TOBACCO PRODUCTS

FDA Spending and New 

Product Review Time 

Frames

Statement of Marcia Crosse 

Director, Health Care

Testimony 

Before the Subcommittee on Health, 

Committee on Energy and Commerce, 

House of Representatives

For Release on Delivery 

Expected at 10:15 a.m. EDT

Tuesday, April 8, 2014

GAO-14-508T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-14-508T, a testimony 

before the Subcommittee on Health, 

Committee on Energy and Commerce, House 

of Representatives

April 8, 2014

TOBACCO PRODUCTS

FDA Spending and New Product Review Time Frames

Why GAO Did This Study

In 2009, the Tobacco Control Act 

granted FDA authority to regulate 

tobacco products such as cigarettes. 

The act authorizes FDA to assess and 

collect user fees from each tobacco 

manufacturer and importer for FDA 

activities related to tobacco product 

regulation. The act also requires that 

manufacturers submit information—for 

example, a statement of the tobacco 

product’s ingredients—to be reviewed 

by FDA in order to market new tobacco 

products. FDA reviews the products 

using a public health standard, taking 

into account the risks and benefits of 

tobacco products on the population as 

a whole, including users and nonusers. 

The act represents the first time that 

FDA has had the authority to regulate 

tobacco products.

This testimony highlights and provides 

selected updates to key findings from 

our September 2013 report, entitled, 

New Tobacco Products: FDA Needs to 

Set Time Frames for Its Review 

Process (GAO-13-723). This report

examined (1) the extent to which FDA 

spent its tobacco user fee funds, and 

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

tobacco product submissions. GAO 

reviewed FDA data on tobacco user 

fees collected by FDA and spent by all 

of CTP’s offices. GAO also analyzed 

CTP data on product submissions, 

including whether specific steps in the 

review process had been completed.

What GAO Recommends

In its September 2013 report, GAO 

recommended FDA establish time 

frames for making decisions on 

submissions. FDA plans to identify 

time frames in spring 2014 and 

implement them by October 2014.

What GAO Found

The Food and Drug Administration (FDA) spent (obligated) less than half of the 

$1.1 billion in tobacco user fees it collected from manufacturers and others from 

fiscal year 2009 through the end of fiscal year 2012; however, FDA’s spending 

increased substantially in fiscal year 2013. Through December 31, 2013, FDA 

spent nearly 81 percent of the approximately $1.75 billion in fees collected by 

that time. According to officials in FDA’s Center for Tobacco Products (CTP), the 

center established by the Family Smoking Prevention and Tobacco Control Act 

(Tobacco Control Act) to implement the act’s provisions, the time it took to award 

contracts contributed to the center spending less than it had planned to spend. In 

fiscal year 2013, FDA was able to carry out a number of activities that were 

originally planned for fiscal years 2011 and 2012, such as efforts to educate 

youth on the dangers of tobacco use. About 79 percent ($1.12 billion) of user 

fees spent as of December 31, 2013, was spent by three CTP offices: Office of 

Health Communication and Education, Office of Science, and Office of 

Compliance and Enforcement.

As of January 7, 2013, CTP had finished initial, but not final, review steps for 

most of about 3,800 submissions it had received for new tobacco products (those 

not on the market on February 15, 2007). Ninety-nine percent of the submissions 

received were made under the substantial equivalence (SE) pathway, through 

which CTP determines whether the 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 to be substantially equivalent) or has 

different characteristics that do not raise different questions of public health. For 

most SE submissions received by January 7, 2013, CTP took more than a year 

and a half from the date a submission was received to the date CTP’s initial 

review steps were completed; initial review steps precede a scientific review step 

during which CTP determines whether the product is substantially equivalent to a 

predicate product. CTP made its first decisions on SE submissions in late June 

2013—about 3 years after FDA’s receipt of the first SE submission—and as of 

December 31, 2013, had made final decisions for 30 of the 4,490 SE 

submissions the agency had received. CTP officials stated that CTP requests for 

additional information from manufacturers for submissions and having to hire and 

train new staff impacted the time it took to review submissions. GAO also found 

that CTP has not had performance measures that include time frames for making 

final decisions on SE submissions by which to assess its progress. Time frames 

would allow CTP to evaluate its efficiency and effectiveness and help it make 

appropriate adjustments.

View GAO-14-508T. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov.
 

Page 1 GAO-14-508T

Chairman Pitts, Ranking Member Pallone, and Members of the 

Subcommittee,

I am pleased to be here today to discuss the Food and Drug 

Administration’s (FDA) implementation of the Family Smoking Prevention 

and Tobacco Control Act (Tobacco Control Act). 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. In June 

2009, the Tobacco Control Act granted the FDA, an agency within the 

Department of Health and Human Services (HHS), authority to regulate 

tobacco products such as cigarettes.1

The Tobacco Control Act also established the Center for Tobacco 

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

The act requires that tobacco 

manufacturers 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 in order to market 

new tobacco products. FDA reviews the products using a public health 

standard, taking into account the risks and benefits of tobacco products 

on the population as a whole, including users and nonusers. The act 

represents the first time that FDA has had the authority to regulate 

tobacco products.

2

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.3

 

1

Pub. L. No. 111-3, div. A, 123 Stat. 1776 (2009). Tobacco products that FDA currently 

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

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

tobacco products—for example, cigars, pipe tobacco, hookah, and e-cigarettes that do not 

make drug claims—through rulemaking. In October 2013, FDA submitted to the White 

House Office of Management and Budget (OMB) a proposed rule to regulate other 

tobacco products that are not currently regulated. As of April 2, 2014, the proposed rule 

was still under review by the OMB and had not been issued by FDA.

The act also authorizes FDA to assess and 

2

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

3

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.
 

Page 2 GAO-14-508T

collect user fees from each tobacco manufacturer and importer and 

specifies that the tobacco user fees may only be applied towards FDA 

activities that relate to the regulation of tobacco products.4

My statement will highlight key findings from our September 2013 report 

on FDA’s review process for new tobacco products, and includes selected 

updates to the report.

All of CTP’s 

activities are funded exclusively through tobacco user fees.

5

To examine 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 

amount spent by all of CTP’s offices.

Among other things, our report examined (1) the

extent to which FDA spent its tobacco user fee funds, and (2) the status 

of CTP’s reviews of new tobacco product submissions.

6

To examine the status of CTP’s reviews 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 

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

We also reviewed FDA and CTP 

documents, such as FDA budget justification documents. In addition, we 

obtained and reviewed updated information from CTP on tobacco user 

fees collected and spent, including spending by each CTP office, through 

December 31, 2013.

 

4

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

government. The Tobacco Control Act specified the total amount of user fees authorized 

to be collected for each fiscal year beginning with fiscal year 2009, and authorized user 

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

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

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

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

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

amount authorized under the Tobacco Control Act. 

5

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

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

6

For the purposes of this testimony, 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.
 

Page 3 GAO-14-508T

dates for each submission. We also reviewed relevant laws, regulations, 

and agency documents (such as guidance documents and draft standard 

operating procedures); we 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.7

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 also 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. In addition, we obtained and examined updated data on the 

number of new tobacco product submissions received by FDA as of 

December 31, 2013. We also discussed factors affecting timeframes with 

CTP officials.

We conducted the work for the report on which this statement is based 

from November 2012 to September 2013, and updated selected

information in April 2014, 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 that the evidence obtained provides a reasonable 

basis for our findings and conclusions based on our audit objectives.

 

7

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-14-508T

FDA spent (obligated) less than half of the tobacco user fees it collected 

from manufacturers and others through the end of fiscal year 2012; 

however, FDA’s spending increased substantially in fiscal year 2013. 

From fiscal year 2009 through the end of fiscal year 2012, FDA had 

collected about $1.1 billion in tobacco user fees; $603 million of these 

user fees remained unspent at the end of fiscal year 2012 and, thus, 

remained available to CTP (see fig. 1). The $513 million CTP did spend 

was substantially less than it had planned to spend. For example, in fiscal 

years 2011 and 2012, CTP spent about 45 percent of what it had planned 

to spend. CTP officials told us 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. 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 contracts than expected were 

awarded, the scope of a contract changed, or CTP was short of staff to 

support the work of the contract.8

 

8

CTP officials told us that fewer than expected contracts were awarded in those fiscal 

years because, for example, CTP and FDA spent significant amounts of time to determine 

the structure of public education campaign contracts.

FDA Spent Less Than 

Half of the User Fees 

Collected by the End 

of Fiscal Year 2012; 

Spending Increased 

Substantially in Fiscal 

Year 2013
 

Page 5 GAO-14-508T

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

2012

Note: 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, other rent, and rent-related activities. 

The proportion of collected tobacco user fees that FDA spent increased 

substantially in fiscal year 2013. Through December 31, 2013, FDA had 

collected nearly $1.75 billion in tobacco user fees and spent nearly 

$1.42 billion; $332 million of these fees remained unspent (see fig. 2).
 

Page 6 GAO-14-508T

Figure 2: Total Tobacco User Fees Spent and Not Spent by FDA as of December 31, 

2013

Note: This figure shows the tobacco user fees collected from fiscal year 2009 through December 31, 

2013 (which totaled about $1.75 billion), the percentage and amount of these fees spent during this 

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

the $1.42 billion spent by FDA, the Center for Tobacco Products and FDA’s Office of Regulatory 

Affairs spent about $1.36 billion. The remaining funds were spent by other FDA entities (including 

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

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

More than half of FDA’s spending on tobacco-related activities through 

December 31, 2013, (61 percent) occurred in fiscal year 2013. FDA spent 

$868 million that fiscal year. As the contracting issues the agency 

encountered in the initial years of the center were addressed, FDA was 

able to carry out a number of activities in fiscal year 2013 that were 

originally planned for fiscal years 2011 and 2012 such as public health 

education campaigns. About 79 percent ($1.12 billion) of user fees spent 

as of December 31, 2013, was spent by three CTP offices: Office of 

Health Communication and Education, OS, and Office of Compliance and 

Enforcement (see fig. 3). In fiscal year 2013, CTP’s Office of Health 

Communication and Education was responsible for the majority of the 

spending, which supported, in large part, its efforts to educate youth on 

the dangers of tobacco use.
 

Page 7 GAO-14-508T

Figure 3: FDA Spending by Center for Tobacco Products Office as of December 31, 

2013

Note: This figure excludes FDA spending on tobacco-related activities in fiscal year 2009. Overhead 

includes U.S. General Services Administration rent and rent-related activities; Center for Tobacco 

Products and FDA overhead (information technology infrastructure and centralized funding for, 

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

spending of FDA headquarters and the Office of the Commissioner. Other offices include CTP’s 

Office of the Center Director, Office of Management, Office of Policy, and Office of Regulation.

Spending for the Office of Compliance and Enforcement includes spending for FDA’s Office of 

Regulatory Affairs, which conducts inspections.
 

Page 8 GAO-14-508T

As of January 7, 2013, 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. Under this pathway for new tobacco products, 

CTP determines whether the 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. About 84 percent (3,165) 

of the 3,788 SE submissions received as of January 7, 2013, were 

provisional SE submissions—that is, they were received by FDA prior to a 

statutory deadline allowing the product to be marketed unless CTP finds 

that they are not substantially equivalent.9 SE submissions received after 

that statutory deadline—called regular SE submissions—cannot be 

marketed until CTP determines they are substantially equivalent. In 

addition to submissions under the SE pathway, FDA had received 

23 submissions under the Exemption from SE pathway and had not 

received any submissions under the Premarket Tobacco Product 

Application (PMTA) pathway.10

 

9

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.

See figure 4 for information on each new 

tobacco product submission pathway and the number of submissions 

FDA received under each as of January 7, 2013.

10Eligibility 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. New tobacco 

products that are not substantially equivalent or are not minor modifications of an existing 

tobacco product are subject to the PMTA pathway, which, among other things, requires 

submission of full reports of investigations of health risks. According to CTP officials and 

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

may be the challenge in demonstrating that a manufacturer has met the public health 

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

CTP Finished Initial, 

but Not Final, Review 

Steps for Most 

Submissions, and 

Lacks Time Frames 

for Its Review 

Processes
 

Page 9 GAO-14-508T

Figure 4: Number of Submissions Received by FDA for Each New Tobacco Product Pathway 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 10 GAO-14-508T

As of January 7, 2013, CTP finished initial, but not final, review steps for 

over two-thirds of the SE submissions the agency received since June 

2010.11 For most SE submissions, CTP took more than a year and a half 

from the date a submission was received to the date CTP’s initial review 

steps were completed. 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.12

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

3 years after FDA’s receipt of the first SE submission—and as of 

December 31, 2013, CTP had made a final decision on a total of 30 of the 

4,490 SE submissions it had received. All 30 final decisions were for 

regular SE submissions—FDA found 17 submissions to be substantially 

equivalent and 13 submissions to be not substantially equivalent to a 

predicate tobacco product. In addition, CTP had refused to accept 

22 of the 59 Exemption from SE submissions because the submissions 

did not meet statutory requirements, and had made no decisions for the 4 

PMTA submissions. Of the 4,490 SE submissions FDA received as of 

December 31, 2013, 201 submissions had been withdrawn by 

manufacturers; of the 63 non-SE submissions FDA received, none were 

withdrawn. (See table 1.) 

These initial review steps are 

followed by a scientific review, which involves an assessment of the new 

product by scientists in different disciplines (such as chemistry and 

toxicology) to determine whether it is substantially equivalent to a 

predicate tobacco product. As of January 7, 2013, CTP had not finished 

scientific review for any SE submissions—that is, had not made any 

decisions on SE submissions.

 

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

12Our analysis of data provided by CTP found that the length of time to determine whether 

regular SE submissions were missing information improved over time.
 

Page 11 GAO-14-508T

Table 1: Number of New Tobacco Product Submissions and Status of FDA Review, as of December 31, 2013 

Decisions

Submission type 

Submissions 

received

Initial review 

completed

Closed review 

without decision

(withdrawal)

Product 

meets criteria 

for marketing

Product 

does not

meet criteria 

for marketing

Refuse to 

accept or 

refuse to file

Substantial 

Equivalence (SE)

Provisional a 3,557 b 3,230 117 0 0 0 

Regular 933 c 862 84 17 13 0 

Total SE 4,490 4,092 201 17 13 0 

Exemption from SEd 59 30 0 0 0 22

Premarket tobacco 

product application 

(PMTA)e 4 0 0 0 0 0 

Source: GAO summary of FDA information.

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

information—for example, a statement of the product’s ingredients—to be reviewed by FDA using the 

public health standard in order to legally market tobacco products in the United States.

a

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.

b

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.

c

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.

d

Manufacturers use the Exemption from SE pathway for new tobacco products with minor 

modifications (adding, deleting, or changing the quantity of an additive) of another product marketed 

by the same manufacturer.

e

In February 2014, CTP made its first decisions on provisional SE 

submissions, finding products in four provisional SE submissions to be 

not substantially equivalent to predicate products. The agency issued 

orders on February 21, 2014, to stop the further sale and distribution of 

four tobacco products currently on the market.

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

other two pathways. Products included in PMTA submissions can only be legally marketed after FDA 

issues an order permitting their marketing.

13

 

13FDA publishes its final decisions—including the four orders for its decisions to stop the 

further sale and distribution of tobacco products on the market that were issued on 

February 21, 2014—on its website: 

http://www.fda.gov/tobaccoproducts/labeling/marketingandadvertising/ucm339928.htm

(accessed Apr. 3, 2014).

According to FDA, the 
 

Page 12 GAO-14-508T

company making the SE submissions did not provide sufficient

information to support a finding of substantial equivalence—for example, 

the company did not fully identify eligible predicate tobacco products as 

required for CTP to perform an SE review.

CTP officials and manufacturers told us 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. Another factor affecting review time frames was 

CTP’s decision to place 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 reviews for regular SE 

submissions over provisional SE submissions, so resources were shifted 

away from provisional 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 would be the most 

effective at addressing the public health burden of tobacco use.

While CTP has been working to address these factors by, for example, 

disseminating information to manufacturers to improve submission quality 

and developing training for staff, CTP has not had performance measures 

that include time frames for making final decisions on SE submissions by 

which to assess its progress.14

 

14The 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.

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 
 

Page 13 GAO-14-508T

monitoring of actual performance against measures are an integral part of 

operating efficiently, achieving effective results, and planning 

appropriately.15 We reported that 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. We recommended 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.16 HHS agreed with our

recommendation, and as of April 2, 2014, FDA officials said that they 

expect to identify performance measures that include time frames for the 

regular SE and Exemption from SE review processes in spring 2014, and 

to implement these performance measures by October 2014.17

In addition, although FDA has increased its staff and training for staff, 

tobacco industry stakeholders expressed concerns about whether CTP 

will have a sufficient number of qualified staff to review the backlog of the 

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

December 31, 2013 and also review new submissions that may be made 

in the future, particularly if FDA asserts jurisdiction over new types of 

tobacco products that are not currently subject to FDA’s regulatory 

authority. CTP officials reported that many additional staff have been and 

will continue to be hired and trained, and the center does not expect 

hiring qualified staff to be a continuing challenge for the purpose of 

conducting product reviews.

 

15While we focused on the timeliness of the reviews in our work, 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.

16GAO-13-723, 39.

17In response to our recommendation, FDA stated that the agency will take a phased 

approach to implementing these performance measures and time frames, starting with 

regular SE submissions and Exemption from SE submissions. FDA stated that as the 

agency gains more experience with reviewing provisional SE submissions, it will begin to 

implement performance measures and time frames with respect to those submissions.
 

Page 14 GAO-14-508T

Chairman Pitts, Ranking Member Pallone, and Members of the 

Subcommittee, this completes my prepared statement. I would be 

pleased to respond to any questions that you may have at this time.

If you or your staff have any questions about this testimony, please 

contact me at (202) 512-7114 or crossem@gao.gov. Contact points for 

our Offices of Congressional Relations and Public Affairs may be found 

on the last page of this statement. GAO staff who made key contributions 

to this testimony are listed in appendix I.

GAO Contact and 

Staff 

Acknowledgments
Appendix I: GAO Contact and Staff 

Acknowledgments

Page 15 GAO-14-508T

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; Sandra George; 

Cathleen Hamann; Erin Henderson; Mariel Lifshitz; Richard Lipinski; and 

Lisa Motley made key contributions to this statement.

Appendix I: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(291212)
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