or changing the quantity of an additive and (1) the 

new product is a minor modification of another tobacco product marketed by the same 

manufacturer; (2) an SE submission is not necessary to ensure that permitting the tobacco 

product to be marketed would be appropriate for the protection of the public health; and 

(3) an Exemption from SE is otherwise appropriate.

The Tobacco Control Act also 

required the Tobacco Products Scientific Advisory Committee—which 

includes individuals knowledgeable in scientific fields involved in the 

manufacture, evaluation, or use of tobacco products—to release a report 

13The PMTA submission must include, among other things, full reports of investigations of 

health risks, and must meet the public health standard described under the Tobacco 

Control Act. To determine whether marketing of a new tobacco product would be 

appropriate for the protection of the public health, CTP applies standards that take into 

account the risks and benefits to the population as a whole, including the likelihood that 

existing users of tobacco products will stop using such products and the likelihood that 

those who do not use tobacco products will start using such products.

14§ 101(b), 123 Stat. at 1812 (codified at 21 U.S.C. § 387k). MRTPs can only be legally 

marketed after FDA issues an order permitting their marketing.

15§§ 6, 101(b), 123 Stat. at 1783, 1791 (codified at 21 U.S.C. §§ 387d(a)(3), (e)). 

Manufacturers are required to report HPHC data at least 90 days prior to introducing a 

tobacco product that was not on the market on June 22, 2009.

16§§ 6, 101(b), 123 Stat. at 1783, 1790-91 (codified at 21 U.S.C. § 387d(d)).
 

Page 8 GAO-14-561 FDA Tobacco Product Regulation

and recommendations about the impact of menthol cigarette use on the 

public health not later than one year after its establishment.17

The Tobacco Control Act requires FDA to assess user fees on 

manufacturers and importers of tobacco products that are subject to FDA 

regulation based on their market share and specifies that tobacco user 

fees can only be applied toward FDA activities related to the regulation of 

tobacco products.18 The total amount of user fees authorized to be 

collected is specified in the act for each fiscal year, beginning in fiscal 

year 2009 (see table 2), and the total amount does not vary based on the 

number of tobacco products under regulation.

 

17§ 101(b), 123 Stat. at 1804 (codified at 21 U.S.C. § 387g(e)). The Tobacco Control Act 

established the Tobacco Products Scientific Advisory Committee, a 12-member advisory 

committee, to review and evaluate safety, dependence, and health issues relating to 

tobacco products and provide appropriate advice, information, and recommendations to 

FDA for tobacco-related regulations. Tobacco Control Act, § 101(b), 123 Stat. at 1824 

(codified at 21 U.S.C. § 387q). The committee was established on March 23, 2010.

18§ 101(b), 123 Stat. at 1826-28 (codified at 21 U.S.C. § 387s(b)-(c)). Tobacco products 

subject to FDA regulation include those products specified in the Tobacco Control Act—

cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco—and any 

other tobacco products that FDA deems to be subject to its authority. User fees are a fee 

assessed to users for goods or services provided by the federal government. The 

Tobacco Control Act specified the total amount of user fees authorized to be collected for 

each fiscal year beginning with fiscal year 2009, and authorized user fees to remain 

available until expended (which means that FDA may carry over user fees to subsequent 

fiscal years if they are not obligated by the end of the fiscal year in which they were 

collected). Fees are collected and available for obligation only to the extent and in the 

amount provided in advance in appropriations acts. For fiscal year 2014, Congress 

appropriated $534 million in tobacco user fees for collection and obligation—the total 

amount authorized under the Tobacco Control Act.

Tobacco User Fees
 

Page 9 GAO-14-561 FDA Tobacco Product Regulation

Table 2: Total Tobacco User Fee Amounts Authorized by the Tobacco Control Act, 

Fiscal Years 2009 through 2019

Dollars in millions

Fiscal year User fee amount

2009 85

2010 235

2011 450

2012 477

2013 505

2014 534

2015 566

2016 599

2017 635

2018 672

2019 and each subsequent year 712

Source: GAO analysis of the Tobacco Control Act. | GAO-14-561

Notes: The amounts shown are the total user fee amounts authorized to be collected by FDA for its 

regulation of tobacco products. Fees are collected and available for obligation only to the extent and 

in the amount provided in advance in appropriations acts, with the exception of user fees assessed 

for fiscal year 2009, which were appropriated by the Tobacco Control Act. All of the Center for 

Tobacco Products’ activities, tobacco-related work of FDA’s Office of Regulatory Affairs, other FDA 

activities related to tobacco regulation (such as work of FDA headquarters and Office of the 

Commissioner), and other activities such as rent are funded only through tobacco user fees. Because 

the Tobacco Control Act was enacted during fiscal year 2009, the $85 million authorization for fiscal 

year 2009 was reduced by a pro-rata amount.

All of CTP’s activities—as well as other FDA tobacco-related activities, 

such as the tobacco-related work of FDA’s ORA, which assists CTP with 

compliance and enforcement activities—are funded through tobacco user 

fees.19 User fees are made available to FDA until expended (which 

means that FDA may carry over user fees to subsequent fiscal years if 

they are not obligated by the end of the fiscal year in which they were 

collected). As of March 31, 2014, FDA had collected about $1.88 billion in 

tobacco user fees.

 

19ORA assists with CTP’s compliance activities by inspecting regulated products and 

manufacturers, conducting sample analyses of regulated products, and reviewing 

imported products offered for entry into the United States.
 

Page 10 GAO-14-561 FDA Tobacco Product Regulation

FDA spent nearly 80 percent of the tobacco user fees collected as of 

March 31, 2014, with more than half of its spending occurring in fiscal 

year 2013. The majority of FDA’s spending was for activities related to 

public education, regulatory science, and compliance and enforcement, 

with spending for public education and regulatory science activities 

exceeding spending for compliance and enforcement activities.

As of March 31, 2014, FDA spent about $1.48 billion (79 percent) of the 

$1.88 billion in tobacco user fees collected (see fig. 1).20 More than half of 

FDA’s spending—$868 million—occurred in fiscal year 2013.

 

20In addition to the work carried out by CTP and ORA, tobacco user fees also support 

U.S. General Services Administration rent, other rent, and rent-related activities and other 

tobacco-related activities carried out by FDA, including headquarters and the Office of the 

Commissioner.

FDA Spent Nearly 

80 Percent of User 

Fees Collected, 

Mostly for Public 

Education, 

Regulatory Science, 

and Compliance and 

Enforcement

FDA Spent 79 Percent of 

User Fees Collected, 

Mostly in Fiscal Year 2013
 

Page 11 GAO-14-561 FDA Tobacco Product Regulation

Figure 1: Total Tobacco User Fees Spent and Not Spent by FDA as of March 31, 

2014

Notes: This figure shows the tobacco user fees collected from fiscal year 2009 through the first half of 

fiscal year 2014 (which totaled about $1.88 billion), the percentage and amount of these fees spent 

during this period, and the percentage and amount of these fees remaining unspent at the end of this 

period. Of the $1.48 billion spent by FDA, the Center for Tobacco Products and Office of Regulatory 

Affairs spent about $1.42 billion. The remaining funds were spent by other FDA entities (including 

headquarters and the Office of the Commissioner) and spent on U.S. General Services 

Administration rent, other rent, and rent-related activities.

FDA spending for tobacco-related activities increased over time, from 

about $67 million in fiscal year 2010 to about $868 million in fiscal year 

2013 (see fig. 2).21 Between fiscal years 2012 and 2013, FDA spending 

nearly tripled. In fiscal year 2014, FDA spent $98 million as of March 31, 

2014, out of the $608 million the agency plans to spend for the fiscal 

year.22

 

21Data include spending for CTP overhead (information technology infrastructure and 

centralized funding for, among other things, furniture, office equipment, and center-wide 

training); ORA; tobacco-related spending of FDA headquarters and the Office of the 

Commissioner; and General Services Administration rent, other rent, and rent-related 

activities.

22According to CTP officials, FDA is on track to meet its fiscal year 2014 spend plan; 

80 percent of the planned acquisitions items will be awarded in the second half of the 

fiscal year, per FDA acquisition deadlines. Additionally, officials noted that the majority of 

the reimbursements for ORA, FDA headquarters, and the Office of the Commissioner will 

also take place in the second half of the fiscal year.
 

Page 12 GAO-14-561 FDA Tobacco Product Regulation

Figure 2: FDA Spending by Center for Tobacco Products (CTP) Office as of March 

31, 2014

Notes: Figure excludes $4.9 million spent by CTP for startup activities in fiscal year 2009.

Other includes CTP overhead (information technology infrastructure and centralized funding for, 

among other things, furniture, office equipment, and center-wide training); the tobacco-related 

spending of FDA headquarters and the Office of the Commissioner; and U.S. General Services 

Administration rent, other rent, and rent-related activities.

Additional CTP offices include CTP’s Office of the Center Director, Office of Management, Office of 

Policy, and Office of Regulations. 

Office of Compliance and Enforcement includes spending for FDA’s Office of Regulatory Affairs’ 

tobacco-related activities.
 

Page 13 GAO-14-561 FDA Tobacco Product Regulation

We previously reported that, as of fiscal year 2012, more than half of 

tobacco user fees collected were unspent and remained available for 

obligation as FDA, particularly OHCE, did not spend as planned in fiscal 

years 2011 and 2012.23 For example, in fiscal year 2012, OHCE planned 

to spend over $264 million, but it spent less than $34 million that year. 

According to FDA, issues related to contracting accounted for most of the 

difference between the amounts actually spent and planned spending. As 

these issues were addressed, FDA carried out a number of activities in 

fiscal year 2013 that were originally planned for fiscal years 2011 and 

2012. (For more information on the activities carried out by each of CTP’s 

offices, and the spending on those activities, see app. I.)

About 79 percent ($1.17 billion) of user fees spent as of March 31, 2014, 

on tobacco-related activities was for activities related to public education, 

regulatory science—which includes product research, product review, and 

regulation and guidance support—and compliance and enforcement. 

These activities were carried out by OHCE, OS, and OCE, respectively. 

Most of the spending was for public education and regulatory science 

activities, with nearly all of the public education spending occurring in 

fiscal year 2013. (See fig. 3.)

 

23See GAO, New Tobacco Products: FDA Needs to Set Time Frames for Its Review 

Process, GAO-13-723 (Washington, D.C.: Sept. 6, 2013).

Most Spending Was for 

Public Education, 

Regulatory Science, and 

Compliance and 

Enforcement Activities
 

Page 14 GAO-14-561 FDA Tobacco Product Regulation

Figure 3: Proportion of FDA Tobacco User Fee Spending by Activity as of March 31, 

2014

Notes: Figure excludes $4.9 million spent by CTP for startup activities in fiscal year 2009.

Other includes CTP overhead (information technology infrastructure and centralized funding for, 

among other things, furniture, office equipment, and center-wide training); the tobacco-related 

spending of FDA headquarters and the Office of the Commissioner; and U.S. General Services 

Administration rent, other rent, and rent-related activities.

Additional CTP activities include those carried out by CTP’s Office of the Center Director, Office of 

Management, Office of Policy, and Office of Regulations. 

Regulatory science includes tobacco product research, product review, and regulation and guidance 

support activities.

Spending for compliance and enforcement activities includes tobacco-related spending of FDA’s 

Office of Regulatory Affairs.

Percentages do not add to 100 percent due to rounding.

Spending for FDA’s public education activities has focused on 

(1) developing and launching public education campaigns to educate 

consumers, particularly youth, on the dangers of tobacco use and 

(2) communicating information on CTP activities to the public. As of 

Public Education Activities
 

Page 15 GAO-14-561 FDA Tobacco Product Regulation

March 31, 2014, 89 percent ($450 million) of the $508 million FDA spent 

on tobacco public education activities went to develop and launch public 

education campaigns (see fig. 4). Almost all of this spending 

($430 million) occurred in fiscal year 2013, when FDA awarded task 

orders for its public education campaigns.

Figure 4: Proportion of FDA Tobacco User Fee Spending on Public Education Activities as of March 31, 2014

Notes: Figure excludes $4.9 million spent by CTP for startup activities in fiscal year 2009.

Other includes CTP overhead (information technology infrastructure and centralized funding for, 

among other things, furniture, office equipment, and center-wide training); the tobacco-related 

spending of FDA headquarters and the Office of the Commissioner; and U.S. General Services 

Administration rent, other rent, and rent-related activities.

Additional CTP activities include those carried out by CTP’s Office of the Center Director, Office of 

Management, Office of Policy, and Office of Regulations. 

Regulatory science includes tobacco product research, product review, and regulation and guidance 

support activities.

Spending for compliance and enforcement activities includes tobacco-related spending of FDA’s 

Office of Regulatory Affairs.

Percentages do not add to 100 percent due to rounding.
 

Page 16 GAO-14-561 FDA Tobacco Product Regulation

Public Education Campaigns

In February 2014, FDA launched its first youth tobacco prevention public 

education campaign, targeting at-risk youth. FDA plans to launch four 

additional campaigns targeted at rural; multicultural; lesbian, gay, 

bisexual, and transgender; and American Indian/Alaska Native youth in 

fiscal years 2015 and 2016. According to CTP officials, CTP has been 

working with contractors to develop research plans and create campaign 

materials for its media campaigns. The task orders for the 5 youth public 

education campaigns—which were awarded in fiscal year 2013 after the 

agency spent about 2 years developing an acquisitions infrastructure—

account for nearly $314 million of the $450 million spent on public 

education campaign efforts since fiscal year 2010. According to FDA, the 

agency focused its public education campaigns on youth prevention 

because tobacco use is almost always initiated and established during 

adolescence. The goal of the public education campaigns is to reduce the 

number of youth who experiment with tobacco use to ultimately reduce 

the number of future tobacco users.24

FDA’s first public education campaign, “The Real Cost” campaign, targets 

youth from ages 12 to 17 who are open to smoking or already 

experimenting with cigarettes. The campaign launched nationally in a 

variety of media outlets, including online, and is expected to run for at 

least 1 year. Campaign messages are intended to make the target 

audience aware of the risks of smoking by highlighting consequences 

that, according to FDA, concern youth, such as loss of control due to 

addiction and health effects like tooth loss and skin damage.25

FDA also awarded an evaluation contract in an effort to determine the 

impact of its youth public education campaigns. Baseline evaluation 

Additionally, the campaign will include messages that specifically address 

the health consequences of menthol cigarettes.

 

24FDA officials noted there are multiple agencies that conduct activities related to tobacco 

issues, including public education activities. To avoid duplication, CTP participates in an 

HHS tobacco control working group that meets monthly. The working group includes 

representatives from the Office of the Surgeon General, Centers for Disease Control and 

Prevention, Health Resources and Services Administration, and the Office of the Assistant 

Secretary for Health, among others.

25Information on FDA’s campaign can be found at “The Real Cost Campaign,” accessed 

May 6, 2014, http://www.fda.gov/TheRealCost. 
 

Page 17 GAO-14-561 FDA Tobacco Product Regulation

began in fiscal year 2014, prior to the launch of the first campaign. 

According to CTP officials, additional evaluations will be conducted at 

various intervals appropriate for each of the campaigns and evaluation 

results will be used to assess changes in key tobacco-related knowledge, 

attitudes, beliefs, and behaviors over several years to determine if 

exposure to the campaigns is associated with a decrease in cigarette 

smoking among youth.26

In addition to its youth-targeted public education campaigns, FDA has 

funded two additional public education campaigns, one targeting 

consumers at the point-of-sale and one for retailer education. Point-ofsale campaign materials target adults who are social smokers and adult 

smokers who are ready to quit. FDA’s “Break the Chain of Tobacco 

Addiction” campaign was developed by CTP in fiscal year 2010 and 

provides retailer education designed to encourage voluntary compliance 

with all FDA regulations. Task orders for these campaigns totaled an 

additional $84 million of the $450 million spent on public education media 

campaigns since fiscal year 2010. Like FDA’s youth-targeted campaigns, 

FDA officials stated that the agency plans to evaluate these campaigns to 

determine their impact.

Communicating CTP Activities

According to FDA officials, the agency’s other public education activities 

involve communicating CTP’s mission and regulatory activities to

stakeholders—including tobacco manufacturers, retailers, public health 

stakeholders, and lawmakers, among others—and the public. FDA issues 

press releases and conducts media outreach, such as outreach to 

publicize tobacco regulations and the results of CTP’s compliance and 

enforcement work; develops and maintains CTP’s website; develops 

written materials such as frequently-asked questions and materials for 

CTP events; and assists the individual offices with written 

communications. In addition, FDA holds webinars to improve education 

 

26We have previously reported on the importance of developing a systematic approach to 

designing program evaluations in order to enhance the credibility of the evaluation and 

ensure resources are being used effectively (see GAO, Designing Evaluations: 2012 

Revision, GAO-12-208G (Washington, D.C.: Jan. 2012)). We have also reported on the 

difficulties associated with evaluating public communications campaigns (see, for 

example, GAO, ONDCP Media Campaign: Contractor’s National Evaluation Did Not Find 

that the Youth Anti-Drug Media Campaign Was Effective in Reducing Youth Drug Use, 

GAO-06-818 (Washington, D.C.: Aug. 25, 2006)).
 

Page 18 GAO-14-561 FDA Tobacco Product Regulation

and dissemination of information to stakeholders and listening sessions to 

provide stakeholders with the opportunity to make comments and raise 

concerns.

FDA spending related to regulatory science has focused on three 

activities: (1) building a scientific research base, including research on 

tobacco products and use patterns, (2) developing and implementing a 

tobacco product review process, and (3) developing the scientific basis to 

support regulations and guidance. As of March 31, 2014, about 

94 percent of the $478 million FDA had spent on regulatory science 

activities went to building a scientific research base on tobacco products 

and tobacco use, including spending for a longitudinal study and centers 

for tobacco regulatory science (see fig. 5). The proportion of spending on 

regulatory science activities that has been dedicated to building the 

scientific research base has remained fairly consistent since fiscal year 

2010.27

 

27Spending on building the scientific research base has primarily been through grants and 

contracts, while product review spending represents staffing within CTP. 

Regulatory Science Activities
 

Page 19 GAO-14-561 FDA Tobacco Product Regulation

Figure 5: Proportion of FDA Tobacco User Fee Spending on Regulatory Science Activities as of March 31, 2014

Notes: Figure excludes $4.9 million spent by CTP for startup activities in fiscal year 2009.

Other includes CTP overhead (information technology infrastructure and centralized funding for, 

among other things, furniture, office equipment, and center-wide training); the tobacco-related 

spending of FDA headquarters and the Office of the Commissioner; and U.S. General Services 

Administration rent, other rent, and rent-related activities.

Additional CTP activities include those carried out by CTP’s Office of the Center Director, Office of 

Management, Office of Policy, and Office of Regulations. 

Regulatory science includes tobacco product research, product review, and regulation and guidance 

support activities.

Spending for compliance and enforcement activities includes tobacco-related spending of FDA’s 

Office of Regulatory Affairs.

Percentages do not add to 100 percent due to rounding.
 

Page 20 GAO-14-561 FDA Tobacco Product Regulation

Building a Scientific Research Base

Since fiscal year 2010, FDA has funded scientific research to better 

understand tobacco products, their impact on the health of users and 

non-users, use patterns and perceptions of tobacco products, and the 

effectiveness of tobacco marketing, advertising, and graphic warning 

labels.28

Table 3: FDA Spending on Tobacco-Related Research Projects as of March 31, 2014

These research projects, funded by FDA tobacco user fees, 

have been conducted in collaboration with other federal entities, such as 

the National Institutes of Health (NIH) and Centers for Disease Control 

and Prevention (CDC), as well as with non-federal entities (see table 3).

Dollars in thousands

FDA spending on research conducted or overseen by FDA or other entities 

(number of projects)

Fiscal year FDA

National Institutes 

of Health a Centers for Disease Control and Prevention

Non-federal 

entities Total b

2010 $0 (0) $529 (3) $5 (3) $4,135 (4) $4,669(10)

2011 322 (3) 10,413 (3) 14,551 (10) 1,947 (5) 27,233(21)

2012 6,874(7) 63,237 (43) 32,923 (15) 3,344(10) 106,378(75)

2013 10,541(10) 177,104 (94) 27,554 (15) 4,842 (15) 220,041(134)

2014c 2,840(13) 9,175(10) 21,237(9) 6,123 (8) 39,375(40)

Total $20,577(33) $260,458(153) $96,270 (52) $20,391(42) $397,696 (280)

Source: GAO analysis of FDA information. | GAO-14-561

Notes: This table presents the research projects completed or in progress (as of March 31, 2014). 

The agencies and non-federal entities listed either conducted or had oversight over the tobacco userfee funded projects.

a

FDA’s research is conducted by its National Center for Toxicological Research.

b

Non-federal entities include, for example, the Research Triangle Institute International, American 

Association of Poison Control Centers, American College of Cardiology, and Battelle Memorial 

Institute.

c

FDA initiated some key long-term projects to help build its scientific 

research base. For example, FDA funded a 5-year contract in fiscal year 

2011 in collaboration with NIH to conduct the Population Assessment of 

Spending is for the first two quarters of fiscal year 2014.

 

28CTP officials reported plans to continue research to show that graphic warning labels 

will benefit public health; however, they did not have a time frame for completing the 

research or issuing a new graphic warning label regulation following a February 2012 

federal appeals court decision that vacated the agency’s original rule.
 

Page 21 GAO-14-561 FDA Tobacco Product Regulation

Tobacco and Health study through an NIH contract. The study is a 

national longitudinal study of tobacco use and how it affects the 

population’s health.29 The study’s objectives include examining reasons

why some people use tobacco and others do not, and how and why 

people start using different tobacco products. According to FDA, study 

findings will provide a scientific framework to inform decisions about 

tobacco products and future changes in tobacco products.30 FDA spent 

$113 million on the study in fiscal year 2011 through March 31, 2014. 

FDA, in collaboration with NIH, also awarded $53 million in grants in fiscal 

year 2013 to fund 14 Tobacco Centers of Regulatory Science to generate 

public health research to inform tobacco regulation and to train tobacco 

regulatory scientists.31

In addition to funding research projects to better understand tobacco 

products already under FDA’s regulatory authority, in fiscal year 2013, 

FDA also funded scientific research related to tobacco products not yet 

under the agency’s authority, including research projects on e-cigarettes 

and cigars.

The Tobacco Centers of Regulatory Science 

funded research including a project focused on understanding the 

cardiovascular effects of tobacco use to determine the specific elements

of tobacco products contributing to cardiovascular injury, which could 

ultimately help inform regulatory standards for tobacco products. FDA 

expects to spend more than $273 million in funding for these research 

projects through fiscal year 2018.

32

 

29The Population Assessment of Tobacco and Health study started to enroll participants in 

September 2013 and plans to enroll up to 59,000 people (both tobacco users and nonusers) ages 12 and older.

For example, in order to inform CTP’s regulatory efforts, the 

30Department of Health and Human Services, Food and Drug Administration, “FDA and 

NIH Study: Population Assessment of Tobacco and Health,” accessed April 24, 2014, 

http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm337005.htm. 

31Department of Health and Human Services, Food and Drug Administration, “Tobacco 

Centers of Regulatory Science,” accessed April 24, 2014, 

http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm369005.htm. The 

14 Tobacco Centers of Regulatory Science include scientists with a broad range of 

expertise, including epidemiology, economics, toxicology, addictions, and marketing, 

located primarily within universities. 

32On April 25, 2014, FDA issued a proposed rule that, if finalized, would deem all products 

that meet the statutory definition of a tobacco product—including currently unregulated 

marketed products, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or 

hookah) tobacco, and dissolvables—to be subject to FDA’s regulation under the Tobacco 

Control Act. 79 Fed. Reg. 23,142 (Apr. 25, 2014).
 

Page 22 GAO-14-561 FDA Tobacco Product Regulation

agency funded research examining consumer perceptions, attitudes, and 

beliefs about new and emerging products, such as e-cigarettes and little 

cigars. According to CTP officials, this research will help inform decisions 

on how to regulate these other tobacco products. (See app. II for 

additional examples of research projects supported by FDA spending.)

Developing and Implementing a Tobacco Product Review Process

FDA’s regulatory science activities also included establishing and 

implementing processes for reviewing submissions made by 

manufacturers to market new tobacco products and submissions for 

marketing MRTPs, and for receiving and assessing adverse event and 

product problem reports. FDA receives submissions for CTP to review 

and determine whether manufacturers may introduce new tobacco 

products to the U.S. market or market MRTPs. CTP developed and 

implemented the review processes for such submissions, which FDA 

began receiving in June 2010 and were mostly submitted through the SE 

pathway.33

FDA made its first decisions on SE submissions in late June 2013—about 

3 years after FDA’s receipt of the first SE submission. As of March 31, 

2014, FDA had made a final decision on a total of 30 regular SE 

submissions,34 finding 17 submissions to be substantially equivalent and 

13 submissions to be not substantially equivalent to a predicate tobacco 

product.35

 

33For additional information on FDA’s new tobacco product review process, see 

FDA had made a final decision on a total of four provisional SE 

GAO-13-723. 

34Regular SE submissions are for new tobacco products not yet commercially marketed. 

Regular SE submissions were received by FDA after March 22, 2011. The tobacco 

products represented in these submissions may not be marketed until CTP issues an 

order that they are substantially equivalent.

35As of March 31, 2014, CTP had refused to accept 36 of the 61 Exemption from SE 

submissions received by FDA because the submissions did not meet statutory 

requirements. CTP had refused to file the 4 PMTA submissions FDA had received as of 

that date. According to CTP officials and industry representatives, one reason for the lack 

of submissions under the PMTA pathway may be the challenge in demonstrating that a 

manufacturer has met the public health standard (appropriate for the protection of the 

public health) for the PMTA pathway. See 

http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm, 

accessed April 10, 2014, for information on FDA’s tobacco product marketing orders.
 

Page 23 GAO-14-561 FDA Tobacco Product Regulation

submissions,36 finding all of them to be not substantially equivalent to a 

predicate and requiring the products to be removed from the market. (See 

table 4).37 CTP officials reported that CTP prioritized regular SE 

submissions over provisional SE submissions because tobacco products 

in provisional SE submissions can remain on the market legally unless 

and until FDA issues an order of not substantially equivalent whereas 

products in regular SE submissions cannot enter the market until FDA 

issues an order that it is substantially equivalent to a predicate.38

 

36Provisional SE submissions are for new tobacco products commercially marketed after 

February 15, 2007, but before March 22, 2011. Provisional SE submissions were received 

by FDA by March 22, 2011. The tobacco products represented in these submissions may 

be commercially marketed unless and until FDA issues an order that they are not 

substantially equivalent.

37As of March 31, 2014, CTP received 70 submissions regarding investigational use of 

tobacco products; 62 have completed review and 8 were pending review. In addition, CTP 

reviewed 62 correspondences regarding investigational use of a tobacco product. Under 

the Tobacco Control Act, FDA may exempt tobacco products intended for investigational 

use from these requirements under conditions as FDA may prescribe by regulation. 

§ 101(b), 123 Stat. at 1812 (codified at 21 U.S.C. § 387j(g)). As of March 31, 2014, 

however, FDA had not issued such regulations, and FDA was exercising enforcement 

discretion for the premarket review requirements when investigators can ensure that 

studies on the tobacco product are well-controlled, data derived from such studies are 

reliable, and study subjects are adequately protected. In addition, the investigational 

tobacco product should not be promoted, advertised, distributed, commercially marketed, 

and/or sold to consumers.

38In addition, CTP officials reported that there were two other reasons for prioritizing 

regular SE submissions over provisional SE submissions: FDA received a large number of 

provisional SE submissions on March 21, 2011 (the day before the statutory deadline for 

submitting provisional SE submissions), making it impractical to prioritize reviews by the 

date the submission was received; and CTP required time to assess which approach to 

reviewing provisional submissions would be the most effective at addressing the public 

health burden of tobacco use.
 

Page 24 GAO-14-561 FDA Tobacco Product Regulation

Table 4: Status of FDA Review of Submissions Made Under Pathways to Market New Tobacco Products and Submissions for 

Modified Risk Tobacco Products (MRTP) as of March 31, 2014

Decisions

Submission type

Submissions 

received

Initial review 

completed

Closed review 

without 

decision 

(withdrawn by 

manufacturer) a

Product 

meets 

criteria for 

marketing

Product 

does not

meet 

criteria for 

marketing

Refuse to 

accept or 

refuse to file

Review 

pending b

Substantial 

Equivalence 

(SE) pathway

Provisional

c

3,564 d 3,231 133 0 4 0 3,427

Regular 981 e 739 201 17 13 0 750

Total SE 4,545 3,970 334 17 17 0 4,177

Exemption from 

SE pathwayf 61 23 0 0 0 36 25

Premarket 

Tobacco Product 

Application 

(PMTA) pathwayg 4 0 0 0 0 4 0 

MRTPh 7 0 1 0 0 6 0 

Source: GAO summary of FDA information. | GAO-14-561

Notes: The Tobacco Control Act also requires that manufacturers of new tobacco products submit 

information—for example, a statement of the product’s ingredients—to FDA and receive marketing 

authorization before introducing those new tobacco products into the U.S. market.

a

The reviews for submissions represented in this column were pending as of March 31, 2014—that is, 

they were not withdrawn by manufacturers and FDA had not reached a final decision. Initial review 

steps include the Center for Tobacco Products’ (CTP) determination of whether the new product is a 

type regulated by FDA and whether the submission is missing information.

b

FDA may refuse to accept or refuse to file a submission if the submission is missing certain 

information, such as a full statement of the components, ingredients, additives, and properties of the 

tobacco product that is the subject of the submission.

c

Manufacturers use the SE pathway if a new tobacco product has the same characteristics as a 

predicate tobacco product (a product commercially marketed in the United States on February 15, 

2007, or previously found by FDA to be substantially equivalent); or has different characteristics, but 

does not raise different questions of public health.

d

Provisional SE submissions are for new tobacco products commercially marketed after February 15, 

2007, but before March 22, 2011. Provisional SE submissions were received by FDA by March 22, 

2011. The tobacco products represented in these submissions may be commercially marketed unless 

and until CTP issues an order that they are not substantially equivalent.

e

Regular SE submissions are for new tobacco products not yet commercially marketed. Regular SE 

submissions were received by FDA after March 22, 2011. The tobacco products represented in these 

submissions may not be marketed until CTP issues an order that they are substantially equivalent.

f

Manufacturers use the Exemption from SE pathway for new tobacco products if the product is 

modified by adding, deleting, or changing the quantity of an additive and the modification would be a 

minor modification of another product marketed by the same manufacturer.

g

Manufacturers use the PMTA pathway for new tobacco products that do not meet the criteria for the 

SE or Exemption from SE pathways. Products included in PMTA submissions may only be legally 

marketed after FDA issues an order permitting their marketing. According to CTP officials and 

industry representatives, one reason for the lack of submissions under the PMTA pathway may be 

the challenge in demonstrating that a manufacturer has met the public health standard (appropriate 

for the protection of the public health) to obtain approval under the PMTA pathway.
 

Page 25 GAO-14-561 FDA Tobacco Product Regulation

h

In addition to conducting reviews of submissions, FDA designed and 

implemented a system in fiscal year 2013 to receive and assess tobacco 

product adverse event and product problem reports to inform the 

agency’s regulation of tobacco products. The reports are submitted by 

tobacco product consumers and healthcare professionals using the 

FDA/NIH Safety Reporting Portal.

Manufacturers submit applications to FDA to market MRTP products, which are products that are 

sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with 

commercially marketed tobacco products. Manufacturers must submit data from studies on the health 

risks associated with the MRTP in comparison to the health risks of other products on the market, the 

MRTP’s effect on the likelihood that current tobacco users will stop using tobacco products, and the 

likelihood that persons who do not use tobacco products will start using the MRTP.

39

Regulation and Guidance Support

CTP’s OS has been systematically 

assessing the adverse events, product quality problems, and product use 

errors included in the reports to inform FDA regulation of tobacco product 

development, manufacture, and marketing. According to CTP officials, the 

ongoing assessment of the reports is critical to identifying and 

understanding risks, especially as the tobacco industry develops novel 

products in response to market and regulatory influences. For example, 

the assessment of adverse events reported by a large and diverse 

population of consumers may reveal problems that were not anticipated 

while the product was being used in research studies.

FDA’s regulatory science activities also include developing the scientific 

basis to support regulations and guidance for the tobacco industry, 

including proposed regulations to deem additional tobacco products to be 

subject to FDA’s authority and guidance on reporting and submission 

review. According to FDA officials, from fiscal years 2010 through 2013, 

much of FDA’s initial work to develop tobacco regulations and guidance 

focused on activities related to requirements in the Tobacco Control Act, 

including activities to develop regulations on menthol flavoring in 

cigarettes and guidance for industry’s reporting of HPHCs in regulated 

tobacco products.

 

39The FDA/NIH Safety Reporting Portal is used by consumers, healthcare professionals, 

and other individuals to report safety concerns about products such as medical products, 

foods, cosmetics, and veterinary products. HHS, the Department of Defense, and the 

Department of Veterans Affairs created the portal to improve coordination among federal 

agencies for adverse event and product problem reporting.
 

Page 26 GAO-14-561 FDA Tobacco Product Regulation

FDA has evaluated the science of menthol in cigarettes to determine what 

action, if any, the agency will take to regulate menthol. In March 2011, 

FDA received the Tobacco Products Scientific Advisory Committee report 

on menthol in cigarettes, which found that the removal of menthol 

cigarettes from the marketplace would benefit public health in the United 

States.40 Following the report, FDA conducted an additional, independent 

evaluation on the effects of menthol in cigarettes, which resulted in similar 

conclusions.41 On July 24, 2013, FDA issued an Advanced Notice of 

Proposed Rule Making to obtain comments or other information that may 

inform the regulatory actions FDA might take with respect to menthol in 

cigarettes.42

FDA also worked on developing guidance for HPHCs. In August 2011, 

FDA issued a public notice listing 96 HPHCs in tobacco products and 

tobacco smoke that research indicated were harmful or potentially 

harmful to health. Based on public comment and FDA’s review of the 

scientific literature, FDA published a list of 93 HPHCs in April 2012.

According to CTP officials, FDA is reviewing the responses 

to the notice.

43

 

40Department of Health and Human Services, Food and Drug Administration, Tobacco 

Products Scientific Advisory Committee, Menthol Cigarettes and Public Health: Review of 

the Scientific Evidence and Recommendations (Silver Spring, Md.: Mar. 23, 2011).

Also, in March 2012, FDA issued draft guidance for industry on reporting 

41Department of Health and Human Services, Food and Drug Administration, Preliminary 

Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol 

Cigarettes, accessed April 14, 2014, 

http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PeerReviewofScientificInf

ormationandAssessments/UCM361598.pdf. 

4278 Fed. Reg. 44,484 (July 24, 2013).

4377 Fed. Reg. 20,034 (Apr. 3, 2012).
 

Page 27 GAO-14-561 FDA Tobacco Product Regulation

on these HPHCs.44 FDA also conducted research required by the 

Tobacco Control Act to ensure it publishes a list of HPHCs that will not be 

misleading to the public.45 Based on this research, the Tobacco Products 

Scientific Advisory Committee and FDA’s Risk Communication Advisory 

Committee made recommendations on further research and strategies 

FDA might use to effectively communicate the HPHC information to the 

public. Although FDA planned to publish a proposed regulation to 

implement the Tobacco Control Act requirements related to the testing 

and reporting of HPHCs by December 2013, it has not done so.

46

FDA also issued guidance for industry on other topics, including the 

recommended components of product review submissions and the 

product review process. For example, in January 2011—about 2 months 

prior to the statutory deadline for submitting provisional SE submissions—

FDA issued a guidance document for tobacco manufacturers to use for 

making SE submissions,47

 

44Department of Health and Human Services, Food and Drug Administration, Center for 

Tobacco Products, Draft Guidance for Industry: Reporting Harmful and Potentially Harmful 

Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the 

Federal Food, Drug, and Cosmetic Act (Silver Spring, Md.: March 2012). In its draft 

guidance, FDA noted that given the short time frame between issuance of the draft 

guidance and the required HPHC reporting date, FDA did not intend to enforce the 

statutory requirement for manufacturers to provide data on all HPHCs; rather, FDA 

established an abbreviated list of HPHCs for manufacturers to use for initially reporting 

HPHC data. According to the draft guidance, FDA will implement and enforce the statutory 

requirement to report all HPHCs on FDA’s list “as appropriate.” FDA issued a public notice 

describing the criteria the agency had tentatively concluded it would use to assist the 

agency in identifying HPHCs and listing 96 HPHCs the agency had identified using those 

criteria, in August 2011. 76 Fed. Reg. 50,226 (Aug. 12, 2011).

and in September 2011 FDA issued a draft 

guidance document with responses to frequently asked questions for SE 

45§ 101(b), 123 Stat. at 1791 (codified at 21 U.S.C. § 387d(d)).

46FDA announced this planned publication date in the Fall 2013 Regulatory Plan and the 

Unified Agenda of Federal Regulatory and Deregulatory Actions, accessed June 9, 2014, 

http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0910-AG59. 

According to HHS, as of June 4, 2014, the agency plans to update the estimated 

publication date in the next edition of the Unified Agenda. 

47Department of Health and Human Services, Food and Drug Administration, Section 

905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (Silver 

Spring, Md.: Jan. 5, 2011).
 

Page 28 GAO-14-561 FDA Tobacco Product Regulation

submissions.48

FDA’s tobacco compliance and enforcement activities have been focused 

on (1) tobacco retailer inspections; (2) inspections and enforcement of 

domestic manufacturers and imported tobacco products, and 

determinations of eligible predicate products in SE submissions; 

(3) surveillance and review of tobacco promotions, advertising, and 

labeling; and (4) outreach and small business assistance. As of March 31, 

2014, about 68 percent of the $181 million FDA spent on compliance and 

enforcement activities was for tobacco retailer inspection activities (see 

fig. 6), which has accounted for the majority of compliance and 

enforcement spending each year since fiscal year 2010.

According to CTP officials, in fiscal year 2014, FDA plans 

to issue final guidance on frequently asked questions for SE submissions 

and draft guidance for investigational tobacco products.

 

48Department of Health and Human Services, Food and Drug Administration, Center for 

Tobacco Products, Draft Guidance for Industry and FDA Staff Demonstrating The 

Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked 

Questions (Silver Spring, Md.: Sept. 22, 2011).

Compliance and Enforcement 

Activities
 

Page 29 GAO-14-561 FDA Tobacco Product Regulation

Figure 6: Proportion of FDA Tobacco User Fee Spending on Compliance and Enforcement Activities as of March 31, 2014

Notes: Figure excludes $4.9 million spent by CTP for startup activities in fiscal year 2009.

Other includes CTP overhead (information technology infrastructure and centralized funding for, 

among other things, furniture, office equipment, and center-wide training); the tobacco-related 

spending of FDA headquarters and the Office of the Commissioner; and U.S. General Services 

Administration rent, other rent, and rent-related activities.

Additional CTP activities include those carried out by CTP’s Office of the Center Director, Office of 

Management, Office of Policy, and Office of Regulations. 

Regulatory science includes tobacco product research, product review, and regulation and guidance 

support activities.

Spending for compliance and enforcement activities includes tobacco-related spending of FDA’s 

Office of Regulatory Affairs. 

Percentages do not add to 100 percent due to rounding.

Tobacco Retailer Inspections

To help ensure that U.S. retailers are in compliance with tobacco laws 

and regulations, FDA began awarding contracts to states and territories in 
 

Page 30 GAO-14-561 FDA Tobacco Product Regulation

fiscal year 2010 to implement its tobacco retailer inspection program.49

Tobacco retailer inspections, according to FDA officials, include 

undercover purchases to determine if retailers are selling to minors or are 

engaging in other practices prohibited under the Tobacco Control Act and 

its implementing regulations, such as the restriction on sales through 

vending machines and the ban on cigarettes with certain characterizing 

flavors, such as grape, coconut, and chocolate. If violations are identified, 

FDA may issue a warning letter or take enforcement action, such as 

assessing civil monetary penalties or imposing no-tobacco-sale orders.

As 

of March 31, 2014, FDA had awarded over $91 million in contracts for 

retail inspections.

50

As of March 31, 2014, 45 states and territories were under contract with 

FDA to conduct retailer compliance inspections—a threefold increase 

over the number at the end of fiscal year 2010 (see table 5).

Warning letters are the agency’s principal means of notifying retailers of a 

first time violation and are used to encourage prompt voluntary 

compliance. If subsequent violations are found during re-inspection, FDA 

may initiate administrative action that can result in the imposition of a fine, 

or civil monetary penalty, based on the number of violations and period of 

time within which they occurred. For example, at one retailer that had 

already received a warning letter for a violation, inspectors found two 

additional violations less than a year later—for selling tobacco products to 

minors and failing to verify the age of a person purchasing tobacco 

products. As a result, FDA assessed a civil monetary penalty against this 

retailer for three violations within a 24-month period.

51

 

49The Tobacco Control Act directs FDA, to the extent feasible, to contract with states and 

territories to carry out inspections of tobacco retailers in connection with enforcement of 

the act. § 103(g), 123 Stat. at 1837 (codified at 21 U.S.C. § 372(a)(1)(B)).

As of 

March 31, 2014, over 279,000 retailer compliance inspections had been 

50FDA may impose a no-tobacco-sale order prohibiting the sale of tobacco products at 

retail outlets that have committed repeated violations of the law. § 103(c), 123 Stat. at 

1835 (codified at 21 U.S.C. § 333(f)(8)). According to FDA officials, other enforcement 

actions can include seizures, injunctions, and criminal prosecution.

51FDA plans to collaborate with tribal communities to contract with the agency to enforce 

regulations on tribal lands. According to FDA, the agency has contracted with an 

American Indian-owned company to further its efforts to collaborate with American Indian 

tribes and gain insight on the best approaches to disseminate information about the 

Tobacco Control Act to Indian tribes and to tobacco retailers located on tribal lands.
 

Page 31 GAO-14-561 FDA Tobacco Product Regulation

conducted, resulting in issuance of more than 14,000 warning letters and 

1,347 civil monetary penalties. While FDA plans to contract with 

additional states and territories in fiscal year 2014, according to FDA 

officials, the agency is in the process of contracting with third parties, 

including private entities, to facilitate inspections in those states and 

territories not currently under contract. According to FDA, it awarded one 

new contract to a private contractor in April 2014 to facilitate retailer 

inspections in Florida and two additional third-party contracts in May 2014 

to facilitate retailer inspections in North Dakota and South Dakota. CTP 

officials said that in addition to third-parties, CTP has its own inspectors 

on staff to inspect in states not currently under contract with FDA. As of 

March 31, 2014, the office has completed more than half of the planned 

100,000 retailer inspections for fiscal year 2014.

Table 5: State and Territorial Retail Inspection Contracts Awarded, Inspections 

Conducted, and Advisory and Enforcement Actions Taken by FDA as of March 31, 

2014

Fiscal year

Cumulative number 

of states and 

territories awarded 

contracts

Number of 

inspections a Warning 

letters issued

Civil monetary 

penalties 

assessed

2010 15 0 0 0 

2011 40 24,404 1,022 1 

2012 44 87,462 4,107 383

2013 45 109,906 5,992 535

2014 45 b 57,474 3,107 428

Total 45 279,246 14,228 1,347

Source: GAO analysis of FDA data. | GAO-14-561

a

This count includes the number of states and territories with a contract in each fiscal year.

b

In addition to awarding contracts, FDA developed training programs for 

state and territorial inspection officials to ensure inspections are 

performed in accordance with FDA requirements. Specifically, according 

to CTP officials, CTP’s OCE is responsible for providing technical support 

through periodic conference calls with inspection program coordinators, 

conducting annual in-person training regarding changes to the program, 

and requiring annual refresher training for inspectors. As of March 31, 

2014, OCE reported training inspectors in all states and territories 

awarded contracts for retailer inspections, with more than 1,000 program 

coordinators and inspectors trained in fiscal year 2013. The office also 

developed a system for collecting and tracking information during 

Data for fiscal year 2014 includes activities for the first two quarters (as of March 31, 2014).
 

Page 32 GAO-14-561 FDA Tobacco Product Regulation

inspections called the Tobacco Inspection Management System. 

According to OCE officials, inspectors use their mobile devices to upload 

data into the system, which is subsequently reviewed by OCE for 

potential violations. When appropriate, OCE issues enforcement actions.

Manufacturer and Import Inspections and Enforcement

FDA conducts inspections of registered domestic manufacturing facilities, 

oversees imported tobacco, and determines the status of the predicate 

product cited in SE submissions.52 Beginning in fiscal year 2012, FDA has 

conducted biennial inspections of tobacco manufacturing facilities—FDA’s 

ORA conducts these inspections with the support of OCE as subject 

matter experts. According to FDA, the agency inspects manufacturing 

facilities for compliance with Tobacco Control Act requirements, including 

product and ingredient listing; packaging, labeling, and advertising 

requirements; and marketing authorization for new or modified risk 

tobacco products.53 As of March 31, 2014, FDA conducted 116 

inspections at 100 registered manufacturing facilities.54

FDA also implemented an import compliance program for tobacco 

products beginning in fiscal year 2012.

According to FDA 

officials, no warning letters have been issued or other enforcement 

actions taken as a result of manufacturer inspections.

55

 

52FDA also conducts investigations where free smokeless samples are distributed. Since 

beginning these investigations in fiscal year 2012, FDA had conducted 23 investigations 

as of March 31, 2014.

According to FDA officials, ORA 

and U.S. Customs and Border Protection review imported tobacco 

products, conduct field exams, and maintain import bulletins and alerts 

that identify tobacco products in violation of the Tobacco Control Act. Any 

tobacco product found to violate regulatory requirements may be refused 

entry into the United States. For example, imported tobacco products that 

53Department of Health and Human Services, Food and Drug Administration, Report to 

Congress: Progress and Effectiveness of the Implementation of the Family Smoking 

Prevention and Tobacco Control Act (Silver Spring, Md.: Sept. 27, 2013). FDA has not 

established tobacco product manufacturing practices for tobacco manufacturers. FDA 

officials said they plan to do so.

54As of April 29, 2014, FDA reported there were 104 registered manufacturing facilities.

55Imported tobacco products must conform to the same regulatory requirements as 

domestic tobacco products with the following exception: foreign firms are not required to 

register their facility and to list their tobacco products.
 

Page 33 GAO-14-561 FDA Tobacco Product Regulation

are labeled or advertised as “light,” “mild,” or “low,” and cigarettes that are 

labeled as having certain characterizing flavors other than tobacco and 

menthol, such as strawberry, grape, and vanilla, may be detained. As of 

March 31, 2014, FDA published four import alerts, including one for 

flavored cigarettes; one for regulated tobacco products using “light,” 

“mild,” or “low” in advertising or labeling; one for smokeless tobacco 

products without the required warning label; and one for tobacco products 

found to be not substantially equivalent—and refused the entry of two 

tobacco product imports.

OCE also assists OS in the tobacco product review process by 

determining if the tobacco product to which the new tobacco product is 

being compared in an SE submission meets the statutory requirements 

for a predicate tobacco product. In fiscal years 2011 through 2013, OCE 

completed over 1,350 predicate eligibility determinations.56 In addition, 

OCE is responsible for ensuring that the tobacco products in provisional 

SE submissions found to be not substantially equivalent are no longer 

sold or distributed in the United States as of the date on the FDA-issued 

not substantially equivalent order.57

Promotion, Advertising, and Labeling Surveillance

FDA also conducts surveillance activities for the promotion, advertising, 

and labeling of tobacco products. CTP’s OCE conducts routine monitoring 

and surveillance of websites and social media, publications, and tobacco 

industry promotion and sponsorship of events that sell, distribute, 

promote, or advertise regulated tobacco products; and reviews and 

evaluates regulatory submissions of tobacco product labeling, advertising, 

 

56More than 650 determinations were related to an SE submission and more than 700 

determinations were made in a stand-alone grandfathered review.

57In February 2014, FDA issued draft guidance stating that FDA does not intend to take 

enforcement action for 30 days on previously purchased products that a retailer has in its 

inventory. Department of Health and Human Services, Food and Drug Administration, 

Center for Tobacco Products, Guidance for Industry and Tobacco Retailers: Enforcement 

Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially 

Equivalent (Draft Guidance), accessed March 14, 2014, 

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformati

on/UCM386629.pdf. 
 

Page 34 GAO-14-561 FDA Tobacco Product Regulation

and consumer information materials.58 Additionally, CTP’s OCE is 

responsible for ensuring that warning statements on smokeless tobacco 

product labeling and advertising are in compliance with requirements in 

the Tobacco Control Act, such as the packaging and advertising bearing 

the warning statement.59

Outreach and Small Business Assistance

From fiscal year 2010 through March 31, 2014, 

OCE officials reported monitoring over 3,000 websites and over 68,000 

issues of publications, resulting in 155 warning letters to manufacturers, 

distributors, and online retailers for violations. For example, warning 

letters were issued to (1) a website for selling clove cigarettes, a 

regulated tobacco product containing a characterizing flavor which is 

prohibited under the Tobacco Control Act; (2) a tobacco manufacturer for 

promoting the sale of cigarette tobacco (a regulated tobacco product) 

labeled as pipe tobacco (an unregulated tobacco product) on its website; 

and (3) a manufacturer for offering its tobacco products online as “light” 

and “mild” without an FDA order to market a modified risk tobacco 

product.

In addition to the three key compliance and enforcement activities 

mentioned above, CTP also conducts outreach and small business 

assistance activities to help ensure compliance with the Tobacco Control 

Act and regulations. OCE and its Office of Small Business Assistance are 

responsible for outreach and small business assistance. According to 

FDA officials, these activities include responding to inquiries from small 

manufacturers and retailers and providing information on relevant tobacco 

guidance and regulations, primarily through webinars that addressed 

certain topics, such as common issues identified during FDA’s scientific 

 

58For more information on these surveillance activities, see Department of Health and 

Human Services, Food and Drug Administration, Progress and Effectiveness of the 

Implementation of the Tobacco Control Act. 

59The Tobacco Control Act requires any smokeless tobacco product imported, sold, or 

distributed in the United States to have a product package label that includes one of the 

following required statements, “WARNING: This product can cause mouth cancer;” 

“WARNING: This product can cause gum disease and tooth loss;” “WARNING: This 

product is not a safe alternative to cigarettes;” “WARNING: Smokeless tobacco is 

addictive.” § 204, 123 Stat. at 1846 (codified at 15 U.S.C. § 4402(a)). The act also 

imposes specific requirements for the display of the warning label, including placement on 

the package and the type, size, and color of font used on the label. The act also includes 

requirements for advertisements of smokeless tobacco products, including the amount of 

space a warning must comprise and the language in which the advertisement appears.
 

Page 35 GAO-14-561 FDA Tobacco Product Regulation

evaluation of substantial equivalence reports and regulations regarding 

distribution of free samples of smokeless tobacco.

FDA faced challenges related to starting up a new center, which affected 

CTP’s efforts to educate the public, build the regulatory science base, and 

enforce the new law and regulations. While FDA officials indicated that 

the agency has taken steps to address some of the challenges it faced—

such as those related to contracting and staffing—challenges related to 

building the scientific basis for regulating a previously unregulated 

product and setting review time frames remain. Despite these challenges, 

neither FDA officials nor public health and tobacco industry stakeholders 

identified any limitations in FDA’s authority to carry out its responsibilities 

under the Tobacco Control Act.

According to CTP officials, one challenge FDA encountered, but which 

they believe the agency has addressed, was a lack of an acquisitions 

infrastructure that would allow it to quickly award contracts for public 

education activities. According to these officials, FDA had to develop a 

contracting mechanism of a sufficient size and scope to allow FDA to 

solicit and award large public education campaign contracts, which had 

never been done by the agency before. This process also included 

determining the type of contracts to award. The officials said that it took 

about 2 years before two pools of contractors were established, from 

which FDA could draw for future public education campaigns, delaying 

public education campaigns that were originally slated to launch in fiscal 

year 2012. CTP officials reported it was important to build an FDA 

contracting infrastructure for these campaigns, because public education 

activities are FDA’s continuing responsibility. CTP officials stated that to 

decrease the toll of tobacco use on public health, public education 

activities must be managed by FDA, with a sustained fiscal and personnel 

commitment. While doing so delayed efforts to launch its public education 

campaigns, CTP officials told us they do not expect similar delays in the 

future.

Additionally, according to CTP officials, CTP’s OCE faced initial 

challenges in getting up and running—in particular in setting up the 

retailer inspection program, including the contracts for the program. 

According to CTP officials, in a very short period of time and with limited 

staff in place, CTP’s OCE had to draft an initial request for proposals to 

award contracts to states and help them navigate through the contracting 

process, commission state and territorial officials to conduct retail 

compliance inspections, develop and implement training programs for 

FDA Encountered 

Challenges As It 

Established CTP, 

Including Setting 

Review Time Frames
 

Page 36 GAO-14-561 FDA Tobacco Product Regulation

inspectors, coordinators, and retailers, and develop a new information 

technology system to collect and report retailer compliance inspection 

data. However, these officials reported that since the early stages of the 

tobacco program, the center has built a strong FDA tobacco compliance 

and enforcement infrastructure, and noted that if additional tobacco 

products are deemed to fall under the authority of CTP, they should be 

able to expand and cover them relatively easily.

CTP officials also reported FDA has taken steps to address challenges 

stemming from staffing and information technology that slowed the 

development and implementation of the product review processes 

needed for regulating tobacco products. In 2013, we reported that a 

shortage of experienced staff and challenges finding qualified staff 

contributed to long review times for new tobacco product submissions.60

CTP officials reported that the training of OS staff for product reviews will 

always be challenging because much of the training must be on-the-job, 

but they do not expect that this challenge will be an impediment to 

conducting new tobacco product and MRTP reviews. To help prepare OS 

staff for conducting reviews, CTP has drafted reviewer’s guides, which 

identify specific procedures staff should implement in each step of review. 

CTP officials also reported that OS—the office responsible for new 

tobacco product reviews—increased the number of positions over time 

from 18 in fiscal year 2010 to 205 in fiscal year 2014, and that they do not 

expect that finding qualified staff will be a challenge for OS moving 

forward (see fig. 7).61

 

60

(For information on CTP positions by office, see 

app. III.)

GAO-13-723, 27.

61OS staff is responsible for the regulatory science activities carried out by CTP, including 

building a product research base, conducting product reviews, and providing support for 

regulations and guidance.
 

Page 37 GAO-14-561 FDA Tobacco Product Regulation

Figure 7: Center for Tobacco Products (CTP) Office of Science (OS) Positions as of 

March 31, 2014

Notes: Information for fiscal year 2014 is as of March 31, 2014.

According to CTP, there were no OS staff in fiscal year 2009. Positions include students and 

consultants, including special government employees, at the end of each fiscal year.

Tobacco industry stakeholders expressed concerns, however, about 

whether CTP will have a sufficient number of staff to review the backlog 

of the more than 4,000 new tobacco product submissions received as of 

March 31, 2014, and also review new submissions that may be made in 

the future, particularly if new types of tobacco products—such as cigars 

or e-cigarettes—are deemed to be subject to FDA’s regulatory authority 

as the agency has proposed. In addition, CTP officials reported that a 

slow information technology system impacted the rate at which staff could 

enter data during reviews of SE submissions, which slowed down review 

times for such submissions. CTP officials told us that in January 2014, 

CTP deployed a new information technology system (known as the Office 

of Science Review Information System) to support the tracking, 

management, and review of submissions. They told us they expect this 

new system to provide for more efficient oversight of reviews, and they 

expect to use the system if new types of tobacco products are deemed to 

be subject to FDA’s regulatory authority.
 

Page 38 GAO-14-561 FDA Tobacco Product Regulation

FDA will continue to face challenges as it conducts regulatory science 

activities for what FDA considers to be a complex product that had not 

been subject to previous regulation. The following examples illustrate the 

continuing challenges related to implementing a tobacco product review 

process, building the scientific research base, and building the scientific 

basis to support regulations and guidance:

• Novel issues in submissions. CTP officials told us that product 

reviews continue to have novel issues that OS officials need to 

carefully consider in light of establishing precedent for future reviews. 

They said that this will continue to be a challenge as OS staff conduct 

additional reviews and tobacco manufacturers make changes to their 

products.

• Incomplete submissions. CTP officials also reported that SE 

submissions for new tobacco products have been challenging to 

review because they have not been complete. Industry stakeholders 

reported that determining and providing what CTP would consider 

sufficient information in SE submissions has been challenging 

because FDA’s guidance has been lacking. For example, as we 

previously reported, industry stakeholders told us that the SE 

guidance document issued by FDA in January 2011 did not direct 

manufacturers to include some information, such as environmental 

assessments, that CTP later requested from manufacturers in its 

September 2011 draft guidance or through direct communication with 

manufacturers. CTP officials noted that the agency has made efforts 

to publish additional guidance and conduct webinars to address the 

issue and that they plan to develop a standardized form for 

manufacturers to use when submitting information for review. 

According to CTP officials, as of April 25, 2014, CTP was developing 

a proposed regulation on the content and format of SE submissions, 

but the center could not identify an estimated time frame for 

implementing such a regulation. CTP officials noted that they have 

begun seeing some overall improvement in submissions, but they 

expect that incomplete submissions will continue to be a challenge 

moving forward.

• Regulating menthol in cigarettes. According to FDA officials, the issue 

of menthol in cigarettes is complex and there is a broad range of 

scientific evidence on the issue. As a result, FDA has not acted on 

findings from the Tobacco Products Scientific Advisory Committee’s 

2011 report that the removal of menthol cigarettes from the market 

would benefit public health, nor has it acted on the findings from its 

own additional, independent evaluation on menthol, which took an 

additional 2 years before the agency issued an advanced notice of 
 

Page 39 GAO-14-561 FDA Tobacco Product Regulation

proposed rulemaking. According to public health stakeholders, FDA 

could have taken action on menthol in cigarettes based on the 2011 

report from the Tobacco Products Scientific Advisory Committee. In 

July 2013, about 4 years after the passage of the Tobacco Control Act 

and about 2 years after the release of the advisory committee report, 

FDA issued an Advanced Notice of Proposed Rule Making to obtain

comments on its evaluation and on potential regulatory action. 

According to CTP officials, as of March 25, 2014, FDA was in the 

process of reviewing what it considers to be an unusually large 

number of comments—174,000—received in response to the notice.

• Reporting HPHC data to the public. FDA officials stated that the 

agency needs to evaluate the quality of HPHC data and conduct more 

research before it can meet the Tobacco Control Act requirement to 

provide the public with understandable and not misleading information 

regarding HPHCs in tobacco products. While CTP has established a 

list of HPHCs, FDA has not released HPHC information to the public 

by the April 1, 2013, deadline required in the act because, according 

to CTP officials, the center has needed to evaluate the quality of 

HPHC data collected from manufacturers and the center does not yet 

have sufficient evidence that the HPHC data can be presented to 

consumers in an understandable way that is not misleading. Industry 

stakeholders stated that because CTP has not provided standards or 

regulations for how HPHC testing should be conducted, the HPHC 

data that manufacturers have spent time and money producing for 

FDA may not be useful because of the variation in testing methods 

used by manufacturers. According to CTP officials, CTP is developing 

a proposed regulation related to manufacturers’ testing and reporting 

of HPHC data. The Tobacco Products Scientific Advisory Committee 

and FDA’s Risk Communication Advisory Committee made 

recommendations on further research and strategies to communicate 

HPHC information in public education campaigns to help consumers 

make informed decisions about tobacco products, and according to 

CTP officials, FDA does not plan to release its list of HPHCs that will 

be understandable and not misleading to the public as required by the 

Tobacco Control Act until additional research is completed.62

 

62 According to HHS, CTP has begun incorporating messages about the chemicals in 

tobacco products and specific HPHCs into its ongoing tobacco prevention campaign 

targeting at-risk youth, and additional messages may be incorporated into future public 

education campaigns currently in development.

As of 

June 4, 2014, CTP officials had not publicly disclosed an updated 
 

Page 40 GAO-14-561 FDA Tobacco Product Regulation

timeline for developing a proposed regulation related to the testing 

and reporting of HPHCs, but indicated it plans to do so. 

• Regulating other tobacco products. According to CTP officials, there is 

much that needs to be learned about the types of tobacco products 

that FDA does not currently regulate, and FDA will not be able to 

obtain some information about these types of products until they are 

subject to FDA’s authority and FDA can require that manufacturers 

provide the information. However, the agency conducted research 

and developed information regarding these products in order to 

propose deeming additional types of tobacco products to be subject to 

its regulatory authority.63 In April 2014—about 3 years after FDA 

announced its intention to deem additional types of tobacco products 

to be subject to its regulatory authority—FDA issued a notice of 

proposed rulemaking that would subject other types of tobacco 

products, such as e-cigarettes, to federal regulations, including 

minimum age requirements.64

Finally, relating to the product review processes, we have previously 

recommended that FDA establish and monitor performance measures for 

its review of new tobacco product submissions.

In the view of public health 

stakeholders, FDA has moved too slowly to deem additional tobacco 

products to be subject to its authority, allowing new types of tobacco 

products that stakeholders believe negatively impact public health to 

enter the U.S. market. However, CTP officials said that agencies must 

comply with certain requirements in developing regulations and that 

FDA was required to meet these requirements before issuing a 

proposed rule. In addition, the officials explained that FDA spent a 

significant amount of time ensuring that support for its proposed 

regulation to deem additional tobacco products subject to the 

agency’s authority was strong and complete, which included spending 

time ensuring a strong scientific underpinning for regulation.

65

 

63Among other things, CTP conducted and funded research on the initiation, use, 

perception, and toxicity of cigars, e-cigarettes, and other unregulated tobacco products.

Specifically, in 

64FDA issued the proposed rule on April 25, 2014. Comments on the proposed rule are 

due to FDA within 75 days, or July 9, 2014. 79 Fed. Reg. 23,142 (Apr. 25, 2014).

65The Tobacco Control Act does not mandate a time frame for CTP’s review of new 

tobacco product submissions with the exception of PMTA submissions. For PMTA 

submissions, the act requires CTP to issue an order stating whether the product may be 

marketed as promptly as possible, but not later than 180 days after FDA’s receipt of a 

submission.
 

Page 41 GAO-14-561 FDA Tobacco Product Regulation

September 2013, we recommended that FDA establish performance 

measures that include time frames for making decisions on new tobacco 

product submissions, and monitor performance relative to the established 

time frames, to allow CTP to evaluate its efficiency and effectiveness and 

help it make appropriate adjustments.66 HHS agreed with our 

recommendation, and on April 18, 2014, announced new performance 

measures for regular SE submissions, Exemption from SE submissions, 

and MRTP submissions received in fiscal years 2015 through 2018, 

meaning that FDA will start monitoring the time it takes to review and take 

action on these submissions.67 FDA has not, however, specified when it 

will establish time frames for provisional SE submissions—the type of SE 

submission that comprises the bulk of submissions received by FDA and 

that represent new tobacco products that may continue to be marketed 

unless and until CTP finds that they are not substantially equivalent. 

According to FDA, as the agency gains more experience with reviewing 

provisional SE submissions, it intends to identify and implement 

performance standards for these submissions as well.68 The continued 

lack of time frames for reviews of provisional SE submissions will limit 

CTP’s ability to evaluate policies, procedures, and staffing resources in 

relation to CTP’s review process for provisional SE submissions and, in 

turn, limit CTP’s ability to reasonably assure efficient operations and 

effective results.

 

66GAO-13-723. 

67According to FDA, the time before October 1, 2014, will be used to develop tracking 

systems for monitoring progress in meeting the performance goals. See Department of 

Health and Human Services, Food and Drug Administration, “Establishing Four 

Performance Measures,” accessed April 21, 2014, 

http://www.fda.gov/TobaccoProducts/NewsEvents/ucm393894.htm. FDA officials 

indicated that submissions for any newly deemed tobacco products received in fiscal 

years 2015 through 2018 would not be subject to the performance measures and time 

frames established on April 18, 2014.

68CTP prioritized its review of regular SE submissions over provisional SE submissions, 

and the agency made its first decisions on a regular SE submission in June 2013—about 

8 months prior to its first decision on a provisional SE submission, which occurred in 

February 2014. Furthermore, CTP had completed the review process for seven times as 

many regular SE submissions (30 decisions) than provisional SE submissions (4 

decisions) as of March 31, 2014.
 

Page 42 GAO-14-561 FDA Tobacco Product Regulation

In the 5 years since the Tobacco Control Act was enacted, FDA has set 

up a new center and undertaken numerous activities to regulate a 

previously unregulated product using a public health standard, and the 

agency remains in the process of conducting research and setting up its 

regulatory structure. FDA has taken some steps to address our previous 

recommendation to institute performance measures for its review of new 

tobacco products by establishing time frames for regular SE and 

Exemption from SE submissions, as well as for MRTP submissions, and 

by planning to monitor its progress towards meeting those time frames. 

However, we remain concerned that the agency has not yet established 

any performance measures for the more than 3,000 provisional SE 

submissions, representing tobacco products that can stay on the market 

unless and until FDA finds them not substantially equivalent. It is 

important that the agency move forward on reviewing these 

submissions—particularly, those that FDA has identified as having the 

greatest potential to have a public health impact—to ensure that only 

products that meet the act’s requirements are permitted to be on the 

market. The agency has indicated that it intends to identify and implement 

performance measures for these provisional SE submissions as it gains 

more experience reviewing them. We continue to believe that until FDA 

establishes performance measures including time frames for completing 

reviews of the large backlog of provisional SE submissions, the agency’s 

ability to operate efficiently, achieve effective results, and plan 

appropriately will be hampered. This will be particularly pressing as FDA 

moves forward with plans to deem additional types of tobacco products to 

be subject to its regulatory authority, which has the potential to generate a 

substantial number of new submissions requiring review. Similarly, it will 

be important for the agency to establish time frames for submissions for 

any newly deemed products, as FDA has indicated that the just-released 

time frames will not apply to submissions for newly-deemed products.

We provided a draft of this report to HHS for comment, and its comments 

are reproduced in appendix IV. HHS agreed with the need for 

performance measures related to its new tobacco product review 

process. In its comments, the department noted several reasons why it 

has been difficult for FDA to set performance measures for provisional SE 

submissions. According to HHS, FDA received a large number of 

provisional SE submissions in a short period of time, which required the 

agency to prioritize the review process based on the complexity of the 

public health concerns likely to be raised by the products under review. 

As a result, HHS noted that the initial reviews are more complicated, with 

unpredictable time frames. Additionally, because provisional SE 

Concluding 

Observations

Agency Comments
 

Page 43 GAO-14-561 FDA Tobacco Product Regulation

submissions were received early in CTP’s SE review process, HHS 

commented that many submissions have deficiencies that require 

corrections from manufacturers and further slows the review and approval 

process. However, HHS noted that the knowledge gained during the 

review of provisional SE submissions will inform the process in the future 

and allow FDA to eventually set performance goals for these 

submissions.

While we acknowledge there are complexities to the provisional SE 

review process, we believe that it is critical that FDA set performance 

measures for managing the review process of provisional SE 

submissions, including establishing time frames for review and monitoring 

progress toward meeting those time frames. Since these products can 

remain on the market unless and until FDA determines they are not 

substantially equivalent, it is important for FDA to effectively manage the 

review of these products to fulfill its responsibility to protect the public 

health. 

HHS also provided technical comments that were incorporated, as 

appropriate. 

We are sending copies of this report to the Secretary of Health and 

Human Services, the Commissioner of FDA, and other interested parties. 

In addition, the report will be available at no charge on the GAO website 

at http://www.gao.gov.

If you or your staff have any questions about this report, please contact 

me at (202) 512-7114 or at crossem@gao.gov. Contact points for our 

Office of Congressional Relations and Office of Public Affairs can be 

found on the last page of this report. Other major contributors to this

report are listed in appendix V.

Marcia Crosse

Director, Health Care
Appendix I: Summary of Center for Tobacco 

Products Offices and Key Activities

Page 44 GAO-14-561 FDA Tobacco Product Regulation

This appendix provides a summary of the offices that comprise the Food 

and Drug Administration’s (FDA) Center for Tobacco Products (CTP), 

their key activities, spending on each key activity, and examples of 

activities through March 31, 2014 (see table 6).

Table 6: Summary of Center for Tobacco Products (CTP) Offices, Spending, and Key Activities as of March 31, 2014

CTP office and key activities

Spending in fiscal 

years 2010-2014a

(in millions) Examples of activities

Office of the Center Director

Leadership and Management $16 • Oversee all tobacco program operations

Office of Compliance and Enforcement

Tobacco Retailer Inspections $123 • Contract with states and territories for tobacco retailer inspections

• Commission and train inspection program participants

• Conduct advisory and enforcement actions in response to Tobacco 

Control Act violations

Manufacturer and Import 

Inspections and Enforcement

$36 b

• Conduct inspections of domestic tobacco manufacturers

• Implement and enforce import compliance program for tobacco 

products

• Consult with CTP’s Office of Science on status of predicate product 

cited in substantial equivalence submissions

Promotion, Advertising, and 

Labeling Surveillance

$19 • Surveillance of tobacco product websites and social media

• Surveillance of tobacco product advertisements in magazines and 

other publications

• Review of tobacco labeling and advertising submissions 

Outreach and Small Business 

Assistance

$3 • Respond to questions from small businesses and retailers

• Provide educational webinars on relevant tobacco regulation and 

guidance topics for small businesses and retailers

Office of Health Communication and Education

Public Education Campaigns $450 • Establish contracting mechanism for multi-year tobacco education 

campaigns

• Launch initial youth campaigns

• Develop and implement retailer education campaign on new 

tobacco laws and regulations

• Fund research to inform and improve campaigns

Communicating CTP Activities $58 • Educate and inform key audiences about CTP’s creation, FDA’s 

authorities over tobacco, and its work related to tobacco regulation

Appendix I: Summary of Center for Tobacco 

Products Offices and Key Activities
Appendix I: Summary of Center for Tobacco 

Products Offices and Key Activities

Page 45 GAO-14-561 FDA Tobacco Product Regulation

CTP office and key activities

Spending in fiscal 

years 2010-2014a

(in millions) Examples of activities

Office of Management

Administrative Services $47 • Manage administrative programs such as travel, CTP Document 

Control Center, acquisitions, training, safety and security, 

organization changes, and emergency planning

• Establish office spend plans to budget CTP funds according to 

strategic center priorities

• Establish administrative infrastructure for partnership with the 

National Institutes of Health

Office of Policyc

Policy, Research Analysis, and 

Liaison Activity

$28 • Host listening sessions with members of industry

• Represent CTP at external public health stakeholder and industry 

meetings

• Conduct outreach calls to public health stakeholders and members 

of industry

Office of Regulations 

Issue Guidance $4 • Issue revised draft guidance on compliance with reissued 1996 rule

• Issue draft guidance on tobacco retailer training programs and civil 

monetary penalties

• Issue final guidance regarding use of light, mild, low, and similar 

descriptors; substantial equivalence submissions; harmful and 

potentially harmful constituents (HPHC) in tobacco products and 

tobacco smoke

Issue Regulations $14 • Reissue 1996 rule establishing restrictions on the sale and 

promotion of cigarettes and smokeless tobacco products

• Issue final rule requiring graphic warnings on cigarette packages 

and in cigarette advertising

• Clear proposed rule establishing requirements for submission of 

data needed to calculate user fees for manufacturers and importers

Office of Science

Building a Scientific Research 

Base 

$449 • Coordinate with federal agencies to develop a tobacco research 

plan/strategy for providing the scientific research base needed to 

inform FDA’s regulatory decisions

• Design and conduct an experimental study to test the relative 

effectiveness of graphic warnings

• Meet with manufacturers on the science of smoked, smokeless, and 

dissolvable tobacco products and e-cigarettes, and conduct 

manufacturer site visits to learn more about the manufacturing, 

marketing, and distribution of tobacco products

• Conduct focus groups with adults and youth on their understanding 

and interpretation of HPHCs and conduct an experimental study to 

test the effects of HPHC lists on consumer understanding and 

perceptions of tobacco products

• Fund research at federal agencies and other private entities to 

better understand tobacco products, health effects, use patterns, 

and risk perceptions
Appendix I: Summary of Center for Tobacco 

Products Offices and Key Activities

Page 46 GAO-14-561 FDA Tobacco Product Regulation

CTP office and key activities

Spending in fiscal 

years 2010-2014a

(in millions) Examples of activities

Developing and Implementing a 

Tobacco Product Review 

Process 

$25 • Develop and implement process for review and evaluation for 

Substantial Equivalence (SE) submissions

• Review SE submissions, modified risk tobacco product applications, 

investigational use, postmarket, and premarket tobacco product 

applications

• Hold webinars to update industry on SE submissions

• Design and implement a system to receive, process, and assess 

tobacco product adverse event and product problem reports

• Host two Tobacco Products Scientific Advisory Committee meetings 

related to modified risk tobacco products

Regulation and Guidance 

Support

$5 • Host Tobacco Products Scientific Advisory Committee meetings to 

address statutory requirements

• Publish (draft) guidance, including guidance on applications for 

premarket review of new tobacco products and industry reporting of 

HPHCs

• Hold public workshops; e.g., tobacco product analysis

• Issue advanced notices of proposed rulemaking

Source: GAO summary of FDA information. | GAO-14-561

Notes: Spending for compliance and enforcement activities includes tobacco-related spending of 

FDA’s Office of Regulatory Affairs.

a

Information for fiscal year 2014 includes activities for the first two quarters (as of March 31, 2014).

b

Includes the tobacco-related spending of FDA’s Office of Regulatory Affairs.

c

According to CTP officials, as a result of an organizational review, entities within the Office of Policy 

were reassigned as of April 1, 2014, to the Office of the Center Director, the Office of Management, 

and the Office of Science.
Appendix II: Examples of Tobacco-Related 

Research Projects Supported by Food and 

Drug Administration Spending

Page 47 GAO-14-561 FDA Tobacco Product Regulation

This appendix provides examples of research projects supported by the 

Food and Drug Administration (FDA) spending of tobacco user fees in 

fiscal years 2010 through March 31, 2014. Although FDA spending 

supported these research projects, in addition to FDA, other federal 

agencies, such as the National Institutes of Health (NIH) or the Centers 

for Disease Control and Prevention (CDC), as well as non-federal entities, 

such as research institutes, conducted or had oversight over these 

research projects (see table 7).

Table 7: Examples of Tobacco-Related Research Projects Supported by FDA 

Spending and the Entity Conducting or Overseeing the Project as of March 31, 2014 

Fiscal year Research project examples (entity conducting or overseeing project)

2010 • Marketing of New Tobacco Product Use Among Adults (NIH)

• National Youth Tobacco Survey (CDC) 

• Brand Comparison of 50 Tobacco Products (CDC) 

• Experimental Study for Cigarette Graphic Health Warnings 

(Non-federal entity) 

• Focus Groups on Tobacco Products and HPHCsa

2011

 (Non-federal 

entity) 

• Uptake of Carcinogens by Menthol Cigarette Smokers (NIH)

• Evaluating the Toxicity and Inflammation in Human Tissue 

Produced by Tobacco Products (FDA) 

• National Youth Tobacco Survey (CDC) 

• Brand Comparison of 50 Tobacco Products (CDC) 

• Influences on Tobacco Use Decisions (Non-federal entity) 

• Experimental Study of Emerging Tobacco Products (Non-federal 

entity) 

• Experimental Study on Presentation of HPHCsa

2012

 (Non-federal entity) 

• Rapid Response Human Testing of Smokeless Tobacco Products 

(NIH) 

• Survey of Microbes in Snuff Smokeless Tobacco Products (FDA) 

• National Youth Tobacco Survey (CDC) 

• Brand Comparison of 50 Tobacco Products (CDC) 

• Experimental Study on Little Cigar Topography (Non-federal entity) 

• Data on Poison Events Associated with Tobacco Products 

(Non-federal entity) 

• Epidemiological Studies of Tobacco Use and Cardiovascular 

Outcomes (Non-federal entity) 

• Focus Groups on Hookah, E-Cigarettes (Non-federal entity) 

Appendix II: Examples of Tobacco-Related 

Research Projects Supported by Food and 

Drug Administration Spending
Appendix II: Examples of Tobacco-Related 

Research Projects Supported by Food and 

Drug Administration Spending

Page 48 GAO-14-561 FDA Tobacco Product Regulation

Fiscal year Research project examples (entity conducting or overseeing project)

2013 • The Impact of Tobacco Exposure on the Lungs (NIH)

• Market Research to Predict Emerging Tobacco Product Use in 

Diverse Young Adults (NIH) 

• Influence of Advertising and Product Type on E-Cigarette Demand 

among Smokers (NIH) 

• Biomarkers for Bladder Cancer Associated with Tobacco Smoke 

(FDA) 

• National Youth Tobacco Survey (CDC) 

• Brand Comparison of 50 Tobacco Products (CDC) 

• Population Assessment of Tobacco and Health Study 

(Non-federal entity) 

• Assessment of Tobacco Pharmacology and Behavior in Humans 

(Non-federal entity) 

2014 • Genetic Biomarkers of Nicotine Addictions (NIH) b

• Effects of Hookah Tobacco Smoke in the Human Respiratory 

System (NIH) 

• Expansion of National Youth Tobacco Survey (CDC) 

• Harmful and Potentially Harmful Constituent Method Development 

and Baseline Analysis (CDC) 

• Biomarkers for Tobacco Smoke Associated with Bladder Cancer 

(FDA) 

• Nicotine Self-Administration in Rodents (FDA) 

• Pharmacokinetics and Topography of E-Cigarettes (Non-federal 

entity) 

Source: GAO analysis of FDA information. | GAO-14-561

Note: Non-federal entities include, for example, the Research Triangle Institute International, 

American Association of Poison Control Centers, American College of Cardiology, and Battelle 

Memorial Institute.

a

HPHC stands for harmful and potentially harmful constituent.

b

Information for fiscal year 2014 includes examples for the first two quarters (as of March 31, 2014).
Appendix III: Positions at the Center for 

Tobacco Products (CTP) at the End of Each 

Fiscal Year as of March 31, 2014

Page 49 GAO-14-561 FDA Tobacco Product Regulation

Fiscal year

Office 2009 2010 2011 2012 2013 2014

Office of Health Communication 

and Education

a

0 14 33 37 47 49

Office of Science 0 18 90 134 179 205

Office of Compliance and 

Enforcement 0 37 79 101 117 151

Other CTP Offices 1 b 74 128 155 159 153

Total 1 143 330 427 502 558

Source: GAO analysis of FDA data. | GAO-14-561

Notes: Position numbers include students and consultants, including special government employees. 

a

Data for fiscal year 2014 includes activities for the first two quarters (as of March 31, 2014).

b

Appendix III: Positions at the Center for 

Tobacco Products (CTP) at the End of Each 

Fiscal Year as of March 31, 2014

Other CTP offices include the Office of the Center Director, the Office of Management, the Office of 

Policy, and the Office of Regulations. According to CTP officials, as a result of an organizational 

review, entities within the Office of Policy were reassigned as of April 1, 2014, to the Office of the 

Center Director, the Office of Management, and the Office of Science.
Appendix IV: Comments from the Department 

of Health and Human Services

Page 50 GAO-14-561 FDA Tobacco Product Regulation

Appendix IV: Comments from the 

Department of Health and Human Services
Appendix IV: Comments from the Department 

of Health and Human Services

Page 51 GAO-14-561 FDA Tobacco Product Regulation
Appendix IV: Comments from the Department 

of Health and Human Services

Page 52 GAO-14-561 FDA Tobacco Product Regulation
Appendix V: GAO Contact and Staff 

Acknowledgments

Page 53 GAO-14-561 FDA Tobacco Product Regulation

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

In addition to the contact named above, Kim Yamane, Assistant Director; 

Hernán Bozzolo; Sandra George; Cathleen Hamann; Erin Henderson; 

and Mariel Lifshitz made key contributions to this report.

Appendix V: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(291166)
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