NEW TOBACCO 

PRODUCTS

FDA Needs to Set 

Time Frames for Its 

Review Process

Report to the Ranking Member, 

Subcommittee on Primary Health and 

Aging, Committee on Health, 

Education, Labor, and Pensions, 

U.S. Senate

September 2013

GAO-13-723

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-13-723, a report to the 

Ranking Member, Subcommittee on Primary 

Health and Aging, Committee on Health, 

Education, Labor, and Pensions, U.S. Senate

September 2013

NEW TOBACCO PRODUCTS

FDA Needs to Set Time Frames for Its Review 

Process

Why GAO Did This Study

In 2009, the Family Smoking 

Prevention and Tobacco Control Act 

granted FDA, an agency within the 

Department of Health and Human 

Services (HHS), authority to regulate 

tobacco products such as cigarettes. 

The act requires that tobacco 

manufacturers submit information to be 

reviewed by FDA in order to market 

new tobacco products and established 

tobacco user fees to fund FDA’s 

tobacco-related activities. The act 

represents the first time that FDA has 

had the authority to regulate tobacco 

products.

Manufacturers have raised concerns 

about the progress of CTP, the FDA 

center established by the act to 

implement its provisions. GAO was 

asked to examine CTP’s review of new 

tobacco product submissions, 

responses to meeting requests, and 

use of funds. This report examines 

(1) the status of CTP’s reviews of new 

tobacco product submissions; (2) how 

CTP responded to manufacturers’ and 

other entities’ meeting requests, and 

the length of time CTP took to hold the 

meetings; and (3) the extent to which 

FDA has spent its tobacco user fee 

funds. GAO analyzed data regarding 

submissions received by FDA as of 

January 7, 2013; reviewed data on 

meeting requests, spending plans, and 

amounts obligated; and interviewed 

CTP and tobacco industry officials.

What GAO Recommends

GAO recommends that FDA establish 

performance measures that include 

time frames for making decisions on 

new tobacco product submissions and 

that the agency monitor performance 

relative to those time frames. HHS 

agreed with GAO’s recommendations.

What GAO Found

As of January 7, 2013, the Food and Drug Administration’s (FDA) Center for 

Tobacco Products (CTP) had finished initial, but not final, review steps for most 

of about 3,800 submissions for new tobacco products (those not on the market 

on February 15, 2007). Ninety-nine percent of the submissions received by FDA 

were made under the substantial equivalence (SE) pathway. CTP determines 

whether the new tobacco product in an SE submission 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 that do not raise different

questions of public health. Initial review steps include CTP’s determination of 

whether the new product is a type regulated by FDA and whether the submission 

is missing information. For most SE submissions, CTP took more than a year 

and a half from the date a submission was received to the date these initial steps 

were completed. Of the 3,788 SE submissions, 3,165 were received by FDA prior 

to a statutory deadline (March 22, 2011) allowing the product to be marketed 

unless CTP finds that they are not substantially equivalent. SE submissions 

received after that date cannot be marketed until CTP determines they are 

substantially equivalent. In late June 2013, CTP made a final decision on 6 of the 

3,788 SE submissions, finding that 2 of the products were substantially 

equivalent and that 4 were not; the remaining submissions were still undergoing 

CTP review. CTP officials and manufacturers told GAO that several factors (such 

as CTP requests for additional information from manufacturers for submissions 

and having to hire and train new staff) impacted the time it took CTP to review 

SE submissions. While CTP is working to address these factors by, for example, 

disseminating information to manufacturers to improve submission quality and 

developing training for staff, CTP does not have performance measures that 

include time frames for making final decisions on submissions by which to 

assess its progress. Without time frames, CTP is limited in its ability to evaluate 

policies, procedures, and staffing resources in relation to its review process and, 

in turn, is limited in its ability to reasonably assure efficiency and effectiveness.

A variety of outside entities (such as manufacturers) have requested meetings 

with CTP to discuss new tobacco product submissions, public health activities, 

and other issues, and four CTP offices have received meeting requests. Those 

offices granted more meetings (72) than they denied (22) of all the meeting 

requests they received through January 7, 2013. The number of calendar days 

from the date a meeting was requested to the date it was held ranged from 1 to 

262 days, and the averages among the four offices ranged from 51 to 97 days.

FDA spent (obligated) less than half of the nearly $1.1 billion in tobacco user 

fees it collected from manufacturers and others through the end of fiscal year 

2012; $603 million of these user fees remained unspent and, thus, remained

available to CTP. CTP spent substantially less than planned in fiscal years 2011 

and 2012. CTP had planned on spending a total of $611 million for fiscal year 

2012; instead, the center spent $272 million for that year. CTP officials told GAO 

that the time it took to award contracts contributed to the center spending less 

than planned. For example, CTP planned to award a $145 million contract in 

fiscal year 2012 for a public health education campaign, but most of that amount 

was not awarded until the first quarter of fiscal year 2013.

View GAO-13-723. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov.
Page i GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Letter 1 

Background 5

CTP Finished Initial, but Not Final, Review Steps for Most 

Submissions, and Lacks Time Frames for its Review Process 14

CTP Granted Most Meeting Requests, but the Time from Request to 

Date Held Varied Widely 29

FDA Spent Less than Half of the $1.1 Billion in User Fees Collected 33

Conclusions 39

Recommendations for Executive Action 39

Agency Comments 40

Appendix I Staffing Resources for Conducting Reviews of New Tobacco 

Product Submissions 42

Appendix II Comments from the Department of Health and Human 

Services 45

Appendix III GAO Contact and Staff Acknowledgments 51

Tables

Table 1: Description of FDA Center for Tobacco Product (CTP) 

Offices 6

Table 2: Types of Submissions under the Substantial Equivalence 

(SE) Pathway 7

Table 3: Tobacco Control Act Authorization of Tobacco User Fees, 

Fiscal Years 2009 through 2019 13

Table 4: Meeting Requests Received by FDA Center for Tobacco 

Products (CTP) through January 7, 2013 30

Table 5: Calendar Days from Date Meeting Request Received to 

Date Meeting Held, by Center for Tobacco Products (CTP) 

Office 32

Table 6: Center for Tobacco Products (CTP) Planned and Actual 

Spending, Fiscal Years 2011 and 2012 36

Table 7: Time Spent on Review of New Tobacco Product 

Submissions for the Center for Tobacco Products (CTP) 

Office of Science by Job Title 44

Contents 
Page ii GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figures

Figure 1: Key Review Steps Performed by FDA’s Center for 

Tobacco Products (CTP) for Substantial Equivalence (SE) 

Submissions as of January 7, 2013 9

Figure 2: Number of Submissions Received by FDA for Each New 

Tobacco Product Pathway as of January 7, 2013 15

Figure 3: Provisional and Regular Substantial Equivalence (SE) 

Submissions Received by FDA as of January 7, 2013, by 

Fiscal Year Quarter 17

Figure 4: Finished Review Steps for Provisional and Regular 

Substantial Equivalence (SE) Submissions Received by 

FDA, as of January 7, 2013 20

Figure 5: Time Taken for Initial Review Steps for Provisional 

Substantial Equivalence (SE) Submissions 23

Figure 6: Time Taken for Initial Review Steps for Regular 

Substantial Equivalence (SE) Submissions 24

Figure 7: Meeting Requests Received by FDA Center for Tobacco 

Products (CTP) Offices, by Type of Entity 31

Figure 8: Total Tobacco User Fees Spent and Not Spent by FDA 

through Fiscal Year 2012 34

Figure 9: Center for Tobacco Products (CTP) Planned and Actual 

Spending, by Office, Fiscal Years 2011 and 2012 37

Figure 10: Center for Tobacco Products (CTP) Office of Science 

(OS) Staff Time Spent Conducting Reviews of New 

Tobacco Products 43
Page iii GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Abbreviations

AI Advice and information

CTP Center for Tobacco Products

FDA Food and Drug Administration

HHS Department of Health and Human Services

OCD Office of the Center Director

OCE Office of Compliance and Enforcement

OP Office of Policy

OS Office of Science

PMTA Premarket tobacco product application

SE Substantial equivalence

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Page 1 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

441 G St. N.W.

Washington, DC 20548

September 6, 2013

The Honorable Richard Burr

Ranking Member

Subcommittee on Primary Health and Aging

Committee on Health, Education, Labor, and Pensions

United States Senate

Dear Senator Burr:

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

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

United States. The Centers for Disease Control and Prevention reports 

that smoking and exposure to secondhand smoke account for over 

440,000 premature deaths per year. In June 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 the concern of 

tobacco use by young people and to regulate the manufacturing, 

marketing, and distribution of tobacco products using a public health 

standard.1

 

1

Pub. L. No. 111-31, div. A, 123 Stat. 1776 (2009) (hereafter, “Tobacco Control Act”).

Tobacco products that FDA currently regulates include cigarettes, cigarette tobacco, rollyour-own tobacco, and smokeless tobacco products. The Tobacco Control Act enables 

FDA to assert jurisdiction over other tobacco products—for example, cigars, pipe tobacco, 

hookah, and e-cigarettes that do not make drug claims—through rulemaking. In April 

2011, FDA announced its plans to issue a proposed rule to regulate other tobacco 

products, such as e-cigarettes, that are not currently regulated, but as of July 2, 2013, the 

agency had not issued a proposed rule or specified which other products it planned to 

propose to regulate.

Under this standard, FDA regulates tobacco products as 

appropriate for the protection of public health while taking into account the 

risks and benefits of tobacco products on the population as a whole, 

including users and nonusers. The Tobacco Control Act requires that 

manufacturers of tobacco products submit information—for example, a 

statement of the product’s ingredients and a description of the methods 

used for manufacturing the product—to be reviewed by FDA using this 

public health standard in order to introduce new tobacco products into the 

 
 

Page 2 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

market after February 15, 2007.2

The Tobacco Control Act also established the Center for Tobacco 

Products (CTP) within FDA to be responsible for implementing the act.

The Tobacco Control Act represents the 

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

3

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

and it implements the act by reviewing submissions for marketing new 

tobacco products, enforcing prohibitions on the sale of certain tobacco 

products, developing and issuing regulations and guidance, engaging in 

public education about the risks associated with tobacco product use, and 

performing other activities.4 The act also authorizes FDA to assess and 

collect user fees from each tobacco manufacturer and importer to be 

spent on only FDA’s tobacco regulation activities.5

Tobacco manufacturers have raised concerns about CTP’s progress in 

implementing the provisions of the Tobacco Control Act. You asked us to 

look at CTP’s review of new tobacco product submissions, responses to 

meeting requests, and use of resources. This report examines (1) the 

status of CTP’s reviews of new tobacco product submissions; (2) how 

CTP has responded to requests for meetings from manufacturers and

other entities, and the length of time CTP has taken to hold the meetings; 

and (3) the extent to which FDA has spent its tobacco user fee funds. We 

also provide information on staffing resources for conducting reviews of 

new tobacco product submissions. (See app. I.)

All of CTP’s activities 

are funded exclusively through tobacco user fees.

To examine the status of CTP’s review of new tobacco product 

submissions, we analyzed data maintained by CTP’s Office of Science 

(OS)—the CTP office primarily responsible for conducting reviews of new 

tobacco product submissions—regarding all submissions received by 

FDA as of January 7, 2013. This included data on whether specific steps 

 

2

Tobacco Control Act, § 101(b), 123 Stat. at 1808 (codified at 21 U.S.C. § 387j(b)(1)).

3

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

4

In addition to the term submission, CTP uses the terms report, request, and application 

(depending on the new tobacco product) to refer to the package of information that 

manufacturers provide to FDA for review in order to legally market a new tobacco product.

5

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

fees are a fee assessed to users for goods or services provided by the federal 

government.
 

Page 3 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

of the review process were completed for each submission, and key 

dates for each submission. We calculated the number of calendar days to 

complete key steps in the review process and the number of days a 

submission was pending in a particular step in the process. In addition, 

we reviewed relevant laws, regulations, and agency documents (such as 

guidance documents and draft standard operating procedures) and we 

viewed CTP webinars on new tobacco product submissions. We also 

interviewed OS officials to learn about the process for tracking and 

reviewing submissions, and to identify factors that contributed to the time 

CTP took to review new tobacco product submissions. We compared 

CTP’s review processes against internal control standards, which specify 

that performance measures such as time frames and the monitoring of 

actual performance against measures are an integral part of operating 

efficiently, achieving effective results, and planning appropriately.6

To examine on how CTP responded to requests for meetings and the 

length of time CTP has taken to hold the meetings, we reviewed and 

analyzed data from the four CTP offices that received meeting requests 

from manufacturers and other entities: OS, the Office of the Center 

Director (OCD), the Office of Compliance and Enforcement (OCE), and 

the Office of Policy (OP). For each of the four offices, we analyzed data 

provided by officials from the office on meeting requests received as of 

January 7, 2013, including the date requests were received and the date 

meetings were held. We analyzed the data from each of the four offices 

separately because the data maintained by each office varied. For 

example, OS officials only maintain data on the date the meeting request 

was received by FDA while OP officials maintain data on the date the 

meeting request was received by FDA and by OP. We analyzed the 

number of meeting requests granted, denied, transferred, withdrawn, and 

pending. We also analyzed the number of calendar days from the date 

the request was received by FDA or a specific CTP office, depending on 

Finally, 

we interviewed industry representatives from manufacturers and tobacco 

trade associations to learn about factors that may have contributed to the 

time taken by CTP to review submissions.

 

6

See GAO, Standards for Internal Control in the Federal Government, 

GAO/AIMD-00-21.3.1 (Washington, D.C.: Nov. 1999) and its supplemental guide, 

Internal Control Management and Evaluation Tool, GAO-01-1008G (Washington, D.C.: 

Aug. 2001). 
 

Page 4 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

available data, to the date the meeting was held.7

To examine on the extent to which FDA has spent its tobacco user fee 

funds, we reviewed FDA’s data, including information from CTP on 

tobacco user fees from the fourth quarter of fiscal year 2009 through the 

fourth quarter of fiscal year 2012, such as the amounts collected by FDA 

and the amounts spent by all seven CTP offices:

Finally, we reviewed a 

relevant FDA guidance document, and interviewed officials from each of 

the four CTP offices to learn about the processes for scheduling and 

holding meetings.

8 OS, OCD, OCE, OP, 

Office of Management, Office of Regulations, and Office of Health 

Communication and Education. We analyzed these data to determine 

how collection related to spending over time. Further, we reviewed FDA 

and CTP documents, such as FDA budget justification documents, CTP’s 

spend plan (which is used by CTP to identify its plans for spending user 

fee funds on staffing, acquisitions, and operational needs), and CTP 

quarterly reports to Congress (which describe CTP’s implementation of 

the Tobacco Control Act provisions).9

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 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 November 2012 to September

2013 in accordance with generally accepted government auditing 

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

obtain sufficient, appropriate evidence to provide a reasonable basis for 

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

 

7

We did not analyze calendar days from the date a meeting request was received to the 

date a response was communicated because not all of the offices maintained data on the 

date a response to a meeting request was communicated with outside entities.

8

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. 

9

We also reviewed CTP’s data on the number of staff members employed in each CTP 

office at the beginning and end of each fiscal year, and we interviewed officials from OS 

about the responsibilities and activities of the staff in their office. OS officials provided selfreported data on how OS staff spend their time.
 

Page 5 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

FDA’s authority to regulate tobacco products under a public health 

standard is unique among its regulatory responsibilities. CTP is the FDA 

center with primary responsibility for executing this regulatory 

responsibility, and its offices conduct work in several areas, including 

reviewing submissions for new tobacco products to determine if such 

products can be legally marketed in the United States, and responding to 

meeting requests from manufacturers and other entities. All of CTP’s 

activities are funded through tobacco manufacturer user fees, as required 

by the Tobacco Control Act.10

FDA—primarily through CTP—undertakes four broad categories of 

activities in carrying out its responsibilities and authorities under the 

Tobacco Control Act:11 (1) reviewing submissions for marketing new 

tobacco products and setting scientific standards for tobacco products; 

(2) enforcing statutory and regulatory requirements prohibiting the sale, 

marketing, and distribution of certain tobacco products; (3) developing 

and issuing regulations and guidance, conducting compliance checks, 

and removing violative products from the market pursuant to the Tobacco 

Control Act; and (4) engaging in public education and outreach activities 

about the risks associated with tobacco product use, and promoting 

awareness of and compliance with the Tobacco Control Act. CTP is 

organized into seven offices. (See table 1.) Within CTP, OS is the office 

primarily responsible for conducting reviews of new tobacco product 

submissions; however, OS staff duties are not limited to reviewing new 

tobacco product submissions.

 

10Tobacco Control Act, § 101(b), 123 Stat. at 1826 (codified at 21 U.S.C. 

§ 387s(c)(2)(B)(i)). 

11CTP may work with other FDA offices such as the Office of Regulatory Affairs, which 

conducts inspections, and other HHS agencies such as the National Institutes of Health, 

which conducts research, to implement the Tobacco Control Act. 

Background 

FDA Oversight of Tobacco 

Products 
 

Page 6 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Table 1: Description of FDA Center for Tobacco Product (CTP) Offices

Office Description

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

other six 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 policies to implement the Tobacco Control Act.

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.

Under the Tobacco Control Act, a manufacturer may make a submission 

to FDA for CTP’s determination of whether the manufacturer may 

introduce a new tobacco product to the market in the United States. CTP 

reviews submissions made by manufacturers through one of three 

pathways:

• Substantial Equivalence (SE) pathway: Manufacturers make a 

submission under the SE pathway if either (1) a new tobacco product 

has the same characteristics as a predicate tobacco product—that is, 

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

2007, or a product previously found by CTP to be substantially 

equivalent; or (2) the new tobacco product has different 

characteristics from a predicate tobacco product, but does not raise 

different questions of public health. There are two types of 

submissions made under the SE pathway—provisional and regular—

that are defined by the date that the product came on the market and 

when the manufacturer made the submission. For provisional SE 

submissions, a manufacturer may market the new product that is the 

subject of the submission while CTP conducts its review of the 

submission, but for regular SE submissions, a manufacturer may not 

New Tobacco Product 

Submissions and CTP’s 

Review Process
 

Page 7 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

market the new product until CTP completes its review and 

determines that the product meets the SE requirements. (See 

table 2.)

Table 2: Types of Submissions under the Substantial Equivalence (SE) Pathway

SE submission type Statutory criteria for SE submission type

When manufacturer may legally market the new 

tobacco product in the United States

Provisional • New tobacco product commercially 

marketed after February 15, 2007, but

before March 22, 2011,

and

• SE submission made to FDA by 

March 22, 2011.

May be commercially marketed unless the FDA Center for 

Tobacco Products (CTP) issues an order that the new 

tobacco product is not substantially equivalent.

Regular • Does not meet the statutory criteria for a 

provisional SE submission. 

Cannot be marketed until CTP issues an order that the new 

tobacco product is substantially equivalent.

Source: GAO summary of FDA information.

Note: A substantially equivalent tobacco product is one that CTP has found to either have 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.

• Exemption from SE pathway: Manufacturers make a submission 

under the Exemption from SE pathway if (1) the new product is a 

minor modification (adding, deleting, or changing the quantity of an 

additive) 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 public health; and (3) an Exemption from SE is 

otherwise appropriate. 

• Premarket Tobacco Product Application (PMTA) pathway: 

Manufacturers make a submission under the PMTA pathway if the 

new tobacco product does not meet the criteria of the SE or 

Exemption from SE pathways—that is, the new tobacco product is not 

substantially equivalent to a predicate product or is not a minor

modification of an appropriate product for modification. The PMTA 

submission must include, among other things, full reports of 

investigations of health risks, and must meet the public health 
 

Page 8 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

standard described under the Tobacco Control Act (that is, would be 

appropriate for the protection of public health).12

The 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.13

CTP reviews of SE submissions—primarily conducted by OS—include 

three key steps:14

 

12Tobacco Control Act, § 101(b), 123 Stat. at 1807 (codified at 21 U.S.C. § 387j). To 

determine whether marketing of a new tobacco product would be appropriate for the 

protection of public health, CTP applies standards that take into account the risks and 

benefits to the population as a whole, including users and nonusers of tobacco products; 

increased or decreased likelihood that existing users of tobacco products will stop using 

such products; and increased or decreased likelihood that those who do not use tobacco 

products will start using such products.

(1) jurisdiction review to determine if the product is 

regulated by FDA, (2) completeness review to determine if the 

submission is missing information, and (3) scientific review to determine if 

the product is substantially equivalent or not (see fig.1).

13Tobacco Control Act, § 101(b), 123 Stat. at 1809 (codified at 21 U.S.C. § 387j(c)(1)).

14In addition to OS, CTP officials told us that OCE participates in the SE review process 

by confirming that the tobacco product to which the new tobacco product in the 

submission is being compared meets the statutory requirements for a predicate tobacco 

product. A predicate product is a tobacco product commercially marketed in the United 

States on February 15, 2007, or previously found by FDA to be substantially equivalent, in 

each case, provided the product has not been removed from the market at FDA’s request 

or has not been determined by a judicial order to be misbranded or adulterated.
 

Page 9 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 1: Key Review Steps Performed by FDA’s Center for Tobacco Products (CTP) for Substantial Equivalence (SE) 

Submissions as of January 7, 2013

Note: The steps in this figure represent key steps in CTP’s review process for SE submissions. There 

are other steps in the review process that are not represented in this figure.

a

The jurisdiction and completeness review steps are facilitated by OS’s 

project managers. During jurisdiction review, project managers use a 

checklist to determine whether the new tobacco product is an FDAregulated tobacco product (that is, whether it is a cigarette, cigarette 

tobacco, roll-your-own tobacco, or smokeless tobacco).

A substantially equivalent tobacco product is one that CTP has found to either have 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.

15

 

15According to CTP officials, project managers determine whether the product (including 

any component, part, or accessory of the product) is made or derived from tobacco; 

whether it is a drug or medical device; and whether it meets established definitions for any 

type of FDA-regulated tobacco product.

During 

completeness review, project managers use another checklist to 

determine whether the submission is missing information that OS will 

need for scientific review, such as the product’s full brand name and a 

rationale for why a comparison between the new and the predicate

tobacco products’ characteristics should find that the new product is 

substantially equivalent. When project managers determine that 

additional information is needed to make SE determinations, OS issues 

administrative advice and information (AI) letters to manufacturers. 

Initially, CTP officials said they had given manufacturers 60 days to 
 

Page 10 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

respond to administrative AI letters, but in April 2012, CTP began giving 

manufacturers 30 days to respond to an administrative AI letter.

After OS finishes these initial two steps in the SE review process, the next 

step is a scientific review, which involves an assessment of the product 

by scientists in different disciplines (such as chemistry and toxicology).16

 

16According to CTP officials, in late 2012, CTP began issuing notices to each 

manufacturer about the manufacturer’s submission after finishing completeness review 

and before beginning scientific review. According to CTP officials, the notice informs the 

manufacturer that its submission will be undergoing scientific review and that the 

manufacturer has 45 days to make any amendments to the submission. In addition, in late 

2012, CTP began segmenting the review process into three phases. The first phase 

includes FDA’s receipt of a submission, jurisdiction review, and completeness review. The 

second phase includes the notice sent to manufacturers 45 days prior to beginning 

scientific review and OCE’s review to determine whether the tobacco product to which the 

new tobacco product in the submission is being compared meets the statutory 

requirements for a predicate tobacco product. The third phase includes scientific review. 

In this phase, CTP may issue a preliminary finding letter if the manufacturer has not 

provided the information needed to make a final decision. CTP issued its first preliminary 

finding letter in April 2013. The preliminary finding letter provides the manufacturer with 30 

days to provide the missing information, and OS then makes a decision on whether the 

product is substantially equivalent or not substantially equivalent. In this report, we present 

information about jurisdiction and completeness review steps (which are in the first phase) 

and scientific review (which is in the third phase).

These scientists work to determine whether the product is substantially 

equivalent to a product already on the market—that is, has the same 

characteristics as a predicate tobacco product, or has different 

characteristics but does not raise different questions of public health. 

During scientific review, OS may issue scientific AI letters to request 

additional information that the scientists determine is needed to make a 

final determination (such as clarification of ingredients and additional 

testing results). In these letters, CTP officials told us that OS requests 

that manufacturers respond within 60 days. If OS determines that the SE 

criteria have been met, then CTP will issue an SE order, and the product 

may continue being marketed by the manufacturer (if it was a provisional 

SE submission) or may be legally introduced into the U.S. market (if it 

was a regular SE submission). If neither of these criteria is met, then CTP 

will issue an order that the product is not substantially equivalent and the 

manufacturer must remove the product from the market (if it was a 

provisional SE submission) or cannot introduce the product into the 

market under the SE pathway (if it was a regular SE submission).
 

Page 11 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

According to CTP officials, reviews of Exemption from SE and PMTA 

submissions also include jurisdiction, completeness, and scientific review 

steps. However, the specific activities within each review step for those 

pathways may differ from the specific activities involved in review steps 

for SE submissions.

The Tobacco Control Act does not require CTP to conduct meetings with 

outside entities, but CTP officials reported that they are valuable because 

they increase knowledge of tobacco regulation among public health 

groups, promote compliance among manufacturers, and clarify 

information needed for new tobacco product submissions. However, each 

CTP office follows different processes for receiving and processing 

meeting requests. In the event that an outside entity—for instance, a 

manufacturer or a public health advocacy organization—wants to meet 

with CTP officials, it can request a meeting in various ways. For example, 

manufacturers can submit written requests to the Director of OS by mail, 

courier, or electronically to FDA’s document center. Manufacturers have 

requested meetings with OS to discuss their new tobacco product 

submissions, as well as study protocols and other scientific issues. 

Manufacturers, tobacco trade associations, and other entities have also 

proposed meetings with OS, OCD, OCE, and OP to educate CTP on 

tobacco industry operations (for example, current practices in tobacco 

product manufacturing), and to discuss industry’s views on FDA’s 

approaches to tobacco regulation (for example, industry feedback on 

published guidance documents). State, local, and tribal governments, as 

well as academic and scientific organizations, have requested meetings 

in order to coordinate public health efforts or share relevant knowledge. 

CTP officials told us that CTP follows FDA’s practice not to grant 

meetings for which the topic of discussion is in draft guidance. 

Additionally, according to officials, one office within CTP may transfer a 

meeting request to another office within CTP in order to provide the most 

knowledgeable and appropriate agency officials at the meeting. However, 

a request may not result in a scheduled meeting.

Requests for Meetings with 

CTP Offices
 

Page 12 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

The Tobacco Control Act requires FDA to assess user fees on 

manufacturers of FDA-regulated tobacco products based on their market 

share and specifies that the tobacco user fees can only be applied toward 

FDA activities that relate to the regulation of tobacco products.17 FDA bills 

and collects tobacco user fees from manufacturers on a quarterly basis 

and fees are generally collected the quarter after they are billed. For 

example, fees billed in the fourth quarter of fiscal year 2011 were 

collected in the first quarter of fiscal year 2012. 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).18 (See table 3.)

 

17Tobacco Control Act, § 101(b), 123 Stat. at 1826-28 (codified at 21 U.S.C. § 387s(b)-

(c)). In addition to manufacturers, the Tobacco Control Act authorizes FDA to assess user 

fees on tobacco product importers. FDA currently relies on the U.S. Department of 

Agriculture to determine the manufacturer’s market share for assessing the user fees. 

However, in May 2013, FDA issued a proposed rule that would require manufacturers and 

importers to submit information needed to calculate the amount of user fees assessed 

under the Tobacco Control Act. 78 Fed. Reg. 32,581 (May 31, 2013).

18Fees 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. For each of fiscal 

years 2009 through 2013, Congress appropriated the total amounts of tobacco user fees 

authorized to be assessed and collected under the Tobacco Control Act to FDA. The fiscal 

year 2013 appropriation amount of $505 million, however, was subject to a five percent 

reduction, as a result of the sequestration order issued by the President on March 1, 2013. 

Therefore, the maximum amount of fiscal year 2013 tobacco user fee collections available 

to FDA for obligation was reduced by approximately $25 million, to $480 million. In 

general, actual collections may be less than the amounts authorized and, therefore, the 

amounts credited to the agency’s account may be less than the authorized amount.

Tobacco User Fees
 

Page 13 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Table 3: Tobacco Control Act Authorization of Tobacco User Fees, Fiscal Years 

2009 through 2019

Dollars in millions

Fiscal year User fee amount

2009 85

2010

a

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.

Note: 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. Tobacco Control Act, 

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

a

All of CTP’s activities, other FDA activities related to tobacco regulation 

(such as the tobacco-related work of FDA’s Office of Regulatory Affairs 

and 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.

19

 

19Tobacco user fees are assessed differently than FDA user fees for medical devices and 

human drugs. FDA assesses both application and annual fees against medical device and 

human drug manufacturers for certain types of applications, including premarket review, 

and products. Such user fees, which are standard and do not vary based on market share, 

pay for a portion of FDA activities related to oversight of medical devices and drugs. In 

contrast, tobacco manufacturers do not pay user fees with their submissions for new 

tobacco products; instead, they pay a quarterly fee based on their market share of FDAregulated tobacco products. FDA relies exclusively on tobacco user fee funds to support 

its activities related to tobacco oversight. 

According to CTP officials, 426 full-time equivalent staff in FDA were 

supported by the tobacco user fees in fiscal year 2012, 346 (81 percent) 

of which were in CTP. 
 

Page 14 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

As of January 7, 2013, the vast majority of new tobacco product 

submissions FDA received from manufacturers were made under the SE 

pathway. CTP has finished initial review steps (jurisdiction and 

completeness reviews) for most SE submissions, but CTP has not made 

final decisions for most submissions. For the majority of provisional SE 

submissions, CTP took over a year and a half to complete these initial 

review steps. In late June 2013, CTP made a final decision on 6 of the 

3,788 SE submissions, finding that 2 of the products were substantially 

equivalent and that 4 were not; the remaining submissions were still 

undergoing CTP review. Several factors contributed to the significant 

amount of time it took for review of new tobacco product submissions, 

according to officials from CTP and tobacco manufacturers. CTP officials 

reported taking steps to address factors that contributed to the length of 

time the center has taken to review submissions, but the center has not 

established review time frames by which to assess progress.

As of January 7, 2013, nearly all new tobacco product submissions FDA 

received from manufacturers (99 percent) were SE submissions, most of 

which were provisional SE submissions. FDA received a total of 3,788 SE 

submissions and 23 Exemption from SE submissions from 

manufacturers. FDA did not receive any PMTA submissions. (See fig. 2.)

CTP Finished Initial, 

but Not Final, Review 

Steps for Most 

Submissions, and 

Lacks Time Frames 

for its Review Process

Almost All New Tobacco 

Product Submissions Have 

Been under the SE 

Pathway
 

Page 15 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 2: Number of Submissions Received by FDA for Each New Tobacco Product Pathway as of January 7, 2013

Note: This figure represents new tobacco product submissions received by FDA as of January 7, 

2013.

a

Of the 3,165 provisional SE submissions, 44 were withdrawn by the manufacturer as of January 7, 

2013.

b

Of the 623 regular SE submissions, 20 were withdrawn by the manufacturer as of January 7, 2013.
 

Page 16 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

As shown in figure 2, of the 3,788 SE submissions received by FDA as of 

January 7, 2013, 3,165 (84 percent) were provisional SE submissions 

and 623 (16 percent) were regular SE submissions.20 Almost all of the 

provisional SE submissions were received in the second quarter of fiscal 

year 2011—3,115 of the provisional SE submissions were received within 

the 3 weeks prior to the statutory deadline of March 22, 2011. The 

number of regular SE submissions received in a quarter ranged from 19 

(in the third quarter of fiscal year 2011) to 192 (in the third quarter of fiscal 

year 2012). (See fig. 3.)

 

20Of the 3,788 SE submissions, 64 (44 provisional and 20 regular) were withdrawn by the 

manufacturer as of January 7, 2013. According to FDA officials, manufacturers are not 

required to provide reasons for withdrawing submissions, and FDA does not track such 

information.
 

Page 17 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 3: Provisional and Regular Substantial Equivalence (SE) Submissions Received by FDA as of January 7, 2013, by 

Fiscal Year Quarter

Note: This figure represents 3,788 SE submissions (3,165 provisional and 623 regular) received by 

FDA as of January 7, 2013. FDA did not receive any SE submission from January 1, 2013, through 

January 7, 2013.

a

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 

the Center for Tobacco Products (CTP) issues an order that they are not substantially equivalent.

b

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.
 

Page 18 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

In addition to the 3,788 SE submissions, FDA received 23 Exemption 

from SE submissions from manufacturers as of January 7, 2013.21

Eligibility for the Exemption from SE pathway is limited to new tobacco 

products that are minor modifications of an existing tobacco product 

(adding, deleting, or changing the quantity of an additive) already 

marketed by the same manufacturer. According to CTP officials, a key 

factor contributing to the relatively small number of submissions is that it 

is not common for a manufacturer to change only additives when making 

a change to an existing tobacco product. According to industry 

representatives, a key reason for the relatively small number of 

submissions under this pathway is insufficient guidance from CTP about 

what exactly constitutes a minor modification of another commercially 

marketed tobacco product. FDA did not include a definition of the term 

“minor modification” in its final rule to establish procedures for the 

Exemption from SE pathway because the agency did not have the 

experience needed to provide a useful definition.22

CTP had not received any PMTA submissions as of January 7, 2013.

In the rule, FDA stated 

that as it gains experience in evaluating Exemption from SE submissions, 

it will consider establishing a definition for minor modifications.

23

 

21On June 25, 2013, CTP determined that the new tobacco products in 20 of these 

submissions—which were received by FDA in late September 2011 through late 

December 2012—did not meet the requirements for the Exemption from SE pathway. CTP 

officials reported that they anticipate receiving new SE submissions or PMTA submissions 

for the products identified in these 20 submissions. In addition, from January 8, 2013, 

through June 25, 2013, FDA received an additional seven Exemption from SE 

submissions.

CTP’s guidance document for the PMTA pathway states that PMTA 

submissions should include data from well-controlled studies 

demonstrating that the tobacco product is appropriate for the protection of 

the public health. According to CTP officials and industry representatives, 

one reason for the lack of submissions under this pathway may be the 

challenge in demonstrating that a manufacturer has met the public health 

standard (appropriate for the protection of public health) for the PMTA 

pathway. Data from such studies must address, for example, the health 

risks associated with the product in comparison to the health risks of 

other products on the market and the product’s effect on the likelihood 

2276 Fed. Reg. 38,961 (July 5, 2011) (codified at 21 C.F.R. §1107.1).

23CTP officials also reported that no submissions were received by FDA from January 8, 

2013, through June 25, 2013.
 

Page 19 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

that current tobacco users will stop using tobacco products. According to 

industry representatives, meeting the standards under the PMTA pathway 

may not be feasible for some manufacturers—in particular, for small 

manufacturers (which are manufacturers that have fewer than 350 

employees). Industry representatives reported that small manufacturers 

do not have the research and development resources to design or initiate 

clinical trials that would be needed to support a PMTA submission.

As of January 7, 2013, CTP finished jurisdiction and completeness 

reviews for over two thirds of the provisional and regular SE submissions 

received since June 2010, but had not made a final decision on any of the 

3,788 SE submissions.24 CTP finished both jurisdiction and completeness 

reviews for about 69 percent of provisional SE submissions (2,191 out of 

3,165), and about 67 percent of regular SE submissions (415 out of 623). 

Almost all of the remaining 974 provisional SE submissions and about 

half of the remaining 208 regular SE submissions were through 

jurisdiction review but not completeness review. (See fig. 4.) Provisional 

SE submissions and regular SE submissions were pending in 

completeness review for as long about 1.5 years and 1 year, 

respectively.25

 

24FDA received the first SE submission on June 11, 2010.

As of January 7, 2013, CTP had not finished scientific 

review for any of the SE submissions.

25As of January 7, 2013, provisional SE submissions not yet through jurisdiction review 

were pending in that step for as long as about 2 years, and regular SE submissions not 

yet through jurisdiction review were pending in that step for about 1 year. 

CTP Finished Initial 

Review Steps for Most SE 

Submissions 
 

Page 20 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 4: Finished Review Steps for Provisional and Regular Substantial Equivalence (SE) Submissions Received by FDA, as 

of January 7, 2013

Note: This figure represents 3,788 SE submissions (3,165 provisional and 623 regular) received by 

FDA as of January 7, 2013, including 64 submissions withdrawn by manufacturers as of that date. 

Submissions withdrawn in jurisdiction review are represented in the category labeled none, and 

submissions withdrawn in completeness review are represented in the category labeled only

jurisdiction review. Submissions withdrawn in scientific review are represented in the category labeled 

jurisdiction and completeness reviews.

a

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 

the Center for Tobacco Products (CTP) issues an order that they are not substantially equivalent.

b

CTP officials reported that as of late June 2013, CTP had started 

scientific reviews for all of the 415 regular SE submissions and 42 of the 

2,191 provisional SE submissions that had finished the completeness 

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.
 

Page 21 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

review step as of January 7, 2013.26 CTP officials reported that CTP 

began scientific reviews for provisional SE submissions in May 2013, 

more than a year after they began scientific reviews for regular SE 

submissions in March 2012 because they prioritized completeness 

reviews for regular SE submissions over completeness reviews for 

provisional SE submissions. CTP officials reported that regular SE 

submissions went into scientific review based on the order that FDA 

received submissions (which generally aligned with the order that CTP

finished each submission’s completeness review). CTP officials also 

reported that CTP prioritized scientific reviews for provisional SE 

submissions based on the public health impact of the new tobacco 

product.27

On June 25, 2013—about 3 years after FDA’s receipt of the first SE 

submission—CTP made a final decision on 6 of the 3,788 SE 

submissions. CTP concluded that the new tobacco products in two of the 

submissions were substantially equivalent and that the products in the 

four other submissions were not. These six submissions were regular SE 

submissions received by FDA in fall 2011 (about 1 year and 8 months 

prior to CTP’s final decisions). For each of the two substantially 

According to CTP officials, prioritization of provisional SE 

submissions based on public health impact was necessary because new 

tobacco products in provisional SE submissions may remain on the 

market unless CTP finds that the product is not substantially equivalent to

a predicate tobacco product.

 

26From January 2013 through late June 2013, FDA received an additional 165 regular SE 

submissions. In addition, as CTP was conducting completeness reviews of provisional SE 

submissions during the time period, it determined that in some cases the provisional SE 

submission incorrectly identified multiple new tobacco products (instead of a single 

tobacco product). CTP separated such submissions and, as a result, identified an 

additional 382 provisional SE submissions.

27In June 2012, CTP established four Public Health Impact Tiers for provisional SE 

submissions, and in August 2012, CTP—specifically, chemists in OS—began assigning 

provisional SE submissions to these tiers in order to prioritize scientific reviews for 

products with the greatest potential to raise different questions of public health. Tier 1 

includes submissions with products that have high potential for raising different questions 

of public health, Tier 2 is for products with moderate potential, Tier 3 is for products with 

low potential, and Tier 4 is for products with the lowest potential. According to CTP 

officials, in assigning submissions to a tier, OS chemists apply a variety of criteria, such as 

whether the new tobacco products that are the subject of, and the predicate tobacco 

products referenced in, the submissions are different product types (which would result in 

a Tier 1 assignment) or differ only in the way in which they are labeled (which would result 

in a Tier 4 assignment). CTP randomizes submissions within each tier to determine the 

order for beginning scientific review for submissions in the same tier.
 

Page 22 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

equivalent products, CTP found that the new product had different 

characteristics than the predicate tobacco product but did not raise 

different questions of public health. CTP found that four new tobacco 

products were not substantially equivalent to predicate tobacco products 

due to factors such as inadequate evidence that the products to which the 

new products were being compared were valid predicate products and 

lack of complete information on tobacco product characteristics.28

CTP took over a year and a half from FDA’s receipt of a submission 

through the end of initial review steps for more than half of provisional SE 

submissions, and 6 months for more than half of the regular SE 

submissions. As of January 7, 2013, the median length of time to finish 

initial review steps—from FDA’s receipt of a submission through the end 

of completeness review—for provisional SE submissions was about 

1 year and 9 months, and the length of time ranged from about 9 months 

to about 2.5 years (see fig.5). The median length of time to finish initial 

review steps for regular SE submissions was about 6 months, ranging 

from about 1 month to about 2 years (see fig. 6).

 

28Information about these final decisions, including SE orders issued by CTP and a 

summary of not substantially equivalent decisions, is available at 

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

(accessed July 3, 2013).

CTP Took Over a Year and 

Half for Initial Review 

Steps for the Majority of 

Provisional SE 

Submissions 
 

Page 23 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 5: Time Taken for Initial Review Steps for Provisional Substantial Equivalence (SE) Submissions

Note: 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. 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 FDA’s Center for Tobacco Products (CTP) issues 

an order that they are not substantially equivalent. Percentages for completeness review do not add 

up to 100 percent due to rounding.

a

Jurisdiction review involves the CTP Office of Science’s (OS) determination of whether the submitted 

product is an FDA-regulated tobacco product. This pie chart represents the length of time from FDA’s 

receipt of a provisional SE submission to the end of jurisdiction review for 3,136 (out of 3,165) 

provisional SE submissions. As of January 7, 2013, CTP had not finished jurisdiction review for 

29 provisional SE submissions.

b

Completeness review involves OS’s determination of whether the center requires additional 

information to finish the review process. Completeness review does not begin until jurisdiction review 

is finished. This pie chart represents the length of time from the end of jurisdiction review to the end of 

completeness review for 2,191 of the 3,136 provisional SE submissions through jurisdiction review. 

As of January 7, 2013, CTP had started but not finished completeness review for 945 provisional SE 

submissions.
 

Page 24 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 6: Time Taken for Initial Review Steps for Regular Substantial Equivalence (SE) Submissions

Note: 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. 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 

FDA’s Center for Tobacco Products (CTP) issues an order that they are substantially equivalent. 

Percentages for completeness review do not add up to 100 percent due to rounding.

a

Jurisdiction review involves CTP Office of Science’s (OS) determination of whether the submitted 

product is an FDA-regulated tobacco product. This pie chart represents the length of time from FDA’s 

receipt of a regular SE submission to the end of jurisdiction review for 522 (out of 623) regular SE 

submissions. As of January 7, 2013, CTP had not finished jurisdiction review for 101 regular SE 

submissions.

b

Completeness review involves OS’s determination of whether the center requires additional 

information to finish the review process. Completeness review does not begin until jurisdiction review 

is finished. This pie chart represents the length of time from the end of jurisdiction review to the end of 

completeness review for 415 of the 522 regular SE submissions through jurisdiction review. As of 

January 7, 2013, CTP had started but not finished completeness review for 107 regular SE 

submissions.
 

Page 25 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Several factors have contributed to the significant amount of time it took 

for review of SE submissions, according to CTP officials and industry 

representatives. These officials identified factors such as insufficient 

information provided by manufacturers in submissions; the prioritization of 

regular SE submission reviews over provisional SE submissions; and 

other factors.

CTP officials told us that insufficient information from manufacturers in SE 

submissions has had the most significant impact on review times for 

those submissions. According to CTP officials, the majority of SE 

submissions were incomplete and required follow-up with manufacturers 

to obtain additional information, such as a full description of both the new 

tobacco product and the predicate tobacco product. CTP officials reported 

that they spent significant time sending out AI letters requesting missing 

information from manufacturers and awaiting the manufacturers’ 

responses. Our analysis found that administrative AI letters were 

associated with 2,559 SE submissions, and CTP officials told us that 

some submissions had more than one administrative AI letter. In these 

letters, CTP officials requested that manufacturers respond to requests 

within 60 days or 30 days. In addition, our analysis found that scientific AI 

letters were associated with 81 SE submissions. In these letters, CTP 

requested that manufacturers respond to requests within 60 days, but 

CTP officials reported that it had granted extensions of up to 4 months.

Industry representatives agreed that the lack of completeness of 

submissions had an impact on reviews, but they told us that guidance 

provided by CTP was neither timely nor adequate for manufacturers to 

provide what CTP would consider SE submissions with sufficient 

information. Manufacturers we interviewed said they were not able to 

include all information indicated in CTP guidance that was issued on 

January 5, 2011, for provisional SE submissions, which needed to be 

submitted by March 22, 2011, in order for those products to remain on the 

market provisionally.29

 

29U.S. Department of Health and Human Services, Food and Drug Administration, Section 

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

Md.: Jan. 5, 2011).

Some industry representatives indicated that the 

time it took to prepare a submission was more than CTP estimated, and 

that the deadline for provisional SE submissions was not enough time to 

CTP Officials and 

Manufacturers Identified 

Several Factors That 

Contributed to Review 

Times for New Tobacco 

Product Submissions
 

Page 26 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

incorporate all of the requirements in the guidance in their submissions.30

Additionally, industry representatives we interviewed reported that the 

January 2011 guidance did not direct manufacturers to include some 

information by the March 22, 2011, submission deadline that CTP later 

requested in its September 2011 draft guidance or AI letters, such as an 

environmental assessment.31

CTP placed a higher priority on its review of regular SE submissions than 

on its review of provisional SE submissions, which contributed to longer 

review times for provisional SE submissions when compared to regular 

SE submissions. Specifically, according to OS officials, in the summer of 

2011 CTP prioritized completeness reviews for regular SE submissions 

over provisional SE submissions, so resources were shifted away from 

provisional SE submissions. As a result of this decision—coupled with the 

fact that provisional SE submissions were received earlier than regular 

SE submissions—completeness review times for provisional SE 

submissions were longer than for regular SE submissions. CTP officials 

said that there were three reasons for placing a higher priority on its 

review of regular SE submissions over provisional SE submissions: 

(1) tobacco products in provisional SE submissions could remain on the 

market legally (unless and until CTP issued an order of not substantially 

equivalent), (2) 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 (3) CTP required 

time to assess which approach to reviewing provisional submissions 

 

30CTP estimated the average time taken to provide required information for SE 

submissions at 360 hours per response, including the time to review instructions, search 

existing data sources, gather the data needed, and complete and review the information 

collection. See U.S. Department of Health and Human Services, Food and Drug 

Administration, Section 905(j) Reports: Demonstrating Substantial Equivalence for 

Tobacco Products, (Rockville, Md.: Jan. 5, 2011).

31In September 2011, CTP issued a frequently asked questions document stating that 

manufacturers should include an environmental assessment in their submissions. 

According to CTP, an environmental assessment is information provided to CTP so it can 

determine the environmental impact of granting an SE submission. See U.S. Department 

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

(Rockville, Md: Sept. 5, 2011).
 

Page 27 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

would be the most effective at addressing the public health burden of 

tobacco use.32

Two more factors that had a significant impact on review times were a 

shortage of experienced tobacco product review staff and slow IT 

systems, according to CTP officials. These officials reported that when 

they started reviews of SE submissions the center had a shortage of 

experienced staff and that finding qualified staff was challenging. 

Additionally, CTP officials said that initial training of review staff 

contributed to review times as new staff were unable to review 

submissions until receiving the necessary training. CTP officials also told 

us that a slow IT system impacted the rate at which project managers 

could enter data during jurisdiction and completeness reviews of SE 

submissions, which slowed down those review times.

CTP has taken action to address the factors CTP officials identified as 

contributing to the significant amount of time the center has taken to 

review submissions. CTP has provided additional direction to 

manufacturers in an attempt to decrease delays due to agency requests 

for more information through AI letters. Specifically, it has held webinars 

and published frequently asked questions to provide more guidance to 

manufacturers that prepare submissions. Additionally, CTP officials told 

us that in November 2012 CTP began alerting manufacturers of 

upcoming scientific review of their submissions by issuing a notification to 

manufacturers 45 days prior to starting scientific review. According to 

CTP officials, this notification reminds manufacturers of the option to 

amend their submissions as needed prior to the start of scientific review, 

to facilitate higher quality submissions, and potentially avoid delays in 

scientific review due to the issuance of scientific AI letters. CTP also 

noted that it is working on a standardized form for manufacturers to use 

when submitting new tobacco product information for review.33

 

32CTP officials told us that while provisional SE products could remain on the market prior 

to CTP issuing an order, CTP would have other authorities under which it could address 

any immediate concerns about the adverse health impact of a specific product.

According 

33In June 2013, FDA opened a docket for public comment on electronic submissions of 

tobacco products. Docket No. FDA-2013-N-0602-0001. Electronic Submission of Tobacco 

Product Applications and Other Information; Public Workshop; Request for Comments. As 

a result of this request for public comment and a public workshop held by CTP, CTP 

intends to develop a standardized form for tobacco manufacturers to make new tobacco 

product submissions. 

CTP Has Worked to 

Address Factors That 

Contributed to Review 

Times, but Has Not 

Established Time Frames 

by Which to Assess 

Progress
 

Page 28 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

to CTP officials, this form may take time to develop as it will require FDA 

to issue regulations, but CTP officials anticipate that, when implemented, 

a standardized form should improve review times. To address the 

shortage of staff available for reviews, CTP officials told us they have 

increased OS staff from 12 staff in June 2010 to more than 100 staff in 

January 2013, including scientists and project managers involved in 

submission reviews. Also in 2012, CTP drafted a reviewers’ guide to help 

train staff on aspects of the SE review process. According to CTP 

officials, the center plans to continue to revise its draft reviewer’s guide as 

it further refines its new tobacco product review process. CTP officials 

also reported that CTP had upgraded its IT system as of early 2013, 

which has improved the time taken for data entry on SE submissions. 

They also reported that CTP plans to transition to a new IT system in late 

2013.

Our analysis of data provided by CTP found that for regular SE 

submissions the length of time from the end of jurisdiction review through 

the end of completeness review improved over time. Among regular SE 

submissions received by FDA in fiscal year 2011 and for which CTP had 

finished completeness review as of January 7, 2013, the length of time 

from the end of jurisdiction review to the end of completeness review 

ranged from about 3 months to 1.5 years, with a median length of time of 

about 8 months. In contrast, the length of time for these steps for regular 

SE submissions received in fiscal year 2012 ranged from less than 1 day 

to 11 months, with a median of about 2 months. CTP officials reported 

that actions such as hiring review staff and providing training for review 

staff have resulted in improved review times.

While CTP is moving forward with its reviews of SE submissions and 

efforts to improve review times, CTP does not have time frames for 

reaching a final decision on submissions. Time frames would allow CTP 

to evaluate its efficiency and effectiveness and help it make appropriate 

adjustments. Under federal standards for internal control, control activities 

that establish performance measures, such as time frames, and the 

monitoring of actual performance against measures are an integral part of 

operating efficiently, achieving effective results, and planning 

appropriately.34

 

34While we focused on the timeliness of the reviews in this report, other dimensions of an 

organization’s performance—such as the outcomes to be achieved, quality, and cost—are 

equally important for evaluating overall efficiency and effectiveness.

There are no time frames set by statute for the SE 
 

Page 29 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

pathway, and CTP has not established performance measures that 

include time frames for making final decisions on the review of SE 

submissions. Although CTP officials agreed that establishing time frames 

would be useful for performance evaluation, CTP has not identified 

specific plans to establish such time frames. According to CTP officials, 

they have not yet established time frames because they first need to 

collect and analyze information about how long each review step should 

take. Yet without time frames, CTP is limited in its ability to evaluate 

policies, procedures, and staffing resources in relation to its review 

process and this, in turn, limits CTP’s ability to reasonably assure 

efficiency and effectiveness. As a result, CTP is limited in its ability to 

determine the adjustments needed to make improvements. For example, 

CTP is limited in its ability to evaluate whether OS staff are performing 

efficiently and effectively in relation to specific review steps, and as a 

result, CTP may not appropriately make adjustments such as changing 

an individual staff member’s responsibilities or increasing the number of 

available staff.

As of January 7, 2013, CTP granted more meetings than it denied. The 

number of calendar days from the date a meeting request was received to 

the date a meeting was held varied widely, and CTP officials reported that 

logistics and subject matter contributed to these variations.

As of January 7, 2013, CTP’s offices had responded—granted, denied, or 

transferred—to over 93 percent of the meeting requests they received 

through January 7, 2013.35 Based on the data provided by CTP officials 

from the four offices that received meeting requests from outside entities, 

CTP’s offices responded to 108 of the 116 meeting requests received as 

of January 7, 2013 (see table 4). Of these 108 responses, 72 of the 

meeting requests were granted, 22 were denied, and 14 were transferred 

to another office within CTP.36

 

35The first meeting request was received by OCD on December 16, 2009.

According to CTP officials, in some cases, 

36The data compiled by the CTP offices did not include data on whether the transferred 

meeting requests were either granted or denied by the office receiving the transferred 

request. As a result, a transferred meeting request may also be counted as granted or 

denied in the office that received the transferred request.

CTP Granted Most 

Meeting Requests, but 

the Time from 

Request to Date Held 

Varied Widely

CTP Granted More 

Meetings Than It Denied
 

Page 30 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

the CTP office denied a meeting request because the office was able to 

address the entity’s questions by telephone and a formal meeting was 

no longer necessary. The remaining eight meeting requests were pending 

or withdrawn as of January 7, 2013. CTP officials told us that since 

January 7, 2013, they responded to three of the five pending meetings by 

granting two meetings and denying one. According to CTP officials, as of 

July 2013, the other two meetings were still pending because the meeting 

requester had not responded to CTP.

Table 4: Meeting Requests Received by FDA Center for Tobacco Products (CTP) through January 7, 2013

Number 

granted

Number 

denied

Number 

transferred a Number pending b Number withdrawn Total requests

Office of Center Director 22 6 4 0 0 32

Office of Compliance and Enforcement 3 6 2 1 0 12

Office of Policy 32 0 1 2 1 36

Office of Science 15 10 7 2 2 36

Total requests 72 22 14 5 3 116

Source: GAO analysis of FDA data.

a

According to CTP officials, in some cases, the CTP office denied a meeting request because the 

office was able to address the entity’s questions by telephone and a formal meeting was no longer 

necessary.

b

Of the 116 meeting requests from outside entities, most (74) were 

requested by tobacco manufacturers. Public health advocacy 

organizations had the second highest number with 19 meeting requests 

(see fig. 7).

The data compiled by the CTP offices did not include data on whether the transferred meeting 

requests were either granted or denied by the office receiving the transferred request. As a result, a 

transferred meeting request may also be counted as granted or denied in the office that received the 

transferred request.
 

Page 31 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 7: Meeting Requests Received by FDA Center for Tobacco Products (CTP) 

Offices, by Type of Entity

Note: This figure presents the type of entity requesting meetings with CTP offices for the 116 meeting 

requests received through January 7, 2013.

a

Of the 74 meeting requests by tobacco manufacturers, 35 of the meeting 

requests were granted, 20 were denied, and 12 were transferred.

Other entities include an animal rights organization, two federal agencies, two local, state, or tribal 

governments, and one entity for which CTP data did not indicate the type of entity that requested the 

meeting.

37

 

37The data compiled by the CTP offices did not include data on whether the transferred 

meeting requests were either granted or denied by the office receiving the transferred 

request. As a result, a transferred meeting request may also be counted as granted or 

denied in the office that received the transferred request.

The 

remaining 7 meeting requests were pending or withdrawn as of 

January 7, 2013. For the other types of entities, most of the requested 

meetings were granted. For example, all 19 meetings requested by public 

health advocacy organizations were granted. The topics of meeting 

requests differed among entities. For example, CTP data indicate that 

tobacco manufacturers typically requested meetings about tobacco 

product regulation and public health advocacy organizations generally 
 

Page 32 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

requested meetings in order to provide information to CTP that may be 

useful for CTP’s work.

The number of calendar days taken from the date a CTP office received a 

meeting request to the date the meeting was held varied widely.38

Table 5: Calendar Days from Date Meeting Request Received to Date Meeting Held, 

by Center for Tobacco Products (CTP) Office

For 

example, in OP, the number of days from the date a meeting request was 

received to the date a meeting was held ranged from 3 days to almost 

five months, with half of the responses to meeting requests taking more 

than about 1.5 months. Further, for OCD, the number of days from the 

date a meeting request was received to the date a meeting was held 

ranged from 9 days to more than 8 months with at least half of the 

responses to meeting requests taking over 2.5 months. (See table 5.)

Calendar Days

CTP Office 

(number of requests granted) Minimum a Median Maximum Average

Office of Center Director (n=22) 9 82 262 97

Office of Compliance and Enforcement (n=3) 1 39 112 51

Office of Policy (n=30) 3 45 150 52

Office of Scienceb (n=12) 22 86 149 79

Source: GAO analysis of FDA data.

a

In general, the amounts in this table represent the number of calendar days from the date a 

meeting request was received by the CTP office to the date on which the meeting was held for 67 of 

the 72 meeting requests for which the request was granted. Data were insufficient for calculating the 

calendar days for the remaining meetings that were granted. All of the requests were received 

through January 7, 2013.

b

For tobacco manufacturers, the type of entity with the most meeting 

requests, the amount of time taken from the date the meeting request 

was received to the date the meeting was held also varied by office. For 

For the Office of Science, the amounts represent the number of calendar days from the date a 

meeting request was received by any FDA office (instead of the date it was received by the Office of 

Science). Data maintained by the Office of Science did not include the dates that meeting requests 

were received by the office.

 

38We analyzed the CTP offices separately because the data maintained by each office 

varied. For example, OS officials maintain data only on the date the meeting request was 

received by FDA while OCD officials maintain data only on the date the meeting request 

was received by OCD.

The Time Taken from 

Meeting Request to Date 

Held Varied Widely; CTP 

Reported That Logistics 

and Subject Matter 

Contributed to Variations
 

Page 33 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

example, the minimum number of days from a meeting request to the 

date the meeting was held for OS was about a month, and the maximum 

was about 5 months, with half of the responses to meeting requests 

taking more than about 3 months. The minimum number of days from a 

meeting request to the date the meeting was held for OP was 3 days, and 

the maximum was almost 4 months, with half of the responses to meeting 

requests taking more than about 1.5 months.

According to CTP officials, logistics for scheduling meetings and the 

subject of the request contributed to the wide variation in time taken from 

the date of the request to the date the meeting was held. For example, 

OP officials said that the entity requesting the meeting may have to 

coordinate travel for several people across many locations in order to 

schedule a meeting and this coordination may contribute to a longer 

period of time before the meeting will take place. In addition, the subject 

matter of the request was another factor that CTP officials reported as 

contributing to the time taken by CTP offices to hold a meeting. For 

example, officials from OS said that CTP is a new regulatory agency and, 

as a result, it sometimes receives meeting requests on subject matters 

with which the center is unfamiliar and officials must involve many entities 

within both CTP and FDA to determine several things, including which 

office within CTP should host the meeting and what information the 

requested entity should prepare.

As of the end of fiscal year 2012, FDA had spent less than half of the 

tobacco user fees collected and CTP had spent less than planned. CTP 

officials reported that issues related to contracting contributed to lower 

than expected spending.39

 

39For 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.

FDA Spent Less than 

Half of the $1.1 Billion 

in User Fees 

Collected 
 

Page 34 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

As of the end of fiscal year 2012, FDA had spent less than half of the 

$1.1 billion in tobacco user fee funds collected (46 percent) from fiscal 

year 2009 through fiscal year 2012, leaving more than $603 million 

(54 percent) unspent.40

Figure 8: Total Tobacco User Fees Spent and Not Spent by FDA through Fiscal Year 

2012

(See fig. 8.) Of the almost $513 million spent 

during this time, CTP spent almost $468 million. The remaining funds 

were spent by other FDA entities, such as the Office of Regulatory Affairs.

Note: FDA currently relies on the U.S. Department of Agriculture to determine a manufacturer’s 

market share for the purpose of assessing tobacco user fees. Based on this assessment, FDA bills 

and collects tobacco user fees from manufacturers on a quarterly basis and fees are generally 

received the quarter after they are billed. This figure shows the tobacco user fees collected from fiscal 

year 2009 through fiscal year 2012 (which totaled about $1.1 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. The total amount collected is the amount received through fiscal year 2012. 

The figure does not include about $62 million that was billed in fiscal year 2012 but collected in fiscal 

year 2013. Of the almost $513 million spent by FDA, the Center for Tobacco Products spent almost 

$468 million. The remaining funds were spent by other FDA entities (including the Office of 

Regulatory Affairs, Headquarters, and the Office of the Commissioner) and include funds spent on 

U.S. General Services Administration rent. 

 

40The total amount collected is the amount received through fiscal year 2012, and does 

not include the tobacco user fee funds billed at the end of fiscal year 2012 and collected 

in the first quarter of fiscal year 2013 (which as of February 28, 2013, totaled about 

$62 million).

FDA Spent Less than Half 

of the User Fees Collected 

and CTP Spent Less than 

Planned
 

Page 35 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

In fiscal years 2011 and 2012, CTP spent less than the amounts it 

identified in its spend plan—that is, spent less than planned. According to 

CTP officials, the center’s spend plan identifies plans for spending CTP’s 

user fee funds on staffing, acquisitions, and operational needs.41 The 

spend plan is based on user fee funds anticipated to be collected by FDA 

and user fee funds that CTP did not spend in the previous fiscal year.42

Based on the spend plan for fiscal year 2011, all seven CTP offices had 

planned on spending a total of $225.4 million for fiscal year 2011, and 

these offices spent $106.4 million for that year.43 CTP continued to spend 

less than planned for fiscal year 2012. (See table 6.) CTP officials 

reported that based on spending through the third quarter of fiscal year 

2013, the difference between the amount of planned spending and the 

amount of actual spending in fiscal year 2013 will be less than the 

differences between planned and actual spending in previous years. 

CTP planned to spend more than $810 million in fiscal year 2013, and as 

of June 30, 2013, CTP has spent or is committed to spend over 

$712 million.44

 

41CTP also develops spend plans for other FDA entities that carry out tobacco-related 

activities (which include the Office of Regulatory Affairs, Headquarters, and Office of the 

Commissioner) based on discussions about the tobacco related activities that these other 

FDA entities will perform.

42User fees that have not been spent can be carried over to subsequent fiscal years.

43CTP did not develop a spend plan at the office or overhead level for fiscal year 2010, 

the first year of its operation. However, CTP planned to spend almost $212 million in fiscal 

year 2010, which includes overhead, and spent about $67 million.

44In addition, CTP officials project that they will have $256 million in unspent tobacco user 

fee funds to carry over to fiscal year 2014, which is less than half of the amount they 

carried over to fiscal year 2013. CTP officials also project that unspent funds or funds 

carried over to subsequent fiscal years will continue to decrease.
 

Page 36 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Table 6: Center for Tobacco Products (CTP) Planned and Actual Spending, Fiscal 

Years 2011 and 2012

Dollars in millions

CTP Non-Overhead CTP Overheada Total

Fiscal year

b

Planned Spent Planned Spent Planned Spent

2011 $225.4 106.4 79.2 27.8 304.6 134.1

2012 $585.0 245.7 25.6 26.0 610.5 271.7

Source: GAO summary of FDA data.

Note: 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. In addition, amounts from CTP and overhead may not 

equal total due to rounding.

a

Overhead includes information technology infrastructure and centralized funding for (among other 

things) furniture, office equipment, and center-wide training.

b

Specifically, six of the seven CTP offices spent less user fee funding than 

CTP planned for fiscal years 2011 and 2012. For example, for fiscal year 

2011, CTP’s Office of Health Communication and Education, OCE, and 

OS planned to spend about $30 million more than they actually spent; 

and the Office of Management was the only CTP office that planned to 

spend less than it actually spent—it planned to spend about $1 million 

less than it spent. (See fig. 9.)

This total does not include amounts planned or spent for other FDA entities and on U.S. General 

Services Administration rent. Other FDA entities include the Office of Regulatory Affairs, 

Headquarters and the Office of the Commissioner. In fiscal years 2011 and 2012, these entities spent 

$11.1 million and $24 million, respectively.
 

Page 37 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 9: Center for Tobacco Products (CTP) Planned and Actual Spending, by Office, Fiscal Years 2011 and 2012

Note: Planned refers to the amount indicated in CTP’s annual spend plan. 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.

CTP officials told us that issues related to contracting accounted for most 

of the difference between the amounts spent and planned spending. 

Specifically, they reported that the time it took to award contracts resulted 

in CTP not spending the funds that the center planned to spend for a 

given fiscal year. For example, according to CTP officials, CTP’s Office of 

Health Communication and Education had planned to award a $55 million 

contract for communications support services for part of its public 

education campaign for fiscal year 2011. This office also planned to 

award a related $145 million contract in fiscal year 2012 for a public 

health education campaign. However, most of the planned $200 million 

CTP Officials Reported 

That Issues Related to 

Contracting Contributed to 

Lower than Expected 

Spending 
 

Page 38 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

total was not awarded until the first quarter of fiscal year 2013.45

Spending for other contracts for both fiscal years 2011 and 2012 was 

lower than expected for a number of reasons, according to CTP officials: 

fewer than expected contracts were awarded, the scope of a contract 

changed, or CTP was short of staff to support the work of the contract.

CTP 

officials told us that both contracts were not awarded at these amounts in 

fiscal year 2011 or 2012 as planned because CTP and FDA spent 

significant amounts of time to determine the structure of the contract as 

FDA had never conducted a public education campaign of this 

magnitude.

• For fiscal year 2011, CTP’s OCE had planned to award $55 million in 

contracts with states to ensure compliance with tobacco regulations, 

but CTP awarded a total of $24 million for that fiscal year because 

fewer states participated than expected.

• For fiscal year 2012, CTP’s OS entered into an interagency 

agreement with the Centers for Disease Control and Prevention to 

develop analytical methods and establish baseline levels of harmful or 

potentially harmful constituents in tobacco products for $20 million 

less than planned because of a change in scope of the activities for 

this contract.

• For fiscal year 2011, CTP’s Office of Health Communication and 

Education entered into an interagency agreement with the National 

Institutes of Health to support regulatory communications activities. 

The agreement was $3.5 million less than initially planned because 

the Office of Health Communication and Education was just being 

established at the time and it did not have enough staff to support this 

joint effort. As a result, the office reduced the scope of the contract.

In addition to issues related to contracting, CTP officials said that plans to 

hire more staff than it did and planned management related activities that 

were not undertaken were other reasons why the amounts spent were 

lower than planned. According to CTP officials, for fiscal years 2011 and 

2012, CTP had planned to hire more staff than it did and this accounted 

for $6 million and $10 million of the differences between amounts planned 

 

45In order to meet the guarantee of these contracts, the minimum amount was awarded in 

fiscal year 2012 and that amount was about $300,000.
 

Page 39 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

to be spent and spent, respectively. Further, according to CTP officials, 

lower than planned spending for other management activities (such as 

computer updates and planning potential reorganization) is another 

reason why the amounts spent by CTP were lower than planned. For 

example, for fiscal year 2011, the CTP spend plan included $35 million for 

planning associated with establishing two new offices within CTP. 

According to CTP officials, this amount was expected to cover 

contingencies, such as computer updates or management development, 

if they were needed. However, the officials reported that this reserve was 

not used because funds were available in the Office of Management to 

handle any issues related to the addition of these new offices.

Four years after the Tobacco Control Act established CTP and about 

3 years after the first new tobacco product submission, FDA has received 

about 4,000 submissions and collected over $1.1 billion in tobacco user 

fee funds. Although CTP has finished initial review steps for most of these 

submissions, as of June 2013, the center made a final decision on only 

6 submissions and the time taken on reviews has been significant. 

Certainly, insufficient information provided by manufacturers in 

submissions, the prioritization of regular SE submission reviews over 

provisional SE submissions, and other factors have contributed to the 

time CTP has taken in its reviews. Yet, as CTP moves forward with its 

work, the lack of performance measures like time frames for reviews of 

SE submissions will limit CTP’s ability to evaluate policies, procedures, 

and staffing resources in relation to CTP’s submission review process 

and, in turn, limit CTP’s ability to reasonably assure efficient operations 

and effective results. An entity that is limited in its ability to evaluate its 

performance will be hard-pressed to determine what adjustments it 

should make to its operations or how to plan for the future.

To improve CTP’s ability to operate efficiently, achieve effective results, 

and plan appropriately, we recommend that the Secretary of Health and 

Human Services direct the Commissioner of FDA to

• establish performance measures that include time frames for making 

final decisions on SE submissions and Exemption from SE 

submissions, and

• monitor FDA’s performance relative to those time frames, such as 

evaluating whether staff are performing reviews of these submissions 

efficiently and effectively.

Conclusions 

Recommendations for 

Executive Action 
 

Page 40 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

We provided a draft of this report to HHS for comment. In its written 

comments, reproduced in appendix II, HHS agreed with our 

recommendations. Specifically, HHS stated that FDA will identify 

performance measures and time frames for regular SE and Exemption 

from SE review processes within 6 months of our report’s publication and 

that FDA will monitor its progress to determine if subsequent SE reviews 

meet the identified time frames. In addition, HHS commented that FDA 

will identify performance measures and time frames for the provisional SE 

review process as FDA gains more experience reviewing these SE 

submissions. HHS further stated that based on the actual performance of 

meeting the identified time frames, FDA will make modifications to the 

review process, if appropriate, in order to meet agency objectives.

HHS also provided additional information on CTP activities in its 

comments. For example, HHS stated that CTP is working to reach 

determinations on SE and Exemption from SE submissions as 

expeditiously as possible, and that CTP has continued to make progress 

on conducting product reviews and in its process and timeliness for 

responding to requests for meetings with CTP offices. Regarding tobacco 

user fee funds, HHS commented that CTP is projecting that it will 

decrease the amount of unspent tobacco user fee funds to carry over at 

the end of fiscal year 2013 to the mid-$200 millions, which is less than 

half of the amount carried over at the end of fiscal year 2012. HHS also 

suggested that our report should include information on all user fee 

spending, including spending by FDA entities other than CTP. We do 

report total user fees spent and not spent by FDA, including spending by 

both CTP and other FDA entities, through fiscal year 2012. In comparing 

spend plans with actual spending, we reported on spending by CTP, 

which comprised more than 90 percent of the $513 million spent by FDA 

through fiscal year 2012. In reporting on CTP spending, we clearly note 

that other FDA entities, including the Office of Regulatory Affairs, 

Headquarters, and the Office of the Commissioner, spend tobacco user 

fee funds, and that these entities spent $11 million in fiscal year 2011 and 

$24 million in fiscal year 2012.

HHS also provided technical comments that were incorporated, as 

appropriate.

Agency Comments
 

Page 41 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

As agreed with your office, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send 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 GAO’s Web site 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 III.

Sincerely yours,

Marcia Crosse

Director, Health Care
Appendix I: Staffing Resources for Conducting 

Reviews of New Tobacco Product 

Submissions

Page 42 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

As of January 7, 2013, the Office of Science (OS)—the only Center for 

Tobacco Products (CTP) office involved in all steps of reviewing new 

tobacco product submissions—had 124 staff members on board, and the 

majority of the staff (102 or 82 percent) reported spending some portion 

of their time reviewing new tobacco product submissions. OS has other 

responsibilities in addition to reviewing new tobacco product submissions, 

including research to meet regulatory science needs and to evaluate the 

population and public health impact of tobacco products. According to OS 

officials, of the 102 staff who reported spending time on reviewing 

submissions, 60 percent or 61 staff reported that in general they spent at 

least half of their time working on reviews of new tobacco product 

submissions. The remaining 41 staff reported generally spending less half 

of their time on reviews of new tobacco product submissions.1 (See 

fig. 10.)

 

1

According to OS officials, specific details on how many full-time equivalent staff spent 

time on reviews of new tobacco product submissions were not available. In the absence of 

specific data, we obtained data from OS on the proportion of time (none of the time, less 

than 50 percent of the time, or 50 percent or more of the time) each OS position spent on 

new tobacco submissions, for staff on board as of January 7, 2013.

Appendix I: Staffing Resources for 

Conducting Reviews of New Tobacco 

Product Submissions
Appendix I: Staffing Resources for Conducting 

Reviews of New Tobacco Product 

Submissions

Page 43 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Figure 10: Center for Tobacco Products (CTP) Office of Science (OS) Staff Time 

Spent Conducting Reviews of New Tobacco Products

Note: This figure represents the percentage of staff that spent less than or at least half of their time 

working on reviews of new tobacco product submissions, as reported by 124 OS staff that were on 

board as of January 7, 2013. According to OS officials, specific details on how many full-time 

equivalent staff spent time on reviews of new tobacco product submissions were not available. In the 

absence of specific data, we obtained data from OS on the proportion of time (none of the time, less 

than 50 percent of the time, or 50 percent or more of the time) staff members in each OS position 

spent on new tobacco submissions, for staff on board as of January 7, 2013.

The amount of time an OS staff person reported spending on new 

tobacco product submissions varied by job title. Specifically, the 

23 project managers, the OS officials responsible for coordinating the 

reviews of new tobacco product submissions, and 17 scientists (such as 

chemists and toxicologists) reported spending at least half of their time 

working on reviews of new tobacco product submissions. Meanwhile, the 

Deputy Director for Research and the Special Assistant to the Director 

reported spending less than half of their time on the review of new 

tobacco product submissions. (See table 7.)
Appendix I: Staffing Resources for Conducting 

Reviews of New Tobacco Product 

Submissions

Page 44 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Table 7: Time Spent on Review of New Tobacco Product Submissions for the Center for Tobacco Products (CTP) Office of 

Science by Job Title

Time on reviews 

of submissions Office of Science Job titles

50 percent or more • Director, Office of 

Science

• Associate Director 

Regulatory Science 

Management

• Associate Director 

for Science Policy

• Medical Officer

• Regulatory Health 

Project Manager

• Director, Regulatory 

Science Informatics

• Regulatory Health 

Information Specialist

• Director, Deputy 

Director, Product 

Science

• Chemist

• Engineer

• Toxicologist

• Pharmacologist

• Interdisciplinary 

Scientist

• Fellow

• Statistician

Less than 

50 percent

• Deputy Director for 

Research

• Special Assistant to 

the Director

• Conflict of Interest 

Specialist

• Health Scientist 

Administrator

• Psychologist/Behavioral 

Scientist/Neuroscientist

• Epidemiologist

• Social Scientist

•

Source: GAO summary of FDA information.

Note: This table shows the job titles for which CTP staff reported generally spending 50 percent or 

more of their time on new tobacco product submission reviews or less than 50 percent of their time 

(but more than 0 percent) on new tobacco product submission reviews, as reported by Office of 

Science staff that were on board as of January 7, 2013. The number of staff for each job titled varied 

from 1 to 23 staff. The job title with 23 staff was regulatory health project manager.
Appendix II: Comments from the Department 

of Health and Human Services

Page 45 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Appendix II: Comments from the Department 

of Health and Human Services
Appendix II: Comments from the Department 

of Health and Human Services

Page 46 GAO-13-723 FDA Reviews of New Tobacco Product Submissions
Appendix II: Comments from the Department 

of Health and Human Services

Page 47 GAO-13-723 FDA Reviews of New Tobacco Product Submissions
Appendix II: Comments from the Department 

of Health and Human Services

Page 48 GAO-13-723 FDA Reviews of New Tobacco Product Submissions
Appendix II: Comments from the Department 

of Health and Human Services

Page 49 GAO-13-723 FDA Reviews of New Tobacco Product Submissions
Appendix II: Comments from the Department 

of Health and Human Services

Page 50 GAO-13-723 FDA Reviews of New Tobacco Product Submissions
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 51 GAO-13-723 FDA Reviews of New Tobacco Product Submissions

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

In addition to the contact named above, Kim Yamane, Assistant Director; 

Danielle Bernstein; Hernán Bozzolo; Britt Carlson; Cathleen Hamann; 

Richard Lipinski; and Lisa Motley made key contributions to this report.

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(291082)
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