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EXAMINING THE IMPLEMENTATION OF THE 

TOBACCO CONTROL ACT 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

APRIL 8, 2014 

Serial No. 113–139 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 2 

Hon. Brett Guthrie, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 2 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 3 

Hon. Eliot L. Engel, a Representative in Congress from the State of New 

York, opening statement ...................................................................................... 5 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 6 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 8 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

prepared statement .............................................................................................. 53 

WITNESSES

Marcia Crosse, Director, Health Care, Government Accountability Office ......... 9 

Prepared statement .......................................................................................... 12 

Answers to submitted questions ...................................................................... 59 

SUBMITTED MATERIAL

H.R. 389, the Transparency in Tobacco User Fees Act of 2013, submitted 

by Mr. Pitts ........................................................................................................... 55 

(1) 

EXAMINING THE IMPLEMENTATION OF THE 

TOBACCO CONTROL ACT 

TUESDAY, APRIL 8, 2014 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON ENERGY AND COMMERCE, COMMITTEE ON HEALTH, Washington, DC. 

The subcommittee met, pursuant to call, at 10:17 a.m., in room 

2322 of the Rayburn House Office Building, Hon. Joe Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Burgess, Shimkus, Murphy, Lance, Cassidy, Guthrie, Griffith, Bilirakis, Ellmers, Upton 

(ex officio), Pallone, Engel, Capps, Green, Barrow, Christensen, 

Castor, and Waxman (ex officio). 

Staff present: Gary Andres, Staff Director; Noelle Clemente, 

Press Secretary; Paul Edattel, Professional Staff Member, Health; 

Sydne Harwick, Legislative Clerk; Carly McWilliams, Professional 

Staff Member, Health; Charlotte Savercool, Legislative Coordinator; Heidi Stirrup, Policy Coordinator, Health; John Stone, Counsel, Health; Ziky Ababiya, Democratic Staff Assistant; Karen Lightfoot, Democratic Communications Director and Senior Policy Advisor; Karen Nelson, Democratic Deputy Staff Director, Health; Anne 

Morris Reid, Democratic Senior Professional Staff Member; and 

Matt Siegler, Democratic Counsel. 

Mr. PITTS. The subcommittee will come to order. Chair will recognize himself for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

The Tobacco Control Act, TCA, was signed into the law on June 

22, 2009. The TCA established the Center for Tobacco Products, the 

CTP, within FDA, and gave FDA authority over the regulation of 

tobacco products, including restricting their sale, distribution, advertising and promotion. In addition, FDA has the authority to require changes in the design and characteristics of current and future tobacco products, such as the reduction or elimination of 

harmful ingredients and additives. The sole funding source for CTP 

is user fees assessed on tobacco manufacturers and importers. 

GAO has conducted a comprehensive study on the law’s implementation, and in September 2013, it released a report entitled 

‘‘New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process.’’ The report examines CTP’s review of new tobacco 

product submissions, responses to meeting requests, and use of its 

2 

user fees. Among its findings, GAO reports that CTP lacks basic 

performance measures ‘‘like time frames for reviews of submissions’’ and that this ‘‘limits CTP’s ability to evaluate policies, procedures and staffing resources in relation to CTP’s submission review 

process, and in turn limits CTP’s ability to reasonably assure efficient operations and effective results.’’ 

GAO concludes that ‘‘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.’’ This report raises troubling concerns about CTP’s performance, and its ability to effectively implement the Tobacco Control 

Act, and respond to the thousands of new product submissions it 

has received in a timely manner. 

As the subcommittee with oversight of FDA and the Center for 

Tobacco Products, we were hoping to hear directly from the FDA, 

however, Dr. Marcia Crosse of GAO is here today to walk us 

through the report and GAO’s ongoing efforts to oversee implementation of the act. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The Tobacco Control Act (TCA) was signed into law on June 22, 2009. 

The TCA established the Center for Tobacco Products (CTP) within FDA and gave 

FDA authority over the regulation of tobacco products, including restricting their 

sale, distribution, advertising, and promotion. In addition, FDA has the authority 

to require changes in the design and characteristics of current and future tobacco 

products, such as the reduction or elimination of harmful ingredients and additives. 

The sole funding source for CTP is user fees assessed on tobacco manufacturers 

and importers. 

GAO has conducted a comprehensive study on the law’s implementation, and, in 

September 2013, it released a report entitled ‘‘New Tobacco Products: FDA Needs 

to Set Time Frames for Its Review Process.’’ 

The report examines CTP’s review of new tobacco product submissions, responses 

to meeting requests, and use of its user fees. 

Among its findings, GAO reports that CTP lacks basic performance measures ‘‘like 

time frames for reviews of. . . submissions’’ and that this ‘‘limit[s] CTP’s ability to 

evaluate policies, procedures, and staffing resources in relation to CTP’s submission 

review process and, in turn, limit[s] CTP’s ability to reasonably assure efficient operations and effective results.’’ 

GAO concludes that ‘‘[a]n 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.’’ 

This report raises troubling concerns about CTP’s performance and its ability to 

effectively implement the Tobacco Control Act and respond to the thousands of new 

product submissions it has received in a timely manner. 

As the subcommittee with oversight of FDA and the Center for Tobacco Products, 

Dr. Marcia Crosse of GAO is here today to walk us through the report and GAO’s 

ongoing efforts to oversee implementation of the act. 

Thank you. 

Mr. PITTS. Yield the balance of my time to the gentleman from 

Kentucky, Mr. Guthrie. 

OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF KENTUCKY 

Mr. GUTHRIE. Thank you, Mr. Chairman. Thank you for yielding 

and holding this hearing today. 

3 

Congress granted the Center for Tobacco Products the authority 

to regulate tobacco products, but unfortunately, the process has 

been fraught with problems. I have heard from many in the industry, including constituents, who have been stuck in the dysfunctional CTP approval process. 

As a result of CTP’s inaction, many reduced risk or harm reduction products are not being approved and are not available to consumers. There are examples of ingredients that could be potentially 

hazardous, and are removed from products sold in other international markets, but because of the burdensome process at the 

FDA, and the unlikelihood that their submission would even be reviewed, they have to leave the ingredient in their products sold in 

the U.S. So consumers overseas are offered a potentially less harmful product than American consumers have access to. 

There are a number of examples like this, very minor tweaks 

that require substantial equivalence or SE submissions, and they 

just sit at CTP waiting approval. For March 2011 until June 2013, 

CTP did not rule on one single filing, and at that point, they ruled 

on six of nearly 4,000 submissions. To date, I believe they have 

made only 12 determinations. It appears that CTP is just not doing 

their job. 

I have a bill, House Resolution 389, that would exercise oversight 

over CTP, and require they submit a report to Congress on their 

activity. It is a good-government, commonsense approach to ensure 

that this agency of government works, and is accountable to Congress and the committee that is vested with its authority. 

Tobacco user fees are not subject to reauthorization, so there is 

little opportunity for the industry to enter into discussions with 

FDA the way pharmaceutical companies or device manufacturers 

can. As the oversight body, I believe we should be able to see how 

these funds are being used, the number of applications being reviewed or still pending, and get a clear picture of the division’s 

work. 

Mr. Chairman, my—by its inaction, CTP is blocking consumers 

from having access to less harmful products, with the little sign of 

improvement, I encourage my colleagues to support my bill, which 

would ensure we receive a clear picture of CTP’s activities moving 

forward. 

I yield back. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognizes the ranking member of the subcommittee, Mr. 

Pallone, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman, and thank you for calling today’s important hearing on the implementation of the Tobacco Control Act. 

This year marks 5 years since the Tobacco Control Act became 

law, which, for the first time, provided FDA the authority to regulate tobacco products. 

The Center for Tobacco Products was given an enormous but 

critically overdue task to protect the public health from the danVerDate Mar 15 2010 11:06 Oct 30, 2014 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 F:\113-139 TOBACCO ACT ASK OK 10-23-14\113-139 TOBACCO ACT PDF MADE WAYN
4 

gers of tobacco use, and many members of this committee, including myself, led by Mr. Waxman, were proud to work on this 

groundbreaking law. 

We have known for 50 years about the terrible health effects of 

smoking. Tobacco companies initiated and sustained the Nation’s 

tobacco epidemic, and for decades deliberately misled the public 

about the risks of smoking. Meanwhile, new findings in the latest 

Surgeon General’s report indicated cigarettes are even more hazardous and addictive than they previously were known. Each year, 

480,000 Americans die from smoking-related causes, and smoking 

costs the country over $289 billion in health bills and lost productivity. 

So I think we can all agree that the Center for Tobacco Products 

has a lofty task moving forward, but I wanted to highlight a few 

of the important benefits FDA has begun to execute. 

They have restricted the sale of and marketing of tobacco products to children, they have set standards for companies who make 

claims about the harms on their products, they have implemented 

a new science-based public health standard for the review of tobacco products, and they have begun to review these new product 

applications. Of course, there is a lot more work to be done. There 

are a number of regulatory actions that I believe still need to occur 

to protect the public from the dangers of other tobacco products, 

and this includes banning candy-flavored cigars that appeal to our 

youth, and ending e-cigarette marketing practices that target kids. 

We should also raise taxes on all tobacco products, and close loopholes that let tobacco companies avoid Federal taxes. In addition, 

I believe we must remove barriers to quitting tobacco use by making certain that tobacco cessation coverage is available to all Americans through the Affordable Care Act. 

Mr. Chairman, I hope this will be the first in a number of oversight hearings on the tobacco law. For the past few years, my colleagues and I have asked for tobacco hearings. In fact, the most recent request would have examined the recent alarming trends in 

the currently unregulated tobacco products like e-cigarettes. Just 

last week, we learned that about—some data came forward that reports of poisonings caused by accidental ingestion of e-liquids, and 

that is the liquid containing nicotine used to refill e-cigarette cartridges. That—the incidents tripled from 2012 to 2013. And while 

I appreciate the views of GAO and look forward to Ms. Crosse’s testimony and comments, today’s hearing should have included the 

FDA. It is important that we offer our administration some courteousness. That includes allowing for sufficient time in scheduling 

hearings. So I hope you will ensure that the Director of the Center 

for Tobacco Products and the FDA have a legitimate ability to update members on FDA’s regulatory efforts. 

I would like to yield the balance my time to the gentleman from 

New York, Mr. Engel, if he would like to use it. 

5 

OPENING STATEMENT OF HON. ELIOT L. ENGEL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW 

YORK 

Mr. ENGEL. Well, I thank my friend for yielding to me, and I 

want to thank both the ranking member and the chairman for 

holding this hearing. 

I want to echo the comments of Ranking Member Pallone, and 

then I also wish that this hearing could have been scheduled at a 

time that would have allowed the FDA to participate. The implementation of a Family Smoking Prevention and Tobacco Control 

Act is critically important, and I think members of this committee 

would have benefitted from hearing the FDA’s perspective. 

That being said, however, I do appreciate the willingness of GAO 

to come here today to testify about their oversight efforts on the 

law. 

My district includes parts of the Bronx, where over 100,000 people have asthma. I live in that borough. This borough has some of 

the highest rates of asthma-related emergency room visits in all of 

New York. This reality is due in no small part to the prevalence 

of smoking and secondhand smoke exposure. Just Friday, a report 

by New York State Comptroller, Thomas DiNapoli, found that asthma-related medical expenses and lost productivity are costing my 

State an estimated $1.3 billion a year. Eliminating the use of tobacco products amongst children and youth can play an important 

role in reducing these asthma-related costs. 

So I am pleased that we are holding hearings on this today, and 

I look forward to the testimony. 

And I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognizes the chairman of the full committee, Mr. Upton, 

5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you, Mr. Chairman. 

You know, it has been 5 years since the Family Smoking Prevention Tobacco Control Act was signed into law. We have a collective 

responsibility as the FDA’s authorizing committee to ensure the 

Agency is implementing the law, and all laws, in a fair, consistent 

and transparent manner. FDA’s decision should always be based on 

sound scientific evidence, with the health of our Nation’s citizens 

in mind. 

The GAO has done a thorough job overseeing the implementation 

efforts conducted by the Center for Tobacco Products to date, and 

their work continues. 

I want to thank Dr. Marcia Crosse from the outset for her hard 

work on this front, and for her responsiveness to the committee 

staff. 

GAO has raised a number of concerning issues about the efficiency and consistency of CTP’s regulatory activities to date. For 

instance, they issued a report in September of last year noting that 

the center had yet to set any performance measures or reviewed 

timelines to ensure accountability and gauge progress. I am a firm 

believer that transparency does breed accountability. Congressman 

6 

Guthrie, as he noted, did introduce The Transparency in Tobacco 

User Fees Act, H.R. 389, which is a commonsense piece of legislation that would require the FDA to submit annual reports to Congress on how those user fees have been spent. FDA has such a statutory requirement for user fee programs, such as PDUFA, and the 

insight gained from such reports has led to improvements across 

the board. 

And again, I welcome our witnesses. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

It has been almost 5 years since the Family Smoking Prevention and Tobacco 

Control Act was signed into law. We have a collective responsibility as the FDA’s 

authorizing committee to ensure the agency is implementing this law- and all lawsin a fair, consistent and transparent manner. FDA’s decisions should always be 

based on sound, scientific evidence with the health of our Nation’s citizens in mind. 

The Government Accountability Office has done a thorough job overseeing the implementation efforts conducted by the Center for Tobacco Products (CTP) to date, 

and their work continues. I would like to thank Dr. Marcia Crosse from the outset 

for her hard work on this front and for her responsiveness to committee staff. 

GAO has raised a number of concerning issues about the efficiency and consistency of CTP’s regulatory activities to date. For instance, they issued a report in September 2013, noting that the center had yet to set any performance measures or 

review timelines to ensure accountability and gauge progress. 

I am a firm believer that transparency breeds accountability. Congressman Guthrie has introduced the Transparency in Tobacco User Fees Act, H.R. 389, which is 

a commonsense piece of legislation that would require FDA to submit annual reports to Congress on how the user fees have been spent. FDA has such a statutory 

requirement for user fee programs such as PDUFA, and the insight gained from 

such reports has led to improvements across the board. 

I welcome the opportunity to examine these issues in greater detail with today’s 

hearing. 

Mr. UPTON. I yield the balance of my time to the vice chair of 

the Health Subcommittee, Dr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the chairman for yielding. 

The Chairman is correct; this subcommittee has an obligation as 

the principle authorizing committee that allowed the Center for Tobacco Products to be created in the first place, we have a responsibility for its oversight. The fact of the matter is, they have been 

up and running for 5 years, and this is the first hearing and they 

are not here. 

We need to know how the Agency is implementing the law. We 

need to know what taxes are collecting and how they are allocating 

the resources. We have asked these questions over and over again 

for 5 years. 

And here is the bottom line. Somebody already said it: tobacco— 

when used as directed, tobacco products cause 580,000 deaths 

every year. 

The Food and Drug Administration is charged with seeing that 

medicines and devices are safe and effective. 480,000 deaths every 

year. You can’t call that safe, but it darned sure is effective. 

The fact of the matter is, this Agency never belonged within the 

Food and Drug Administration in the first place. I argued against 

that when the bill passed 5 years ago. I will continue to argue 

7 

against it today, but the fact of the matter is, they are in the same 

building, and as long as they are housed in the same building, it 

is this committee’s obligation to require an accounting of how are 

the user fees collected, how are they spent. My understanding is 

there is over $1 billion in user fees that have been collected in the 

5 years since this agency was created, and almost half of that remains unspent. 

To put that number in perspective, it is 5 times the amount of 

user fees collected from medical device manufacturers, and we 

don’t have an accurate accounting as to how the money has been 

spent and how it will be spent. We know there were challenges 

about the graphic labels, and that is tied up in the courts. 

Stakeholders complain of the lack of any regulatory guidance, despite the fact they were given statutory direction by this committee. 

Here is the bottom line. Since we approved this agency within an 

agency, has it improved the health of Americans? Every statistic 

tells us it is going in the wrong direction. 

So this morning, where is the FDA? They could not find the time 

to come here and testify. In fact, this is the third time this year 

that they have been asked to come and testify before this committee. This committee, both sides of the dais, Republican and 

Democrat, should be seriously concerned about the fact that the 

FDA, the head of the Center for Tobacco Products, will not come 

to this committee and testify. They are always traveling, they are 

always out of town. Make your other directors available to us within that same agency. We don’t mind hearing from them. We don’t 

always have to hear from the same person, but at least make an 

effort to accommodate the committee staff when they ask you to be 

here when we have these hearings. 

Mr. WAXMAN. The gentleman yield? 

Mr. BURGESS. I hope the GAO can shine light on these actions. 

Mr. WAXMAN. I would like the clarification about FDA not being 

here, because as I understand it, they were notified last week, a 

week. They said they needed more time, so it sounds like we 

haven’t accommodated them to be here, not that they haven’t accommodated us. 

Mr. BURGESS. Yes, but this—just reclaim my time, this is the 

third time that we have asked Mr. Zeller to come here and testify, 

and the third time that he has been traveling for a speech or participating in another event. So after the FDA staff informed the 

committee staff that Mr. Zeller could not testify on April 7, committee staff informed the FDA that any or all of the various office 

heads within the Center for Tobacco Products could speak and testify to their regulatory activities. Food and Drug Administration informed the committee staff that there wasn’t enough time to draft 

and clear formal testimony by April 7. In response, the committee 

staff told FDA that we would not require formal testimony be submitted, an arrangement that we have previously agreed to in special circumstances. The Food and Drug Administration decided 

they did not want to participate without submitting formal testimony, but they were open to testifying at some point in the future. 

And I think this subcommittee should do everything it can to ensure that that condition is met. 

8 

I yield back. 

Mr. PITTS. The Chair now recognizes the ranking member of the 

full committee, Mr. Waxman, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Mr. Chairman. 

I think we are making a big to-do about nothing. The FDA has 

been offered a number of dates. We wouldn’t accept their request. 

I don’t think we have accommodated them, and I think this is a 

little silly. If we are going to have a hearing, FDA ought to be here. 

But let us look at the big picture. Twenty years ago, this subcommittee held a famous hearing. Seven tobacco CEO executives, 

seven tobacco CEOs testified at that hearing and denied that cigarettes are harmful, that nicotine is addictive, that they didn’t manipulate nicotine, that they certainly wouldn’t go after kids, and 

their denials that day galvanized the antismoking movement. 

A lot has happened in the last 20 years. Smoking rates have 

dropped, smoke-free laws have become widespread. In 2009, Congress passed the Family Smoking Prevention Tobacco Control Act 

on a bipartisan basis. The tobacco companies are trying to circumvent this law. The law banned the sale of candy-flavored cigarettes. So what did the tobacco companies do? They started selling 

candy-flavored little cigars. The law restricted marketing of cigarettes and smokeless tobacco to kids, but companies are using the 

same tactics to promote e-cigarettes to kids. 

We have asked repeatedly for hearings in this committee to examine these outrageous practices, but the committee has refused to 

hold any hearings. 

Today we are finally holding a hearing on that law that was 

passed in 2009, which I authored, but we are focusing on a very 

narrow issue. The timelines for reviewing applications submitted 

by the tobacco companies, not the public health issues that American families care about, and FDA is not able to testify because the 

committee would not accommodate the Agency’s reasonable request 

for adequate time to prepare. This is a missed opportunity. 

In the 50 years since the first Surgeon General report on smoking, we have made tremendous progress in reducing tobacco use. 

We have cut adult and youth smoking rates in half or more, we 

have prevented millions of premature smoking-related deaths. 

Since the enactment of the Tobacco Control Act, FDA has restricted 

the sale and marketing of cigarettes and smokeless tobacco to 

youths. FDA has set standards for companies that assert their 

products reduce harms, and the Agency has undertaken reviews of 

new tobacco product applications using a new public health standard, marking the first time this industry has been regulated. But 

our work is far from done. These are the things we ought to be 

looking at. More than 480,000 Americans die each year from smoking. Each day, thousands of children try their first cigarette. Cigarette use has declined, but we have seen an alarming increase in 

the use of candy-flavored little cigars and e-cigarettes by our kids. 

That should concern us, but not at today’s hearing. 

9 

There is a long list of things we need to do. First, FDA must continue implementation of the Tobacco Control Act, and take full advantage of its authorities. That is why I and other members have 

repeatedly called on FDA to issue deeming regulations that will 

stop companies from marketing e-cigarettes to kids, and using 

candy-like flavors to entice our kids to smoke. 

Secondly, we must take coverage—we must make coverage of tobacco cessation more accessible to current smokers through the Affordable Care Act. 

Third, we must raise the taxes on all tobacco products, and close 

the loopholes that let companies avoid Federal taxes, like the lower 

tax rates for pipe tobacco. 

Fourth, we must support effective public health campaigns and 

tobacco control programs that discourage smoking. 

And fifth, we must encourage other nations to adopt strong tobacco control measures, and stop the tobacco companies using trade 

agreements to challenge these policies. 

We are unlikely to tackle these issues during today’s hearing, so 

I hope this will be the first of a series of hearings into the tobacco 

industry’s practices, and our progress on tobacco control. 

I appreciate GAO for testifying, and the work they have done, 

but it just reminds me that after the series of hearings that we had 

in 1994 which changed the tobacco issue forever, we hadn’t had a 

hearing in this committee for many, many years after the Republicans took control, until one day we had a hearing, not on all these 

health issues, but why we shouldn’t encourage people to use 

smokeless tobacco as a way to wean off smoking. Trade one addiction for another. Of course, we never invited anybody else to come 

in and testify about the other public health measures that were in 

place to encourage people and help people give up smoking. 

So you sometimes wonder, is this committee concerned about 

public health or are they concerned about special interests. And I 

put that question out there for people to think about. 

Yield back my time. 

Mr. PITTS. The Chair thanks the gentleman. 

That concludes the opening statements. As always, the written 

opening statements of all members will be made part of the record. 

We have one panel today, one witness. I will invite our witness 

to please come to the witness table and introduce her at this time, 

Dr. Marcia Crosse, Director, Health Care, U.S. Government Accountability Office. Your written testimony will be made a part of 

the record, and you will be given 5 minutes to summarize your testimony. 

So at this time, Chair recognizes Dr. Crosse, 5 minutes for an 

opening statement. 

STATEMENT OF MARCIA CROSSE, DIRECTOR, HEALTH CARE, 

GOVERNMENT ACCOUNTABILITY OFFICE 

Ms. CROSSE. Thank you. Chairman Pitts, Ranking Member 

Pallone, and members of the subcommittee, I am pleased to be here 

today as you examine implementation of the Family Smoking Prevention and Tobacco Control Act, enacted almost 5 years ago in 

June 2009. 

10 

The act represents the first time that FDA has had the authority 

to regulate tobacco products. It requires that tobacco manufacturers submit information to be reviewed by FDA in order to market 

certain 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 non-users. The act also established the Center for Tobacco 

Products, CTP, within FDA. CTP 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, and engaging in public education about 

the risks associated with tobacco product use. The act also authorizes FDA to assess and collect user fees from each tobacco manufacturer and importer. All of CTP’s activities are funded exclusively 

through user fees, and unspent user fees may be carried over from 

year to year. 

My statement today will discuss the extent to which FDA has 

spent its tobacco user fees, and the status of CTP’s reviews of new 

tobacco product submissions. 

At the end of fiscal year 2012, just over 3 years after the Tobacco 

Control Act was passed, CTP had spent less than half of the user 

fees it had collected to that point. The time it took to award contacts contributed to the center spending less than it had planned. 

In fiscal year 2013, CTP was able to award contracts for a number of activities, including media campaigns to educate youth on 

the dangers of tobacco use. By the end of last year, CTP had spent 

over 80 percent of the approximately $1.75 billion in user fees collected by that time. 

Turning to product reviews. It has taken FDA a number of years 

to begin making decisions on submissions for new tobacco products. 

Nearly all of the almost 4,500 submissions received by CTP were 

made under the substantial equivalence, or SE, pathway. Under 

the SE pathway, CTP determines whether the product has the 

same characteristics as a predicate tobacco product, or has different 

characteristics that do not raise different questions of public 

health. About 80 percent of the SE submissions FDA received were 

provisional SE submissions. This means they were received by FDA 

prior to a statutory deadline in March 2011, allowing the product 

to be marketed unless CTP finds that they are not substantially 

equivalent. SE submissions received after that deadline are called 

regular SE submissions, and these products cannot be marketed 

until CTP determines that they are substantially equivalent to 

predicate products. 

CTP made its first decisions on SE submissions in June 2013, 

and, as of December 31, 2013, CTP has made a final decision on 

a total of 30 of the 4,490 SE submissions it had received. All 30 

final decisions, that is, substantially equivalent or not substantially 

equivalent, were for regular SE submissions. 

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

submissions, finding products in 4 submissions to be not substantially equivalent to predicate products, and issued orders to stop 

the further sale and distribution of these 4 products. CTP officials 

and manufacturers told us that several factors increased the time 

it took CTP to review SE submissions, such as CTP requests for 

11 

additional information from manufacturers, and having to hire and 

train staff. However, we found that CTP has not had performance 

measures that include time frames for making final decisions on 

SE submissions. We reported last year that the lack of such performance measures limits CTP’s ability to reasonably assure efficient operations and effective results. We recommended that FDA 

establish such performance measures, and the Agency agreed with 

our recommendation. 

As of last week, FDA officials said that they expect to identify 

performance measures that include time frames for some types of 

submissions in spring 2014, and to implement the measures by October 2014. However, the Agency has not determined when it will 

establish performance measures for the largest part of its backlog 

of submissions, the provisional SE submissions for products that 

are currently on the market. 

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

staff, tobacco industry stakeholders express concerns about whether CTP will have a sufficient number of qualified staff to review 

the current backlog, and also review new submissions that may be 

made in the future, particularly if FDA asserts jurisdiction over 

new types of tobacco products. 

In summary, in the past year, FDA has taken a number of steps, 

such as media campaigns and conducting product reviews, that 

have begun to result in actions and final decisions. However, there 

are many remaining challenges for the Agency, particularly if it expands the scope of its authority to include additional types of tobacco products. 

Mr. Chairman, this completes my prepared statement. I would be 

happy to respond to any questions that you or members of the subcommittee may have. 

[The prepared statement of Ms. Crosse follows:] 

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Mr. PITTS. The Chair thanks the gentlelady. 

I will begin the questioning. Recognize myself 5 minutes for that 

purpose. 

Dr. Crosse, GAO’s September 2013 report recommended that 

FDA establish performance measures that include time frames for 

making decisions, and that the Agency monitor performance relative to these time frames. What actions, if any, has FDA taken 

in response to these recommendations? 

Ms. CROSSE. They agreed with the recommendations, and they 

have told us that this spring, they will establish time frames for 

2 types of submissions, for the regular SE submissions and for the 

exemption from SE submissions, but that is a subset of the larger 

pool. They have not yet determined when they are going to establish time frames for the larger portion of their backlog, and that 

is the earlier submissions that were made prior to the March 2011 

deadline. 

Mr. PITTS. These seem like general, good government practices 

that FDA should have already implemented, without GAO having 

to make such a recommendation. Are there not time frames for review in the Tobacco Control Act? 

Ms. CROSSE. The Tobacco Control Act only established time 

frames for review for one type of application, and that type of application is one that requires more information to be provided. It 

is one where there is no predicate product on the market, and the 

act established a 180 day time frame for decisions on those applications. It did not establish time frames for the substantial equivalence submission, which have made up the vast majority of submissions that FDA has received. 

Mr. PITTS. How does FDA prioritize reviews of the substantial 

equivalence submissions? 

Ms. CROSSE. Right now, the officials have told us that they are 

prioritizing the regular SE submissions, and those are for products 

that are not yet on the market, for products that need approval by 

FDA before those products can be marketed. So they are 

prioritizing ones for products that are not on the market. Among 

the provisional SE submissions, they have divided those submissions into 4 groups, 4 tiers, that they have assigned risk levels to, 

and they are prioritizing those that they believe pose the highest 

risk. 

Mr. PITTS. Now, is it true that some of these submissions are for 

products that actually have reduced levels of harmful ingredients, 

and if so, would there be a way for FDA to prioritize these types 

of submissions? 

Ms. CROSSE. It is possible, but there is another pathway, the 

modified risk tobacco product submissions. FDA has received only 

7 submissions of that type, and that is where the manufacturer is 

making a claim that it actually reduces the risk, and none of those 

have had sufficient information for FDA to proceed. So all of those 

submissions are at a halt at this point, and withdrawn by the manufacturer. 

The products that have come in through the regular SE pathways are not making claims that they reduce the risk to public 

health, although it is possible that they could. 

32 

Mr. PITTS. We have heard that one factor affecting the long time 

frames for FDA review is the fact that it took them a while to get 

the Center for Tobacco Products up and running. They have had 

now 5 years. Have they gotten any faster over time? 

Ms. CROSSE. They have gotten somewhat faster in the initial 

steps that they go through in determining their jurisdiction, and in 

determining the completeness of the application, particularly for 

the regular submissions, they now feel that they are at a point 

where they can establish some time frames for those reviews. They 

haven’t made enough decisions on the provisional SE submissions 

for us to determine whether or not they are getting any faster. 

There have only been just 4 decisions, all for a single type of product, from a single manufacturer. 

Mr. PITTS. All right, thank you. 

The Chair recognizes the ranking member, Mr. Pallone, 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

Dr. Crosse, in April 2011, FDA indicated that it would issue regulations asserting jurisdiction over additional tobacco products like 

e-cigarettes, little cigars and pipe tobacco, and as you testified in 

October, FDA submitted a proposed deeming rule to OMB, but the 

rule has not yet been issued by FDA. 

Over the past few years, we have seen dramatic increases in the 

use of e-cigarettes and flavored little cigars among youth, and there 

is also evidence that manufacturer activity targeting youth has 

driven this growth in alternative tobacco products, and that FDA, 

in action, made it easier for manufacturers to do so. 

So I would like to find out more about FDA’s proposed regulations and the public health costs of delay. And my first question, 

I have a lot, is last week, the Centers for Disease Control and Prevention at CD—or Prevention—I am sorry. The Centers for Disease 

Control and Prevention, or the CDC, reported that the number of 

calls to poison centers involving e-cigarette liquids rose from 1 per 

month in September 2010, to 215 per month as of February of this 

year. 

Did you see this CDC report, and if so, what were your impressions? 

Ms. CROSSE. Yes, I did see the CDC report, and I think it is concerning because nicotine, in a liquid form like that, can be a potent 

poison. With the growth of e-cigarettes, there are more liquids 

being distributed, as I understand it, for refill purposes, both to 

businesses and in some quantities for purchase by individuals. And 

as with any poison, it is a concern if children can have access to 

that. 

Mr. PALLONE. Well, in fact, members of this committee have repeatedly written to FDA raising the alarm about the various risks 

that e-cigarettes pose to children and adolescents. We pointed out 

that e-cigarette makers are producing products with kid-friendly 

flavors such as cookies and cream milkshake, and we have called 

on FDA to issue deeming regulations to bring an end to manufacturers targeting our youth through aggressive ad campaigns, as 

well as event sponsorships and other tactics once used by cigarette 

manufacturers. 

33 

So, Dr. Crosse, last September CDC reported that between 2011 

and ’12, the percentage of high school students who had used ecigarettes more than doubled. Are you aware of these findings? 

Ms. CROSSE. I have seen the CDC statistics, yes. 

Mr. PALLONE. And are you also aware that CDC’s Director, Dr. 

Tom Frieden, and other experts, have raised concerns that e-cigarettes could be a gateway product to conventional cigarette and 

other tobacco products use? 

Ms. CROSSE. Yes, I have seen that statement. 

Mr. PALLONE. The importance of FDA issuing deeming regulations extends beyond e-cigarettes. Flavored cigars, for example, are 

also currently unregulated. In October, CDC reported that sales of 

little cigars have skyrocketed over the past decade, and more than 

40 percent of middle and high school students who smoke were reportedly using these flavored products. 

Dr. Crosse, I would like to ask you a series of questions regarding FDA’s ability to take specific actions if the Agency asserts jurisdiction over e-cigarettes and flavored little cigars. 

First, could the Agency prohibit the sales of these products to minors, and require age verification prior to purchase? 

Ms. CROSSE. It is my understanding that they have that authority. 

Mr. PALLONE. Could the Agency prohibit brand name sponsorships of events that are widely attended by youth? 

Ms. CROSSE. Yes, I believe that they could extend that current 

prohibition to new products that were deemed under their control. 

Mr. PALLONE. Could FDA prohibit the use of characterizing flavors that are attractive to kids? 

Ms. CROSSE. Yes, I believe that they have the authority. 

Mr. PALLONE. And finally, could FDA take steps to inform the 

public about the harms of ingesting, inhaling or absorbing e-cigarette nicotine cartridges through the skin or eyes? 

Ms. CROSSE. Yes, they have authority to conduct public education 

campaigns. 

Mr. PALLONE. I just think it is crucial that FDA acts quickly to 

deem additional tobacco products. In the absence of regulation, 

manufacturers take advantage of regulatory loopholes to target impressionable children and teens. The recent Surgeon General’s report reiterated what we have known for a long time, that exposure 

to nicotine in youth increases the risk of lifelong tobacco product 

use. 

So do you have any insight into why release of the deeming rule 

has been delayed? 

Ms. CROSSE. I don’t have any information on that. FDA has announced that its deeming regulation will include a number of tobacco products that it does not currently regulate. I do not know 

what the delays are for this deeming rule. 

Mr. PALLONE. I mean if, you know, obviously, Mr. Chairman, if 

at any point Dr. Crosse could get us more information about, you 

know, the delay or when this is going to come out, we would appreciate you providing the committee with that and, you know, and 

any written followup. If I could ask through the chairman. 

34 

Ms. CROSSE. Yes. I have no information beyond the Commissioner’s statement last week at the Appropriations hearing that it 

would be very soon. 

Mr. PALLONE. OK. So let me just say that evidence from GAO, 

CDC, this committee and others has demonstrated that the use of 

e-cigarettes, little cigars and other unregulated products has increased dramatically, and this is due on part to inaction on the 

deeming rule. So I just have to emphasize, Mr. Chairman, that 

FDA has to act quickly to assert jurisdiction over all these tobacco 

products. 

Thank you. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognizes the gentleman from Kentucky, Mr. Guthrie, 5 

minutes for questions. 

Mr. GUTHRIE. Thank you, Mr. Chairman. And thank you for coming today. I appreciate that, Dr. Crosse. 

Do you have any more data on what the backlog at CTP looks 

like, and can you let us know how many of the SE submissions 

within the backlog relate to different—product changes, label 

changes and name changes? It is not just product changes they can 

regulate, it is label and name as well. 

Ms. CROSSE. I don’t have information at the moment on that. We 

are conducting further work, and we expect to issue a report in late 

June, that was mandated by the Tobacco Control Act, that actually 

will have some additional information. 

Mr. GUTHRIE. OK, thanks. And it is my understanding, and you 

said, that 99 percent of submissions to the FDA are SEs, substantial equivalence, which in theory these should be quicker to review 

than new products submission, and yet as you note, it is taking 

years for them to be reviewed. And FDA has similar pathways for 

other products in other FDA agencies. It takes roughly 5 months 

to review a 510(k) for medical devices, 6 to 10 for new pharmaceutical drugs coming to market, and the CTP is taking years for 

these steps, for these SEs. 

Can you discuss the approval times at CTP compared to those of 

drug and device centers at FDA, and in your opinion, why does 

CTP have such a lag on decision-making when other centers are 

able to turnaround products in a better manner? 

Ms. CROSSE. Well, CTP was starting from scratch, and they indicated that they had a number of delays because they needed to hire 

staff, they needed to develop a process, and they needed to develop 

the science around tobacco products because these products had not 

been previously regulated. They needed to gain an understanding 

of the risks posed by different types of tobacco products, the constituents within tobacco products, and what risks might be posed 

by changes to tobacco products. 

Mr. GUTHRIE. Are they beyond those points now, or are they 

still—— 

Ms. CROSSE. They still have a significant amount of research underway, and, in fact, that has absorbed a lot of the budget of the 

Office of Science, which is the office that makes decisions about 

substantial equivalence. They say that they are much further along 

that process. They clearly are much slower than the Center for 

Drugs or the Center for Medical Devices, although I will note that 

35 

GAO reported in 1983, on the Center for Devices that had been established in 1976, and we commented at that time that they were 

being very slow to fulfill the requirements of their authority. So I 

think—— 

Mr. GUTHRIE. But—— 

Ms. CROSSE [continuing]. It is an issue when you are starting up 

a center from scratch. 

Mr. GUTHRIE. But there were some subsequent reauthorizations 

the product manufacturers and FDA worked through to try to find 

a way to work. Do you think that—in your opinion, do you think 

that Congress should impose statutory timelines? 

Ms. CROSSE. You know, I don’t think I have enough information 

to speak to that point at this point in time, because I think they 

are still feeling their way through it, and I think we haven’t had 

enough information to base that decision on. They have a concern— 

not my concern—their concern is that when a product is approved 

through the SE pathway, it then can become a predicate. And so 

they don’t want to make mistakes because they want to have an 

understanding of what the likely public health impact would be of 

a new product, because it then becomes a predicate that a subsequent product can use. 

Mr. GUTHRIE. OK, and then my final question, my legislation 

would require the CTP to provide annual reports to Congress, all 

it does is outlining how their user fees are being spent, the number 

of submissions received, the number of applications approved or denied, and the number still pending and the number of modified risk 

products. That is what this application does—that is what this legislation I proposed does. 

In your opinion, is this information that the CTP has readily 

available? I mean if we pass this bill today, would that information 

be available for the CTP to provide, or do you think it would be 

a burden on the CTP to provide that information? 

Ms. CROSSE. No, I believe this is information that they have 

readily available. And, in fact, my understanding is that the appropriators have put report language in to require something similar. 

Mr. GUTHRIE. Do you think that is helpful information for Congress to have? 

Ms. CROSSE. I think it is appropriate for Congress to have information on the operations of the center. There is already a required 

report, but it does not require that those specifics be included. 

Mr. GUTHRIE. Well, and I thank you for coming. I think you— 

all—every time you testify, you always do a good job, and you do 

your job well and testify well. I appreciate it very much. 

Ms. CROSSE. Thank you. 

Mr. GUTHRIE. Thank you, and I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the gentlelady, Dr. Christensen, 5 minutes for 

questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. Good morning, 

Dr. Crosse. 

Ms. CROSSE. Good morning. 

Mrs. CHRISTENSEN. Thank you for your testimony. I remember 

when the law was being drafted, and one of the key issues for the 

Congressional Black Caucus for many organizations and for all of 

36 

the living past HHS Secretaries was a menthol issue, and I know 

that FDA was granted broad authority to address menthol as an 

additive in cigarettes, ranging from doing nothing, to reducing the 

concentration, to removing menthol altogether. And I appreciate 

the approach the FDA has taking around the issue of other 

flavorings and the sensitivity. 

My question to you would be, are you able to provide an update 

about where FDA is on the menthol issue, in particular, what types 

of studies have been conducted, whether menthol—have they been 

able to determine whether menthol exacerbates directly or indirectly the incidence of lung cancer, et cetera, and if there are any 

preliminary results? 

Ms. CROSSE. I am afraid I don’t have that information. That is 

specific to menthol. 

Mrs. CHRISTENSEN. OK. Well, my other question goes back to the 

fees. Again, we thank you for your testimony on the fees. My colleagues have commented on user fee carryover, and how the user 

fees are being spent, and I want to make sure the record is clear 

on a few points. 

What portion of FDA’s tobacco user fees have been spent as of 

December 31, 2013? 

Ms. CROSSE. They have spent 81 percent of the user fees they 

have received through that time. 

Mrs. CHRISTENSEN. Thank you. You mentioned that most of the 

user fees were spent by 3 offices at FDA, one of which is the Office 

of Health, Communication and Education, and as you stated today, 

FDA devoted a portion of its fiscal year 2013 user fees on a public 

health education campaign. From your review of FDA’s user fee 

spending, can you tell the subcommittee whether the Agency’s user 

fee spending is consistent with the purposes and authorities of the 

Tobacco Control Act? 

Ms. CROSSE. Yes. We did not identify any spending that was not 

consistent with their authorities, and the different provisions of the 

Tobacco Control Act. 

Mrs. CHRISTENSEN. Thank you. Since the investment in the Real 

Cost Campaign has come up this morning, I wanted to take a moment to comment on the importance of this campaign. 

It is an evidenced-based campaign that launched in February, 

and will target millions of youth between the ages of 12 and 17 

who are already experimenting with cigarettes, that are open to 

smoking. So, Mr. Chairman, we know that the vast majority of current smokers started when they were kids. Every day in the U.S., 

more than 3,200 kids smoke their first cigarettes, and more than 

700 youth aged under 18 become daily smokers. So these statistics 

underscore the need for targeted youth tobacco prevention efforts, 

particularly when you put this investment in context. The amount 

FDA spent on the Real Cost Campaign for the entire year was less 

than the amount the tobacco industry spends on marketing and 

promotional efforts for a single week. 

Well, I have some more time. Yes. So the GAO makes clear that 

FDA review of new products must become more efficient and effective. I am concerned that they are not placing enough priority on 

requiring changes to products that are already on the market to 

make them less harmful or addictive. The most recent Surgeon 

37 

General’s report found that cigarettes are more dangerous today 

than they were when the first Surgeon General’s report on smoking 

was issued 50 years ago. Remarkably, cigarette smokers today 

have a higher risk for lung cancer than smokers in 1964, despite 

smoking fewer cigarettes. The Surgeon General report also found 

that some, if not all, of this increased risk is likely caused by 

changes in the composition and design of cigarettes. Fortunately, 

FDA now has the authority to set product standards that require 

changes to products to make them less harmful or addictive. 

Do you know if FDA plans to respond to the alarming findings 

in the more recent Surgeon General’s report, and if there are any 

plans underway for FDA to use its authority to set product standards? 

Ms. CROSSE. I am not aware of specific regulatory actions that 

FDA may have underway, but they do have a number of different 

studies, scientific studies, to try to understand, I think, the impact 

and the risks posed by different constituents in tobacco products. 

Mrs. CHRISTENSEN. Thank you. 

And, Mr. Chairman, I yield back the balance of my time. Thank 

you. 

Mr. PITTS. The Chair thanks the gentlelady. 

Now recognizes the gentleman from Pennsylvania, Dr. Murphy, 

5 minutes for questions. 

Mr. MURPHY. Hello, Doctor. Good to have you here today. 

Ms. CROSSE. Thank you. 

Mr. MURPHY. You say in your report CTP is limited in its ability 

to evaluate policies, procedures and staffing resources in relation to 

its substantial equivalence review process, and in turn is limited 

in its ability to reasonably assure efficiency and effectiveness. 

So in your conversations with the Agency, did you get a feel for 

how the approval process would be affected if FDA proposes deeming regulations for other products that it doesn’t currently regulate? 

Ms. CROSSE. Well, certainly, industry expressed concerns to us 

that, if the number of products to be regulated is greatly expanded, 

that FDA will not have sufficient resources, will not have sufficient 

staff to be able to review those applications. FDA assured us that 

they believe that the challenges of initially staffing the office are 

behind them, and that they believe they could go through routine 

processes if they need to hire or train additional staff, and that additional products under their regulatory authority would not pose 

new challenges. 

Mr. MURPHY. Will that fulfill all the things that they need to do 

prior to issuing deeming regulations to make sure the backlog isn’t 

made worse? 

Ms. CROSSE. I don’t believe that it is required that they complete 

those steps prior to issuing deeming regulations. You know, we 

think that it is important that they get their processes under control with routine procedures and time frames established for staff 

so that they can better determine how many staff they need. We 

think that without having those kinds of benchmarks in place, it 

is difficult for them to determine for themselves whether they have 

the essential resources, and whether there are bottlenecks in certain parts of their process. 

38 

Mr. MURPHY. OK, thank you. Is it fair to say that reviewing new 

tobacco product submissions, and approving or denying them for 

entrance into the marketplace, is one of the core functions to the 

Center for Tobacco Products under the Tobacco Control Act? 

Ms. CROSSE. Yes, it is one of the core functions. 

Mr. MURPHY. And is it also fair to say that reviewing substantial 

equivalence applications is one of the three main determinations 

that CTP has in carrying out this core function of reviewing new 

tobacco products for marketplace suitability? 

Ms. CROSSE. That is part of their authority, yes. 

Mr. MURPHY. You state in your study CTP is ‘‘limited in its ability to evaluate policies, procedures and staffing resources in relation to its substantial equivalence review process, and in turn, is 

limited in its ability to reasonably assure efficiency and effectiveness.’’ 

So given your review that CTP is limited in its ability to reasonably assure efficiency and effectiveness, in this core function of reviewing SC or premarket applications, do you believe CTP is presently capable of handling even more responsibilities and a much 

greater volume of applications which would result from the new 

deeming rule CTP and FDA plan to propose to dramatically expand 

its scope of authorities under the Tobacco Control Act? 

Ms. CROSSE. You know, I don’t think I have sufficient insight 

into that, but even if FDA proposes this deeming, I believe it will 

be a number of years before such regulations would go into effect 

in the normal course of how long it takes to get a regulation in 

place, so there may be a number of years further before any new 

products would actually begin to be regulated by FDA. So I can’t 

speak to what may happen in the future in terms of—— 

Mr. MURPHY. Sure. 

Ms. CROSSE [continuing]. Them dealing with their backlog. 

Mr. MURPHY. Well, we want to work you in this, but I am trying 

to find out if you have confidence that CTP can at this time, given 

its backlog it already has of SE applications, efficiently and effectively process a whole new onslaught of applications that would 

rise from a new deeming rule. 

Ms. CROSSE. I think were they to arrive today, that would pose 

a problem. As I say, I can’t predict how soon new product applications might arrive, and what the status would be of their backlog 

at that point in time. 

Mr. MURPHY. Well, what do you infer from the fact that—I understand there is zero premarket tobacco product applications have 

been submitted. There is no statutory—do you have any thoughts 

on that? 

Ms. CROSSE. Actually, there were—I believe that there were four 

that were submitted—— 

Mr. MURPHY. OK. 

Ms. CROSSE [continuing]. But none were found to have all of the 

information that FDA required. 

You know, it is a different standard. It is not unlike with medical 

devices where there are many more products that go through the 

510(k) process, as opposed to the PMA process. Here, this is for 

products where there is no predicate product that they can point 

to, so there is not a similar prior product on the market before FebVerDate Mar 15 2010 11:06 Oct 30, 2014 Jkt 037690 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 F:\113-139 TOBACCO ACT ASK OK 10-23-14\113-139 TOBACCO ACT PDF MADE WAYN
39 

ruary 15, 2007, that they can point to and say this product is like 

that, or like an approved product through the SE process to say 

that that is a predicate. So, you know, as more products get approved through the SE—— 

Mr. MURPHY. Um-hum. 

Ms. CROSSE [continuing]. Process, there may be predicates available that could continue to allow products—— 

Mr. MURPHY. Well, is it—— 

Ms. CROSSE [continuing]. To go in that pathway. The PMTA 

process requires a lot of different information than manufacturers 

may have yet developed. 

Mr. MURPHY. I hope one of the questions you can answer in writing later on is about a new product review being more complex 

than a substantial equivalence review, and help us with that information. 

Thank you very much. I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

And now recognizes the vice chairman of the subcommittee, Dr. 

Burgess, 5 minutes for questions. 

Mr. BURGESS. Thank you, Mr. Chairman, and Dr. Crosse, welcome to our subcommittee again. 

Ms. CROSSE. Thank you. 

Mr. BURGESS. I am sorry I had to step out for a moment, but just 

tell me if you have already—and I apologize if you have already addressed this, but what is the average time that a substantial 

equivalence has been sitting at the Center for Tobacco Products? 

Ms. CROSSE. The bulk of the applications have been sitting there 

since March of 2011. They received over 3,000 applications in the 

first 3 weeks of March 2011, just prior to the deadline for a provisional SE product, and so that those products can be marketed 

until FDA makes a decision. And so the bulk of the backlog has 

been sitting there for now more than 3 years. 

Mr. BURGESS. So you evaluate other agencies that have a substantial equivalence pathway, do you not? 

Ms. CROSSE. Yes, well, the medical devices at FDA. 

Mr. BURGESS. So is this an unusual backlog, given your experience with other substantial equivalence pathways? 

Ms. CROSSE. I do think it is an unusual backlog. I think it was 

a bit of an unusual circumstance because of the deadline that resulted in this bolus of applications all in a very short period of 

time, rather than a growing steady stream. 

Mr. BURGESS. OK. Given that, the way the information was delivered, does it seem to be that they are accommodating at the Center for Tobacco Products now, accommodating this bolus that they 

received? 

Ms. CROSSE. They have, as of yet, only made four decisions. So 

they still have that bolus sitting there. They have made some 

progress in sorting through it, but they have not yet reached decisions. 

Mr. BURGESS. And the 4 decisions that they have reached, were 

those positive or negative decisions? 

Ms. CROSSE. Those were negative decisions. They ordered four 

products off the market. 

40 

Mr. BURGESS. Can you give the committee—and maybe I should 

know this, but can you give the committee an idea of what were 

those products? 

Ms. CROSSE. They were four products that are called bidis, I believe. They are an Indian type of cigarette, and FDA said that sufficient information on a predicate had not been supplied by the manufacturer in order to meet the standard for a determination of substantial equivalence. 

Mr. BURGESS. So was that a product that was already on the 

shelves prior to the passage of the CTP? 

Ms. CROSSE. No. If it required a provisional SE application, it 

would have been a product that came onto the market in the 

United States after February 15, 2007, but before March 22, 2011. 

So in that window of time, products that came onto the market 

were required to submit these provisional SE applications. 

Mr. BURGESS. Well, what is your opinion on why the Center for 

Tobacco Products has this lag in their decision-making, when other 

centers are able to turn things around in a more timely fashion? 

Ms. CROSSE. Well, they did have to staff up from scratch. They 

had to develop their procedures. They have taken a lot of time, 

they tell us, to try to understand the science of tobacco, which they 

did not have sufficient information on before, and they have now 

engaged both in contracts with CDC and with NIH, and with universities, to try to gain a better understanding of the risks posed 

by different types of tobacco products and constituents in tobacco 

products. 

Mr. BURGESS. Dr. Crosse, I believe I could help them there. 

When used as directed, 480,000 deaths a year. What is there to the 

science that they don’t understand? It is a dangerous product. 

Ms. CROSSE. Well, the standard requires that they determine 

whether or not the new product is any more dangerous, poses different dangers to public health than the existing products, because 

the existing products are allowed to continue to be marketed. 

Mr. BURGESS. So what if Congress were to establish a timeline 

of 90 days for substantial equivalence applications, and 180 days 

for new tobacco product applications, would that be helpful or hurtful? 

Ms. CROSSE. I don’t know whether or not they could meet that 

standard at the current time. There may come a point in time 

where they have regular procedures and where they do not have 

such a backlog, but I don’t know if that would help them or not. 

I just don’t have the information to say. 

Mr. BURGESS. Well, it can’t be a resource or a revenue issue, correct? 

Ms. CROSSE. That is correct. They tell us that they now have 

over 500 staff, and they believe that that is a fairly steady state 

for them, and they have resources, they have not expended all their 

user fees. 

Mr. BURGESS. 500 staff in an agency that didn’t even exist 5 

years ago, and a surplus of user fees. You know, I just have to say 

I am mystified as to why we are having to study this. It shouldn’t 

even be a problem. 

Thank you, Mr. Chairman. I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

41 

Now recognize the gentleman from Texas, Mr. Green, 5 minutes 

for questions. 

Mr. GREEN. Thank you, Mr. Chairman, and the Ranking Member 

for having the hearing today, and, Dr. Crosse, for your testimony. 

The 2009 Tobacco Control Act was historic in saving legislation 

representing the first time the FDA was granted the authority to 

regulate tobacco products, and I hope this is just the first series of 

hearings on implementation of the Tobacco Control Act. And I 

agree with my Texas colleague that this was the first new center 

in the FDA in 20 years. Is that correct? 

Ms. CROSSE. Yes, actually, and that was when the Center for 

Drugs and Biologics was divided into two centers. So, even in that 

situation, it was not creating a center from scratch. 

Mr. GREEN. OK. Well, and I guess I am concerned like he is, we 

have that number of staff members and yet we are not moving as 

quick as we could. 

The law is necessary. The next step is addressing tobacco use, 

which is is initiated and sustained by the aggressive and sometimes dubious strategies of the tobacco industry. Its continued effective implication would allow the FDA to reduce tobacco product 

addictiveness and harm, and take other necessary actions. According to the GAO report, tobacco product, FDA needs to set time 

frames for review process. The FDA Center for Tobacco Products 

created by the Tobacco Control Act has gotten off to a slow start, 

and I want a better understanding what is the issue. 

I understand it is conducting your reviews to the tobacco products submissions, and the Agency is using a new public health 

standard, one that is different than the safe and effective standard 

used for medical products. Can you describe that standard that the 

FDA must be using in reviewing these submissions? 

Ms. CROSSE. Yes. They need to understand whether or not the 

product is going to pose any different risks to public health than 

currently legal tobacco products, and by that, that means to the 

public health in general, both to the users of those products, but 

also to non-users, to people who may be exposed in other ways, either to fumes or in some other way to the constituents of that product. 

Mr. GREEN. The GAO report focused on the need for the FDA to 

establish time frames for making decisions on submissions as a 

performance measure to improve the CTP review process. I want 

to ask you more about GAO’s recommendation. In making its recommendation, did GAO consider other performance measures besides established timelines that could be helpful in reviewing the 

SE submissions in a more timely manner? 

Ms. CROSSE. Well, in part, we particularly focused on the time 

frames because it was clear that this was taking substantial 

amounts of time, and that they had not established any benchmarks either for individual staff performance or for the performance of the center as a whole. 

We certainly think it is important that they understand what 

kinds of guidances are necessary, and what kind of communications 

with industry may be helpful, but also what kinds of information 

is most important to share with the public. And it is only in the 

last year that they have put out those major contracts for media 

42 

campaigns to try to address their responsibility for reducing the 

use of tobacco products by youth. 

Mr. GREEN. OK. Mr. Chairman, I appreciate this hearing, and 

hopefully, we will have someone from the FDA because they have 

come to our hearings pretty often, and to come back and explain 

what they are doing 5 years later. 

I also want to remind my colleagues that, according to the GAO, 

the vast majority of substantial equivalence backlog for products 

that can remain on the market while the FDA reviews their applications, the majority of the substantial equivalence applications 

submitted to FDA were incomplete, slowing down the review process as the Agency had to request additional information and await 

responses from tobacco companies. 

Last week the FDA announced 1⁄4 of the regular substantial 

equivalence applications had already been resolved, and FDA has 

stated the Agency is ready to initiate review of any newly submitted applications. 

Even as the FDA becomes more efficient in its review process, it 

is important to make sure that the new products coming on the 

market through the substantial equivalence pathway are not causing greater harm to the public health. And I would hope our subcommittee would continue to monitor this to see just how the Tobacco Control Act is being enforced, because a lot have supported 

it and feel like the FDA needs to do their job. 

So I yield back my time. 

Mr. BURGESS [presiding]. Gentleman yields back. 

The Chair recognizes the gentlelady from North Carolina, 5 minutes for questions, please. 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you, Dr. 

Crosse, for being with us today on this issue. 

I too was hopeful that a representative from the FDA would be 

with us. I know it is difficult for you to be able to answer some of 

the questions simply based on the study and report that was put 

forward, and I know that you can see, and I think you share with 

us the questions of why this hasn’t moved quicker than it should. 

I think you have identified a few things. One, because they collect 

the user fees, there is plenty of revenue, they have got their staff 

in place. What is left? What is left to keep them from moving forward in a more timely fashion? 

Ms. CROSSE. Well, one thing that they have told us that they continue to try to determine is exactly what information they may 

need in applications. Representative Green was correct in that a 

number of the initial applications did not contain information that 

FDA determined subsequently—— 

Mrs. ELLMERS. Um-hum. 

Ms. CROSSE [continuing]. That they needed in order to reach decisions. Now, some of those deadlines required that applications 

come in—— 

Mrs. ELLMERS. Um-hum. 

Ms. CROSSE [continuing]. Prior to FDA putting out guidance on 

what was needed. And so there has been a lot of back-and-forth. 

At this point in time though, certainly, you know, there has been 

sufficient time, I believe, for them to have—— 

Mrs. ELLMERS. That they should have—— 

43 

Ms. CROSSE [continuing]. For them to have identified what kinds 

of information they need in an application. 

Mrs. ELLMERS. So at what point did the FDA put out the guidance for those application requests? 

Ms. CROSSE. I don’t have a date in my head. I’m sorry. We can 

find out—— 

Mrs. ELLMERS. Well, if you can get that—— 

Ms. CROSSE. We can find out—— 

Mrs. ELLMERS [continuing]. I would like to know. 

Ms. CROSSE. Yes. 

Mrs. ELLMERS. I want to make sure that there are guidelines in 

place, first of all. But there again, I am kind of stumped, and I realize that much of what we do and the government can be very bureaucratic and not necessarily move as quickly as the private marketplace, but as you can see, this is affecting the private marketplace. I mean, obviously, there are products that can’t move forward and get on the market as a result of this, and one of the 

things that I have been thinking about in relation to this is how 

does this particular situation with the Tobacco Control Act differ 

from other user-fee industry-related—what is missing? One of the 

things that I support my colleague Brett Guthrie for his legislation, 

and I also associate myself to Dr. Burgess’ comments on setting a 

timeline in place as well, but one of the things that I realize is 

missing is this can just go on into perpetuity. There is no sundown, 

there is no re-evaluation or need for reauthorization of this particular act. 

In your opinion, would this be helpful for us to be able to help 

enforce what the CTP is doing? 

Ms. CROSSE. You know, I don’t think I am in a position to weigh 

in on whether or not it would be helpful to have it sunset. The user 

fee structure is quite different. The responsibilities assigned to 

FDA—— 

Mrs. ELLMERS. Um-hum. 

Ms. CROSSE [continuing]. Under this act are quite different. 

Mrs. ELLMERS. Um-hum. 

Ms. CROSSE. The user fees are intended to fund not only the reviews of the product applications as they are for devices or for 

drugs, for example, but also to fund the research, the media campaigns and the enforcement of—— 

Mrs. ELLMERS. Um-hum. 

Ms. CROSSE [continuing]. The requirements of the Tobacco Control Act, and FDA has undertaken a lot of enforcement actions to 

try to ensure that teenagers are prevented from having access to 

purchase tobacco products. 

Mrs. ELLMERS. But at the same time, I mean, there is obviously, 

as you can see, and I know you agree, there is just this incredible 

backlog. 

So, I mean, are there other situations like this where we have 

user fees that are being shared, where there isn’t a sundown provision, or there isn’t reauthorization in place? 

Ms. CROSSE. You know, I am not qualified to speak to user fees 

across the Federal Government. I don’t believe there are similar 

circumstances at FDA, but there may be user fee programs in other 

government agencies that are similar, that I just am not aware of. 

44 

Mrs. ELLMERS. OK. Well, there again, I think this is just one of 

those issues that we are all kind of baffled by why this is, and it 

almost seems as if it is not an organized effort to keep products 

from moving forward. And I do think that this is something that 

I would like to continue to work on, and there again—I am out of 

time. 

Thank you very much for coming today, and helping us to understand this issue. 

And, Mr. Chairman, I yield back the remainder of my time. 

Mr. BURGESS. Gentlelady yields back. 

The Chair now recognizes the distinguished gentleman from Louisiana, the Honorable Bill Cassidy, 5 minutes for questions, please. 

Mr. CASSIDY. Thank you. 

The increase in sales of pipe tobacco. People aren’t buying a lot 

more pipes, so I presume they are rolling this in some sort of paper 

and making their own cigarettes? 

Ms. CROSSE. GAO put out a report last year, or 2012, rather, 

that pointed out a huge shift in the use of pipe tobacco for rollyour-own cigarettes, subsequent to the changes in taxation on different types of tobacco products in the Children’s Health Insurance 

Program Reauthorization Act, CHIPRA, in 2009, when taxes were 

greatly increased on certain types of tobacco products. There was 

a tremendous shift so that consumers were no longer using rollyour-own tobacco, but rather using pipe tobacco for roll-your-own 

cigarettes. And we have substantial data pointing to a huge shift 

in that market, and a huge loss of revenue to the Federal Government because of that shift. 

Mr. CASSIDY. Can you make a guestimate as to whether or not 

there has been any discouragement—let me start over. If we know 

that there is a certain amount of regular cigarettes which are purchased, and then there is the roll-your-own, we have raised taxes 

on the regular cigarettes, does it not look like it is the same 

amount of tobacco being consumed, or is there a decrease in the per 

capita use of tobacco? 

Ms. CROSSE. The data in that report did not point to any decrease in the overall use of tobacco but rather to a shift in order 

to avoid taxes. 

Mr. CASSIDY. So we shifted, if you will, from something which is 

at least filtered to something that is unfiltered, arguably which has 

more health implications by using it unfiltered. 

Ms. CROSSE. You know, some roll-your-owns, I believe, actually 

can attach a filter from some machines, and I can’t speak to what 

the proportion is of the different types of roll-your-own tobacco 

cigarettes that are made in these tobacco shops now using pipe tobacco instead of roll-your-own tobacco. 

Mr. CASSIDY. Now, under the Family Smoking Prevention Tobacco Control Act, roll-your-own tobacco is any tobacco product 

which, I am reading here, because of its appearance, type, packaging, labeling, is suitable for use or likely to be offered to or purchased by consumers of tobacco for making cigarettes. Cigarette tobacco is defined as a product consisting of loose tobacco intended 

for use by consumers in a cigarette. 

45 

In your opinion, does the product labeled as pipe tobacco, about 

which you reported in April of ’12, meet either or both of these definitions? 

Ms. CROSSE. You know, the Treasury, which imposes the taxes, 

indicated that it was difficult for them to make that distinction between the roll-your-own tobacco and the pipe tobacco that’s sold in 

tobacco shops. 

Mr. CASSIDY. So related to that then, let me just ask specifically, 

are there any provisions in the Tobacco Control Act which permit 

a manufacturer product which meets either definition, to exempt 

themselves from the act simply by labeling their product something 

other than roll-your-own? Could it be the exact same tobacco, in 

this bag it is called roll-your-own, taxed, and here it is pipe tobacco, not taxed? 

Ms. CROSSE. I can’t speak to that. I know that the pipe tobacco 

is allowed to be flavored, so that if it is a flavored product, it could 

not currently be labeled as roll-your-own, because that is currently 

regulated by FDA and flavorings are prohibited. But in terms of 

the constituents or, you know, the extent to which the tobacco has 

been finely chopped or requires a certain blend, I don’t know if that 

could be the same. 

Mr. CASSIDY. OK, thank you. 

I will yield the remainder of my time to Mr. Guthrie. 

Mr. GUTHRIE. Thank you. One of my colleagues on the other side 

did mention that last week, right before this hearing, CTP put out 

that they are working to get rid of the backlog, and it is a massive 

move to get rid of the backlog. But as I understand it, there are 

two lines. There is one line you get into to say, if you get in this 

line, we are going to tell you to go to that line, and that line is the 

one that matters, and all they did was say we are not going to 

make you go through two lines now, you are going to have to go 

to the back of the other line. 

So there was no—the announcement that they made, it is my understanding, did not improve the determinations whether it is safe 

or unsafe, or can be sold or not sold. All it did was say, we are just 

going to make one line longer by getting rid of the other line. Is 

that an accurate description? 

Ms. CROSSE. You know, that is not my understanding of the announcement that they made. I believe that the announcement focused on the regular SE submissions, and the line for products that 

are not currently allowed to be on the market, you know, those provisional SEs—I would restate, the large bolus of applications that 

are sitting there waiting in the queue, those products are currently 

on the market. They do not have to await an FDA decision to enter 

the market, they are on the market. They are waiting for a decision 

about whether or not they can remain on the market or have to be 

removed. 

So FDA is focusing on working at the backlog of applications for 

products that cannot enter the market until they have reached a 

decision. That is a smaller group. They received something over 

900 applications for those products, and they have reached 30 decisions. So that is the backlog—my understanding of their announcement is that is the backlog that they are focusing on right now. 

Mr. BURGESS. OK—— 

46 

Mr. GUTHRIE. Thank you. 

Mr. BURGESS [continuing]. Well, the gentleman’s time has expired. 

The Chair now recognizes the gentlelady from California, 5 minutes for questions, please. 

Mrs. CAPPS. Thank you, Mr. Chairman. And, Dr. Crosse, thank 

you for your testimony. 

As a public health nurse, the issue of tobacco use and our Nation’s wellbeing and healthcare expenditures is one that we cannot 

ignore. Thanks to the Tobacco Control Act, tobacco companies can 

no longer mark ‘‘light’’ or ‘‘low-tar’’ cigarettes, misleading smokers 

who may otherwise have quit, but we do know there is much more 

we need to do to hold tobacco companies accountable for their marketing, and I urge the chairman to hold a hearing on the many 

issues that Ranking Member Waxman pointed out, but especially 

on e-cigarettes and the other products that continue to be targeted 

at our young people. 

We should not lose sight of why the Tobacco Control Act requires 

tobacco companies to receive authorization to market their products 

in the first place, and I encourage the subcommittee to hold hearings on the continual efforts by tobacco companies to skirt the 

rules, as opposed to a hearing like this, based on the business concerns of these same companies. 

Dr. Crosse, I understand that there were some initial roadblocks 

that slowed down the review process for substantial equivalence, or 

SE submissions, and are being addressed by FDA. 

Ms. CROSSE. That is my understanding. 

Mrs. CAPPS. OK. Could you please comment on the extent to 

which incomplete submissions from manufacturers has been a 

roadblock to the review process? 

Ms. CROSSE. Yes. Both FDA and manufacturers told us that incomplete submissions did slow down the review, that manufacturers did not have a good understanding of what information was required, and FDA itself was still developing its understanding of 

what information it might need in order to reach a decision. And 

so virtually every application that has come in has required some 

communication with the manufacturer to try to either understand 

part of the application, or to obtain additional information to supplement the application. 

Mrs. CAPPS. So this clearly needs to be addressed. 

And could you elaborate on the steps FDA has taken to improve 

its review process? 

Ms. CROSSE. Well, they have undertaken a lot of research to understand the science behind different tobacco products, they have 

organized their staff and their procedures in order to have a number of routine steps that an application goes through, so that there 

now is a jurisdictional review initially, and then a completeness review that takes place before a product enters actually the scientific 

review for the merits of the product. 

And so they have organized a process, they have developed steps, 

they have identified staff who are responsible for the different 

steps of the process, but they have yet to complete the process for 

very many of the applications. 

47 

Mrs. CAPPS. In September of last year, the GAO recommended 

that FDA establish time frames for making decisions on new tobacco product submissions. 

You indicated in your testimony today that FDA agreed with 

GAO’s recommendations, and plans to identify time frames for decision-making on new tobacco products submission. And the agency, is it still on track to identify these time frames this spring? 

Ms. CROSSE. Yes, it is on track to identify time frames for the 

regular SE submissions. They have not yet decided when they will 

have time frames in place for the provisional SE submissions because they tell us they do not yet have enough experience themselves with getting something through the complete process to 

know what time frames to establish. 

Mrs. CAPPS. Well, it is helpful for the subcommittee to hear that 

FDA has already agreed to establish and implement performance 

measures, including decision-making time frames, for regular SE 

submissions. Excuse me. 

Once these standards are in place, we can better monitor FDA’s 

progress. As FDA has focused on regular SE submissions, and continues to undertake these reviews, have the review times improved? 

Ms. CROSSE. The review times have improved, we understand, 

for the regular SE submissions. It is not clear that they have improved for the provisional SE submissions because they haven’t 

made very many decisions yet, so we can’t see any kind of trend. 

Mrs. CAPPS. I see. For decades, tobacco companies deliberately 

misled the public about the risks of smoking, and there is evidence 

that today’s products are perhaps even more harmful and addictive 

than those from past decades. 

My colleagues on the other side of the aisle have talked about 

setting time frames for review of these SE submissions. Mr. Chairman, we need to hear from FDA about the wisdom of this approach. We should be incentivizing tobacco companies to manufacture products that reduce harmfulness, not delay that process further. 

And I yield back the balance of my time. 

Mr. BURGESS. Gentlelady yields back. 

Now recognize the gentleman from Virginia, Mr. Griffith, 5 minutes. Your questions, please. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. Thank you, 

Dr. Crosse, for being here today. Appreciate that. 

I was a little concerned with some of the folks who said, on the 

other side of the aisle, that we needed to be more accommodating. 

I was pleased that the acting chairman went through the list of 

things that we did to accommodate the FDA. Not only did we say 

that other people could show up, as opposed to the head of this particular department, but that they didn’t have to have a written 

statement that had to be approved in advance, we are just trying 

to get to the information. 

And, you know, I had to make the comment to the acting chair 

that when I ran for election, I thought I was being elected to the 

United States Congress, not to a discussion committee to accommodate every whim of bureaucracy. And so I am a little disturbed that 

the FDA didn’t bother to send somebody here to testify today, parVerDate Mar 15 2010 11:06 Oct 30, 2014 Jkt 037690 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 F:\113-139 TOBACCO ACT ASK OK 10-23-14\113-139 TOBACCO ACT PDF MADE WAYN
48 

ticularly in light of the fact of the accommodations that were made 

to say, OK, you don’t have to have a written statement, you can 

send somebody who is, you know, a deputy. We understand they 

might say, ‘‘I don’t know the answer to that question, that is a little bit outside of my realm, but I will get you an answer.’’ Sometimes those things happen, but it is interesting that, you know, 

with all the busy schedules that so many of us are keeping, we 

were able to have this hearing, but nobody from the—how many 

employees did you say there were, over 500, with this particular division of the FDA? 

Ms. CROSSE. Yes. 

Mr. GRIFFITH. That none of those 500-and-some people could accommodate the United States Congress. 

That being said, I will say that the Agency, you know, as it 

states, is responsible for advancing the public health by helping to 

speed innovations. Further, they state the Agency protects, promotes the health and safety of all Americans by promoting innovation that addresses public health needs. 

Ms. Crosse, is it your opinion that the FDA is able to keep pace 

with the advances in science and product technology, not only for 

the Center for Tobacco Products, but for other industries it regulates? And before you answer, let me tell you one of the concerns 

I have is working on the mobile apps that are out there, and I have 

talked to the FDA about this, but you can do all kinds of things 

on your cell phone today that you didn’t used to be able to do, and 

I related to them on one occasion that, in Africa, a team of doctors 

were able to put together a $8 hack that would send pictures back 

of parasites found in children’s stool, and get it immediately analyzed by somebody in the United States. And I said can we use that 

in our country if somebody comes up with that, or does it have to 

first go through your regulatory process, and the answer was basically, well, if they are using it to diagnose what type of parasite 

it is, that makes it diagnostic, it would have to be regulated. Sometimes it seems they are just not, my opinion, they are just not able 

to keep up. 

If you can answer that question, both in regard to the Center for 

Tobacco Products and in other areas from your observation, to the 

best of your ability. 

Ms. CROSSE. Well, I can’t speak directly to the mobile apps, but 

we have previously examined activities at FDA, and raised some 

concerns certainly in the Center for Devices about their ability to 

have staff with all of the technical expertise for the rapidly changing technologies, and for the software that is included in medical 

devices, for example. That has been a concern that we have identified in the past, and that FDA has acknowledged is a challenge for 

them. 

Mr. GRIFFITH. I appreciate that. 

I would say in regard to the tobacco products, and I don’t know 

the answer, we all want to know what is in the products, what the 

health effects are of those products, and we certainly want them 

to get that done in a timely fashion. I will say that, you know, 

when I was in the fourth grade, growing up in Virginia, they used 

to teach us the history that one of the first times that somebody 

was smoking a cigar, walking down the streets of London, someVerDate Mar 15 2010 11:06 Oct 30, 2014 Jkt 037690 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 F:\113-139 TOBACCO ACT ASK OK 10-23-14\113-139 TOBACCO ACT PDF MADE WAYN
49 

body ran into a local store where they all kept water buckets in 

case a fire broke out, and threw water on the man because he was 

on fire, he had smoke coming out of his mouth. 

So it would seem to me that if we could get to some more of these 

smokeless products, it would probably help folks. That is the gut 

reaction. I would like to see the science on it. 

Do you think that they are going to be able to give us some of 

that, and reduce this backlog dramatically in the next couple of 

years? 

Ms. CROSSE. Well, with regard to smokeless products, I think 

that that depends upon the applications that are submitted to 

them. That is dependent upon the industry. Some of those products 

are currently not deemed to be subject to FDA regulation, and so 

products of those types can enter the market right now. I think 

that there is not currently a sufficient understanding, though, of 

the risks posed by those products, and whether or not they simply 

allow someone who smokes to co-use those types of products, or use 

those products in situations where they can’t use a cigarette because of restrictions on where they can smoke, or whether or not 

it allows them to cease use of tobacco products, which we do know 

is dangerous to their health. 

Mr. GRIFFITH. Yes. And we certainly need to get the answers to 

these questions because, you know, even a number of healthcare 

individuals have indicated that there is a good possibility that 

things like the e-cigarette may be a step in between smoking the 

smoke tobacco and moving away from using the product at all. 

Ms. CROSSE. Yes, of course, if they are making smoking cessation 

claims, then they would be subject to regulation as a drug, and 

subject to regulation in a different part of FDA. So, you know, I 

think the concern is whether or not they become a gateway product 

to allow young people to then begin smoking cigarettes, and I think 

the science is just not there yet to know. 

Mr. GRIFFITH. Yes, ma’am. I appreciate that, and I hope that the 

center will get to work and get it done. 

Thank you so much, and I yield back. 

Mr. BURGESS. The gentleman’s time has expired. 

The Chair now recognizes the gentleman from Illinois, Mr. 

Shimkus, 5 minutes for your questions, please. 

Mr. SHIMKUS. Thank you, Mr. Chairman. If I can get the staffer 

to move. Mike Bilirakis. Thank you. 

Mr. BILIRAKIS. Gus Bilirakis. 

Mr. SHIMKUS. Yes, yes, yes. Well, anyway, your staffer, get him 

to move. Thanks. Mike’s dad. 

Mr. BILIRAKIS. Yes. 

Mr. SHIMKUS. That is his dad, former committee member, it is 

an easy mistake. 

So welcome. And actually, I am following a lot of Morgan’s comments, and a lot of comments all other folks have made, but I want 

to start with—I was going to flip the questions around, but you 

ended up with this whole, if there is a statement of smoking cessation claimed, it goes into another part or another area of regulation, versus just tobacco use product, is that correct? 

Ms. CROSSE. That is my understanding, yes. 

50 

Mr. SHIMKUS. And because another former colleague, not Mike 

Bilirakis, but Steve Buyer, when we passed this bill in 2009, kept 

trying to address these issues of nicotine gum, snuff, and now you 

could make some debate about e-cigarettes, that, yes, do provide 

nicotine to the individual consumer, but you could also argue, especially with e-cigarettes, that in the vaporized form versus a burning 

form, and all those issues, there may be some health benefits over 

a burned tobacco product is kind of the debate, and so, in this process, we need to get the FDA to move in the direction of evaluating 

this, right? Or shouldn’t the FDA, in essence, be like the referee 

on the court in making judgments? 

Ms. CROSSE. Well, I think that the statute gives them that authority and that responsibility, and that they have announced that 

they intend to deem additional tobacco products, and as I understand it, virtually all additional tobacco products, as subject to 

their regulation. 

Mr. SHIMKUS. And so intent to deem, I guess that is part of the 

reason why we are here, right? How long does it take to have an 

intent to deem, and how long should it? 

Ms. CROSSE. Well, rulemaking, as I am sure you are aware, is 

typically a years-long process. They first announced their intent to 

deem in 2010, but it was not clear whether they at that time intended to deem all products at once, or product after product individually. My understanding is that they now have made a determination to deem multiple products at one time, and so, therefore, 

needed to develop the information to support that rulemaking. We 

had other work that had examined rulemaking at FDA that had a 

range of 1 year to 14 years, so this is still in that range. 

Mr. SHIMKUS. Yes, but the importance of the intent to deem is 

to provide information to the consuming public, the adult consuming public, correct? 

Ms. CROSSE. Well, yes, and to make determinations about the 

safety and controls that might be required for different types of 

products. 

Mr. SHIMKUS. Because they should be using science and evidence 

in this decisionmaking process, correct? 

Ms. CROSSE. That is what they are saying that they are trying 

to develop, is a scientific base to understand the risks posed by different types of tobacco products. 

Mr. SHIMKUS. And we would hope that they will do that sooner 

rather than later for all of us involved. I would think that would 

be the argument. 

And then on the—my time is running short, but also following 

up on Morgan’s comments is technology and moving rapidly, bureaucracy does not, we fight that issue across the board in the 

telecom world. And you talk about apps, but is the FDA’s ability 

to keep up with the innovation and science and product technology 

for the Center for Tobacco Products, have you seen that that is lagging also? 

Ms. CROSSE. Well, I think it is too soon to say whether it is lagging. I think they have just been mounting it in the last several 

years. And so—— 

Mr. SHIMKUS. You know, I think that is what frustrates a lot of 

us here, and I know people—there is a role for government, but in 

51 

the private sector, you can’t mount something for years. You would 

never have a product, you would never have a return on investment, and your competitors would move right past you. So we 

would wish that they would move expeditiously. 

And thank you, Mr. Chairman, I yield back. 

Mr. BURGESS. Gentleman yields back. 

That being all the members of the subcommittee, the Chair now 

recognizes Mr. Bilirakis, 5 minutes for questions, please. 

VOICE. Is that Mike or Gus? 

Mr. BILIRAKIS. Yes. Either one. I can get Mike—— 

Mr. BURGESS. Either one. 

Mr. BILIRAKIS [continuing]. In short notice if you want him. 

Thank you, but I am a member of the subcommittee as well, but 

turning to—thank you very much for appearing today. I appreciate 

it very much, Doctor. 

Turning to staffing levels at the Center for Tobacco Products, 

how many FTEs are currently in the various offices? 

Ms. CROSSE. My understanding is that they currently have a 

total of about 511 staff, and the figures I have are that the Office 

of Science, which is the office that makes the decisions on product 

reviews, they have 194 staff, and that the Office of Health Communications has 44 staff, and the Office of Compliance and Enforcement has 116 staff. 

Mr. BILIRAKIS. Thank you. Do most of these employees have previous experience regulating tobacco products in other government 

agencies? 

Ms. CROSSE. No, because tobacco products weren’t regulated previously, and so they may have experience in regulating products, 

but not necessarily tobacco products. They did bring in a number 

of scientists who had done research on tobacco products, but not for 

purposes of regulation. 

Mr. BILIRAKIS. Thank you. 

Next question. Has FDA implemented the small business provisions included in the statute, including the establishment of the office to assist small tobacco manufacturers for the provision of technical assistance, and has the Agency issued any small business 

guidance? 

Ms. CROSSE. You know, I am not certain. We can get back to you 

on that. I know that they have had some implementation in that 

area, but we did hear concerns from manufacturers that that was 

an issue for them in terms of being able to get the information that 

they needed. 

Mr. BILIRAKIS. You are not sure about the small business guidance? 

Ms. CROSSE. I am just not sure. I don’t think that we looked at 

it explicitly. 

Mr. BILIRAKIS. OK, you will get back to me? 

Ms. CROSSE. Yes, we will. 

Mr. BILIRAKIS. All right, thank you very much. 

Anybody like some time here? 

Thank you. I yield back, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. 

That concludes the questions by the members of the subcommittee. I would remind all members they have 10 business days 

52 

to submit questions for the record, and ask the witness to respond 

to the questions promptly. Members should submit their questions 

by the close of business on Tuesday, April 22. 

Without objection, the subcommittee is adjourned. Thank the 

witness. 

[Whereupon, at 11:49 a.m., the subcommittee was adjourned.] 

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