PARENTS BE AWARE: HEALTH CONCERNS ABOUT

DIETARY SUPPLEMENTS FOR OVERWEIGHT

CHILDREN

HEARING

BEFORE THE

SUBCOMMITTEE ON

OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

JUNE 16, 2004

Serial No. 108–93

Printed for the use of the Committee on Energy and Commerce

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house

PARENTS BE AWARE: HEALTH CONCERNS ABOUT DIETARY

SUPPLEMENTS FOR OVERWEIGHT CHILDREN

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PARENTS BE AWARE: HEALTH CONCERNS ABOUT

DIETARY SUPPLEMENTS FOR OVERWEIGHT

CHILDREN

HEARING

BEFORE THE

SUBCOMMITTEE ON

OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

JUNE 16, 2004

Serial No. 108–93

Printed for the use of the Committee on Energy and Commerce

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house

2

COMMITTEE ON ENERGY AND COMMERCE

JOE BARTON, Texas, Chairman

W.J. ‘‘BILLY’’ TAUZIN, Louisiana

RALPH M. HALL, Texas

MICHAEL BILIRAKIS, Florida

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

JAMES C. GREENWOOD, Pennsylvania

CHRISTOPHER COX, California

NATHAN DEAL, Georgia

RICHARD BURR, North Carolina

ED WHITFIELD, Kentucky

CHARLIE NORWOOD, Georgia

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi, Vice Chairman

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

CHARLES F. BASS, New Hampshire

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

DARRELL E. ISSA, California

C.L. ‘‘BUTCH’’ OTTER, Idaho

JOHN SULLIVAN, Oklahoma

JOHN D. DINGELL, Michigan

Ranking Member

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

PETER DEUTSCH, Florida

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

LOIS CAPPS, California

MICHAEL F. DOYLE, Pennsylvania

CHRISTOPHER JOHN, Louisiana

TOM ALLEN, Maine

JIM DAVIS, Florida

JANICE D. SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

BUD ALBRIGHT, Staff Director

JAMES D. BARNETTE, General Counsel

REID P.F. STUNTZ, Minority Staff Director and Chief Counsel

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

JAMES C. GREENWOOD, Pennsylvania, Chairman

MICHAEL BILIRAKIS, Florida

CLIFF STEARNS, Florida

RICHARD BURR, North Carolina

CHARLES F. BASS, New Hampshire

GREG WALDEN, Oregon

Vice Chairman

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

JOE BARTON, Texas,

(Ex Officio)

PETER DEUTSCH, Florida

Ranking Member

DIANA DEGETTE, Colorado

TOM ALLEN, Maine

JANICE D. SCHAKOWSKY, Illinois

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

JOHN D. DINGELL, Michigan,

(Ex Officio)

(II)

C O N T E N T S

Page

Testimony of:

Ayoob, Keith, Associate Professor of Pediatrics, Albert College of Medicine ................................................................................................................. 60

Barash, Jonathan, Former President, DBS Labs .......................................... 55

Beales, J. Howard, III, Director, Bureau of Consumer Protection, Federal

Trade Commission ........................................................................................ 10

de la Rocha, Jose, Director, Quality Control, Pal Labs ................................. 55

Gay, Dennis, President, Basic Research; Daniel Mowrey, Director of Scientific Affairs, Basic Research; Mitchell Friedlander, Marketing Consultant, Basic Research; and Nathalie Chevreau, Nutritional Research

Center, Basic Research ................................................................................. 57

Hoppin, Alison, Associate Director for Pediatric Services, MGH Weight

Center, Massachusetts General Hospital .................................................... 26

Kaye, Edita, Founder, The Skinny Pill Company .......................................... 55

Rayman, Jerry, Vice President of Sales, Pal Labs ......................................... 56

Regalado, Guy, Former Vice President of Sales and Marketing, Dynamic

Health of Florida ........................................................................................... 55

Wechsler, Howell, Acting Director, Division of Adolescent and School

Health, The Centers for Disease Control and Prevention ......................... 18

(III)

(1)

PARENTS BE AWARE: HEALTH CONCERNS

ABOUT DIETARY SUPPLEMENTS FOR OVERWEIGHT CHILDREN

WEDNESDAY, JUNE 16, 2004

HOUSE OF REPRESENTATIVES,

COMMITTEE ON ENERGY AND COMMERCE,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

Washington, DC.

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

2123, Rayburn House Office Building, James C. Greenwood (chairman) presiding.

Members present: Representatives Greenwood, Stearns, Bass,

Walden, Ferguson, Barton (ex officio), DeGette, Schakowsky, and

Waxman.

Staff present: Kelli Andrews, majority counsel; Mark Paoletta,

majority counsel; William Harvard, legislative clerk; Bud Albright,

majority staff director; Andy Black, majority policy coordinator;

David Nelson, minority senior investigator; and Jessica McNiece,

minority research assistant.

Mr. GREENWOOD. The hearing will come to order.

The Chair recognizes himself for the purposes of making an

opening statement.

Reports concerning the increase of obesity in America’s children

have been broadcast throughout the media in recent weeks and

months. The June 7 issue of Time magazine has a cover story on

obesity problems facing Americans both young and old. Today the

committee will examine the exploitation of parents desperate to

find a solution to their children’s weight problems. These parents

are sometimes persuaded to turn to dietary supplements marketed

with the promise of weight loss for their kids. What we have

learned from our investigation is that these promises are at best

empty or at worst, dangerous.

Today we focus on several products that have been marketed and

manufactured for the express purpose of providing a weigh loss

benefit for children as young as 6 years of age. These products with

names that invite certain weight loss in children, Skinny Pill for

Kids, PediaLean and PediaLoss have been represented to America’s

parents to be safe and effective for weight loss in children. None,

I repeat none of these products has been tested in any scientifically

credible manner in children. None of these products has any legitimate basis upon which to claim that they would be effective in

helping children lose weight.

2

Several of these products also contained ingredients which would

be harmful to children. For example, we’ve learned that an herb

called uva ursi was contraindicated for children under 12 years of

age, yet this ingredient found its way into a dietary supplement

called the Skinny Pill for Kids and was promoted to millions of parents on national television by Edita Kaye. The fact that this product was being marketed at all for children when it contained an ingredient children should not take is outrageous.

I have watched the tapes of Ms. Kaye and her laboratory formulator defending this product, a product that thankfully a child has

never ingested.

And let me be clear to Ms. Kaye, PAL Labs and anyone else

there who is deciding whether to put an ingredient contraindicated

for children in a product for kids: It is no answer to the American

public that only small amounts of these ingredients were incorporated in the pills.

The company that testify at our hearing today provided false

hope and promises and parents and children in the marketing of

their respective products. Given the delicate nature of children’s

health, this type of misleading advertising is even more egregious.

One of the dietary supplements for children that the committee

investigated, PediaLean, is still available for purchase today. The

fact that two of these products, the Skinny Pill for Kids and

PediaLoss I am told are not being sold anymore in no way changes

the larger issues at stake here today.

These companies, Edita Kaye and her Fountain of Youth Group

DBS Labs and Basic Research, promoted and offered for sale products for young children to take by doing little if any of their own

legitimate research on the health effects of their products on children. Nor did any company even attempt to determine that the

products worked before promoting it for purpose. They did this simply to make money at the expense of desperate parents, parents

hoping against all hope for a safe and effective magic solution for

their children’s weight problems.

The fact that some of these companies ultimately made little or

no money on these products does not alleviate the concern that the

rapid rise from obesity will be exploited by dietary supplement

manufacturers for monetary benefit.

It is also important to point out that while Edita Kaye’s Skinny

Pill for Kids was pulled before it ever hit the shelves, sparing children around the country the ill effects of ingesting this product and

that her national promotional efforts for her product were a year

and a half ago, she refused to voluntarily cooperate with the committee’s investigation every step of the way.

I expect that Ms. Kaye will stand by her statements made on national television that she is happy that the promotional launch of

her ill-fated Skinny Pill for Kids opened up the debate on this issue

of finding a solution to the increasing number of overweight children in the U.S. If Ms. Kaye believes she opened this debate, it is

only fitting that she be present at this public forum to continue the

debate. I am disappointed that she was not willing to voluntarily

aid the committee in our investigation into this matter.

Several agencies have extensive work relating to obesity in children. I look forward to hearing about the work the Centers for DisVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 95442.TXT HCOM1 PsN: HCOM1
3

ease Control has done in this arena and the information it believes

is useful to aid parents and their children in combating weight related problems.

The Federal Trade Commission has done extensive to combat

misleading advertising in the dietary supplement industry, and in

particular in supplements marketed to children. We know that they

recently settled an action with Ms. Kaye regarding her promotional

efforts with respect to the Skinny Pill for Kids and other of her

products. We look forward to hearing more about this settlement

and look forward to hearing about other work the Commission has

done in this area.

In addition, we are joined by some medical experts who will be

able to shed light on some of the problems associated with taking

these dietary supplements designed for use by children and the

problems that can arise when young children are led to believe that

there is a magic pill.

I am hopeful that at the end of this hearing the public, particularly parents, are more informed about what little science and research goes into these products before they are marketed for children. I hope that parents after hearing testimony today will turn

skeptical eyes toward claim of weight loss from a pill.

The uniqueness of this subcommittee’s oversight function is its

ability to promote change by providing the public with information.

The more information that parents have about these dietary supplements promoted for their children, the more informed will be

their decisions regarding their children.

The Chair now recognizes the gentlelady from Colorado, Ms.

DeGette for her opening statement.

Ms. DEGETTE. Thank you, Mr. Chairman.

Today’s hearing addresses a topic of great concern, the potential

dangers of dietary supplements for pediatric populations and the

extent to which these products are being marketed to some uninformed parents and adolescents and children. This hearing is of

particular interest to me because it highlights the substantial differences between how we treat claims about dietary supplement

versus pharamaceuticals, and also how we treat products for children versus adults. There is a substantial difference in both of

these cases.

Dietary supplements such as the three products that we are examining today, the Skinny Pill for Kids, PediaLean and PediaLoss

are not subject to the same stringent regulations as food additives

or drugs. This, of course, is because of the Dietary Supplement

Health Education Act, DSHEA, which has greatly limited the

power of the FDA to stop sales of dangerous substances, only until

after substantial public harm has occurred. Nor does that agency

have the same power they exercise over drugs to assure that labeling and advertising are not false or misleading.

Some say that the law has allowed ‘‘buyer beware’’ to replace and

‘‘safe and effective when used as directed.’’ I am concerned that

consumers do not have enough understandable information under

this law and that the law loosens the oversight that could prevent

marketing of dangerous or ineffective substances to children and

adults. These dietary supplements for overweight children are a

tragic example of how loose the oversight is, but they are not the

4

only example. We had another hearing earlier this spring on

ephedra and other dietary supplements that are providing a real

risk to consumers.

The Federal Trade Commission, today represented by Mr.

Beales, is here to provide information about the credibility of advertising claims about weight loss effects and the safety of those

products. The FTC will discuss its recent filing of a complaint

against one of the witnesses today Basic Research. I’m very interested to learn from the FTC about the extent of false and deceptive

advertising in the dietary supplement industry and whether the

FTC’s current enforcement powers are sufficient.

This hearing also highlights the substantial difference between

testing requirements in pediatric versus adult populations. I, like

many of my colleagues on the subcommittee, have worked hard on

the pediatric rule which requires testing for drugs that are given

to pediatric populations and on post market surveillance of medical

devices used by children. The FDA has worked with Congress and

the pharmaceutical industry to improve testing for these drugs and

devices, so we have made significant progress for a majority of

products. But yet for dietary supplements like this PediaLean

which the box and bottle look to me like remarkably like an FDA

approved drug, I think that’s probably the intention, we have a disturbing situation in which the product, at least with the Skinny

Pill for Kids which thank goodness is not being sold, it included a

substance that was determined to be dangerous to children.

The Skinny Pill for Kids was widely advertised, but as the chairman said, it was never distributed.

The situation remains that we do not have adequate information

on the effects of supplements in children. This committee’s work on

the pediatric role was based on a determination that children are

not just mini adults and that medical products for children must

be tested for efficacy and toxicity.

The committee does not take the protection of children lightly,

nor does it formulate policy based on dubious science. Two of the

witnesses today will speak to the science behind these dietary supplements, and I am pleased that they are with us today because

I think, frankly, there is too much junk science receiving credence.

The Federal Government plays a substantial role in protecting consumers from these invalidated claims, and this science I believe

warrants an examination. The hearing is an opportunity to learn

about the science, and I thank the chairman for holding it.

I just want to add one more thing. I understand the purposes behind DSHEA, and I support many of those goals. But given the last

hearing and now this hearing, Mr. Chairman, I really think we

need to look at DSHEA to see whether or not there are ways we

can make distribution of these dietary supplements more safe for

the health of our constitutes.

And I yield back the balance of my time.

Oh, Mr. Chairman, before I yield, I’d ask unanimous consent to

put Mr. Dingell and Mr. Waxman’s opening statements, and any

other members opening statements in the record.

Mr. GREENWOOD. Without objection, that will be the order.

The gentlelady from Chicago, Ms. Schakowsky.

5

Ms. SCHAKOWSKY. Let me begin by thanking Chairman Greenwood for holding this hearing on such an important topic.

The issue of childhood obesity has become one of great concern

for all of us as it has become clear that we are now faced with an

epidemic in this country that threatens the future health of millions of American children and adults.

It is also clear that, as a result of the increased media attention

on this issue, parents have become more aware of this problem and

the significant risks that it poses to their children. For that reason,

we have a responsibility to make sure that parents in their efforts

to provide remedies to this very complex and chronic problem do

not give their children dietary supplements that, despite their marketing and labels, have been proven to be neither effective nor safe.

In addition to what appears to be a significant lack of resources

and funding made available to the Federal Trade Commission and

the Food and Drug Administration to screen these products, it

should be recognized that the ability of these agencies to protect

families from the unethical manufacturing and marketing of dietary supplements has been weakened considerably by the limited

authority provided to them by the 1994 Dietary Supplement Health

and Education Act, DSHEA.

It is evident that under the current system outlined by DSHEA,

manufacturers of dietary supplements can get around current

guidelines, allowing them to not only move their product into the

market but also make health claims that mislead desperate parents who are searching for solutions to help their children.

I feel, then, that it is important to ask what steps the Bush Administration and Congress have taken and should take to strengthen the current law and subsequentially address the roadblocks that

exist which prevent the FTC and FDA from doing more to protect

consumers from these untested products.

There is a significant amount of research available from the CDC

and the World Health Organization that outlines steps that parents, children, physicians and communities can take in their efforts

to address the increasing prevalence of childhood obesity. It is

these proven effective interventions such as improved nutrition

education, increased access to healthy foods and increased opportunities for children to engage in physical activities that we should

be actively promoting to families and within schools.

In addition to promoting what we know to be effective in the

fight against obesity, I believe that it is our responsibility to make

sure that families are protected from the manufacturing and marketing of products that are not only unproven in regards to their

efficacy in inducing weight loss, but also unproven to be safe for

both children and adults.

I look forward to hearing from today’s panelists about how we

can best inform and protect consumers from business practices that

are not credible and jeopardize consumer safety.

Thank you, Mr. Chairman.

[Additional statements submitted for the record follows:]

6

PREPARED STATEMENT OF TOM ALLEN, A REPRESENTATIVE IN CONGRESS FROM THE

STATE OF MAINE

I am pleased that Chairman Greenwood and Ranking Member Deutsch called this

hearing today to look at the marketing and distribution of dietary supplements targeted at children.

We all recognize that obesity in the U.S. is reaching epidemic proportions. In

Maine, nearly 27 percent of high school students are overweight and nearly 59 percent of Maine adults are overweight or obese. Nationally, approximately two-thirds

of American adults are overweight and 15 percent of 6- to 19-year-olds are overweight—a number that has tripled over the past two decades. Obesity represents

a tremendous burden on our health care system—costing Americans more than $117

billion per year. Obesity is associated with an increased risk for heart disease, the

leading cause of death in the U.S., as well as cancer, diabetes, and muscle problems.

Overweight children and their parents, often desperate for an easy solution to

weight loss, are lured by the bold, exaggerated marketing claims of dietary supplement manufacturers and their so called ‘‘clinical studies.’’ The average American

does not know that there are virtually no standards regulating how these supplements are made, ingredients are often not fully disclosed—disguised behind ‘‘scientific-sounding’’ trademarks, and there is no requirement—or national database—

for adverse event reporting. And yet parents are being encouraged to give these pills

to children as young as six. It is certainly a case of ‘‘buyer-beware.’’ But do parents,

and their children know this? In the case of dietary supplements marketed as ‘‘diet

aids,’’ it is often impossible to figure out exactly what you are getting, what the side

effects could be, and whether there is any evidence that the supplement will have

the desired effect.

A 2002 Harris poll determined that most people believe that if a supplement is

on the market it must have been approved by ‘‘some government agency’’; that manufactures are prohibited from making claims for their products unless they have the

data to back up those claims; and that companies are required to include warnings

about potential risks and side effects. In the case of dietary supplements, all of

these assumptions are false. In 2002, the FTC found that at least half of all weightloss ads contained false or misleading statements. These companies thrive by playing on people’s desperate search for a quick-fix to lose weight.

Thank you to our panelists for joining us today. I particularly look forward to

hearing from our expert witnesses about their views of the safety and efficacy of

these products, and the appropriateness of promoting these supplements to children

as young as 6.

PREPARED STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF MICHIGAN

Mr. Chairman, thank you for continuing the investigation into the unfortunate

consequences of the Dietary Supplement Health Education Act. Last summer this

investigation exposed the statutory limitations and regulatory failures in dealing

with ephedra, the herbal form of a stimulant drug that caused death and a number

of serious health problems. As a direct result of pressure from this Committee, the

Food and Drug Administration (FDA) finally decided that enough damage had been

done to the public health and banned that so-called dietary supplement.

I am also pleased with another positive achievement of this investigation. Our inquiries to the Drug Enforcement Administration (DEA) and FDA regarding the sale

of dangerous steroid precursors as dietary supplements ultimately helped produce

Administration support for H.R. 3866, the ‘‘Anabolic Steroid Control Act of 2004.’’

The bill passed the House with almost unanimous support and is currently pending

Senate action.

Today, we look at another category of products that may potentially cause not

only physical harm to the public but also make a serious dent in the wallets of

American consumers desperate to find an ‘‘easy way’’ to treat their overweight children. Again we will see how unscrupulous operators ignore public health consequences as they bend, break, and otherwise abuse a weak law to sell products that

could seriously injure the uninformed user. Further, their advertising claims attract

the most vulnerable: parents and children who hope to lose pounds easily without

undergoing important lifestyle changes, such as diet and exercise.

Given current judicial interpretations, weak statutory language, clever uncovering

of legal loopholes, and shoddy enforcement, the current law cannot adequately protect the public from these modern-day patent medicine peddlers. I therefore joined

Rep. Susan Davis and Rep. Henry Waxman, in introducing H.R. 3377, the ‘‘Dietary

Supplement Access and Awareness Act of 2004.’’ Passage of this bill would be the

7

first step toward undoing the harm to the public health and the personal pocketbooks of millions of Americans who, because of the fraudulent claims which dominate this industry, have endangered their health and squandered billions of dollars

on products that have not the slightest scientific evidence to support manufacturers’

claims.

Mr. Chairman, thank you again for this Subcommittee’s focus on the public health

threats posed by certain dietary supplements. I look forward to the testimony presented today.

Mr. GREENWOOD. The Chair thanks the gentlelady and will now

introduce our first panel.

We’re pleased to have with us and we welcome Mr. Howard

Beales, who is the Director of the Bureau of Consumer Protection

of the Federal Trade Commission.

Good morning, sir.

Mr. BEALES. Good morning. And thank you very much for the opportunity to——

Mr. GREENWOOD. Well, I am not ready. I am just saying good

morning and I have not asked you to speak yet.

Mr. BEALES. I am sorry.

Mr. GREENWOOD. But I will. Thank you.

We have Dr. Howell Wechsler, who is the Acting Director, Division of Adolescent and School Health for the Centers for Disease

Control and Prevention.

Good morning, sir. Good to have you here.

We also have Dr. Alison Hoppin. Am I saying that right? Who

is the Associate Director for Pediatric Services at MGH Weight

Center in Massachusetts General Hospital.

And we expect shortly to have with us Dr. Keith Ayoob, who is

the Associate Professor of Pediatrics at the Albert Einstein College

of Medicine.

The Chair recognizes the presence of the gentleman from Florida,

Mr. Stearns. Do you have an opening statement you would like to

make? The Chair would recognize the gentleman from Florida.

Mr. STEARNS. Thank you, Mr. Chairman. Obviously, I am very,

very excited that you are holding this hearing.

I Chair the Subcommittee on Commerce, Trade, and Consumer

Protection and we also deal in major league sports. And I am glad

that you are investigating dietary supplement issues for the year

or so.

And I am very interested in how Howard Beales from the Federal Trade Commission will testify today on its actions before us.

Basic Research, for one, has provided us that the active ingredient

in their products has been hyped up, some sort of hyper fiber which

I think they sell for about $40 a bottle on the Internet and I guess

the real question is does it work. Is there validity and research and

support to support their advertising claims and what is the Federal

Trade Commission to make sure that it has been demonstrated?

Can the parents feel comfortable buying this product? And are they

better off, perhaps, just with a salad and perhaps with fiber from

fruit?

As a member of the Florida delegation I’m struck by the prevalence of connections to Florida by some of our witnesses and some

of the manufacturing distribution. So, I would be curious to see

how that works out.

8

So, Mr. Chairman, I appreciate your hard work here and I look

forward to the hearing.

Mr. GREENWOOD. The Chair thanks the gentleman from Florida.

And before we swear in the first panel, I would like to, for the

benefit of the members of the committee, have you view a brief

video that I think illustrates this issue if our technical people are

ready to do that.

[Video shown, interview of Edita Kaye and Dr. Ayoob done by

Katie Couric.]

Ms. COURIC. Obesity in children has reached epidemic proportions. According to

the Centers for Disease Control, more than 6 million kids in the United States are

severely overweight, that is 15 percent of our children and adolescents. But is a diet

pill for children the answer? Edita Kaye is the creator of skinny.com and the new

Skinny Pill for Kids. And Dr. Keith Ayoob is an Associate Professor of Pediatrics

at Albert Einstein College of Medicine.

Good morning to both of you.

Dr. AYOOB. Good morning.

Ms. COURIC. Let me start with you, if I could, Edita Kaye.

Ms. KAYE. Good morning to you.

Ms. COURIC. Good morning. Nice to see you.

Ms. KAYE. Thank you.

You have been marketing a Skinny Pill for adults on a website and now you have

a Skinny Pill for Kids. Why?

Ms. KAYE. Yes.

Ms. COURIC. Obviously for the reasons I just outlined?

Ms. KAYE. Well, I will tell you why. Because in the past 36 months that I have

been selling the Skinny Pill, which is a dietary nutritional supplement for women

and men, I have had requests; we have almost 500,000 people who have used our

product and it is safe and successful. And there is a wonderful food plan that goes

with it. And moms have been writing to me, emailing me, calling me saying ‘‘Edita,

what can I do for my kids.’’ And children have called me. And it breaks your heart,

Katie, the letters and emails that I get. Kids get thrown into garbage cans. They

have no self-esteem. They are afraid to go to school. They cannot play with their

friends. They cannot eat in the restaurants that their friends eat in.

So I thought, okay, I will come up with something that I am going to call the

Skinny Pill for Kids, and to me I am ringing a great big bell out there across America.

Ms. COURIC. What is in this pill?

Ms. KAYE. In this pill we have B vitamins, which are wonderful and they help

with energy, right? We have dietary fibers which are wonderful because what they

do is they give you a feeling of fullness so you do not eat as much.

Ms. COURIC. Right.

Ms. KAYE. Or as often.

Ms. COURIC. In other words, it is all natural ingredients, right?

Ms. KAYE. Absolutely. These are—no one has questioned the contents of the Skinny Pill.

Ms. COURIC. There is no ephedra——

Dr. AYOOB. Excuse me. Excuse me.

Ms. KAYE. No, no, no, no.

Ms. COURIC. Wait for a second, Doctor. You’re going to get to—I am going to get

to you in a second because I am sure you have some serious issues with the whole

notion of marketing a Skinny Pill for children, and what are they?

Dr. AYOOB. Yes, I do, big time issues. First of all, I work with this issue every

single day and kids are the most important people in the world to me.

I have a real issue when somebody is marketing a bogus product that has no scientific evidence behind it and when it includes herbs that are essentially diuretics

and that have never been tested on kids. I would never recommend this product for

anybody.

Ms. COURIC. And, in fact, it contains, niacin folate, vitamin B12——

Dr. AYOOB. And can——

Ms. COURIC. Wait a second. Pectins, clumodin, uva ursi, whatever that is, Berchu

leaves and juniper berry. And you say it is based on scientific research done in Australia and the U.K.?

Ms. KAYE. Yes. It comes together with a food plan. We know that pectins, such

as the fibers that are in this product, are ways of helping satisfy children’s fullness.

9

The B vitamins are—you know, there is nothing in this product that you cannot get

in other vitamins.

But what I am saying here is you have got it—you know, I will tell you what the

experts are saying to our kids. They are saying, ‘‘Look, you are fat, here is what

you have to do. Turn off the TV and stop eating fast foods.’’ How real is there? It

is not going to happening——

Ms. COURIC. Doctor?

Dr. AYOOB. Excuse me.

Ms. KAYE. What I am saying is——

Dr. AYOOB. Excuse me. I have a real issue with that. I am sorry. But ingredients

in this product have never been tested on kids. Edita, you do not have any evidence

and until you do have evidence, you should not be making bogus claims. This pills

is not going to help anybody lose weight. A balanced eating plan and a lifestyle

change that parents can gradually work on is what is going to help kids lose weight.

Ms. COURIC. Has this been tested on children?

Ms. KAYE. I produce this in a lab. It has formulators——

Ms. COURIC. Has it been tested on children?

Ms. KAYE. This particular product, some of the ingredients have and I do not

know about the others.

Ms. COURIC. But this particular substance——

Ms. KAYE. I do not know——

Ms. COURIC. Excuse me, Dr. Ayoob. Does that not make you—give you real cause

for concern?

Ms. KAYE. No. Because what happens, Katie, is what I am saying is you need to

take some supplements and you need to eat skinny foods. And no one is saying that

I am not doing that. In fact, I welcome that Dr. Ayoobs of the world come and help

me, help me do something about this problem. Let us get doctors working on this

with me, dieticians, nutritionists, parents, grown ups——

Dr. AYOOB. Katie, the only way—Katie, the only way this——

Ms. COURIC. Go ahead, Dr. Ayoob.

Dr. AYOOB. The only way you are going to lose from this product is from your

pocketbook, not from your body.

Ms. KAYE. No, that——

Dr. AYOOB. And I take kids much more seriously than this. And, Edita, if you

want me to help you, I will.

Ms. KAYE. Oh, thank you. Thank you.

Dr. AYOOB. I will help you take it off the market.

Ms. COURIC. Okay. He wants you to take it off the market——

Dr. AYOOB. I will help you take it off the market.

Ms. COURIC. [continuing] though, that is way of——

Dr. AYOOB. Absolutely. I am not even sure this is legal—these are legal herbs to

put and to give to kids.

Ms. COURIC. Let me ask you both——

Dr. AYOOB. FTC had a press conference last week about making——

Ms. COURIC. Go ahead. I’m sorry.

Dr. AYOOB. [continuing] bogus claims for health products. And I think this has

never been tested on kids. I would not give these herbs. They’re diuretic herbs. You

do not give those to 6 year old children.

Ms. COURIC. Let me just ask you about the psychological impact of this. To tell

children that frankly there is a magic bullet, yes you say there is——

Ms. KAYE. That is not what I am saying.

Ms. COURIC. [continuing] and an eating plan.

Ms. KAYE. That is not what I am saying.

Ms. COURIC. But in the adult website you do say ‘‘magic will happen.’’ And

frankly——

Ms. KAYE. Well, magic happens when you take——

Ms. COURIC. [continuing] is this not misleading and psychologically difficult for

kids?

Ms. KAYE. Because, Katie, I will tell you what happens, okay. Here is what happens. I say to kids, look, let us use this time that you have blessed me with. Let

us say to kids, look, this morning when you are having that glass of orange juice,

have an orange. An orange has fiber in it. I am saying tonight at bedtime——

Dr. AYOOB. Katie?

Ms. KAYE. [continuing] have some peanut butter. That is wonderful.

Dr. AYOOB. Katie——

Ms. KAYE. That is when the magic happens.

Ms. COURIC. Dr. Ayoob——

Dr. AYOOB. Excuse me.

10

Ms. KAYE. And there are foods——

Ms. COURIC. [continuing] we are almost out of time. You get the last word, Dr.

Ayoob.

Dr. AYOOB. Thank you very much, Katie.

Katie, this is a bogus product. There are ingredients that I would never give to

kids. I am not even sure it is legal to have this in and give this to kids. And a sensible eating plan with a lifestyle, a healthy eating style is the way to get kids to

lose weight.

Ms. COURIC. All right.

Dr. AYOOB. Pills are not the answer.

Ms. COURIC. That will be the last word.

Thank you both very much. We will be back after this.

Ms. KAYE. Thank you, Katie.

Mr. GREENWOOD. Bogus products or miracle pill, that is what

this hearing is about. And we are now about ready to hear testimony for our first panel.

First let me inform our witnesses that pursuant to the rules of

this committee you are entitled to be represented by counsel. Do

any of the witnesses wish to be represented by counsel today?

Okay.

It is the practice of this subcommittee to take our testimony

under oath. Do any of you object to giving your testimony under

oath. Okay.

In that case, I am going to ask if you will stand and raise your

right hands, please.

[Witnesses sworn.]

Mr. GREENWOOD. Okay. Thank you. You are under oath.

And, Mr. Beales, you are now recognized for your opening statement.

TESTIMONY OF J. HOWARD BEALES III, DIRECTOR, BUREAU

OF CONSUMER PROTECTION, FEDERAL TRADE COMMISSION; HOWELL WECHSLER, ACTING DIRECTOR, DIVISION OF

ADOLESCENT AND SCHOOL HEALTH, THE CENTERS FOR

DISEASE CONTROL AND PREVENTION; ALISON HOPPIN, ASSOCIATE DIRECTOR FOR PEDIATRIC SERVICES, MGH

WEIGHT CENTER, MASSACHUSETTS GENERAL HOSPITAL

Mr. BEALES. Thank you, Mr. Chairman. And good morning to

you and the members of the subcommittee.

I am the Director of the FTC’s Bureau of Consumer Protection.

And I would like to thank the subcommittee for taking a leadership

role to ensure the truthfulness and accuracy of marketing for dietary supplements to children.

There is little doubt that the dietary supplement industry is a

large and growing segment of the consumer health care market.

According to a recent CDC study, more than a third of American

adults use some form of complementary and alternative medicine.

Although similar statistics are not available for children, children’s

supplements comprise a niche market with estimated sales of over

a half a billion dollars as of July 2002.

Over the past decade we have filed 15 law enforcement actions

challenging false or unsubstantiated claims about the efficacy or

safety of children’s dietary supplements, including five this year.

Among the kinds of problems we’ve seen are zinc lozenges sold to

reduce the severity of cold symptoms in children when, in fact, the

11

1The written statement presents the views of the Federal Trade Commission. Oral testimony

and responses to questions reflect my views and do not necessarily reflect the views of the Commission or any Commissioner. 2The Commission’s authority in this area derives from Section 5 of the Federal Trade Commission Act, which prohibits ‘‘unfair or deceptive acts and practices in or affecting commerce,’’

Continued

one study that focused on children failed to find any benefit in reducing their cold symptoms.

We have also challenged unproven claims that dietary supplements can improve or even cure AD/HD, a condition that NIH estimates affects 3 to 5 percent of school-aged children in the United

States.

We have taken action against marketers of body building supplements containing steroid hormones popular among teenage athletes

and required them to place strong warnings in their future advertising and labeling about the potential risks of using steroid hormones.

FDA recently notified specific companies that the sale of these

products is prohibited by the Food, Drug and Cosmetic Act.

Finally, given the concern about the increasing rate of childhood

obesity, we are vigorously investigating and bringing cases against

marketers of dietary supplements for weight loss in children who

promise dramatic, easy, rapid or weight loss without any basis for

their claims.

For example, earlier this year the FTC challenged advertising

that allegedly claimed that ‘‘Skinny Pill for Kids’’ safely burned fat,

blocked new fat deposits, normalized insulin and blood sugar levels

and reduced the risk of obesity-related diseases. Prompt Commission action stopped this marketing campaign before the children’s

product actually entered the marketplace.

Yesterday, the Commission issued two new complaints against

marketers whose products include weight-loss products marketed

specifically for children. The Commission’s complaints alleged that

Basic Research, which sold a product called, ‘‘PediaLean,’’ and DBS

Labs and Dynamic Health which sold a product called ‘‘PediaLoss’’

made deceptive weight loss claims in their advertisements.

The Commission will continue to actively challenge deceptive

marketing of dietary supplements, both to children and adults.

Thank you for focusing attention on this important consumer

health issue and for giving the FTC an opportunity to discuss its

role. We look forward to working with the subcommittee on initiatives concerning our dietary supplement program, and I look forward to your questions.

[The prepared statement of J. Howard Beales III follows:]

PREPARED STATEMENT OF J. HOWARD BEALES III, DIRECTOR, BUREAU OF CONSUMER

PROTECTION, FEDERAL TRADE COMMISSION

Mr. Chairman and members of the Subcommittee, I am J. Howard Beales, Director of the Bureau of Consumer Protection, Federal Trade Commission (‘‘FTC’’ or

‘‘Commission’’). The Commission is pleased to have this opportunity to provide information concerning our efforts to ensure the truthfulness and accuracy of the marketing of dietary supplements for children.1

The mission of the Federal Trade Commission is to prevent unfair competition

and to protect consumers from unfair or deceptive practices in the marketplace. As

part of this mission, the Commission has a longstanding and active program to combat fraudulent and deceptive advertising claims about the health benefits and safety

of dietary supplements, especially those products marketed to or for children.2

12

and Section 12, which prohibits the false advertisement of ‘‘food, drugs, devices, services or cosmetics.’’ 15 U.S.C. §§45, 52. 3Source: Nutrition Business Journal, Supplement Business Report 2003. 4 Barnes, P. et al., CDC Advance Data Report #343. Complementary and Alternative Medicine

Use Among Adults: United States, 2002 (May 27, 2004). Reprint available at http://

www.nccam.nih.gov. The study found that 36% reported using some form of complementary and

alternative medicine, and that 19% specifically used natural products such as herbs, other

botanicals and enzymes, most without consulting a healthcare practitioner. 5Source: Nutrition Business Journal (July 2002). 6The conference was sponsored by the National Institute of Child Health and Human Development and the Office of Dietary Supplements of NIH. See Dietary Supplement Use in Children:

Who, What, Why, and Where Do We Go From Here (Feb. 2001). Executive Summary available at: <http://www.nichid.nih.gov/about/od/prip/pastevents/executivelsummary.htm.> 7See, e.g., Vital Basics, Inc. et al., Dkt. No. C-4107 (2004) (consent); Creative Health Institute,

Inc. and Kyl L. Smith, Dkt. No. C-4108 (2004) (consent) (Respondents included the marketer,

the individual who developed the product and others); see also The Quigley Corp., Dkt. No. C3926 (2000) (consent); QVC, Inc., Dkt. No. C-3955 (2000) (consent) (Respondents included the

products’ manufacturer and marketer as well as the home shopping channel on which the products were advertised). The Commission’s cases generally are available at www.ftc.gov.

The dietary supplement industry represents a substantial and growing segment

of the consumer healthcare market with industry sales for 2002 estimated to be

$18.8 billion.3 A recent survey of complementary and alternative medicine use in the

United States shows that more than one-third of U.S. adults age 18 and over are

turning to alternative medicine, including herbal products, enzymes and other dietary supplements.4 The market for children’s supplements has also been growing.

Industry analysts estimate annual sales of children’s supplements reached $510 million as of July 2002 and represented one of the top niche markets in the supplement

industry.5

The supplement category encompasses a broad range of products, from vitamins

and minerals to herbals and hormones. Products promoted specifically for children

extend beyond traditional multivitamins to include preventives and cures for a variety of childhood ailments ranging from colds to more serious conditions like attention deficit/hyperactivity disorder (AD/HD). Most recently, the Commission has seen

the appearance of a few children’s products promoted for weight loss.

Certainly, some supplements offer the potential for real health benefits to consumers. The scientific research on the associations between supplements and health

is accumulating rapidly. A 2001 NIH conference on Dietary Supplement Use in Children, however, found that little is known about the evidence base to support appropriate indications for use in children or about the safety of children’s supplements.6

Commission law requires that claims about the safety and efficacy of any healthrelated product, including dietary supplements, be substantiated by competent and

reliable scientific evidence before the claims are made. The Commission seeks to ensure that consumers get accurate information so that they can make informed decisions about how to manage their own healthcare. Bad information can pose a threat

to the health and well-being of consumers. In recent years the Commission has

brought several actions against deceptive promotions of supplements to children as

part of its broader supplement law enforcement program. The agency also has made

an effort to educate parents about the appropriate and safe use of children’s supplements. The Commission’s testimony today will highlight some of those enforcement

and education efforts.

The FTC’s Dietary Supplement Advertising Program

The agency has committed a significant portion of its consumer protection resources to combating false, misleading, or unsubstantiated claims in advertising for

healthcare products, including dietary supplements. Over the past decade the Commission has filed or settled more than 100 law enforcement actions challenging allegedly false or unsubstantiated claims about the efficacy or safety of a wide variety

of supplements. The Commission has focused its enforcement priorities on national

advertising claims for products with unproven benefits; products promoted via the

Internet and elsewhere to treat or cure serious diseases; and products that may

present significant safety concerns to consumers.

As in all its advertising programs, the Commission works to make sure its enforcement actions have a strong impact, for example, by holding accountable not just

the supplement manufacturer but other parties that play a role in deceptive marketing, such as ad agencies, infomercial producers, distributors, and catalog companies.7 The Commission has sought to obtain meaningful relief for consumers, going

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8See, e.g., Vital Basics, Inc. et al., Dkt. No. C-4107 (2004) (consent) ($1 million in consumer

redress); FTC v. Seasilver USA, Inc., et al., Civil Action No. CV-5-0676-RHL-LRL (D. Nev. Mar.

4, 2004) (final stipulated order) ($4.5 million in redress). The Seasilver defendants also agreed

in a separate settlement with FDA to destroy $5.3 million in misbranded products. 9See, e.g., Global World Media Corp., Dkt. No. C-3772 (1997) (consent) (warning on ephedra

risks and ban on marketing of certain products in media with majority youth audience); Christopher Enterprises, Inc., et al., Civil Action No. 2:01 CV-0505 ST (D. Utah 2001) (final stipulated

order) (ban on marketing of comfrey products for internal use and application on external

wounds). 10See Working Agreement Between FTC and FDA, 3 Trade Reg. Rep. (CCH) ¶ 9,859.01 (1971). 11See Federal Trade Commission Attacks $1 Billion in Deceptive Health Marketing Since December, FTC Press Release (July 10, 2003), available at <http://www.ftc.gov/opa/2003/07/

diethealth.htm>. 12 A complete list of FTC cases involving children’s supplements, including citations, is attached as Attachment A. The Commission files a complaint in a case when it has ‘‘reason to

believe’’ that the practices cited in the complaint violate the FTC Act. A consent order that is

reached in settlement of such allegations does not constitute an admission by the respondent

that a law violation has occurred. 13See, e.g., Dietary Supplements: An Advertising Guide For Industry, Part B.5., available at

<http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm>. 14Last December the NIH’s National Center for Complementary and Alternative Medicine

(NCCAM) announced the results of research it had funded on echinacea, an herb popularly used

to treat colds and other upper respiratory infections. The placebo-controlled study involved 534

children ages 2 to 11 and found no benefit in children, either for shortening the duration or

lessening the symptoms of colds. Further, the study found that echinacea use was associated

with an increased risk of rash. James A. Taylor et al., EFFICACY AND SAFETY OF ECHINACEA IN

TREATING UPPER RESPIRATORY TRACT INFECTIONS IN CHILDREN, 290 J. OF THE AM. MED. ASS’N

2824 (Dec. 3, 2003).

etary relief for consumer redress or disgorgement of profits.8 Finally, when the marketing of a supplement raises safety concerns, the Commission has required that

strong warning statements be placed in labeling and advertising and, in certain

cases, has imposed limits on how and to whom the product can be marketed.9

The Commission coordinates all of its enforcement efforts closely with the Food

and Drug Administration (FDA). As you know, the two agencies have overlapping

authority over the marketing of dietary supplements and operate under a longstanding liaison agreement whereby the FTC has primary responsibility for claims

made in advertising and the FDA for claims made in labeling.10 Since December

2002, the FTC and FDA have intensified the level of this cooperation with steppedup enforcement against deceptive supplement marketing. The staff of the two agencies have formed a joint enforcement task force that has led to improved information

sharing and more effective joint actions that make the best use of the unique enforcement tools available to each agency. Both agencies have benefitted. For the

FTC’s part, the joint effort has helped us to bring more than 40 actions targeting

fraudulently marketed supplements and other health products in the 18 months

since the inception of the task force.11

Actions Involving Children’s Supplements

The agency’s efforts to police the supplement marketplace include especially close

scrutiny of products marketed for use in children or otherwise targeted to appeal

to young consumers. In the last ten years, thirteen of the Commission’s actions

against deceptive supplement advertising have addressed children’s products, including three actions to date in 2004.12 These actions have involved products making allegedly unfounded promises to prevent colds, products allegedly deceptively

touted as safe and natural alternatives for the treatment of attention deficit/hyperactivity disorder (AD/HD), and, most recently, products promoted to help children

lose weight. Some of the challenged products have contained stimulants or hormones that raise safety concerns or herbs with known toxicity.

1. Substantiation of Claims for Children’s Dietary Supplements

The Commission has made it clear to the supplement industry that it will carefully evaluate the research for supplements marketed to children or to any other

specific population, to make sure that the evidence supports safety and efficacy for

the population to whom the product is marketed.13 In some instances, research that

has been conducted on children has failed to find the same effect as research conducted for the same product using an adult population.14

For example, the Commission’s 1999 action against Quigley Corporation focused, in part, on claims made about the benefits of the company’s ‘‘Cold-Eeze’’ zinc

lozenges and ‘‘Kids- Eeze’’ zinc bubble gum for reducing the severity of cold symptoms and even preventing colds in children. In fact, although there was some limited evidence at the time on the effect of zinc on cold symptoms in adults, there was

14

15The Commission also challenged other claims as unsubstantiated and beyond the existing

science, including claims, not specific to children, that the products would relieve allergies and

reduce the risk of contracting pneumonia. 16 Attention Deficit-Hyperactivity Disorder Information Page, NIH National Institute of Neurological Disorders (Mar. 21, 2003), available at <http://www.ninds.nih.gov/healthlandlmedical/

disorders/adhd.htm>. 17 Although not directly marketed for AD/HD, an earlier Commission case, Zygon International, Inc., challenged, as unsubstantiated, claims that the company’s ‘‘SuperBrain Nutrient

Program’’ would enhance intelligence and memory. Marketing for the product included claims

that pregnant women taking the product would enhance the intelligence of their children. 18The Vital Basics case also challenged safety and efficacy claims for ‘‘V-Factor,’’ a supplement

marketed as a male sexual performance enhancer. 19Specifically the consent orders required that the following statement be displayed prominently in advertising and labeling: ‘‘WARNING: This product contains steroid hormones and

may cause breast enlargement, testicle shrinkage, and infertility in males, and increased facial

and body hair, voice deepening, and clitoral enlargement in females. Higher doses increase these

risks. If you are at risk for prostate or breast cancer you should not use this product.’’

no evidence on cold prevention, and the one zinc study using a children’s population

failed to find any benefit in reducing cold symptoms in children.15

2. Purported AD/HD Treatments

It has been estimated that AD/HD affects 3 to 5 percent of school-aged children

in the United States.16 A variety of supplement products and ingredients on the

market are promoted with claims ranging from increasing concentration, improving

behavior, or enhancing school performance, to promises of complete cures for AD/

HD. Due to the prevalence of these promotions and the serious nature of the health

condition at issue, the Commission has focused much of its enforcement efforts on

this category of children’s supplements. To date, the Commission has settled six actions against companies marketing a variety of supplements for the treatment of

AD/HD or its symptoms, focusing on the most widely promoted products and those

making claims that allegedly far exceed any scientific evidence of a benefit.17

The first two actions involved a multi-level marketer, New Vision International, Inc., and Max F. James, a high level distributor for New Vision, both

charged with making unsubstantiated claims for a combination of dietary supplements called ‘‘God’s Recipe’’ that included an herbal drink containing grape seed extract, a mineral capsule, and a multi-enzyme tablet containing alfalfa and barley

sprouts. The package was promoted through compelling testimonials as a cure for

AD/HD and a natural alternative to Ritalin. Subsequent actions included a consent

order with J&R Research settling charges that the company made unsubstantiated

claims that its pycnogenol supplement was effective in treating not only AD/HD, but

also cancer, heart disease, arthritis, diabetes, and multiple sclerosis; a consent order

with Efamol Nutraceuticals, Inc. settling charges of unsubstantiated claims that

two essential fatty acid supplements, ‘‘Efalex’’ and ‘‘Efalex Focus,’’ could treat or

cure AD/HD; and a consent order with Natural Organics, Inc. challenging the deceptive marketing of a multi-ingredient supplement called ‘‘Pedi-Active A.D.D.’’

Most recently, the Commission settled charges against Vital Basics, Inc. relating

to the marketing of ‘‘Focus Factor,’’ a multi-ingredient supplement purported to improve focus, memory, concentration, and academic performance in children, teenagers, adults, and senior citizens alike. The campaign for Focus Factor involved

widely disseminated television and radio infomercials and Internet marketing. The

Commission’s consent order included a $1 million consumer redress payment.18 The

Commission also obtained a consent order against Kyl Smith, the developer of

Focus Factor, and his company Creative Health Institute, along with an additional $60,000 payment for consumer redress.

3. Bodybuilding Supplements Appealing to Young Athletes

Dietary supplements marketed to increase athletic performance and strength may

be particularly attractive to young athletes and bodybuilders. For that reason, in

1999 the Federal Trade Commission challenged ads promoting a category of bodybuilding supplements that raised safety concerns and were popular among teenage

athletes. The Commission brought action against two marketers of supplements containing androstenedione and other steroid hormones, MET-Rx USA, Inc. and AST

Nutritional Concepts. Both companies were charged with making unsupported

safety claims for their products, and were required to place strong warnings in future advertising and labeling warning against the potential risks of using steroid

hormones, including potential unwanted changes in male and female sexual characteristics and increased danger for persons at risk of prostate or breast cancer.19 The

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20The specific warning for the 1997 order was: ‘‘WARNING: This product contains ephedrine

which can have dangerous effects on the central nervous system and heart and could result in

serious injury. Risk of injury increases with dose.’’ 21The consent order prohibited dissemination of ads for Herbal Ecstacy and similar products

containing ephedra in any media where more than 50% of the audience is under 21 years of

age. 22The warning reads: ‘‘Warning: External Use Only. Consuming this product can cause serious liver damage. This product contains comfrey. Comfrey contains pyrrolizidine alkaloids,

which may cause serious illness or death. This product should not be taken orally, used as a

suppository, or applied to broken skin. For further information contact the Food and Drug Administration: http://vm/cfsan.fda.gov.’’ The final stipulated order also included a $1.4 million

judgment that was suspended pro

ucts that contained the powerful cardiovascular and central nervous system stimulant, ephedra, which has since been banned by the Food and Drug Administration.

In bringing these actions, the Commission coordinated closely with the Food and

Drug Administration, as well as the Department of Justice’s Drug Enforcement

Agency and the White House Office of National Drug Control Policy, to better understand the risks these products posed and how young athletes used them. The

agency also worked with the National Federation of State High School Associations

to help raise awareness among student athletes about the dangers of using any performance-enhancing substances. In addition, earlier this year, the FDA sent 23 companies warning letters indicating that the agency considers the marketing of products containing androstenedione to be prohibited. Specifically, the FDA warning letters indicated that such products are adulterated under the Federal Food, Drug, and

Cosmetic Act because androstenedione is a new dietary ingredient for which there

is not adequate evidence of safety.

4. Other Cases Raising Safety Concerns

When necessary, the Commission will impose additional remedies, beyond warning requirements, to ensure that potentially dangerous supplements do not harm

young consumers. In the Commission’s 1997 action against Global World Media

Corp., for example, the agency challenged the marketing of a supplement named

‘‘Herbal Ecstacy,’’ a product containing a high dosage of ephedra, that was promoted

as an ‘‘absolutely safe’’ natural alternative to street drugs to get ‘‘high.’’ The product

was advertised with psychedelic print and television ads in media with large youth

audiences, including even MTV and Nickelodeon in some markets. The Commission’s order required strong warning statements in advertising and labeling.20 And,

to further protect young consumers to whom the marketing had been targeted, the

order also prohibited any future advertising of Herbal Ecstacy and similar ephedra

products in media with a predominantly young audience.21 Since that time, FDA has

banned ephedra products because of serious safety risks.

In another matter, the Commission addressed the marketing of several products

containing comfrey, an herb associated with severe liver toxicity. Christopher Enterprises, Inc. used the Internet and other media to market various cure-all remedies containing comfrey. Some of these comfrey products were promoted for use in

young children as a cough and cold remedy and even for use in babies and pregnant

women for treatment of a variety of infections. The Commission alleged that the

company’s safety claims were false. Because of the severe risks associated with this

herb, the Commission’s 2001 consent order banned the company from marketing

any comfrey product either for internal use or for application to open wounds. The

consent order further required that products sold for external use were required to

be labeled and advertised with warning statements making it clear that comfrey can

cause serious liver damage and even death.22

Most recently, the Commission charged Direct Marketing Concepts, Inc. with

making several false and unsubstantiated claims about the safety and efficacy of

two dietary supplements marketed through widely-aired infomercials. In addition to

challenging claims that the products could prevent or cure cancer and other diseases

and cause substantial weight loss, the Commission also challenged a claim relating

to the safety of one product for children and pregnant women. Specifically, the Commission complaint charged the marketers with making unfounded claims that ‘‘Supreme Greens,’’ a combination of numerous plant and herbal ingredients, was safe

for everyone, including pregnant women, children, and persons on medication.

5. Weight Loss Supplements

Given the concern about the increasing rate of childhood obesity, marketing of dietary supplements for weight loss in children is another subject of ongoing FTC investigations and law enforcement. With weight loss advertising in general, the ComVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6621 95442.TXT HCOM1 PsN: HCOM1
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23The November 2002 workshop brought together government officials, scientists, public

health groups, marketers of weight loss products, advertising professionals, and representatives

of various media outlets. A report describing the results was issued in December 2003. ‘‘Deception in Weight-Loss Advertising Workshop: Seizing Opportunities and Building Partnerships to

Stop Weight-Loss Fraud,’’ FTC Staff Report (Dec. 2003). http://www.ftc.gov/reports/index.htm. 24 Available at <http://www.ftc.gov/bcp/conline/pubs/buspubs/redflag.pdf>. 25FTC Consumer Feature, Promotions for Kids’ Dietary Supplements Leave Sour Taste, (May

2000), available at <http://www.ftc.gov/bcp/conline/features/kidsupp.htm>.

mission is concerned that consumers not be misled by ads promising dramatic, easy,

rapid weight loss without diet or exercise.

In one recent case, involving a product called ‘‘Skinny Pill for Kids,’’ the FTC challenged advertising by The Fountain of Youth Group, LLC and its principal

Edita Kaye. The company claimed on its web site and in other media that Skinny

Pill for Kids was the ‘‘First thermic and herbal formula ever developed for weight

loss for children 6 to 12.’’ According to the ads, Skinny Pill for Kids would burn fat,

block new fat deposits, normalize insulin and blood sugar levels, reduce the risk of

obesity-related diseases including heart disease, high blood pressure and diabetes,

and was proven safe by scientific research. The complaint alleged that these claims

were unfounded or outright false. Prompt Commission action stopped this marketing campaign before the children’s product actually entered the marketplace.

Currently, the Commission also is pursuing two other non-public law enforcement

matters that include weight loss products marketed specifically for children.

The Commission’s efforts to stop the deceptive marketing of weight loss products

to children is part of a larger ongoing effort to stop weight loss scams. Going back

more than a decade, the agency has maintained an aggressive law enforcement program against weight loss scams, bringing more than 100 cases against false and

misleading weight loss claims. In November 2002, the Commission held a public

workshop to explore approaches, in addition to traditional law enforcement, to curb

ongoing weight loss fraud.23 Based, in part, on the workshop, the Commission

launched a new initiative to enlist the media in screening out facially false weight

loss ads before they are run. As part of this effort, the Commission has published,

and widely disseminated to television, newspapers and magazine publishers, its Red

Flag: Bogus Weight Loss Claims 24 brochure, which provides media outlets with easy

guidelines for spotting and stopping false claims. Thus far, the response from media

has been encouraging.

Consumer Education Efforts

As the Red Flags brochure exemplifies, the Commission’s consumer protection activities are not limited to law enforcement. The agency complements traditional

cases with a variety of creative and effective education and outreach for both consumers and industry. In May 2000 the FTC published a feature article on promotions for children’s dietary supplements.25 That article described the FTC’s enforcement efforts against various deceptive promotions of children’s supplements

and detailed some of the concerns surrounding the safety and efficacy of these products. It also provided practical pointers for parents about safe and responsible use

of supplements, urging parents to consult with a pediatrician before starting their

child on any supplement. The article was reprinted in large and small markets, and

was featured in numerous local and regional radio broadcasts, reaching parents

throughout the country. The Commission will continue to look for opportunities for

consumer education, in partnership with other health and law enforcement authorities. This approach can help parents better protect their children against ineffective

and sometimes dangerous health products.

Conclusion

The Commission will continue to have an active program to challenge deceptive

marketing of dietary supplements in general and children’s supplements specifically.

The agency will continue to monitor promotions of children’s products, staying alert

for new categories of supplements, such as children’s weight loss products, and taking action as warranted against unfounded safety and efficacy claims. The Commission thanks this Subcommittee for focusing attention on this important consumer

health issue and for giving the Federal Trade Commission an opportunity to discuss

its role. The Commission looks forward to working with the Subcommittee on initiatives concerning our dietary supplement program.

17

APPENDIX A

FTC ADVERTISING CASES—CHILDREN’S SUPPLEMENTS

Direct Marketing Concepts, Inc., d/b/a Today’s Health and Direct Fulfillment, et al.,

No. 04-CV-11136-GAO (D. Mass.) (Complaint filed June 1, 2004)(Alleged false

and unsubstantiated claims that ‘‘Supreme Greens,’’ a multiple ingredient plant

and herbal supplement, could cure of prevent cancer, heart disease, diabetes,

and arthritis, could cause substantial weight loss, and was safe for everyone,

including pregnant women, children, and persons on medication. Also, alleged

false and unsubstantiated claims that ‘‘Coral Calcium Daily’’ could prevent,

treat, or cure cancer and other serious diseases.)

Vital Basics, Inc., Robert B. Graham, and Michael B. Shane, C-4107 (Apr. 26, 2004)

(Consent Order) (Alleged unsubstantiated efficacy claims for the dietary supplement ‘‘Focus Factor’’ and safety claims for the dietary supplement ‘‘V-Factor

Natural Pack,’’ which contains yohimbine and L-arginine. Focus Factor was

marketed to improve memory, mood, and concentration in children and adults.

V-Factor was marketed to improve male sexual performance. Failure to disclose

materials connections with endorsers of the products. $1 million in consumer redress is required by the order.)

Creative Health Institute, Inc., and Kyl L. Smith, C-4108 (Apr. 26, 2004) (Consent

Order) (Alleged unsubstantiated efficacy claims for the dietary supplement

‘‘Focus Factor.’’ Dr. Smith developed Focus Factor and advertised and sold it

through CHI at least from 1997 to 2000. $60,000 in consumer redress is required by the order.)

The Fountain of Youth Group, LLC, and Edita Kaye, No. 3:04-CV-47-J-99HTS (M.D.

Fla.) (Feb. 10, 2004) (Stipulated Final Order for Permanent Injunction)(Complaint alleged false and unsubstantiated weight-loss and health claims

for their dietary supplement products—Skinny Pill AM, Skinny Sleep PM, Skinny Carbs, and Skinny Pill for Kids. The Order contains a judgment of $6 million, which was suspended due to defendants’ inability to pay.)

Natural Organics, Inc., et al. D. 9294 (Sept. 6, 2001) (Consent Order) (Alleged unsubstantiated claims that company’s dietary supplement, ‘‘Pedi-Active A.D.D.,’’

treats or mitigates Attention Deficit Hyperactivity Disorder and improves attention span and scholastic performance of children who have difficulty focusing on

their schoolwork.)

Christopher Enterprises, Inc., et al., No. 2:01 CV-0505 ST, (D. Utah) (Stipulated

Final Order for Permanent Injunction and Settlement of Claims for Monetary

Relief (Dec. 3, 2001) (Alleged false safety claims and unsubstantiated efficacy

claims for products containing the herbal ingredient comfrey. Order includes

judgment for $1.4 million, which is suspended provided respondents pay

$100,000 for consumer redress. The order prohibits the defendants from marketing any comfrey product for ingestion, for use as a suppository, or for external use on open wounds, unless they have evidence that the product is free of

pyrrolizidine alkaloids and that it is safe. The defendants are also required to

place a warning disclosure in any ad, promotional material or product label for

any comfrey products intended for topical use. The specific claims challenged in

the complaint are also prohibited by the order.)

Efamol Nutraceuticals, Inc., C-3958 (June 22, 2000) (Consent Order) (Alleged unsubstantiated efficacy claims for the products Efalex and Efalex Focus, marketed and sold by the company for the mitigation or cure of the effects of Attention Deficit Disorder(ADD) or Attention Deficit Hyperactivity Disorder(ADHD)

J & R Research, Inc., C-3961 (July 19, 2000) (Consent Order) (Alleged unsubstantiated efficacy claims for the product Pycnogenol, marketed and sold by the company for the mitigation or cure of the effects of Attention Deficit Disorder(ADD)

or Attention Deficit Hyperactivity Disorder(ADHD).)

New Vision International, Inc., et al., 127 F.T.C. 278 (1999) (Consent Order) (Alleged unsubstantiated claims that dietary supplements called ‘‘God’s Recipe’’

would cure ADD/ADHD.)

Max F. James, 127 F.T.C. 324 (1999) (Consent Order) (Alleged unsubstantiated

claims for ‘‘God’s Recipe’’ by James, a high level distributor of the product; see

New Vision International, Inc.)

AST Nutritional Concepts and Research, Inc., et al., No. 99-WY-2197 (D. Colo) (May

4, 2000) (Permanent Injunction)(Alleged unsubstantiated safety claims made for

purported body-building supplements that contain androstenedione, ‘‘androgen,’’

and other steroid hormones, and in some cases, stimulants.)

Met-RX USA, Inc., et al., No. SACV99-1407 DOC(ANX) (C.D. Cal.) (Nov. 24, 1999)

(Stipulated Final Order For Permanent Injunction and Other Equitable Relief)

18

(Alleged unsubstantiated safety claims made for purported body-building supplements that contain androstenedione, ‘‘androgen,’’ and other steriod hormones, and in some cases, stimulants.)

Global World Media Corp., 124 F.T.C. 426 (1997) (Consent Order) (Alleged explicit

safety and no side effects claims for Ecstacy supplement advertised to produce

a natural ‘‘high,’’ in media with large youth audiences, and without disclosing

health and safety risks.)

The Quigley Corp., C-3926 (Feb. 10, 2000) (Consent Order) (Alleged unsubstantiated

claims by Quigley that Cold-Eezer and Cold-Eeze brand zinc lozenges that it

manufactures can prevent colds and alleviate allergy symptoms and that KidsEeze Bubble-Gum can reduce the severity of cold symptoms in children.)

QVC, Inc., C-3955 (June 14, 2000) (Consent Order) (Alleged unsubstantiated claims

on its ‘‘home shopping’’ network that Cold-Eezer or Cold-Eeze brand zinc lozenges can prevent colds and alleviate allergy symptoms.) Zygon International, Inc., 122 F.T.C. 195 (1996) (Consent Order and up to $195,000

in consumer redress for all products) (Alleged unsubstantiated claims that

SuperBrain Nutrient Program improves memory and enhances the intelligence

of children and also benefits pregnant women; that Fat Burner pills cause

weight loss; and that Day and Night Eyes pills improve day vision and night

blindness.)

Mr. GREENWOOD. Thank you, Dr. Beales. And we thank you for

the good work of the Commission.

Dr. Wechsler, you are recognized for your opening statement.

TESTIMONY OF HOWELL WECHSLER

Mr. WECHSLER. Mr. Chairman, members of the committee, thank

you for the opportunity. I am the Acting Director of the Division

of Adolescent and School Health at the Centers for Disease Control

and Prevention, which is part of the U.S. Department of Health

and Human Services. Today, I will summarize for you the latest

scientific information we have on the overweight epidemic among

children and adolescents, and highlight HHS’ comprehensive strategy for combating this epidemic.

The latest data, in fact, were released just yesterday by CDC,

and they show that between 1999 and 2002, 16 percent of children

and adolescents were overweight, and another 15 percent were at

risk for overweight. Since 1980 the prevalence of overweight has

more than doubled among children, among adolescents it has tripled. The increases in overweight cut across all regions, ages and

racial and ethnic groups. However, more African-American and

Mexican-American youth are overweight compared to white youth. An estimated 400,000 adult deaths and a cost of $117 billion in

each year in the United States are associated with obesity. Most

of this disease occurs in adults, but children who are overweight

often develop risk factors for diseases such as Type 2 diabetes, high

blood pressure and elevated cholesterol. Sixty percent of overweight

children have at least one additional risk factor for cardiovascular

disease, 25 percent have two or more.

Type 2 diabetes, which is strongly associated with obesity, was

virtually unknown in children and adolescents 10 years ago. Today

it accounts for almost 50 percent of new cases of diabetes among

youth in some communities.

Overweight adolescents have a 70 percent chance of becoming

overweight or obese adults and childhood overweight that persists

into adulthood is typically more severe than overweight or obesity

that developed during adulthood.

Overweight and obesity represent a major long-term public

health crisis that if not reversed, the gains in life expectancy and

19

quality of life seen in recent decades will erode and more healthrelated costs will burden the Nation.

Many factors have contributed to the unfavorable trends in physical activity and nutrition that have fueled the obesity epidemic.

Consequently, there will be no silver bullet, no single change strategy to end the epidemic. Multiple strategies addressing multiple

factors will be needed. The critical challenge is to help young people and their families adopt healthy eating and physical activity

behaviors.

Addressing overweight and obesity is a top priority for HHS, and

I’ll briefly describe seven key components of the Department’s comprehensive strategy for reducing overweight and obesity.

First, is providing strong national leadership through President

Bush’s HealthierUS Initiative and Secretary Thompson’s Steps to

a HealthierUS initiative which promotes community programs to

support responsible health choices.

Second is delivering clear effective health messages to ensure

that consumers have the information they need to improve their

health. Some ways we do that include the Dietary Guidelines for

Americans, the nutrition facts label, 5 A Day for Better Health Program to promote food and vegetable consumption and the President’s Council on Physical Fitness and Sports.

HHS is communicating health messages directly to children

through ‘‘VERB,’’ CDC’s media campaign to increase physical activity among 9 to 13 year olds. We do this through advertising and

marketing promotions using television, radio, print and websites.

After just 1 year, campaign impact has been demonstrated by reports of increased free-time physical activity among girls, 9-10 year

olds, and children from low- to moderate-income households. It is

showing effectiveness.

The third component is monitoring the problem and programs to

address the problem. We have nationally representative data on

overweight and diet and physical activity among young people

through the National Health and Nutrition Examination Survey. In

addition, we have surveillance systems in place that allows us to

collect not only national, but State and city data on height and

weight among high school students on physical activity and nutrition, as well as what programs are in place in schools to address

those issues.

The fourth component is identifying and addressing research

gaps. The National Institutes of Health is funding the studies that

evaluate interventions designed to prevent childhood overweight

and promote physical activity and healthy eating.

The fifth component, we synthesize research findings to identify

effective policies and programs to figure out for the public what

works.

The sixth component is developing and disseminating researchbased tools to help schools and community based organizations implement effective policies and programs.

And the seventh and final component is helping community and

State agencies and organizations implement effective programs.

Secretary Thompson’s Steps to a HealthierUS initiative is enabling community based agencies to implement effective programs to

address obesity as well as diabetes and asthma.

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With 2004 funding, CDC is supporting obesity prevention programs in 28 States. What are the State health departments doing?

They’re helping children and adolescents by encouraging restaurants to make fruit and vegetables more available, to improve

lighting, sidewalks and crosswalks in neighborhoods, to clean up

vacant lots for use as play areas, to train health care professionals

to promote behavior changes.

In addition, CDC provides funding to 23 States to implement

school based physical activity and nutrition programs where the

State education agencies are strengthening policies, improving curricula, implementing professional development activities and involving families and community.

In conclusion, CDC, NIH and all the HHS agencies are leading

the Nation in conducting the research necessary to learn more

about strategies to prevent overweight among children and adolescents. We know, however, there are no quick fixes when it comes

to losing weight. It is only through proper diet and physical activity

that we can maintain and improve our health. We know that no

one strategy alone will be sufficient and our chances for success

will be greater if we use multiple strategies to address multiple factors, and if we involve multiple sectors of society at the community,

State and national levels.

HHS is leading the national effort to combat overweight in children through a comprehensive multifaceted, multilevel approach.

We are committed to doing all that we can to help our young people

enjoy good health now and for a lifetime.

I thank you for your interest.

[The prepared statement of Howell Wechsler follows:]

PREPARED STATEMENT OF HOWELL WECHSLER, ACTING DIRECTOR, DIVISION OF ADOLESCENT AND SCHOOL HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION,

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

INTRODUCTION

Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing. I am Dr. Howell Wechsler, Acting Director of the Division of Adolescent and School Health at the Centers for Disease Control and Prevention (CDC), which is part of the U.S. Department of Health and Human Services.

Today, I will present an overview of the overweight epidemic among children and

adolescents; describe the scientific information available on effective interventions

to prevent overweight among young people; and identify a number of Department

of Health and Human Services (HHS) initiatives and programs designed to combat

this epidemic.

The National Institutes of Health defines obesity and overweight using a Body

Mass Index (BMI), which is a calculation of a person’s weight in kilograms divided

by the square of their height in meters. Health professionals often use a gender and

age specific BMI ‘‘growth chart’’ to help them assess whether a child or adolescent

is overweight. Children are considered overweight if they are at or above the 95th

percentile of the sex-specific BMI for age growth charts. Doctors and other health

care professionals are the best people to determine whether an overweight child or

adolescent’s weight and growth patterns place the individual at risk for health problems. At the current time, there is no definition of obesity for children and adolescents, because BMI is not a reliable measure of fatness for children, especially

across varying ages and degrees of maturity, in contrast to adults who have already

reached their peak height. There is also concern related to the potential stigma associated with using the term ‘‘obesity’’ for children.

OVERVIEW OF OVERWEIGHT AMONG CHILDREN AND ADOLESCENTS IN U.S.

In the United States, obesity and overweight has risen at an epidemic rate during

the past 20 years. The prevalence of overweight has more than doubled among chilVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00028 Fmt 6633 Sfmt 6621 95442.TXT HCOM1 PsN: HCOM1
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dren and has tripled among adolescents since 1980. Approximately 15.3 percent of

children aged 6 to 11 years and 15.5 percent of adolescents aged 12 to 19 years were

overweight in 1999-2000. There are no signs that the rapid increase in overweight

seen over the past two decades is abating. The latest data, which cover the period

from 1999-2002, is being released today by CDC in the Journal of the American

Medical Association.

The increases in overweight among children and adolescents cut across all regions

of the Nation, ages, and racial and ethnic groups. However, the prevalence of overweight has been growing at a much faster rate among certain populations. For example, more African-American and Mexican-American youth are overweight compared to white youth, and this disparity has grown dramatically over the past two

decades. An economic disparity in the prevalence of overweight is seen among white

adolescents: those from lower income families have a greater prevalence of overweight compared with white adolescents from higher income families.

The primary concern of overweight and obesity is one of health and not appearance. An estimated 400,000 adult deaths each year in the U.S. are associated with

obesity. Total costs (medical costs and days lost from work because of illness, disability or premature death) from obesity in 2000 were estimated to be $117 billion.

We have already begun to see the impact of the obesity epidemic on the health

of young people. Although most of the death and disease associated with overweight

and obesity occurs in adults, children who are overweight often develop risk factors

for diseases such as type 2 diabetes, high blood pressure, and elevated cholesterol

levels. Sixty percent of overweight children have at least one risk factor for cardiovascular disease, in addition to overweight, and 25 percent have two or more. Type

2 diabetes, which is strongly associated with obesity, was virtually unknown in children and adolescents 10 years ago; today, it accounts for almost 50 percent of new

cases of diabetes among youth in some communities. A CDC report predicted that

one in three Americans born in 2000 will develop diabetes during his or her lifetime.

Childhood overweight is also associated with discrimination, poor self-esteem, and

depression.

Furthermore, overweight adolescents have a 70 percent chance of becoming overweight or obese adults. This increases to 80 percent if one or more parent is overweight or obese. Adults who are overweight or obese are at increased risk for premature death, heart disease, type 2 diabetes, certain types of cancer, breathing

problems, arthritis, and psychological problems, such as depression. One final concern is that childhood overweight that persists into adulthood is typically more severe than overweight or obesity that develops during adulthood.

Overweight and obesity represent a major long-term public health crisis. If it is

not reversed, the gains in life expectancy and quality of life seen in recent decades

will erode, and more health-related costs will burden the nation.

GOVERNMENT’S ROLE IN COMBATING THE OBESITY EPIDEMIC

Eating a healthy diet and increasing physical activity reduces weight which is

shown to reduce the risk for many chronic diseases. Often small changes—such as

physical activity for 30 minutes a day or consuming 100 fewer calories a day —can

result in large health benefits. In order for individuals to take action, they must

have the right information to empower their lifestyle choices. The government can

support individual action by:

• Providing leadership;

• Establishing a framework for understanding issues related to overweight and obesity;

• Coalescing and coordinating efforts to address the issues;

• Developing clear, coherent and effective health messages to ensure that consumers have accurate and adequate information to make informed decisions

about improving their health;

• Identifying and addressing research gaps;

• Bringing diverse stakeholders together to address the epidemic (e.g., food industry, consumer organizations and the medical community);

• Coordinating private/public campaigns;

• Providing training and education materials to address the epidemic; and

• Working to improve the health-promoting nature of the environments in which individuals make their decisions.

HHS has made addressing the problems of overweight and obesity top priorities

for the Department. In fact, HHS has a large number of current initiatives and programs underway to address these issues. They include programs in education, communication and outreach, intervention, diet and nutrition, physical activity and fitness, disease surveillance, research, clinical preventive services and therapeutics,

22

and policy and web-based tools. These programs are targeted to a variety of populations including infants and breastfeeding mothers, children and adolescents,

women, minorities, the elderly, the disabled, rural, and the general population.

HHS has adopted a comprehensive, multi-component approach to address the

complex epidemic of obesity among children and adolescents. HHS strategies include:

• Providing strong, national leadership

• Developing and delivering clear, coherent, and effective health messages to ensure

that consumers have accurate and adequate information to make informed decisions about improving their health;

• Monitoring the problem and programs to address the problem so that we can better understand its causes, consequences, and how it changes over time;

• Identifying and addressing research gaps;

• Synthesizing research findings to identify effective policies and programs;

• Developing and disseminating tools to help schools and community-based organizations implement effective policies and programs; and

• Helping national, state, and local agencies and organizations implement effective

programs.

DEPARTMENT OF HEALTH AND HUMAN SERVICES STEPS INITIATIVE

In June 2002, President Bush launched the HealthierUS initiative designed to

help Americans, especially children, live longer, better, and healthier lives. The

President’s HealthierUS initiative helps Americans take steps to improve personal

health and fitness and encourages all Americans to: 1) be physically active every

day; 2) eat a nutritious diet; 3) get preventive screenings; and 4) make healthy

choices concerning alcohol, tobacco, drugs and safety.

In 2003, Tommy Thompson, Secretary of the Department of Health and Human

Services, further advanced the President’s initiative by introducing Steps to a

HealthierUS (Steps). At the heart of this program lies both personal responsibility

for the choices Americans make and social responsibility to ensure that policy makers support programs that foster healthy behaviors and prevent disease. The Steps

initiative envisions a healthy, strong, U.S. population supported by a health care

system in which diseases are prevented when possible, controlled when necessary,

and treated when appropriate.

The Steps Cooperative Agreement Program is one part of Secretary Thompson’s

larger Steps initiative. This program aims to help Americans live longer, better, and

healthier lives by reducing the burden of diabetes, obesity, and asthma and addressing three related risk factors—physical inactivity, poor nutrition, and tobacco use.

In FY 2003, $15 million was provided to 23 communities to support innovative community-based programs that are proven effective in preventing and controlling

chronic diseases. In FY 2004, $44 million will be used to increase funding to existing

Steps communities, fund new communities, and fund one or two national organizations to enhance the capacity of Steps communities.

As part of the Steps initiative, HHS also recently released a report titled Prevention: A Blueprint for Action, which outlines simple steps that individuals and interested groups can take to promote healthy lifestyles and encourage healthy behavior.

The Department’s efforts to promote health and prevent disorders such as obesity

rests, in large part, on developing effective messages that are appropriate for individuals and groups in ways that they can understand and act upon. An example

of this is the CDC’s youth media campaign demonstration, ‘‘VERB. It’s what you do.’’

VERB’s goal has been to promote social norms that support physical activity and

portray fitness as fun and healthy. HHS/CDC has enlisted partner organizations in

the campaign, such as 4-H, Boys and Girls Clubs and the National Hockey League

to brand the VERB message and make it appealing to its pre-teen audience. VERB

also reaches out to parents and other adults influential to young people, encouraging them to support and participate in physical activity with pre-teens.

Campaign strategies include multimedia advertising and marketing promotions

using television, radio, print, and Web sites; contests and community events; and

partnerships with youth organizations, schools, national professional associations,

and entertainment media that are popular with youth. Reported preteen (or

‘‘tween’’) awareness of VERB is high at 74 percent, with 90 percent of these youth

understanding the campaign’s messages. After one year, campaign impact has been

demonstrated by reports of increased free-time physical activity among several important population subgroups, including the nation’s 10 million tween girls, 8.6 million 9-10 year olds, and 6 million tweens from low- to moderate-income households.

For example, after one year of the campaign, the average 9-10 year old in the nation

23

engaged in more sessions of free-time physical activity when compared to children

who were unaware of VERB.

Other important HHS programs that communicate nutrition and physical activity

messages to the American public are the National Cancer Institute’s 5 A Day for

Better Health Program and the President’s Council on Physical Fitness and Sports

(PCPFS). The 5 A Day program seeks to increase to 5 or more the number of daily

servings Americans eat of fruits and vegetables. In addition to its widely known slogan, the 5 A Day program reaches many individuals through health care provider

networks, the internet, and print media. It also has sponsored the development and

evaluation of a number of school-based interventions to promote fruit and vegetable

consumption among children and adolescents.

The PCPFS promotes physical activity for all ages, backgrounds and abilities with

information and publications (www.fitness.gov) and physical activity/fitness motivational awards programs (www.presidentschallenge.org). The Council advises the

President and the Secretary of HHS about issues related to physical activity, fitness,

and sports, and recommends programs to promote regular physical activity for the

health of the nation.

CDC SURVEILLANCE EFFORTS

Through its ongoing National Health and Nutrition Examination Survey, CDC

produces nationally representative data on the prevalence of overweight among children and adolescents based on measured height and weight, as well as on their dietary and physical activity behaviors. In addition, CDC’s biennial Youth Risk Behavior Survey provides national, state, and city data on self-reported height and weight,

physical activity, and dietary behaviors among high school students.

CDC’s School Health Policies and Program Study (SHPPS) is a national survey

periodically conducted to assess school health policies and programs of state education agencies and of nationally representative samples of school districts, schools,

and health and physical education classrooms. SHPPS provides national data on

what schools are doing in relation to physical education, after school physical activity programs, recess, nutrition education, school food service, and vending machine

policies and practices. CDC’s School Health Profiles survey, conducted every other

year, tells us about the extent to which schools are implementing physical activity

and nutrition-related policies and practices in different states and cities.

CDC’S NATIONAL NUTRITION AND PHYSICAL ACTIVITY PROGRAM TO PREVENT OBESITY

With 2004 funding, the CDC will support obesity prevention programs in a total

of 28 states. Of these, 23 states will be funded at the capacity-building level to hire

staff with expertise in public health nutrition and physical activity, build broad

based coalitions, develop state plans, identify community resources and gaps, implement small-scale interventions, and work to raise public health awareness of

changes needed to help state residents achieve and maintain a healthy weight. The

other five states are funded at the basic-implementation level to put their state

plans into action, conduct and evaluate nutrition and physical activity interventions,

train health care and public health professionals, provide grants to communities,

make environmental changes, and strengthen obesity prevention programs in community settings. In addition, CDC provides funding to 23 states for the implementation of school-based policies and programs to help young people avoid behaviors that

increase their risk for obesity specifically unhealthy eating and inadequate physical

activity.

Additionally, the CDC is developing a mechanism to quickly deploy staff (rapid

deployment teams) into communities, worksites and schools to facilitate evaluation

of promising strategies aimed at improving nutrition, increasing physical activity,

and preventing obesity. Each team would collect baseline data, and provide evaluation consultation and technical assistance, identify methodologic gaps, and provide

recommendations to improve the quality of program evaluation.

OTHER HHS EFFORTS

Working groups within the Department’s agencies have recently evaluated current

HHS programs and activities, made recommendations to better coordinate these efforts, and identified areas of opportunity for new initiatives. Two recent major initiatives tied to obesity are the Food and Drug Administration’s (FDA) Obesity Working Group, which will advise the Agency on innovative ways to deal with the increase in obesity and identify ways to help consumers lead healthier lives through

better nutrition, and the National Institute of Health’s (NIH) development of an

Obesity Research Task Force, to develop a strategic plan for obesity research.

24

This past year the FDA made a major change in the nutrition label on foods to

include a separate listing of trans fatty acids. This was the first significant change

in the Nutrition Facts panel since it was established in 1993.

The FDA has also undertaken a broad effort to crack down on misleading information and/or unsafe dietary supplements, and has proposed new regulations to establish good manufacturing practice requirements for dietary supplements. FDA has

focused its enforcement efforts over the past year to ensure consumers are not being

harmed as a result of claims that overstate the effectiveness of dietary supplement

products. The Agency took steps to remove dietary supplements containing ephedrine alkaloids from the market. These products were extensively promoted for aiding

weight control and boosting sports performance and energy. The totality of the

available data showed little evidence of benefit from dietary supplements containing

ephedrine alkaloids except for modest, short-term weight loss insufficient to improve

health, while confirming that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system. These effects are linked to significant adverse

health outcomes, including heart attack and stroke. In March of this year, the Agency announced various efforts to crack down on products containing androstenedione,

or ‘‘andro.’’ This class of products poses substantial safety risks to all Americans,

particularly our nation’s youth and athletes.

One of the key messages of this effort is that there are no safe quick fixes when

it comes to losing weight and improving athletic performance, and it is only through

proper diet, nutrition and exercise that we can improve our physical performance

and, more importantly, maintain and improve our health.

Also, in the school setting, the Health Resources and Services Administration’s

Healthy Schools, Healthy Communities program promotes and establishes comprehensive school-based health centers to improve the health of at-risk school aged

children. Services provided by the centers include nutrition education and counseling, support groups for overweight children, dietary surveillance, and nutrition

screening.

NATIONAL DIETARY GUIDELINES

HHS is collaborating with the U.S. Department of Agriculture to review the Dietary Guidelines that were published in 2000 and to draft new 2005 Dietary Guidelines for Americans. In light of the growing number of overweight and obese Americans, a major focus of the new guidelines will be providing guidance to the public

on maintaining a healthy weight and creating lifestyles that balance the number of

calories eaten with the number of calories expended. These guidelines must: (1) contain nutritional and dietary information and guidelines for the general public, (2)

be based on the preponderance of scientific and medical knowledge current at the

time of publication, and (3) be promoted by each Federal Agency involved in a Federal food, nutrition, or health program.

STRATEGIES FOR COMBATING OVERWEIGHT IN CHILDREN

Overweight and obesity result from an imbalance between caloric intake and caloric expenditure. Many factors have contributed to the unfavorable trends in physical activity and nutrition that have fueled the obesity epidemic. Consequently,

there will be no silver bullet, no single change strategy to solve these problems.

Multiple strategies addressing multiple factors will be needed to successfully combat

the obesity epidemic.

Reviews of research conducted to date indicate that there are at least three behavioral strategies for reducing rates of overweight and obesity that appear to be justified by the current state of knowledge. These are: (1) increased physical activity for

the population, (2) reduced sedentary behaviors, such as television viewing and

video gaming, for children and adolescents, and (3) the promotion of breast feeding

and efforts to increase its duration.

Increased physical activity for overweight patients reduces many of the comorbidities associated with obesity such as hypertension, hyperlipidemia, and glucose intolerance; maintains weight after weight loss; and prevents weight gain. The

dose of physical activity necessary to prevent weight gain among normal or overweight children, adolescents, or adults has not been established, although one hour

of daily, moderate intensity physical activity appears required for weight maintenance in adults after weight loss.

A factor in the prevalence of overweight among our youth may be the amount of

time children and adolescents are sedentary, watching television or playing video

games, for example. One school-based study demonstrated a two percent decrease

in overweight as a result of a curriculum that included reduced television time. A

25

second school-based study demonstrated reduced rates of weight gain in children

who reduced television time.

Breastfeeding is the most appropriate form of feeding for most infants and clearly

reduces the incidence of acute diseases of infancy and early childhood. In addition,

recent studies indicate that breastfeeding reduces the risk of childhood overweight

by 15-20 percent.

While we have good ideas about the types of behaviors we need to promote, the

critical challenge before us is to identify how we can effectively help young people

and their families to adopt these behaviors. gI89Tools to help schools and community-based organizations

HHS has developed, and is continuing to develop, a variety of tools that schools

can use to implement policies and practices recommended by the CDC guidelines.

These include:

• CDC’s School Health Index for Physical Activity and Healthy Eating, a widely

used self-assessment and planning tool that enables schools to identify the

strengths and weaknesses of their health promotion policies and programs, develop an action plan for improving student health, and involve teachers, parents, students, and the community in improving school policies and programs.

• Fit Healthy and Ready to Learn, a school health policy guide, developed with CDC

support by the National Association of State Boards of Education, that provides

education policymakers and administrators with sample physical activity and

nutrition policies and information to support the policies.

• CDC’s Building a Healthier Future Through School Health Programs describes

promising practices that states should consider when planning school-based

policies and programs to help young people avoid behaviors that increase their

risk for obesity and chronic disease, especially tobacco use, unhealthy eating,

and inadequate physical activity.

• Power of Choice, an after-school program jointly developed by FDA and the US

Department of Agriculture (USDA) that guides pre-teens toward a healthier

lifestyle by motivating and empowering them to make better food and physical

activity choices in real-life settings.

• Fruit and Vegetables Galore, developed by USDA in collaboration with HHS, provides tips to school foodservice professionals on planning, purchasing, preparing, presenting, and promoting fruits and vegetables. It also includes suggestions for working with teachers by providing them with teaching tools and by

supporting their educational efforts, making daily meal offerings competitive

with other commercial options available to students, and getting students excited about healthful eating.

• Kids Walk to School, a user-friendly manual developed by CDC that provides information and resources for community partners to increase opportunities for

daily physical activity by encouraging children to walk to and from school in

groups accompanied by adults and by encouraging collaboration among partners

to create an environment supportive of walking and bicycling to school safely.

In addition, HHS agencies are developing important new tools, to be released in

the coming months that will help schools promote healthy eating and physical activity.

• Making It Happen—School Nutrition Success Stories (MIH), a joint product of

CDC and USDA, tells the stories of 32 schools and school districts that have

implemented innovative strategies to improve the nutritional quality of foods

and beverages offered and sold on school campuses. The most consistent theme

emerging from these case studies is that students will buy and consume healthful foods and beverages—and schools can make money from healthful options.

• The Health Education Curriculum Analysis Tool is a user-friendly checklist designed by CDC to help schools select or develop curricula based on the extent

to which they have characteristics that research has identified as being critical

for leading to positive effects on youth health behaviors. The companion Physical Education Curriculum Analysis Tool will help school districts develop stateof-the-art physical education curriculum based on insights gained from research

and best practice.

• Media Smart Youth: Food, Fitness, and Fun is a curriculum with supporting materials developed by the National Institute of Child Health and Human Development for youth ages 11-13 years old. It is designed to create awareness of the

role that media play in shaping values concerning physical activity and nutrition, while building skills to encourage critical thinking, healthy lifestyle

choices, and informed decision making, now and in their future.

26

CONCLUSION

Successfully combating the overweight epidemic among children and adults will

require the involvement of many sectors and levels of society. Although national initiatives can play an important role, they are not sufficient by themselves. Community-based initiatives are critical for reaching Americans where they live, work, go

to school, and play. State-level programs are critical for supporting and disseminating community-based activities. HHS is implementing a comprehensive approach

to reach the American people through these various levels.

There is a great deal more that we need to learn about intervention strategies

to prevent overweight among children and adolescents. Key research questions that

need to be addressed include:

• Which are the most important behaviors to target to influence overweight and

obesity?

• Which mediating variables should be targeted to influence obesity-related behaviors?

• Which are the types of interventions that have the greatest impact on the most

critical mediating variables and behaviors?

• How do we translate efficacy study findings into real-world policies and programs?

• How do we effectively and efficiently disseminate effective policies and programs?

• Do the effects of overweight and obesity prevention policies and programs last

over time?

CDC, NIH and other HHS agencies will lead the Nation in conducting the research necessary to answer these questions.

We have, however, learned a great deal about effective strategies for promoting

physical activity and healthy eating among young people. We know that no one

strategy alone will be sufficient and that our chances for success will be greater if

we use multiple strategies to address multiple factors that contribute to caloric imbalance and if we involve multiple sectors of society at the community, state, and

national levels. HHS is leading the national effort to combat the overweight epidemic in children through a comprehensive, multi-faceted, multi-level approach. We

are committed to doing all that we can to help our young people enjoy good health

now and for a lifetime.

I thank you for your interest and the opportunity to share information about

strategies to combat the overweight epidemic in children, and would be happy to

answer your questions.

Mr. GREENWOOD. Thank you very much, Dr. Wechsler.

Dr. Hoppin, you are recognized for your opening statement. Good

morning.

TESTIMONY OF ALISON HOPPIN

Ms. HOPPIN. Good morning. Chairman Greenwood, members of

the committee. Good morning.

My name is Alison Hoppin, and I am a physician specializing in

Pediatric Obesity Medicine. I am grateful for the opportunity to

speak with you today about the ‘‘dietary supplements’’ that are

marketed as weight loss agents for overweight children. I am concerned about the lack of scientific standards displayed in the marketing tactics of some members of this industry. The marketing

claims are misleading at best, sometimes patently false, and these

issues are of particular concern for the products that are marketed

for use in children.

My specialty training is in Pediatric Gastroenterology and Nutrition, and for the past 8 years the focus of my research and patient

care has been on the problems associated with obesity in children

and adolescents. I direct the Pediatric services at the Weight Center at Massachusetts General Hospital, one of the academic medical centers associated with Harvard Medical School. The MGH

Weight Center is a multidisciplinary program for clinical treatment

of adults and children with obesity. It is also a center for research

into the underlying causes, consequences, and treatment of obesity.

27

I am an instructor on the faculty of Harvard Medical School, where

I teach medical students, residents, and fellows in Nutrition and

Pediatric Gastroenterology. I am also the mother of two children,

10 and 12 years old. And it is with this dual perspective of a physician and parent that I speak today.

Our country is now facing an epidemic of obesity. It affects all

socioeconomic and ethnic groups in our society, and all age groups.

Indeed, rates of obesity in children have tripled over the past 30

years. This is not a benign or cosmetic problem. Obesity causes or

worsens more than 40 different medical diseases, including diabetes and heart disease, depression, breast cancer, colon cancer, and

prostate cancer. It is responsible for over 400,000 premature deaths

annually in the United States, and over $100 billion dollars in

health care costs each year. Added to this enormous disease burden

is a heavy emotional burden from obesity, due to pervasive cultural

preferences for thin body types. This leads to criticism, negative

stereotypes, ridicule, and outright bias against individuals with

obesity.

There are no consistently successful low-risk treatments for obesity. Many individuals with obesity lose weight in the short term

with a wide variety of diets, exercise, and behavioral approaches.

However, fewer than 5 percent of adults keep this weight off for 5

years or more, past and current diet fads notwithstanding. Against

these odds, people that are facing the emotional and physiological

burden of obesity understandably feel discouraged and desperate,

and are therefore very vulnerable to products making claims of success.

Children and adolescents are unique in the field of obesity. They

are particularly vulnerable to the emotional consequences of obesity, as the impact of teasing from peers or criticism from adults

is particularly damaging to their self-esteem. As they go through

puberty, adolescents are acutely aware of their changing bodies

and are strongly influenced by the images of their idols in the entertainment world, professional sports, and in the popular press.

They tend to act impulsively and often fail to consider long-term

risks. They are therefore particularly prone to risky dieting behavior, including eating disorders.

I am very concerned about the misinformation that has permeated the field of obesity in the past, and in particular by the

companies marketing ‘‘dietary supplements’’ that take advantage of

the frustration, fears, and desperation that frequently arise in individuals fighting obesity, or in those who are merely dissatisfied by

their body size. Some members of the dietary supplement industry

develop products based on a very shaky foundation of pseudoscience. They then market these products to a vulnerable population. They frequently claim pharmacological effects of the products, but then take no responsibility for assessing or communicating the possibility of pharmacological side effects or toxicities.

In their marketing, many members of the dietary supplement industry display scientific standards that are well below that of companies in the pharmaceutical, food, or cosmetic industries.

Three ‘‘dietary supplements’’ were recently marketed as ‘‘weight

loss’’ treatments for children. Each used combinations of herbal

medicines that were previously marketed to adults with claims for

28

weight loss. The very names of these products; the Skinny Pill for

Kids, PediaLoss, and PediaLean make claims of pharmacological effects, and supplementary marketing materials go further. The

claims that the Skinny Pill ‘‘works overnight with a thermic formula to burn fat while you sleep’’ and ‘‘prevents starch from turning into sugar and then into fat’’ have no basis in scientific fact.

I have reviewed the scant scientific material available to support

or refute these claims. In most cases, the data consist of small

studies in adults using single-ingredient preparations. The study

designs fall short of standards required for scientific proof. Frequently, two studies on the same compound give contradictory results. Extrapolation of results from one study or group of studies

is difficult due to highly variable nomenclature and lack of measurement standards for active ingredients. Moreover, one cannot assume that results of studies on a single-ingredient preparation will

be valid for multiple-ingredient preparations, in which different active ingredients may might interact to change effectiveness or danger from toxicity.

In my review of the literature, I found no studies that tested the

particular combinations of dietary supplements used in the Skinny

Pill for Kids or PediaLoss, in either adults or children. Moreover,

most of the individual ingredients in these preparations have not

been adequately tested for safety in children. Children are not just

small adults, and their responses to drugs or toxins may be quite

different from those seen in adults. This raises serious concerns

about the effects that ingesting these products could have in young

children.

One of these products, PediaLean, makes its claim based on a

purported clinical study of the product in Italian children over 10

years ago, published in an Italian medical journal. It appears that

someone, presumably the company that makes PediaLean, had the

study translated into English. Selected excerpts from the study

were then published in marketing materials for PediaLean, under

the statement that this product is ‘‘Clinically Proven Safe and Effective.’’ However, I have serious concerns about the study design,

particularly the lack of a true control group, and therefore I have

serious doubts about the validity of the authors’ conclusions. There

is no placebo control, and no discussion of how the control group

was selected, so apparently there was no randomization process.

Thirty-eight percent of the subjects dropped out of the study, and

results from these drop-outs was apparently ignored. The study

states that at least 14 percent of patients given PediaLean ‘‘stopped

taking the fiber capsule because they complained of abdominal discomfort or because they had not noticed any reduction in appetite.’’

Ignoring drop-outs like these can greatly bias the results of a

study, and is not an accepted approach to analysis.

The Italian study makes no effort to assess for side effects or toxicity from this product, although it does mention, in passing, that

a significant number ‘‘complained of abdominal discomfort.’’ The active ingredient, glucomannan, is known to swell in the body after

it is taken, and several cases of esophageal and gastrointestinal obstruction have been reported in the literature. I have concerns

about the possibility of esophageal obstruction in patients taking a

compound containing glucomannan, but the Italian study makes no

29

mention of monitoring their subjects for this side effect or other

toxicities. The so-called ‘‘micronization’’ process with which the

glucomannan is treated provides no reassurance against the possibility of obstruction. A compound can swell and stick together in

an obstructive mass regardless of the size of the particles. I have

seen no evidence, in the company’s own materials or elsewhere,

that micronization changes the tendency of glucomannan to clump

together to form an obstructive mass when mixed with water.

Despite these obvious flaws in study design, the marketing

claims for this product include such inappropriately definitive

statements as ‘‘Klein-Becker’s proprietary micronization process

guarantees that PediaLean is not only safe, but is the one and only

weight-control compound designed, manufactured, and clinically

proven safe and effective for use by overweight children and adolescents.’’ On the contrary: there is no valid clinical proof here that

the product is either safe, or effective for weight loss.

Another product, the Skinny Pill for Kids, includes Uva Ursi also

known as bearberry, an ingredient that in several objective sources

is specifically not recommended for children under 12 years of age

because of concerns for liver toxicity. A second ingredient, Juniper

Berry, may cause kidney damage with ‘‘prolonged use’’ or if high

doses are used. These and one other ingredient are considered

weak diuretics, meaning that they increase water loss in the urine,

and this might conceivably cause a transient minor loss of water

weight, which might deceive a patient into thinking that it was

helping with weight control. However, there is no biological reason

to believe that this diuretic effect would cause any loss of fat,

which would be the only ‘‘real’’ type of weight loss.

Another product, PediaLoss, contains just one ingredient that

might conceivably cause weight loss, HCA, although two studies on

this ingredient give contradictory results. A second ingredient,

lecithin, has no support for use as a weight loss agent, and indeed

weight gain has been reported as a possible side effect of this ingredient.

I am not here to make statements disparaging alternative medicine in general, or the fields of herbal medicine or dietary supplements in particular. The field of herbal medicines struggles with

issues such as lack of standardized nomenclature and dosing standards, and suffers from a dearth of data on which to base clinical

decisions. However, I applaud the trend toward creating such

standards and improving evidence-based techniques for determining effectiveness and toxicities of medicines in this field.

My concerns are specific to the marketing practices that have

been used for some dietary supplements, including those that I

mentioned earlier. There is no scientific reason to believe that any

of these supplements have true effectiveness for short- or long-term

control of obesity. Children and adolescents are particularly influenced by advertising or marketing and are less likely than adults

to take a skeptical view of unproven advertising claims. To market

these products to the public with claims of effectiveness is therefore

exploitative. The absence of carefully collected follow-up data provides little reassurance about the safety of these preparations when

used in large numbers of children and adolescents. To target children and adolescents, a group particularly likely to engage in unVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00037 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
30

tested or extreme dieting practices, and a group particularly likely

to be influenced by advertising, is particularly irresponsible. This,

combined with the lack of safety standards in this field, is certainly

risky, and possibly downright dangerous.

I am pleased to see that preliminary inquiries by this committee

requesting further information on these products were met by abrupt withdrawal of the product from the market in two of the three

cases. However, these events do not alter the legislative climate

that allows for unbridled and irresponsible marketing of dietary

supplements with minimal standards of accountability for potential

hazards. In each of the instances noted above, there is inadequate

information to provide a reasonable assurance that the ingredient

does not present a significant or unreasonable risk of illness or injury in children. I support stronger regulation of these products,

based on at least some minimal scientific standards. Stronger regulation is particularly important when products are marketed to vulnerable populations such as the elderly, or the children and adolescents targeted by the products described here.

Thank you for your time and attention to this matter, and I am

happy to answer questions about any of these issues that I raised.

[The prepared statement of Alison Hoppin follows:]

PREPARED STATEMENT OF ALISON HOPPIN

My name is Alison Hoppin, and I am a physician specializing in the field of Pediatric Obesity Medicine. I am grateful for the opportunity to speak with you today

about the ‘‘dietary supplements’’ that are marketed as weight loss agents for overweight children. I am concerned about the lack of scientific standards displayed in

the marketing tactics of some members of this industry. The marketing claims are

misleading at best, sometimes patently false, and these issues are of particular concern for the products that are marketed for use in children.

My specialty training is in Pediatric Gastroenterology and Nutrition, and for the

past eight years the focus of my research and patient care has been on the problems

associated with obesity in children and adolescents. I direct the Pediatric services

at the Weight Center at Massachusetts General Hospital, one of the academic medical centers associated with Harvard Medical School. The MGH Weight Center is

a multidisciplinary program for clinical treatment of adults and children with obesity. It is also a center for research into the underlying causes, consequences, and

treatment of obesity. I am an instructor on the faculty of Harvard Medical School,

where I teach medical students, residents, and fellows in Nutrition and Pediatric

Gastroenterology. I am also the mother of two children—10 and 12 years old. It is

with the dual perspective of a physician and parent that I speak today.

Our country is now facing an epidemic of obesity. It affects all socioeconomic and ethnic groups in our society, and all age groups. Indeed, rates of obesity in children have tripled over the past 30 years. This is not a benign or cosmetic

problem. Obesity causes or worsens more than 40 different medical diseases, including diabetes and heart disease, depression, breast cancer, colon cancer, and prostate

cancer. It is responsible for over 400,000 premature deaths annually in the United

States, and over $100 billion dollars in health care costs each year. Added to this

enormous disease burden is a heavy emotional burden from obesity, due to pervasive cultural preferences for thin body types. This leads to criticism, negative stereotypes, ridicule, and outright bias against individuals with obesity.

There are no consistently successful low-risk treatments for obesity.

Many individuals with obesity lose weight in the short term with a wide variety of

diets, exercise, and behavioral approaches. However, fewer than 5% of adults keep

this weight off for five years or more, past and current diet fads notwithstanding.

Against these odds, people that are facing the emotional and physiological burden

of obesity understandably feel discouraged and desperate, and are therefore vulnerable to products making claims of success.

Children and adolescents are unique in the field of obesity. They are particularly vulnerable to the emotional consequences of obesity, as the impact of teasing from peers or criticism from adults is particularly damaging to their self-esteem.

As they go through puberty, adolescents are acutely aware of their changing bodies

31

and are strongly influenced by images of their idols in the entertainment world, professional sports, and in the popular press. They tend to act impulsively and often

fail to consider long-term risks. They are therefore particularly prone to risky dieting behavior, including eating disorders.

I am very concerned about the misinformation that has permeated the

field of obesity in the past, and in particular by the companies marketing

‘‘dietary supplements’’ that take advantage of the frustration, fears, and desperation that frequently arise in individuals fighting obesity, or in those who are merely

dissatisfied by their body size. Some members of the dietary supplement industry

develop products based on a very shaky foundation of pseudo-science. They then

market these products to a vulnerable population. They frequently claim pharmacological effects of the products, but take no responsibility for assessing or communicating the possibility of pharmacological side effects or toxicities. In their marketing, many members of the dietary supplement industry display scientific standards that are well below that of companies in the pharmaceutical, food, or cosmetic

industries.

Three ‘‘dietary supplements’’ were recently marketed as ‘‘weight loss’’

treatments for children. Each used combinations of herbal medicines that were

previously marketed to adults with claims for weight loss. The very names of these

products—the ‘‘Skinny Pill for Kids,’’ ‘‘PediaLoss,’’ and ‘‘PediaLean,’’—make claims

of pharmacological effects, and supplementary marketing materials go further. The

claims that the Skinny Pill ‘‘works overnight with a thermic formula to burn fat

while you sleep’’ and ‘‘prevents starch from turning into sugar and then into fat’’

have no basis in scientific fact. I have reviewed the scant scientific material available to support or refute these claims. In most cases, the data consist of small studies in adults using single-ingredient preparations. The study designs fall short of

standards required for scientific proof. Frequently, two studies on the same compound give contradictory results. Extrapolation of results from one study or group

of studies is difficult due to highly variable nomenclature and lack of measurement

standards for active ingredients. Moreover, one cannot assume that results of studies on a single-ingredient preparation will be valid for multiple-ingredient preparations, in which different active ingredients may might interact to change effectiveness or danger from toxicity.

In my review of the literature, I found no studies that tested the particular combinations of dietary supplements used in ‘‘The Skinny Pill for Kids’’ or ‘‘PediaLoss,’’

in either adults or children. Moreover, most of the individual ingredients in these

preparations have not been adequately tested for safety in children. Children are

not just small adults, and their responses to drugs or toxins may be quite different

from those seen in adults. This raises serious concerns about the effects that ingesting these products could have in young children.

One of these products, ‘‘PediaLean ,’’ makes its claim based on a purported clinical study of the product in Italian children over ten years ago, published in an

Italian medical journal. It appears that someone, presumably the company that

makes PediaLean, had the study translated into English. Selected excerpts from the

study were then published in marketing materials for PediaLean, under the statement that this product is ‘‘Clinically Proven Safe and Effective.’’ However, I have

serious concerns about the study design, particularly the lack of a true control

group, and therefore I have serious doubts about the validity of the authors’ conclusions. There is no placebo control, and no discussion of how the control group was

selected, so apparently there was no randomization process. Thirty-eight percent of

the subjects dropped out of the study, and results from these drop-outs was apparently ignored. The study states that at least 14% of patients given PediaLean

‘‘stopped taking the fiber capsule because they complained of abdominal discomfort

or because they had not noticed any reduction in appetite.’’ Ignoring drop-outs like

these can greatly bias the results of a study, and is not an accepted approach to

analysis.

The Italian study makes no effort to assess for side effects or toxicity from this

product, although it does mention, in passing, that a significant number ‘‘complained of abdominal discomfort.’’ The active ingredient, glucomannan, is known to

swell in the body after it is taken, and several cases of esophageal and gastrointestinal obstruction reported in the literature. I have concerns about the possibility of esophageal obstruction in patients taking a compound containing

glucomannan, but the Italian study makes no mention of monitoring their subjects

for this or other side effects or toxicity. The so-called ‘‘micronization’’ process with

which the glucomannan is treated provides no reassurance against the possibility

of obstruction. A compound can swell and stick together in an obstructive mass regardless of the size of the particles. I have seen no evidence, in the company’s own

32

1PDR for Herbal Medicines, 2000 pp 779-782;

2McGuffin M et al: American Herbal Products Association’s Botanical Safety Handbook. CRC

Press, Boca Raton FL; 1997 3 AltMedDex, accessed through MICROMEDEX(R) Healthcare Series Vol. 120, 6/7/04

materials or elsewhere, that micronization changes the tendency of glucomannan to

clump and form an obstructive mass when mixed with water.

Despite these obvious flaws in study design, the marketing claims for this product

include such inappropriately definitive statements as ‘‘Klein-Becker’s proprietary

micronization process guarantees that PediaLean  is not only safe, but is the one

and only weight-control compound designed, manufactured, and clinically proven

safe and effective for use by overweight children and adolescents.’’ On the contrary:

there is no valid clinical proof here that the product is either safe, or effective for

weight loss.

Another product, the ‘‘Skinny Pill for Kids ,’’ includes Uva Ursi (also known

as bearberry), an ingredient that in several objective sources is specifically not recommended for children under 12 years of age because of concerns for liver toxicity.1,2,3 A second ingredient, Juniper Berry, may cause kidney damage with ‘‘prolonged use’’ or if high doses are used. These and one other ingredient are considered

weak diuretics, meaning that they increase water loss in the urine, and this might

conceivably cause transient minor loss of water weight, which might deceive a patient into thinking that it was helping with weight control. However, there is no biological reason to believe that this diuretic effect would cause any loss of fat, which

would be the only ‘‘real’’ type of weight loss.

Another product, ‘‘PediaLoss ’’ contains just one ingredient that might conceivably cause weight loss (HCA), although two studies on this ingredient give contradictory results. A second ingredient, lecithin, has no support for use as a weight

loss agent, and indeed weight gain is reported as a possible side effect of this ingredient.

I am not here to make any statements disparaging alternative medicine

in general, or the fields of herbal medicine or dietary supplements in particular.

The field of herbal medicines struggles with such issues as lack of standardized nomenclature and dosing standards, and suffers from a dearth of data on which to

base clinical decisions. However, I applaud the trend towards creating such standards and improving evidence-based techniques for determining effectiveness and

toxicities of medicines in this field.

My concerns are specific to the marketing practices that have been used

for some dietary supplements, including those I mentioned earlier. There is no

scientific reason to believe that any of these supplements has true effectiveness for

short- or long-term control of obesity. Children and adolescents are particularly influenced by advertising or marketing and are less likely than adults to take a skeptical view of unproven advertising claims. To market these to the public with claims

of effectiveness is therefore exploitative. The absence of carefully collected follow-up

data provides little reassurance about the safety of these preparations when used

in large numbers of children and adolescents. To target children and adolescents,

a group particularly likely to engage in untested or extreme dieting practices, and

a group particularly likely to be influenced by advertising, is particularly irresponsible. This, combined with the lack of safety standards in this field, is certainly

risky, and may be downright dangerous.

I am pleased to see that preliminary inquiries by this Committee requesting further information on these products were met by abrupt withdrawal

of the product from the market in two of the three cases. However, these

events do not alter the legislative climate that allows for unbridled and irresponsible marketing of dietary supplements with minimal standards of accountability for

potential hazards. In each of the instances noted above, there is inadequate information to provide a reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury in children. I support stronger regulation of these products, based on at least some minimal scientific standards. Stronger

regulation is particularly important when products are marketed to vulnerable populations such as the elderly, or the children and adolescents targeted by the products described here.

Mr. GREENWOOD. Thank you Dr. Hoppin, and we are very happy

to have you with us. It is a big help.

The Chair recognizes himself for 5 minutes for questions, and let

me start with Mr. Beales. You have announced today that you have

33

filed a complaint against the manufacturer of PediaLean, is that

correct?

Mr. BEALES. Yes, sir.

Mr. GREENWOOD. Let me understand something. Unlike a pharmaceutical product that has a gargantuan burden of proof going before the FDA to prove that the product is in fact safe and effective.

Under the DSHEA Act products like PediaLean have no burden of

proof whatsoever. Help me understand where the burden of proof

comes when the Federal Trade Commission takes an action. Do you

have to prove that the product doesn’t work or do you simply challenge the manufacturer to prove the claims?

Mr. BEALES. Under the FTC Act a manufacturer has to have evidence to substantiate a claim before it makes that claim. And for

products like these, the evidence has to be competent and reliable

scientific evidence. If they do not have that kind of evidence, then

it’s a deceptive practice to make the advertising claim at all. And

what we have to show, our burden is to show that the evidence

they produced is not enough to meet that standard.

Mr. GREENWOOD. Now, you have filed against individual officers

of these companies as well as the company as an entity. Can you

explain to the committee why you have taken that action?

Mr. BEALES. What we generally do in most of our cases is we will

look for any individuals that were actively involved in the practices

and in control of what the company was doing, and name those individuals as well. And that is pretty much true across the board

in our cases.

Mr. GREENWOOD. Looking at the PediaLean box, at the very first

sentence in the back panel says ‘‘There is nothing more effective

than PediaLean in helping your child lose weight.’’ I mean that, in

and of itself, seems to be so patently false given all of the science

tells us that it is diet control and exercise that is most effective in

having anyone lose weight.

Let me turn to Dr. Hoppin for a moment. A number of these

products boast about the fact that they have fiber in them, and

fiber is supposed to suppress appetite. How much fiber does it take,

and can you put enough fiber in a pill to actually have the affect

that eating an apple would have or fiber that is available in cereal

and so forth?

Ms. HOPPIN. I do not believe that you can. There are some very

borderline evidence of studies of fiber supplements in adults that

perhaps suggest a weight loss effect, but it is very shaky and there

is no such evidence in children.

Mr. GREENWOOD. Thank you.

Dr. Beales, tell us what the like sequence of events is going to

be with the complaint that you filed now, how will this play out

with regard to PediaLean?

Mr. BEALES. In both PediaLean and PediaLoss we filed administrative complaints. They will go to trial in front of an administrative law judge at the Commission. And then after the administrative law judge makes a decision, that would be subject to appeal

by either the staff or the respondent to the Commission itself, and

then appeal to the Circuit Courts of Appeals.

34

Mr. GREENWOOD. Have you gathered information with regard to

the volume of sales of these products and do you know anything

about the revenues generated to the companies by these products?

Mr. BEALES. The information that we get in the course of an investigation pursuant to our compulsory process is confidential. And

if we have sales information, I mean we could talk about it in a

non-public briefing but we do not have a public estimate of what

their sales are.

Mr. GREENWOOD. Okay. According to your testimony the FTC

brought charges against Edita Kaye and her company, the Fountain of Youth Group, LLC alleged false and deceptive advertising

claims. These charges arose out of several of her products, including the Skinny Pill for Kids. I think you have notebooks in front

of you. Look at tab 3, page 3. There’s an ad for a Skinny Pill for

Kids taken off the website, www.skinny.com. And under No. 4 on

that page it states it ‘‘offers very real weight loss help through supplements that metabiotically assist children to burn more fat

pounds and inches, block new fat deposits and help regulate insulin

levels to help mitigate fat factors.’’ Did the FTC find this statement

to be false and misleading advertising and if so, why?

Mr. BEALES. We challenged a series of seven different claims

about Skinny Pill for Kids in addition to an eighth claim that the

other claims were scientifically proven. And what we alleged was

that they did not have adequate substantiation to support those

claims and they were, therefore, deceptive.

Mr. GREENWOOD. Okay. Let me just quickly go to Dr. Hoppin. Do

you have that in front of you as well, ma’am? I just ask for your

professional opinion if you think that this product could offer very

real weight loss help through supplements that metabolically assist

children to burn more fat pounds and inches, block new fat deposits and help regulate insulin levels to help mitigate fat factors.

Ms. HOPPIN. Absolutely not——

Mr. GREENWOOD. Would you turn your microphone on, please.

Ms. HOPPIN. Absolutely not. There is no evidence of a regulatory

role of any of these ingredients. Certainly fiber can help slow gastric emptying slightly, so can fat. That is part of the diet. And with

slower gastric emptying, you may have smaller swings in blood

sugar. But that is not a regulatory role for insulin.

Mr. GREENWOOD. Okay. Chair recognizes the gentlelady from

Colorado for 5 minutes.

Ms. DEGETTE. Thank you, Mr. Chairman.

I just want to ask some questions, Dr. Hoppin, about some of

these products because it seems to me that they are supposed to

work in different ways. The Skinny Pill for Kids, the main way it

was supposed to work was through a diuretic effect, is that correct?

Ms. HOPPIN. I am not sure which component of the ingredients

they claim is the main affect, I am afraid. But that would be one

plausible concept.

Ms. DEGETTE. Did that pill also have fiber in it, do you know?

Ms. HOPPIN. Yes, it does.

Ms. DEGETTE. Okay. So it had both.

Now, this PediaLean, it does not have any diuretic, the active ingredient is this glucomannan. How do you say it?

Ms. HOPPIN. Glucomannan.

35

Ms. DEGETTE. Glucomannan. And it does not have diuretics in

it, though, right?

Ms. HOPPIN. Correct.

Ms. DEGETTE. So the way that that one is supposed to work it

is in a capsule and then someone takes it, and then it theoretically

expands in the stomach and makes the child less hungry, right?

Ms. HOPPIN. I suppose so. I have not seen their claims of how

they say it will work. But that would be the idea behind of taking

fiber as a supplement.

Ms. DEGETTE. Now, one of the side effects of this, I think in an

attachment to your testimony you talk about some studies on

adults using this glucomannan of esophageal obstruction, right?

Ms. HOPPIN. Yes.

Ms. DEGETTE. Now, would that be a problem if a capsule was

swallowed and expanded in the stomach?

Ms. HOPPIN. Until it is tested, we have no way of knowing.

Ms. DEGETTE. Okay.

Ms. HOPPIN. In other words, it is the same product that has

caused the esophageal obstruction in the past in some adults. But

until proven otherwise, I do not think that you can say that the

micronization process or encapsulating it makes any difference in

that risk.

Ms. DEGETTE. All right. So we do not know because, as you say,

there is just this one Italian study on children, at least.

Ms. HOPPIN. And they did not even bother to look for toxicity, as

far as I can tell.

Ms. DEGETTE. Okay. Well, I was sitting here reading over the insert in the PediaLean box, and what it said is if your child has difficulty swallowing the capsules, they can sprinkle on bread or onto

a spoonful of applesauce, peanut butter or yogurt; just about in

food. It says it on the box, too. So do you think that would cause

an issue if it expanded in the esophagus of that side effect?

Ms. HOPPIN. Well, thinking hypothetically, if the capsule was at

all protective against the esophageal obstruction, then you have

just gotten rid of that protection. So, yes.

Ms. DEGETTE. Okay. And now in the Italian study that you referenced, did they test for the delivery study in that Italian study,

do you know?

Ms. HOPPIN. No. No.

Ms. DEGETTE. They did not?

Ms. HOPPIN. They only mentioned vaguely and in passing these

14 percent of people that stopped, the subjects that stopped taking

it because of abdominal discomfort.

Ms. DEGETTE. Now, there were 23 subjects and 30 controls in the

Italian study, right?

Ms. HOPPIN. Yes. They started out with quite a few more treatment subjects, and then they just plain ignored those that dropped

out, which is not a——

Ms. DEGETTE. If you were doing a study, how would you conduct

that study?

Ms. HOPPIN. One does what is called an intention to treat approach to analyses, meaning that anybody who is enrolled into the

treatment arm needs to be considered in the final analysis.

36

Ms. DEGETTE. And that would be so like if they did not get any

benefit from the substance or if they had side effects, you just do

not let them go away. You take that into account in your final results, right?

Ms. HOPPIN. Exactly. You have to analyze everybody because

they may well have dropped out because they had side effects or

because it was not effective.

Ms. DEGETTE. Okay.

Mr. Beales, I wanted to ask you a couple of questions about FTC

enforcement actions that it takes. Now, you talked briefly in your

written and oral testimony about the Skinny Pill for Kids product.

And I wanted to ask you what your basis for the FTC’s complaint

that the claims were unfounded or outright false were? What was

the basis for those claims?

Mr. BEALES. Well, what we do in a typical investigation like this

is we will ask the company to produce its substantiation, the evidence that it believes substantiate the claim.

Ms. DEGETTE. Right.

Mr. BEALES. And then we will evaluate the adequacy of that evidence.

Ms. DEGETTE. And what happened in that situation with the

Skinny Pill for Kids?

Mr. BEALES. We alleged that the evidence they had was not adequate to substantiate those claims.

Ms. DEGETTE. I know. Did they produce the evidence then?

Mr. BEALES. I am not sure exactly what they produced. I mean,

what is——

Ms. DEGETTE. But the result was that obviously it was not

enough because the sale was halted, right?

Mr. BEALES. Yes, ma’am. The evidence—well, sometimes people

do not produce anything, sometimes they produce evidence that we

think is inadequate, and I am not sure which is the case for Skinny

Pill.

Ms. DEGETTE. I see. Okay. Now in that particular case were

there any other fines or punishments taken against either the company or the propriety of that pill, Ms. Kaye?

Mr. BEALES. There was a judgment of $6 million which was suspended due to the defendant’s inability to pay. There is an injunction that would prohibit any future unsubstantiated safety or efficacy claims for this or other related kinds of products or claims.

Ms. DEGETTE. Is there any ongoing effort to collect the $6 million

judgment or is it just gone now?

Mr. BEALES. It is—the money is gone. It was suspended because

the defendants did not have the money.

Ms. DEGETTE. Well, what I am saying is you get this judgment

against them and you suspend it because they do not have any

money to pay, but what happens if they start marketing another

product on the Internet or the proprietors are going on TV and

making more money, do you come back and try to collect that?

Mr. BEALES. No, we do not.

Ms. DEGETTE. Do you think that creates a deterrent effect

against these folks doing it in the future?

Mr. BEALES. Well, if they do it in the future, that would violate

the injunction and would be contempt of court and we would proVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00044 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
37

ceed that way, and there would be financial consequences for the

future conduct——

Ms. DEGETTE. How did the Commission determine a $6 million

fine?

Mr. BEALES. Typically what we do is it’s redress as opposed to

a fine. I mean, it is money that would go back to consumers if we

collected the money. And typically what we do is that amount

would be based on what we thought was total sales or total revenue for the product.

Now, that case covers not just Skinny Pill for Kids but also some

adult products because the Skinny Pill for Kids was never actually

marketed.

Ms. DEGETTE. Well, that is what I was just about to say. There

is over $6 million of profit that anybody got from the same Skinny

Pill for Kids, is that right?

Mr. BEALES. No, that is right. And the $6 million is resolving—

is the judgment in the entire case which involves several adult

products as well as Skinny Pill for Kids.

Ms. DEGETTE. Yes. Okay. Thank you.

Mr. GREENWOOD. The time of the gentlelady has expired.

The gentleman from Florida is recognized for 10 minutes.

Mr. STEARNS. Thank you, Mr. Chairman.

Dr. Wechsler, and I guess Dr. Hoppin, this is a question for you.

Adults take Metamucil. And they use this in many ways, but in

many ways it acts as a bulk in which it prevents them from eating.

Does that work as a dietary supplement for adults?

Ms. HOPPIN. It works very well for constipation. It does not work

for weight control.

Mr. STEARNS. It has no bearing then on weight control, in your

opinion?

Ms. HOPPIN. Except for the shaky evidence on guargun and

glucomannan and in two studies that disagree with each other in

adults where there was a minor weight loss effect.

Mr. STEARNS. What’s the difference between glucomannan and

what’s in Metamucil?

Ms. HOPPIN. Different types of vegetable fibers.

Mr. STEARNS. But there is still the husk of these fibers, so to

speak?

Ms. HOPPIN. That is correct.

Mr. STEARNS. Okay. So the glucomannan is basically the product

that adults are taking everyday?

Ms. HOPPIN. It is a different fiber.

Mr. STEARNS. Different fiber, but a fiber. So, okay—is that, Dr.

Wechsler do you agree with that, that basically adults——

Mr. WECHSLER. I have no comment. I defer to her. I defer to her.

Mr. STEARNS. Okay. Okay. So we have established that what is

in this glucomannan is pretty much the same product that adults

are taking everyday for regularity, but you indicated there is some

debate whether it could be used a dietary supplement. Is that a

fair statement of what you said?

Ms. HOPPIN. I guess so. I would be much more skeptical about

the actual use in weight loss.

Mr. STEARNS. Okay.

Ms. HOPPIN. It works very well for mild constipation.

38

Mr. STEARNS. Yes, I understand.

Mr. Beales, has anyone been hurt by the Skinny Pill or any of

these products that you are claiming false advertising, has anyone

been hurt at all? I know the Skinny Pill has not been sold to anybody. But I guess Basic Research and these other products, has

anyone been hurt?

Mr. BEALES. Well, I think in these cases, as in many of our cases,

the injury is economic. People spend money for a product that was

not going to do anything for them.

Mr. STEARNS. Okay. Okay. Of course, I see that on QVC a lot.

I mean, I see all these products—not necessarily on QVC, excuse

me. But on different advertisements for television you can just see

the list of products that they say are going to do these things.

So do you feel that you have enough law in the Federal Trade

Commission regarding deceptive and misleading advertising or do

we in Congress need to help you out with any additional legislation

to avoid these false claims dealing with children that are overweight or possibly deceptive advertising in weight loss supplements?

Mr. BEALES. We think we have ample authority to address these

problems and that we can and have done so quite successfully. For

us DSHEA changed nothing. The approach that the Commission

has always taken to claims about the efficacy of any product is to

examine whether or not there was a reasonable basis to support

that claim. And that remains the case.

Mr. STEARNS. So at this point you have sufficient legislation? You

do not need additional?

Mr. BEALES. We think we do. Yes, sir.

Mr. STEARNS. Is it the FTC’s position that even if a bottle, let

us say, the Skinny Pill for Kids was never sold by virtue of the advertising and marketing, that the owner had violated the law?

Mr. BEALES. If the company has made representations that are

not truthful or not substantiated, that is in and of itself a law violation. And ideally, in a great many cases, we would like to stop

that violation and enjoin that violation before it actually happened.

Before it actually causes injury to the public.

We did that in Skinny Pill. There is one other case that is fairly

recent where we did that as well. It was an anthrax home test kit

that actually if you had anthrax, it said you did not. And if you

did not, it said you did. We stopped sale of that product before any

sales had been made. And I think that is what we strive for. Obviously, most of the time the product has been sold and we are there

at least somewhat after the fact, but that is our goal.

Mr. STEARNS. In the case of Skinny Pill it looks like you got

there sufficiently in advance so that none of these pills were sold,

and that is I think a compliment to the Federal Trade Commission

that you did that.

Is there any indication that these pills would have gone ahead

if you had not gotten involved?

Mr. BEALES. Well, you know, that is always difficult to assess.

There was obviously a reaction from here, apart from us, that

would presumably have influenced in their plans. And I do not

really know. We thought there was enough risk of it going forward

39

that we needed an injunction that would make sure if they did go

forward, they had the evidence they needed to support the claims.

Mr. STEARNS. And I notice as the chairman pointed out going to

the website, a Skinny Pill they had advertised it and talked about

their intent to sell it.

Do you find that when you find these false advertising claims by

different companies that they are first time offenders or are these

people that maybe shutdown their corporation their proprietorship

and go somewhere else and start it up again, or are most of these

people first time offenders?

Mr. BEALES. We see both. We bring a number of cases against

first time offenders. We also see recidivists. And we see both. I

would have to look at exactly what the mix is.

Mr. STEARNS. Okay.

Mr. Chairman, I think I will yield back the balance of my time.

Mr. GREENWOOD. The Chair thanks the gentleman.

The gentlelady from Illinois, Ms. Schakowsky.

Ms. SCHAKOWSKY. What I am really concerned about here is not

only the potential adverse effect, the fact that there may be harm

as well as the fact that they do not work, but what is seemingly

the impotence of our government to do anything serious about

them. And that is what I really wanted to talk about.

In regards to the case that was brought against Edita Kaye, you

say that the fines were dropped because there is no ability to pay,

I understand that there is still income from related activities. She

is still selling her book, as I understand it.

I am trying to understand what penalties are involved. And let

me continue. On the issue of whether anything ever happens to

anyone, were there any adverse effects? My understanding is that

the Federal Trade Commission is not required to keep any adverse

effect reports, that would be required for drugs but it is not required for supplements. And let me go on and then you can answer.

We are also going to hear testimony from Mr. Mitchell Friedlander, who in 1986 was found to make material false claims regarding a number of weight loss products. But we cannot even recall those products. We can say that you cannot sell them anymore,

but I understand that the enforcement even on that is not very

stringent. He is back. He is still involved in the sale of similar

products, PediaLoss and PediaLean. So what are we doing to protect the public and particularly our children in a serious way from

access to these products? Our activities of enforcement and regulation seem pretty inadequate.

Mr. BEALES. Well, I think we have been very aggressive in this

area and that we have done a very good job of keeping products

off the market and keeping sales for products that have been on

the market as low as we could.

What we do for a case that’s initial violation as opposed to a violation of an existing order, is we do not have civil penalty authority

in those cases. We do have equitable remedies available to us. And,

in particular, we can get redress for consumers. That is typically

the total sales of the product. Total sales of a product are substantially greater than profitability on virtually any product, and that

is the amount of money that we will seek in judgment in court.

40

In cases where companies plead the inability to pay, we require

a sworn financial statements to identify the assets and the income

that might be available to satisfy that judgment. That if there are

misstatements on those sworn financial statements, our orders

typically include an avalanche clause, we call it, that would trigger

the full judgment amount.

Ms. SCHAKOWSKY. How does a Friedlander come back today?

Mr. BEALES. In any case when we get an injunction to cover future conduct, we get an injunction that we think is appropriate in

terms of—or we seek an injunction that we think is appropriate in

terms of its claims and product coverage in order to fence in future

violations.

Ultimately what injunction we get is up to a district court judge,

that was the source of the injunction in the Friedlander case in

1986. It was Federal District Court case where the judge entered

his own order.

Ms. SCHAKOWSKY. That applied to what? What was the jurisdiction? You are saying he could go somewhere else and do it and that

would be okay?

Mr. BEALES. Well, it covered—it was a narrow order in terms of

what it covered. We would have liked a broader order, but it was

not what we got from the judge. And we did not think we had a

case that would involve violation of order here. So we proceeded on

a new case in this matter. And that is always a choice we have to

make.

We seek broad enough orders to be able to cover likely future

conduct and other places where the deceptive practice might be employed. And, you know, that is certainly our goal in every case.

Ms. SCHAKOWSKY. Let me just read a quote. According to Richard

Cleland, as quoted in May 2004 ‘‘Consumer Reports,’’ who is the

Assistant Director of the FTC’s Division of Advertising Products,

‘‘There are literally hundreds, perhaps of thousands’’ he was referring to dietary supplement manufacturing companies out there,

‘‘that probably deserve scrutiny.’’ Cleland cited lack of resources for

the reasons why the FTC cannot adequately review all products.

I hear what you are saying that there are these kind of enforcement cases, but there are perhaps thousands out there that are not

even being looked at. And, when we do, here we are with a case

from 1986. Now it is 2004, same person, same product back again.

It seems to me that we need to do something to strengthen our capacity to go after these cases, no?

Mr. BEALES. Well, what we do—I mean I do not think it is a

problem of capacity to go after the cases. I mean, it is, you know,

there are ultimately resource limits on how many cases we can

bring, that is certainly right. We think we have—I mean dietary

supplements in general has been one of my top priorities. In the

time I have been at the Commission we have devote substantial resources to that effort. In the last year in mostly dietary supplements and health related claims, we have enjoined product sales

that are more than a billion dollars of products that were out there

where we have stopped it.

when we get an order, and particularly a Federal district order,

where we have an order like that we can proceed under a civil contempt theory. And in appropriate cases, we an proceed under crimiVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00048 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
41

nal contempt for violations of that order. And we can and have put

people in jail for ongoing violations or repeat conduct of those kinds

of orders.

Ms. SCHAKOWSKY. Thank you.

Mr. GREENWOOD. The gentlelady yield back?

The gentleman from New Hampshire, Mr. Bass.

Mr. BASS. Thank you, Mr. Chairman.

Mr. Beales, we have all kinds of documents here, all dated, time

lined. I am curious to know how the FTC got involved in the two

cases that we are examining here today. Was it a result of a process that you had in place whereby you could identify possible deceptive advertising or unsafe—advertising unsafe products or just

deceptive advertising and begin a process of review or did this

whole thing occur in both instances as a result of the investigative

work of either a network or a news outlet, or this subcommittee’s

staff?

Mr. BEALES. It is a little bit of both. We get our cases in a wide

variety of different ways. We get referral from other law enforcement agencies. We do pay attention to the media. We get complaints from consumers. We monitor advertising on our own, and

particularly in an area that we are interested in like dietary supplements. And any and all of those ways produce cases.

Mr. BASS. Do you feel that the FTC has the capacity—you will

never be able to monitor everything. But do you feel that you have

the capacity to catch this kind of deceptive advertising as appears

to have occurred here before, the products are actually consumed

or is it based, as you said a minute ago, based on catch as catch

can. Well, you did not say that, I am saying that; discovery of problems?

Mr. BEALES. Well, in most cases we are after the fact. In most

cases people do not pre-announce their products and they do not

start marketing them until they are ready to sell them. And so the

marketing and the sales start at more or less the same time.

There are some cases, and Skinny Pill is one of them, were people will begin the marketing before the product is there. And in

those cases we would try very hard to prevent the product from

ever being sold based on those particular claims. And in Skinny

Pill for Kids we were successful. But in most cases, the marketing

has already started, the sales have already started and what we

try to do is to stop it as quickly as we can and get money back for

consumers who may have been injured——

Mr. BASS. Is there a program in the FTC where people just review ads all day long or not?

Mr. BEALES. Not in that sense. I mean, we do not have specialists in ad review. WE do have people who review advertising on an

ongoing basis. But, I mean, we do not have a room where we lock

people up and make them watch all the advertising that is out

there.

Mr. BASS. I think that it might be a good opportunity for you to

make it clear to all the various supplement companies out there

that may think that standards for supplements are unclear, can

you state in simple and clear terms what is required of companies,

dietary supplement companies included in terms of substantiation

of any advertising or marketing claim that they made?

42

Mr. BEALES. Anybody who wants to make claims about the efficacy of a dietary supplement needs to have competent and reliable

scientific evidence to support that claim. There is an extensive

pamphlet that we have on dietary supplements that offers guidance

to industry that has got 36 different examples of ways that you can

go astray. And I think, frankly, the industry understands what the

competent and reliable scientific evidence standard means.

Certainly when there are studies that are critical of dietary supplements, they know what questions to ask. Is it a big enough sample, is it the right dosage, is it the right formulation; those are the

same questions that the industry needs to ask about studies that

support efficacy.

Mr. BASS. Does the FTC publish any kind of guidelines that potential marketers can use to make sure that their products comply

with this?

Mr. BEALES. Well, that’s what this pamphlet is.

Mr. BASS. Okay. I did not see that.

Mr. BEALES. It is ‘‘Dietary Supplements and Advertising Guide

for Industry.’’

Mr. BASS. Fine. And I believe you answered this before. You are

not recommending any changes in policy or law that would make

the job of stopping misleading or deceptive advertising in weight

loss supplements necessary, is that right?

Mr. BEALES. We are not. We think we have adequate authority

to proceed as we are.

Mr. BASS. Dr. Hoppin one question for you. First of all, I would

like to compliment you on your testimony. Just from a structural

standpoint, it was extremely clear and understandable, and I was

able to read it in about 30 seconds and understand it. And that

really helps.

My overall question for you is when you get right down to it, are

there any pills—have you found that anything works to reduce

weight that is the market today?

Ms. HOPPIN. Do you mean from the dietary supplement industry?

Mr. BASS. Anywhere?

Ms. HOPPIN. There are——

Mr. BASS. You can start with dietary supplements. You can go

to diets, if you want, I do not care. But I just want to know, you

know, seat-of-the-pants opinion that you have should consumers

believe anything that they see about pills that you can buy or diets

that you can go on that are really going to work over the long term,

or even the short term?

Ms. HOPPIN. There are not great solutions in this field yet. There

may be at some point in the future.

Weight loss surgery is one of the few effective approaches, and

that comes with some very substantial risks. And so that is not

without its problems.

I have seen nothing in the dietary supplement industry that is

suggestive that it would be useful. Certainly there are very important lifestyle factors that can be changed and must be changed,

both in individuals’ lives but also as a public commitment and a

public change, which is something that Dr. Wechsler is alluding to.

There are two pharamaceuticals on the market for long term

weight control, and both of those are very weak but they are well

43

supported by science that they have an effect on weight loss, just

a wee effect.

Mr. BASS. And these are pharamaceuticals that are available by

prescription?

Ms. HOPPIN. Correct.

Mr. BASS. I see.

Ms. HOPPIN. Yes.

Mr. BASS. All right.

Thank you, Mr. Chairman.

Mr. GREENWOOD. The Chair thanks the gentleman.

The gentleman from California, Mr. Waxman is recognized for 10

minutes.

Mr. WAXMAN. Thank you very much, Mr. Chairman. And I want

to commend you for holding this hearing on this important subject.

I want to move off the subject just a little bit, but it is connected,

and ask Dr. Wechsler about the dubious products we are confronting today that find a market when obesity among children is

a serious ongoing problem in our country. Some have suggested

that the dramatic rise in the consumption of sugar containing soft

drinks is contributing to obesity among children. What does the research say about the impact of soft drinks on calorie consumption?

Mr. WECHSLER. Well, we know that there is not single factor that

is responsible for this epidemic. There are many, many different

factors involved, and it is really impossible to identify how much

of it is due to any individual factor.

We do have several studies that indicate an association between

soft drink consumption and children becoming overweight or adults

putting on weight.

We also have a very recently published solid study that showed

a school-based program that tries to educate children to reduce

their soft drink consumption, which did lead to a reduction in the

prevalence of weight among the child.

So the evidence is still limited, but somewhat promising.

We also know that on average teenagers consume about 11 percent of their calories from full caloric soft drinks. So it seems prudent to take the advice of the dietary guidelines which state that

Americans should choose beverages and foods to moderate their intake of sugars.

Mr. WAXMAN. Are you concerned about the steep rise in soft

drink consumption by children?

Mr. WECHSLER It is one of many dietary and physical activity

factors that there are of some interest for us as possible contributors.

Mr. WAXMAN. What sort of policies have you considered to address the issue?

Mr. WECHSLER Well, my particular area is in the area of school

health, and we think it is important for schools to offer a choice

to make sure that students have an opportunity to have access to

beverage choices in the schools that perhaps have no calories or

much fewer calories.

Mr. WAXMAN. You also advocate that we have less junk food

available and some other alternatives for children in schools?

Mr. WECHSLER Well, we would have to define what we mean by

junk food. But certainly we think it is important for children to

44

have more access to appealing fruits, vegetables, whole grains, low

fat dairy products. They cannot make the healthy choices unless

the healthy choices are there.

Mr. WAXMAN. Well, how would you define junk food?

Mr. WECHSLER I do not use that term. But we do talk about as

the dietary guidelines do, about moderating our intake of saturated

fats and foods high in cholesterol and sugar.

Mr. WAXMAN. Thank you.

Well, I thought this was very helpful. I wanted to ask these questions, get them on the record as part of this overall hearing. And

I thank you for your responses.

I yield back my time, Mr. Chairman.

Mr. GREENWOOD. The gentleman from Oregon is recognized for

10 minutes.

Mr. WALDEN. Thank you, Mr. Chairman.

Mr. Beales, in your statement you mentioned that in the FTC’s

enforcement actions efforts have been made to hold not just the

manufacturer accountable, but other parties involved in deceptive

marketing. In the complaint filed against Basic Research today, did

you hold additional persons involved in marketing accountable, and

if so who and why?

Mr. BEALES. We did. We named Basic Research, A. G.

Waterhouse, Klein-Becker, USA, Nutrisport, Sauvage Dermologic

Laboratories, BAN LLC. We named Dennis Gay, the CEO of the

limited liability corporations, Daniel Mowrey who is an expert endorser and represented to be a medical doctor in some of the challenged ads, and Mitchell Friedlander, who is a marketing consultant and subject to a previous FTC order.

Mr. WALDEN. You said one of those gentleman represented himself as a medical doctor.

Mr. BEALES. We alleged that one of the advertisements represented him as a doctor, yes sir.

Mr. WALDEN. And do you know whether or not he is a doctor?

Mr. BEALES. He is not.

Mr. WALDEN. And the ad represented him that way?

Mr. BEALES. That is what we allege, yes.

Mr. WALDEN. Your allegation? Interesting.

You referenced in your early opening statement some red flags

that the FTC has shared with media outlets regarding dietary

weight loss supplements. What are some of those red flags?

Mr. BEALES. Well, there is a list of seven claims that we think

are claims that are always false and for which there is no scientific

basis. And we have asked the media to screen out advertising that

includes those claims. And that is what this publication is, it is our

media guidance to the media on claims that they should avoid.

That includes claims that a product will cause weight loss of two

pounds or more a week for a month or more without diet and exercise; claims that a product will cause substantial weight loss no

matter what or no matter how much the consumer eats; claims

that a product will cause permanent weight loss even when the

consumer stops using the product; claims that a product will block

the absorption of fat or calories to enable consumers to lose substantial weight; claims that a product will safely enable the consumer to lose more than three pounds a week for more than a

45

month; claims that a product will cause substantial weight loss for

all users. And finally, claims that a product will cause substantial

weight loss by wearing it on the body or rubbing it into the skin.

Mr. WALDEN. Ah.

Mr. BEALES. Earrings, jewelry, sandals. You have to walk for

them to work.

Mr. WALDEN. Well said.

How do you approach the proliferation of these claims on the

Internet? I am amazed every time I log onto the Internet the online

pharmacies that offer everything, the claims that come in as

emails. Are you able to track those? Do you need a national standard?

I mean, consumers are told that everything can be fixed now if

you just buy whatever the product is, and that it has all been clinical tests, and yet you are finding that is not the case. What should

we be doing about that?

Mr. BEALES. Well, the Internet and email in particular poses its

own set of challenges. I mean, the biggest challenge for us with deceptive email, and there is an enormous amount of it out there, is

finding people. The anonymity of email, unfortunately, makes it

very easy to sellers and spammers alike to hide. And that’s exactly

what they do. But I mean it’s a technological problem of finding

people.

What we have done about websites in general is we have pursued with some frequency, a strategy of surfing the web to identify

sites that make particular claims and then we will issue, if we see

claims that we think are deceptive in a particular area, we will

issue a warning letter to that website advising them of what we

think are the problems. And then we will come back again and follow-up and try to see whether or not they have made changes.

Our most recent surf was to address products, dietary supplement products that claim to be cures or treatment for SARS and

there was an earlier one that addressed anthrax cures. We got very

good cooperation in both of those cases, in both of those instances,

from websites where we brought the problems to their attention.

Mr. WALDEN. Were the owners of the websites the ones selling

the product or were they just an intermediary?

Mr. BEALES. It is probably some of each. In some cases it is an

intermediary, but you are—if you are a retailer or a catalogue seller offering products to the public, we would hold that catalogue

seller liable when we think the operator of a website is in essentially that same posture, as well as the manufacturer.

You know, in some cases we go after the manufacturer. In some

cases we go after the seller who is holding it out to the public. In

some cases we go after both.

Mr. WALDEN. See, Mr. Davies and I are working on some legislation that would, hopefully, help address this problem on the internet by establishing some national standards. But I think the only

way you can get at this problem is getting at the money. And the

way you get at the money, is you cannot buy something on the

internet generally unless you give them a credit card number. Now

maybe you can send a check in, and that is a different deal. But

I think ultimately we got to chance the money, and that is what

this is all about. These are companies exchanged in false adverVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00053 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
46

tising promoting products that in some cases either do noting or

nothing good, and then they run and hide and they change their

names and they change their claims. And they do not do anything

until a congressional hearing gets called or you show up at their

doorstep. And it needs to stop.

Mr. BEALES. I agree. And actually, what we do in almost all

these cases is follow the money. What we find, and you know to

take spam as an example, typically the spam will promote a link

to some website. We will buy the product and that is sort of the

first step in our investigation. We will look at who owns that domain name. All too often we find it is one of the many that is registered to Mr. M. Mouse who lives in Orlando or other false registration information.

We will use subpoenas to the financial institutions who are processing the credit cards to try to find out who really owns this

website and proceed to follow the money. And sometimes that is

relatively short and sweet, and sometimes it is a long and winding

road.

Mr. WALDEN. Okay. In the complaint that was filed, the one

today, is that right, with the FTC naming Dennis Gay and Dr.

Mowrey and Mitchell Friedlander individually, looking at the products listed in the complaint, and you will have to forgive my pronunciations here perhaps, but dermalin, APG, Cutting Gel, Tummy

Flattening Gel, Leptoprin, Anorex, a weight control compound and

PediaLean a weight control compound. Do any of these contain

ephedra, especially Anorex?

Can you turn on your mike? I do not think your mike is on.

Mr. BEALES. I’m sorry.

Leptoprin and Anorex at one point did contain ephedra. My understanding is that the formulations that are being sold now no

longer contain ephedra. But at one point, originally—originally

those were ephedra, caffeine and aspirin combination products Mr.

WALDEN. And do you know if the companies recalled the products

that did contain ephedra?

Mr. BEALES. I do not.

Mr. WALDEN. So they could still be out on the market on shelves?

Mr. BEALES. I do not know.

Mr. WALDEN. All right. But if they have not been recalled, I

mean I will make the supposition that they could be out on the

market today or sold——

Mr. BEALES. Well, I do not know at what point the formulation

was sold. I do not know to what extent——

Mr. WALDEN. I see.

Mr. BEALES. [continuing] they are sold through retail as opposed

to direct marketing. I mean, those factors would matter on is it still

out there.

Mr. WALDEN. All right. And the products I read off, do you—are

all these on your list of allegedly false and misleading advertising?

Mr. BEALES. What we have alleged in this case is unsubstantiated claims and that for each of those products we have identified

claims about what the product will do that we think are not supported by competent and reliable scientific evidence.

47

Mr. WALDEN. Dr. Hoppin, in your field of expertise, let us cut to

the chase here, Tummy Flattening Gel work? Are you aware of any

tummy flattening gel that actually flattens one’s tummy?

Ms. HOPPIN. Absolutely not. It’s ludicrous.

Mr. WALDEN. All right.

My time has expired, Mr. Chairman.

Thank you for your testimony today.

Mr. GREENWOOD. The Chair thanks the gentleman and recognizes himself for 10 minutes for a second round of questioning.

Dr. Hoppin, if you would look at tab 39 in that notebook there.

There is an advertisement for PediaLoss from the website. And it

says ‘‘PediaLoss is an appetite suppressant for child 6 years and

older allowing children to enjoy their favorite foods without gaining

weight. This revolutionary new formula slows the absorption of carbohydrates allowing more to be burned for energy and less to be

stored as fat.’’

So the question I have, and that is the claim for PediaLoss,

based on your medical expertise is there any basis for that claim

based on the ingredients that are listed?

Ms. HOPPIN. Not only is there no basis for the claim, it actually

is a pretty bad claim because it is also encouraging lack of dietary

changes, which I think is very damaging.

The only ingredient that in my research looked like it might have

a weight loss effect is the HCA or garcinia cambogia that’s in the

PediaLoss. And as I mentioned, there is actually another ingredient

that has a side effect of weight gain. So I think when you put multiple ingredients together, you simply cannot draw any adequate

conclusions or any support for the claim that it causes weight loss.

Mr. GREENWOOD. Okay. Dr. Wechsler, what recommendations

would you give parents who are trying to help their overweight

children? And we hope that those parents watching this hearing

will never be tempted to buy these phony pills. But what would you

recommend to them?

Mr. WECHSLER Everything that is recommended in the Dietary

Guidelines for Americans; wiser food choices and more physical activity.

Mr. GREENWOOD. In any CDC or HHS guidelines for recommendations is the use of unregulated dietary supplements for

weight loss considered an actual answer to the problem of child

obesity?

Mr. WECHSLER Not at all that I am aware of.

Mr. GREENWOOD. Okay. Dr. Hoppin, would you also turn to tab

40. And there has been some reference, and you have talked about

the Italian study. Do you believe the study provides a sound conclusion that the product in that study was safe and effective for

children?

Ms. HOPPIN. Not at all.

Mr. GREENWOOD. Tell us again why not.

Ms. HOPPIN. The three very important flaws in the study design,

one being that there is no placebo control. We all know that there

are important placebo effects of just about any medication including pain killers and certainly a weight loss medication. And so to

have no placebo control completely invalidates any results that

they got in addition to ignore the dropout, a very substantial group

48

of dropouts from the original study and simply analyze those that

were left in at the end is very inappropriate and invalidates any

findings.

Mr. GREENWOOD. Okay. And what in your opinion are the dangers of these products when they are marketed to children as

young as six?

Ms. HOPPIN. Each may have a different specific medical danger,

so I cannot really say that altogether. The only blanket statement

I can say is that we just do not know. There is no good evidence

that these have been shown to be safe.

Mr. GREENWOOD. And certainly in a case for a product like

PediaLoss where they say allow children to enjoy their favorite

foods without gaining weight. I mean, to tell a parent that it is

okay for your kid to sit there and eat a half dozen cream donuts

as long as he is taking PediaLoss and he is not going to gain

weight, I mean that it seems to be, if anyone would be crazy

enough to believe that but apparently people do, I mean that is

dangerous because it is probably going to allow the problem to get

far worse for the kids.

Ms. HOPPIN. I agree completely. It is actively undermining the

only thing that we know is really important, which is to improve

diet and lifestyle with the increased exercise.

Mr. GREENWOOD. All right. Okay.

Mr. Beales, a final question for me to you. I was very delighted

to hear that when you went after PediaLean, you went after as

Klein-Becker, an array of products. Is that correct, is that the response that you gave to the gentleman from Oregon, that you went

after——

Mr. BEALES. Yes, sir. I believe there is about six products where

we challenged claims and PediaLean is one of them.

Mr. GREENWOOD. Okay. And is that typical if you see a company

marketing an array of products, that rather than simply focus on

one that you try to scoop them all up?

Mr. BEALES. Well, typically—I mean it is a resource tradeoff and

a litigation tradeoff for us. We will try to challenge enough products to get a broad enough order to cover, but we will not examine

or challenge every product where we might have problems because

it just makes the litigation unmanageable and way too costly. So

that is the tradeoff that we make, and we make it differently in

different cases. But typically we will challenge more than just one

if there are other products that have problems, and less than everything we might——

Mr. GREENWOOD. The Chair will yield back his time.

Does the gentlelady from Colorado have questions?

Ms. DEGETTE. Yes.

Mr. GREENWOOD. She is recognized for 10 minutes.

Ms. DEGETTE. Thank you, Mr. Chairman. I was very interested

in Mr. Stearns’ line of questions, and I wanted to kind of clear up

the record because I think a misimpression may have been left in

the record, although no one in this room thinks that there is a

misimpression.

Mr. Beales, when you were talking about the FTC’s legal authority to take actions and how you did not think that that authority

49

needed to be augmented or new laws needed to be passed, you were

referring simply to the extent of the FTC’s legal authority, right?

Mr. BEALES. Yes, ma’am. That is right.

Ms. DEGETTE. And that authority is to take actions against purveyors of different products, not just herbal products or dietary

supplements, but all products when there are false claims being

made about the efficacy of those products, right?

Mr. BEALES. Yes, ma’am.

Ms. DEGETTE. the FTC does not have any authority before the

product is marketed to assess the product to see if it has any efficacy, correct?

Mr. BEALES. That is correct.

Ms. DEGETTE. You are really talking about the FTC’s authority

for false claims, right?

Mr. BEALES. Yes. Well, I mean, our authority is broader than

just false claims.

Ms. DEGETTE. Right.

Mr. BEALES. But, yes. I am only talking about the FTC’s

authority——

Ms. DEGETTE. Not, say, the FDA’s authority under DSHEA or

under any other Federal statute, right?

Mr. BEALES. Right. We do not have a position on FDA’s authority

or a recommendation.

Ms. DEGETTE. Okay. And when you were responding to Mr.

Stearns’ questions, you were not talking about authority for authorization of these supplements or any of that kind or that body

of law, were you?

Mr. BEALES. No. I understood Mr. Stearns to be asking me about

the FTC’s authority——

Ms. DEGETTE. Right. I think he was. I am just trying to clear up

the record now.

Dr. Hoppin, you probably know if, for example, a pharmaceutical

manufacturer wanted to have FDA approval of a drug designed to

give obese children, they would have to go through rigorous approval process, right?

Ms. HOPPIN. Very rigorous, very expensive approval process.

Ms. DEGETTE. Right. And do you have some sense of what the

general parameters of that process?

Ms. HOPPIN. No very accurate sense, but I am happy to give you

a broad idea. Often several thousand patients and several different

types of studies in order to get an initial indication. And then perhaps some smaller studies to get follow-up indications for a drug.

Ms. DEGETTE. Okay. Now, for dietary supplements under

DSHEA, that kind of rigorous approval process does not happen

within the FDA, correct?

Ms. HOPPIN. That’s correct.

Ms. DEGETTE. Do you know, actually does anybody on the panel

know, Dr. Wechsler you might know also, if the FDA suspects that

a dietary supplement may have some components that would be

harmful to health, do they have authority before the marketing of

those dietary supplements to stop those from going to the market

or, again, is that after the fact?

Mr. WECHSLER I am not aware of the answer to that, but I can

get that information for you.

50

[The following was received for the record:]

The Food and Drug Administration (FDA) regulates dietary supplements under

a different set of regulations than those covering ‘‘conventional’’ foods and drug

products (prescription and Over-the-Counter). Under the Dietary Supplement

Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer

is responsible for ensuring that a dietary supplement is safe before it is marketed.

FDA is responsible for taking action against any unsafe dietary supplement product

after it reaches the market. Generally, manufacturers do not need to register with

FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

FDA’s post-marketing responsibilities include monitoring safety (e.g. voluntary dietary supplement adverse event reporting) and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Two examples of recent post-marketing action taken by FDA involving dietary

supplements are ephedra and androstenedione.

First, in February 2004, the FDA issued a final rule prohibiting the sale of dietary

supplements containing ephedrine alkaloids (ephedra) because such supplements

present an unreasonable risk of illness or injury. Under the Dietary Supplement

Health and Education Act (DSHEA) of 1994, FDA may remove a dietary supplement

from the market if it presents a significant or unreasonable risk of illness or injury

when used according to its labeling or under ordinary conditions of use.

To meet the standard required by the dietary supplement law, the FDA gathered

and thoroughly reviewed evidence about ephedra’s pharmacology; peer-reviewed scientific literature on ephedra’s safety and effectiveness; adverse event reports; and

a seminal report by the RAND Corporation, an independent scientific institute. The

FDA also reviewed tens of thousands of public comments on the agency’s request

in March 2003 for information about ephedra-associated health risks.

In recent years, dietary supplements containing ephedrine alkaloids have been extensively promoted for aiding weight control and boosting sports performance and

energy. The totality of the available data showed little evidence of ephedra’s effectiveness except for modest, short-term weight loss without any clear health benefit,

while confirming that the substance raises blood pressure and otherwise stresses

the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke.

Ephedra, also called Ma huang, is one of the plants that are a source of ephedrine

alkaloids, including ephedrine and pseudoephedrine. When chemically synthesized,

ephedrine and pseudoephedrine are regulated under the Federal Food, Drug, and

Cosmetic Act as drugs. In contrast to the DSHEA-regulated dietary supplements

that contain ephedrine alkaloids, the safety and effectiveness of drug products containing ephedrine alkaloids in drug products have to be proven by the manufacturer.

The issuance of the final rule continued a process that started in June, 1997,

when FDA first issued a proposal that required a statement on dietary supplements

containing ephedrine alkaloids warning that they are hazardous and should not be

used for more than seven days. FDA also proposed to restrict the amount of ephedrine alkaloids in dietary supplements and to prevent combining ephedra with other

ingredients that have a known stimulant effect.

FDA modified this proposed rule in 2000, and in February 2003 it announced a

series of measures that included taking enforcement actions against firms making

unsubstantiated claims regarding enhanced athletic performance for their ephedracontaining products. FDA also issued warning letters to firms promoting these products as alternatives to illicit street drugs. Many firms have complied with FDA’s

warning against making such claims. FDA has also followed up with seizures and

injunctions and joint enforcement actions with the Federal Trade Commission and

the Department of Justice. More detail on these actions can be found at http://

www.fda.gov/ola/2003/dietarysupplements1028.html. As a result, most ephedra-containing dietary supplements advertised for enhanced sport performance have been

removed from the market.

Second, in March of this year, the FDA sent a letter to companies that manufacture, market, and distribute products containing androstenedione, or ‘‘andro,’’ which

acts like a steroid once it is metabolized by the body, and therefore, can pose similar

kinds of health risks as steroids. These products are generally advertised as dietary

supplements that enhance athletic performance based on their claimed anabolic and

androgenic properties to stimulate muscle growth and increase production of testosterone.

51

FDA has sent warning letters to 23 companies asking them to cease distributing

products sold as dietary supplements that contain androstenedione and warning

them that they could face enforcement actions if they do not take appropriate actions. FDA will determine whether further actions are necessary if firms refuse to

cease distribution of these products. Such actions could include seizing violative

product as well as pursuing injunctions or seeking criminal sanctions against persons who violate the law.

Ms. DEGETTE. Okay. As I understand, like with ephedra when

the FDA learned that there were side effects from ephedra, they

had the authority to order that off the market. But, again, that was

after the fact, correct? You need to answer verbally.

Mr. WECHSLER Yes.

Ms. DEGETTE. Thank you.

And this is really what I am concerned then, and I want to say

I am not opposed to DSHEA. I think that it has many benefits. But

as I said in my opening statements, I am concerned when you have

these dietary supplements simply being marketed without scientific

backing, you are always looking after the fact.

Dr. Hoppin, you are nodding your head. Is this a concern that

you share?

Ms. HOPPIN. I certainly do, because as a physician I am very uncomfortable making a decision about treatment with no information. And there is very little science in this field to allow me to

make good treatment decisions. So it would be very helpful to all

clinicians to have better information. And one of the ways that you

encourage that is by requiring it.

Ms. DEGETTE. Right. Thank you.

Thank you, Mr. Chairman. I will yield back.

Mr. WALDEN [presiding]. Mr. Beales, I wanted to ask about the

consent decree that the FTC entered into with Jonathan Barash.

Could you describe that consent decree, what it contains, what you

found, what it means?

Ms. DEGETTE. Yes, sir. The consent decree would require competent and reliable scientific evidence to substantiate weight loss

claims or appetite suppression or fat burning, or carbohydrate absorption claims for PediaLoss or any other covered product or service.

Another product that was involved in this case is a product

called Fabulously Feminine, and it would require competent and

reliable scientific evidence to substantiate claims that that product

or any other covered product or service will increase a woman’s libido, sexual desire or sexual satisfaction. It would prohibit Mr.

Barash from making unsubstantiated efficacy claims for any dietary supplement, food, drug or device and any health related service or program promoting weight loss or sexual enhancement. And

finally, it would prohibit him from misrepresenting any tests or

study.

Mr. WALDEN. So did he sign this consent decree?

Mr. BEALES. Yes, sir.

Mr. WALDEN. Okay. And he agreed to those conditions?

Mr. BEALES. Yes, sir.

Mr. WALDEN. And in effect then does that hold him responsible

for the alleged false and misleading ads for PediaLoss?

52

Mr. BEALES. Yes, it does. Yes, I mean it is—the complaint that

accompanies that order alleges his liability for those deceptive advertising.

Mr. WALDEN. Okay. So he is held responsible for those false and

misleading—he has admitted then, am I correct? I am just trying

to get this correct?

Mr. BEALES. No. He has not—I mean consent agreements are for

settlement purposes. He does not admit to liability. He does agree

to be bound by the order.

Mr. WALDEN. Okay. So he does not admit that he was responsible for alleged false and misleading statements for PediaLoss, but

he agrees never to issue such statements again, is that for a

layperson’s interpretation?

Mr. BEALES. That would be right. Yes, sir.

Mr. WALDEN. Was anyone else named in that consent decree?

Mr. BEALES. Not in the consent decree. There are other

individuals——

Mr. WALDEN. Or in the complaint?

Mr. BEALES. [continuing] named in the complaint. Yes. Vinit

Chabra, Vincent Chabra also known as Vincent Chabra was also

named.

Mr. WALDEN. Who are they?

Mr. BEALES. The Chabra Group is one of the companies that we

involved in the marketing of these products. And Vinit Chabra is

one of the principal of, I presume, of the Chabra Group.

Mr. WALDEN. Do you know if he is under Federal indictment

right now, Mr. Chabra?

Mr. BEALES. Yes, he is.

Mr. WALDEN. All right. Was Dynamic Health of Florida also? Dynamic Health?

Mr. BEALES. Dynamic Health is who we named. And I do not

know for sure whether they are under the indictment that you are

referring to.

Okay. I am sorry. I am told that the indictment names a company named called USA Prescriptions and not Chabra. So he may

not be—and I apologize for——

Mr. WALDEN. Wait a minute.

Mr. BEALES. I am told it names Chabra individually and USA

Prescriptions. I do not know about Dynamic Health of Florida.

Mr. WALDEN. Okay. Thank you.

That is all the questions I have.

Ms. Schakowsky?

Ms. SCHAKOWSKY. I have just a couple of questions. I want to get

at this issue of the health effects a little bit more.

As I understand it, the manufacturer, the distributor or even the

Federal Trade Commission if it gets letters that say there was

some physical adverse effect, there is no requirement for anybody

to get that information to the Food and Drug Administration. The

FDA is the only agency, and of course they are not here today to

testify about any of this, that potentially would have the authority

to ban the product. I understand that with ephedra, that even that

decision is now being challenged in court as to whether they have

the authority to do that. But there is no requirement for anybody

to report adverse effects, is that true?

53

Mr. BEALES. Any information that came to us about adverse effects, we would certainly bring to the FDA’s attention.

Ms. SCHAKOWSKY. But you are not required to do that, are you?

Mr. BEALES. No. I mean, there is nothing that would require the

Federal Trade Commission as an institution to do that. We do that

as a matter of course, and we do it with a great number of other

law enforcement agencies as well.

As far as I know, there is not a requirement for anyone else to

report to FDA, but that would be a question better addressed to

them than to me.

Ms. SCHAKOWSKY. Yes. The other issue which I would like to ask

doctors is that perhaps, unlike ephedra, the potential health effects

of supplements may be long term, so we are talking about liver

damage or a potential kidney damage. So the fact that there is no

pre-screening of these supplements and there is no requirement to

do the kind of testing that would determine that could be putting

our children and adults at risk from long term health effects. Is

that not true? Dr. Hoppin?

Ms. HOPPIN. I would say anything is possible. There is so little

information in this field that we simply can’t say whether we would

expect more short term effects versus long term effects, except that

in some of the relatively objective data sources that I looked

through with some ingredients in particular there were concerns

with long term use for some of the ingredients.

Ms. SCHAKOWSKY. So we just do not know.

Dr. Wechsler, did you want to comment at all?

Mr. WECHSLER No, I have nothing to add.

Ms. SCHAKOWSKY. Thank you. That is all I have. Thank you.

I yield back.

Mr. GREENWOOD. Okay. The Chair thanks the gentlelady.

And the Chair thanks very much our three witnesses for your

time and your expertise. We appreciate it. You are excused.

And the Chair will now call forward the witnesses for our second

panel and ask them to come to the table.

Ms. Edita Kaye, founder of the Skinny Pill Company; Mr. Jose

de la Rocha, Director of Quality Control at PAL Labs; Mr. Jerry

Rayman, Vice President of Sales of PAL Labs; Mr. Guy Regalado,

a former Vice President of Sales and Marketing at Dynamic Health

of Florida; Mr. Jonathan Barash, former President of DBS Labs;

Mr. Dennis Gay, President of Basic Research; Dr. Daniel Mowrey,

Director of Scientific Affairs at Basic Research; Mr. Mitchell Friedlander, Marketing Consultant, Basic Research; Dr. Nathalie

Chevreau of Nutritional Research Center, Basic Research.

And we’re going to ask Dr. Keith Ayoob, Associate Professor of

Pediatrics at Albert College of Medicine to join this panel as well.

Okay. The Chair welcomes all of our witnesses. Thank you for

being with this morning. You may have heard me say to the previous witnesses that it is the practice of this committee to take testimony under oath. And so I ask if any of you object to giving your

testimony under oath. Okay.

Also, I need to advise you that pursuant to the rules of this committee and the House you are entitled to be represented by counsel

this morning for the hearing. Are any of you represented by counsel?

54

Ms. Kaye, if you would pull the microphone toward you, bend it

down so you can talk right into it and make sure it is on. And if

you would identify your attorney.

Ms. KAYE. Mr. Andrew Herman.

Mr. GREENWOOD. And Mr. Herman, would you signify by raising

your hand. Okay.

Any other of our witnesses represented by attorney today? Okay.

Mr. de la Rocha, would you do the same thing; make sure your

microphone is forward and on and identify your attorney?

Mr. DE LA ROCHA. Jeb Hart.

Mr. GREENWOOD. Okay. And Mr. Rayman? Okay. I’m going to

ask each of the witnesses that when I ask you to identify your attorney, make sure your microphone is pulled very close to your

mouth and that it is on.

Mr. Regalado?

Mr. REGALADO. Mr. Robert Smally.

Mr. GREENWOOD. Thank you. And I see him.

Mr. Barash? Okay.

Mr. Gay?

Mr. GAY. Yes. Stefan Nagan.

Mr. GREENWOOD. Okay. And Mr. Nagan identify yourself? Thank

you, sir.

Mr. Friedlander? Not.

And Dr. Chevreau?

Ms. CHEVREAU. Yes. Mr. Nagan.

Mr. GREENWOOD. Okay. Same gentleman.

Very well. In that case——

Mr. BURBAGE. Chairman Greenwood. Mr. Chairman Greenwood,

Dr. Mowrey is represented by Richard Burbage. We are on videotape.

Mr. GREENWOOD. Oh, there is. There he is. How do you do, sir.

Thank you for joining as well.

Mr. BURBAGE. Thank you.

Mr. GREENWOOD. And you heard me, sir, indicate that we take

our testimony under oath. You object to giving your testimony

under oath?

Dr. MOWREY. No, I do not.

Mr. GREENWOOD. Even telephonically.

All right. I’m going to ask all of you rise and you, sir, if you are

able, I know you have a bad back, but raise your right hands,

please.

[Witnesses sworn.]

Mr. GREENWOOD. Okay. You are all under oath.

55

TESTIMONY OF EDITA KAYE, FOUNDER, THE SKINNY PILL

COMPANY; JOSE DE LA ROCHA, DIRECTOR, QUALITY CONTROL, PAL LABS; JERRY RAYMAN, VICE PRESIDENT OF

SALES, PAL LABS; GUY REGALADO, FORMER VICE PRESIDENT OF SALES AND MARKETING, DYNAMIC HEALTH OF

FLORIDA; JONATHAN BARASH, FORMER PRESIDENT, DBS

LABS; DENNIS GAY, PRESIDENT, BASIC RESEARCH; DANIEL

MOWREY, DIRECTOR OF SCIENTIFIC AFFAIRS, BASIC RESEARCH; MITCHELL FRIEDLANDER, MARKETING CONSULTANT, BASIC RESEARCH; NATHALIE CHEVREAU, NUTRITIONAL RESEARCH CENTER, BASIC RESEARCH; AND KEITH

AYOOB, ASSOCIATE PROFESSOR OF PEDIATRICS, ALBERT

COLLEGE OF MEDICINE

Mr. GREENWOOD. And why do we not start with Ms. Kaye. Do

you have an opening statement, ma’am?

Ms. KAYE. No, I do not.

Mr. GREENWOOD. Okay. Very well.

Mr. de la Rocha, do you have an opening statement? Okay. All

right. Now, first of all, see if your microphone is on. Okay.

TESTIMONY OF JOSE DE LA ROCHA

Mr. DE LA ROCHA. I am the Director of Quality Assurance and

Quality Control at PAL Laboratories, Inc. I have been in this position since 1999. Some time in mid- to late October 2002, Jerry

Rayman, PAL’s Vice President of Domestic Sales & Marketing, informed me that a client had asked PAL to prepare a formulation

for a proposed dietary supplement directed at obese children. It

was my understanding that the proposed product was to be for children 12 years of age and older.

The initial formulation contained primarily fibers and no

diuretics. The second formulation was for ‘‘Adults and children

more than 12 years old.’’ At Mr. Rayman’s request, I modified the

formulation. All of Ms. Kaye’s requests were given to me through

Mr. Rayman. I never personally spoke with her.

On or about November 6, 2002, Mr. Rayman informed me that

Ms. Kaye had rejected all our prior drafts and had requested that

we draft a formulation for a dietary supplement intended for children 6 years of age and older. I made the requested modifications

and forwarded them to Mr. Rayman before I left on vacation, on

or about November 27, 2002. Immediately upon my return, on December 9, 2002, Mr. Rayman asked me if there were any medical

concerns with the inclusion of Uva Ursi as an ingredient in the

Skinny Pill for Kids. I consulted the Physicians’ Desk Reference

and informed Mr. Rayman that Uva Ursi was contraindicated in

children under 12 years of age. At that point, he told me that there

was a problem with the formulation that I had proposed because

it contained Uva Ursi and his client, Ms. Kaye, had started a marketing campaign with that formulation.

On that same day, Mr. Rayman and PAL’s then president, Emilio

Ruiz, instructed me to appear on the CNN TV Show, ‘‘Connie

Chung Tonight,’’ because Ms. Kaye was going to appear on it in

order to discuss the Skinny Pill for Kids. Later that afternoon, I

appeared on the show as instructed. At this point, PAL had never

56

produced ‘‘The Skinny Pill for Kids.’’ Moreover, PAL then decided

it would not produce this product.

Thank you.

[The prepared statement of Jose de la Rocha follows:]

PREPARED STATEMENT OF JOSE DE LA ROCHA

I am the director of Quality Assurance and Quality Control at PAL Laboratories,

Inc. (‘‘PAL’’). I have been in this position since 1999. Some time in mid- to late October 2002, Jerry Rayman, PAL’s Vice President of Domestic Sales & Marketing, informed me that a client had asked PAL to prepare a formulation for a proposed dietary supplement directed at obese children. It was my understanding that the proposed product was to be for children 12 years of age and older.

The initial formulation contained primarily fibers and no diuretics. The second

formulation was for ‘‘Adults and children more than 12 years old’’ (Exhibit C). At

Mr. Rayman’s request, I modified the formulation. All of Ms. Kaye’s requests were

given to me through Mr. Rayman. I never personally spoke with her.

On or about November 6, 2002, Mr. Rayman informed me that Ms. Kaye had rejected all our prior drafts and had requested that we draft a formulation for a dietary supplement intended for children six years of age and older. I made the requested modifications and forwarded them to Mr. Rayman before I left on vacation,

on or about November 27, 2002. Immediately upon my return, on December 9, 2002,

Mr. Rayman asked me if there were any medical concerns with the inclusion of Uva

Ursi as an ingredient in the Skinny Pill for Kids. I consulted the Physicians’ Desk

Reference and informed Mr. Rayman that Uva Ursi was contraindicated in children

under twelve years of age. At that point, he told me that there was a problem with

the formulation that I had proposed because it contained Uva Ursi and his client,

Ms. Kaye, had started a marketing campaign with that formulation. On that same

day, Mr. Rayman and PAL’s then president, Emilio Ruiz, instructed me to appear

on the CNN TV Show, ‘‘Connie Chung Tonight,’’ because Ms. Kaye was going to appear on it in order to discuss the Skinny Pill for Kids. Later that afternoon, I appeared on the show as instructed. At this point, PAL had never produced ‘‘The Skinny Pill for Kids’’. Moreover, PAL then decided it would not produce this product.

Mr. GREENWOOD. Mr. Rayman, do you have an opening statement?

Mr. RAYMAN. Yes. Good afternoon.

Mr. GREENWOOD. Good afternoon. You are recognized for your

statement, sir.

TESTIMONY OF JERRY RAYMAN

Mr. RAYMAN. I have been Vice President of Domestic Sales and

working for PAL Labs since 2001.

Some time in September 2002, Edita Kaye contacted me in order

to discuss a possible proposed formulation for a dietary supplement

directed at obese children. In mid- to late October 2002, I asked

Jose Diaz de la Rocha, PAL’s Director of Quality Assurance and

Quality Control, to prepare a formulation for the proposed dietary

supplement. Mr. de la Rocha prepared a formulation for a proposed

product that was to be for children 12 years of age and older.

I was the only agent or employee of PAL that discussed the formulations for the Skinny Pill for Kids with Ms. Kaye.

On or about November 6, 2002, I informed Mr. de la Rocha that

Ms. Kaye had rejected our formulations and had requested that we

draft a formulation for a dietary supplement intended for children

6 years of age and older. She specifically requested a diuretic be

added to the formula. Edita Kaye’s email dated November 7, 2002

confirms her rejection of previous formulations and that she wanted a product for children 6 and up. Edita Kaye approved the product formulated on December 6, 2002. At this point, PAL had never

57

produced the Skinny Pill for Kids. Moreover, PAL then decided it

would not produce this product.

Mr. GREENWOOD. Thank you, sir.

Mr. Regalado, do you have an opening statement, sir?

Mr. REGALADO. No, I do not.

Mr. GREENWOOD. Okay. Mr. Barash, do you?

Mr. BARASH. No, I do not.

Mr. GREENWOOD. Mr. Gay?

Mr. GAY. I do.

Mr. GREENWOOD. Okay. You are recognized for your opening

statement, sir.

TESTIMONY OF DENNIS GAY

Mr. GAY. Chairman Greenwood, and members of the subcommittee. Thank you for this opportunity to appear today.

My name is Dennis Gay, and I am the Chief Executive Officer

of Basic Research, LLC, which is headquartered in Salt Lake City,

Utah. I am accompanied by Dr. Nathalie Chevreau, our Director of

Nutritional Research, our Director of Scientific Affairs Dr. Daniel

Mowrey, Ph.D. is with us today on a remote basis due to an acute

back ailment and possible repeat spinal surgery. Please note that

Dr. Mowrey is also currently taking prescription pain medications

which will effect his reasoning or response. Also with us is Mr.

Mitchell K. Friedlander, a marketing consultant.

Basic Research was started in 1993 with just three people, including myself. We have grown to be a company with an international presence and more than 350 hard working employees, of

whom we are very proud.

We are in the business of promoting health and well being for

the one out of six Americans who takes some type of dietary supplement every single day as well as millions more who occasionally

use supplements or other health and beauty products.

We are appearing here today voluntarily eager to participate in

this process and ready to discuss both our product PediaLean and

its associated website, weightlossfor children.com. Together these

resources assist parents in addressing holistically the health, appearance and self-esteem of overweight children, a problem which

is laminated daily in the media but about which very little is being

accomplished.

PediaLean is a dietary supplement not intended or marketed to

diagnose, treat, cure or prevent any disease. There is nothing magically or mystical about its properties. It is quite simply a highly

micronized purified form of glucomannan, a substance derived from

a tuber known as conjack root. Glucomannan is present in many

food products that we and others around the world consume on a

regular basis. In fact, humans have consumed for hundreds of

years, if not longer.

PediaLean’s use as a weight loss aid is simply a new and highly

refined application of conjack flour, a well established commodity.

To our knowledge there has never been a serious adverse health

event involving PediaLean. We are fully satisfied of its safety when

used as directly.

Conjack flour is a soluble fiber which has very low caloric content

and is not absorbed by digestion. We have provided this committee

58

with a published peer review clinical trial. That study shows that

children who took the active soluble fiber in PediaLean along with

normal caloric diet and modest exercise lost significantly more

weight than overweight children using diet and exercise alone.

I noted that PediaLean should be used as an adjunct to a program of exercise and improved diet, and we present the product in

that context. PediaLean’s advertisement specifically state that it is

not a miracle pill. In fact, basic research has made it an enormous

investment in the area of juvenile overweight, much of which is intended to benefit parents who may never purchase PediaLean. Specifically in addition to developing the product, our company invested in the following:

We selected a panel of credible and highly qualified experts to

advise our customers on strategies promoting juvenile weight loss.

We developed an interactive website for parents to use as a tool in

combating their child’s weight problems. We equipped the website

with tables, charts, calculators and exercise programs. We provided

for information exchanged between parents and our experts as well

as a bulletin board on which parents could post questions and support one another.

PediaLean was not the sole focus of our effort, and in fact was

not marketed to consumers at all until the website was completed.

At considerable expense to our company it was intended to be a

complimentary product, a useful tool to be offered along with the

website. The product was designed to assist parents in effecting behavior changes.

Basic Research fully backs all of its products including

PediaLean based solely on the satisfaction of the customer. If for

any reason the customer is not fully satisfied, he or she is invited

to return the remaining product for a full refund. It is perhaps worthy of note that PediaLean has enjoyed the highest customer satisfaction among our many products. That said, by no means do we

claim to be perfect.

When we have discovered mistakes, some of them in this course

of this inquiry, we have worked to correct them at once. As a company we strive to improve our sales daily. It is not at all uncommon for a young and small business experiencing tremendously

rapid growth to endure some pains for that growth.

We view today’s hearing as an opportunity to contribute in a constructive manner. Even recognizing that we are imperfect, we are

proud of our company, our people and our products and are happy

to join in this important dialog concerning the issue of overweight

children.

Further, Mr. Chairman, we understand that the FTC staff yesterday issued a complaint against us. But as late as this very moment, we still have not seen the complaint. From what little we

know, we do not believe allegations have merit and we intend to

contest the case vigorously. However, in the interest and the fairness in due process, I trust and hope that you will not expect this

morning to address questions bearing directly on a set of allegations we have not yet had a chance to review or analyze.

I appreciate your time, Mr. Chairman.

[The prepared statement of Dennis Gay follows:]

59

PREPARED STATEMENT OF DENNIS GAY, CHIEF EXECUTIVE OFFICER, BASIC RESEARCH

LLC

Chairman Greenwood and Members of the Subcommittee: Thank you for this opportunity to appear today. My name is Dennis Gay, and I am the Chief Executive

Officer of Basic Research LLC, which is headquartered in Salt Lake City, Utah. I

am accompanied by Dr. Nathalie Chevreau, our Director of Nutritional Research.

Our Director of Scientific Affairs, Dr. Daniel Mowrey PhD, is with us today on a

remote basis due to an acute back ailment and possible repeat spinal surgery.

Please note that Dr. Mowrey is also currently taking prescription pain medications

which may affect his reasoning and response. Also with us is Mr. Mitchell K. Friedlander, marketing consultant.

I. BASIC RESEARCH IS A RESPONSIBLE, VITAL COMPANY.

Basic Research was started in 1993, with just three people, including me. We

have grown to be a company with an international presence and more than 350

hardworking employees, of whom we are very proud.

That said, by no means do we claim to be perfect. We have made mistakes. When

we’ve discovered those mistakes—some of them in the course of this very inquiry—

we have worked to correct them at once. As a company, we strive to improve ourselves daily. It is not at all uncommon for a young and small business experiencing

tremendously rapid growth to endure some pains from that growth. We learn from

our missteps; this Subcommittee’s inquiry has in fact helped us discover ways in

which we can improve.

We are in the business of promoting health and wellbeing, particularly for the one

out of six Americans who takes some type of dietary supplement every single day,

as well as the millions more who use supplements and other health and beauty

products on a less frequent basis.

We have hundreds of thousands of satisfied repeat customers who purchase, use,

and enjoy our products. We have an excellent reputation with our customers and

retail partners. We are known for our extraordinary attention to quality in selecting

and processing our raw materials.

We have a real address, a real phone number, and a real headquarters—in short,

we are easy to find. We are appearing here today voluntarily, eager to participate

in this process and ready to discuss both our product PediaLean and its associated

website, weightlossforchildren.com.

Together, these resources assist parents in addressing holistically the health, appearance, and self-esteem of their overweight children—a problem which is lamented daily in the media, but about which very little has been accomplished.

II. PEDIALEAN IS SAFE.

PediaLean is a dietary supplement, not intended or marketed to diagnose, treat,

cure, or prevent any disease. There is nothing magical or mystical about its properties. It is, quite simply, a highly micronized and purified form of glucomannan—

a substance derived from a tuber known as konjac root. Glucomannan is present in

many food products that we and others around the world consume on a regular

basis. The substance itself may sound exotic, but humans have consumed it for hundreds of years, if not longer.

In the patented and unique form found in PediaLean, the product is neither a laxative nor a diuretic. Its use as a weight loss aid is simply a new and highly refined

application of konjac flour, a well-established commodity. To our knowledge, there

has never been a serious adverse health event involving kojac flour. We are fully

satisfied of its safety when used as directed.

III. PEDIALEAN IS EFFECTIVE

Glucomannan is a soluble fiber which has very low caloric content and is not absorbed by digestion.

Research has demonstrated that in children and adolescents, a relatively small

amount can be a very helpful adjunct to changes in diet and exercise.

The principle is simple and sound. I’m certain we will have the opportunity to

share with you more information about PediaLean’s development, safety, and efficacy as this hearing proceeds.

IV. PEDIALEAN WAS INTENDED AS PART OF A GREATER WHOLE.

I noted that PediaLean should be used as an adjunct to a program of exercise and

improved diet, and we present the product in that context. You will note that in

PediaLean’s advertisements, it is specifically stated that this is NOT a ‘‘Miracle

60

Pill.’’ In fact, Basic Research has made an enormous investment in the area of juvenile overweight, much of which can easily benefit parents who never purchase

PediaLean. Specifically, in addition to developing the product, our company invested

in the following:

• We selected a panel of credible and highly qualified experts to advise us and our

customers on strategies for dealing with juvenile weight loss.

• We developed an interactive website for parents to use as a tool in combating

their child’s weight problems.

• We equipped the website with tables, charts, calculators, and exercise programs

to provide parents with comprehensive assistance.

• We provided for information exchange between parents and our experts, as well

as a bulletin board on which parents could post questions and support each

other by sharing experiences.

PediaLean was not the sole focus of our effort, and in fact was not marketed to

consumers at all until our website was complete—at considerable expense to our

company. It was intended to be a complementary product—a useful tool to be offered

along with the website. The product was designed to assist parents in effecting

these changes.

V. WE BACK OUR PRODUCTS FULLY AND CREDIBLY.

Basic Research fully backs all of its products including PediaLean, based solely

on the satisfaction of the customer. If for any reason the consumer is not fully satisfied, he or she is invited to return the remaining product for a full refund. It is perhaps worthy of note that PediaLean has enjoyed the highest consumer satisfaction

among our many products.

Once again, we fully understand that we have room to improve as a company. We

are grateful for the process of self-assessment this inquiry has brought about.

We view today’s hearing as an opportunity to contribute in a constructive manner.

Even recognizing our occasional mistakes, we are proud of our company, our people,

and our products, and are happy to join in this important dialogue concerning the

proper regulation of dietary supplements. Thank you, Mr. Chairman.

Mr. GREENWOOD. Thank you, Mr. Gay.

Mr. Friedlander, do you have an opening statement?

Dr. Chevreau, do you?

Ms. CHEVREAU. No, I don’t.

Mr. GREENWOOD. Okay. Dr. Ayoob, we are glad that you—oh, I’m

sorry. I’m sorry. Pardon me. Dr. Mowrey, do you have an opening

statement, sir?

Dr. MOWREY. No, I do not.

Mr. GREENWOOD. Okay. Now, Mr. Ayoob.

TESTIMONY OF KEITH AYOOB

Mr. AYOOB. Actually, it is doctor.

Good Morning and thank you for the opportunity to speak with

you on a topic of such concern to me: children’s health.

My name is Dr. Keith Ayoob and I do thank you for the opportunity to testify. I hope you will find my comments useful. First,

a summary about my credentials and background: I am an associate professor of pediatrics at the Albert Einstein College of Medicine in New York and the Director of the Nutrition Clinic at the

Rose F. Kennedy Children’s Evaluation and Rehabilitation Center

there.

For 9 years, I served as a volunteer media spokesperson for the

American Dietetic Association, and gave over 800 interviews for

print, television, radio and the Internet on timely nutrition topics

in the media.

I have been on the Board of Editors of the Journal of the American Dietetic Association for approximately 4 years and was an outside reviewer for the Journal for 12 years prior and I am very faVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00068 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
61

miliar with the evaluation of scientific research. During this time,

I have reviewed hundreds of proposed articles for publication in the

Journal about clinical trials conducted in the field of diet and

health research.

I am also on the advisory board of the Children’s Advertising Review Unit of the National Advertising Review Board. In this capacity, I advise the Unit about the accuracy and appropriateness of

food advertising claims for foods targeted for consumption by children.

I first learned about the Skinny Pill for Kids back in early December 2002, when Barbara Hoffman, a reporter with The New

York Post, asked if I’d heard of a new diet pill being marketed to

children 6 to 12 years old. At first I thought she’d misinterpreted

a press release, because as a pediatric nutritionist, I could not

imagine someone coming up with a pill for young children that

promised healthy, safe and effective weight loss. But she referred

me to a website called www.skinny.com that had all the details

about these supplements. I reviewed the website and was both

angry and disgusted by the information contained on the website

about the Skinny Pill for Kids. The information was scientifically

baseless, blatantly exploitative, and potentially very harmful to

children.

When Ms. Hoffman’s story ran in the Post on December 6, 2002,

the television media picked it up and I was invited to debate the

marketer of the pills, Edita Kaye, on NBC’s ‘‘The Today Show’’ the

following Monday, approximately the same time the product was to

begin shipment. I said on that program, and I will reiterate it

today, the Skinny Pill for Kids, as well as these other dietary supplements for children that the committee has looked at are ‘‘junk

science.’’

Before I say a few words about the Skinny Pill for Kids, I would

like to note that I was extremely relieved that, due the pressure

put upon Edita Kaye, the creator and marketer of the pill, by the

medical community and the media, the Pill was pulled from the

market before any child had actually taken it. Further, I also felt

vindicated in my efforts to counteract Ms. Kaye’s public claims

about the product on national television. And now, I’d like to summarize some concerns I had about the ingredients in the product,

as well as the marketing claims Ms. Kaye made.

There is no scientific basis for any of the claims made about the

Skinny Pill for Kids on Ms. Kaye’s website. There is however, scientific evidence against many of the claims she made. The pills

were a concoction of a few vitamins and minerals, along with fiber

and herbs. A few examples of false claims, in my opinion:

‘‘It contains a proprietary blend of safe natural vitamins, minerals, and fat-fighting nutrients’’ In my opinion, these pills are not

safe. They have never been proven safe. They contain diuretic

herbs that should never be given to children.

‘‘It is formulated to help children reduce their risk of obesity-related diseases such as heart disease, high blood pressure, and diabetes.’’ None of the ingredients here will help reduce risk of these

diseases. Children with these diseases should be treated by physicians, not Ms. Kaye, and desperate parents should not be given a

false sense of confidence that this pill is helping their children in

62

any way because it cannot help them. What it can do is to delay

consumers from seeking real treatments and healthier lifestyles to

combat obesity.

‘‘It offers very real weight-loss help through supplements that

metabolically assist children to burn more fat pounds and inches,

block new fat deposits and help regulate insulin levels to mitigate

fat factors.’’

In my opinion, all of these claims are absolutely false and without evidence to support them. No studies have been shown to indicate that these claims are true for the ingredients in the Skinny

Pill for Kids.

As for the vitamins, the amounts of niacin, folate, and vitamin

B12 in the Skinny Pill for Kids, can be obtained far more economically in any standard, over-the-counter multivitamin supplement

that would also contain many other vitamins and minerals. There

is no need to take separate amounts of them. As for the herbal ingredients, she makes false, unproven claims about many of them,

for example: Uva ursi: ‘‘Acts as a diuretic and helps diabetes. It has

also been shown to strengthen heart muscle.’’ She’s only right

about it being a diuretic herb, and that’s a huge concern. The Physicians’ Desk Reference for Herbs, which is the standard reference

text well accepted by health professionals, has stated with scientific

backing that uva ursi was contraindicated for children under the

age of 12 years, the very population of these pills, as it has been

associated with liver damage.

Glucomannan: She says that ‘‘This substance actually picks up

and removes fat from the colon wall. It is good for obesity because

one of its primary functions is the removal of fat. It has been recognized for normalizing blood sugar and it expands up to sixty times

its own weight and, in so doing, helps maintain a feeling of fullness

and curbs appetite.’’ Glucomannan is just a food thickener that has

never been proven safe or effective for weight loss.

Buchu Leaf: ‘‘Aids in controlling diabetes and digestive disorders

and fluid retention.’’ For weight loss, it has never been shown to

be effective. It can however, function as a diuretic and should not

be given to children.

Juniper Berry: ‘‘Helps regulate blood sugar and aids in fluid retention.’’ This is another diuretic herb. Children who need diuretics

should be under the care of a physician, not Ms. Kaye.

One statement on her website was true regarding glucomannan:

‘‘It is important to drink a large glass of water with this ingredient,

as it can lodge in the throat and expand thereby causing breathing

problems.’’ This should be an indicator to the committee that this

is an inappropriate supplement to give to children, especially those

6 years of age.

The issue is simple: the Skinny Pill for Kids should never have

been even thought about for children, let alone marketed to them.

Since fiber pills have not been shown to have much effect on

weight loss, I am also concerned about another supplement for

overweight children called PediaLean. Again, there is no scientific

basis for the claims about this product, although the marketers,

Klein-Becker, seem to want you to believe otherwise. I have reviewed the website for the product, www.pedialean.com, and have

63

concerns about their purported ‘‘clinical evidence’’ for safety and efficacy.

These are a few comments I have about the cited ‘‘clinical evidence’’ that PediaLean helps children lose weight. First, the study

was not published in any journal I have ever heard of. I have been

on the Board of Editors of the Journal of the American Dietetic Association for several years. I read and review numerous manuscripts, good and bad, all the time. I would never have had the

chance to review this one however, because this would never have

made it to my desk. The associate editor or the editor-in-chief

would have screened this and rejected it out of hand, and I am very

grateful that they do not waste my time with this type of study.

Second, the study was a single study, done in the early 90’s on

a small number of children. many of whom dropped out. The copy

I received was translated from Italian and the full name of the

journal was not revealed, only an abbreviation. This is highly unusual for a translated study that being used to make specific

claims, as it limits the ability of the reader to verify the publication.

Third, there are not even any units assigned to the numbers associated with the claimed weight loss. I have no idea if they are

indicating pounds or kilos when they refer to weight loss.

And finally, the study has never been replicated. It has no controls. Without controls, I have no idea if the results were due to

the pills, or correction it has no valid controls or placebo controls.

Without controls, I have no idea if the results were due to the pills

or to the fact that children had to take two pills with a large glass

of water before meals. Every researcher knows that you need valid

controls to make your study meaningful. This is research 101.

When you do not include control groups, it suggests that you may

not want the reader to know the results. This study suggests that

the researchers didn’t want the results to be accurate. They just

wanted them Tuesday, so to speak.

For a company to rely on a study conducted in Italy over 10

years ago, of such poor quality and questionable conclusions, to

support their marketing statements that a product is safe and effective for a 6 year old, is disturbing.

The makers of Pedialoss also developed a pill with ingredients

that promise but cannot deliver weight loss. The ingredients in

Pedialoss, inulin and lecithin, have never been scientifically shown

to aid in weight loss. Once again, this is a sham product that cannot deliver what it promises because its claims are baseless and yet

another example of junk science.

These supplements are also expensive. The Skinny Pill for Kids

was to cost $40 per month. PediaLean cost almost $80 a month. I

would rather see parents put their hard earned money toward buying healthy food and taking their children for healthy physical activities.

Childhood overweight is a serious issue. It needs a serious solution. True lasting results to the obesity problems of children and

adults are not going to be found in an over-the-counter supplement.

If they are, then a body of sound, scientific evidence should come

before the claims. It is completely inappropriate to allow people to

market ‘‘supplements’’ with no evidence that they work, and then

64

wait until there is a complaint or even harm, before they are investigated.

The loopholes in the laws that permit these types of supplements

to be marketed should be closed. They should be closed and nailed

shut. My only regret in the judgment imposed on Ms. Kaye is that

the multi-million dollar fines attached to their judgment were forgiven for her lack of ability to pay. That makes for a rather weak

judgment. Only if she, and others of her ilk, were hit in their pocketbooks, where they’d feel it most, and were held responsible for

paying back the fine, even over the course of many years, might

they think twice about marketing junk supplements to vulnerable

children and their families.

Thank you for you time and I am prepared to answer any questions you may have on these or other matters.

[The prepared statement of Keith Ayoob follows:]

PREPARED STATEMENT OF KEITH-THOMAS AYOOB

Good Morning and thank you for the opportunity to speak with you on a topic

of such concern to me: children’s health.

My name is Dr. Keith Ayoob and I thank you for the opportunity to testify. I hope

you will find my comments useful. First, a summary about my credentials and background:

• I am an associate professor of pediatrics at the Albert Einstein College of Medicine in New York and the Director of the Nutrition Clinic at the Rose F. Kennedy Children’s Evaluation and Rehabilitation Center there. • For nine years, I served as a volunteer media spokesperson for the American Dietetic Association, and gave over 800 interviews for print, television, radio and

the Internet on timely nutrition topics in the media. • I have been on the Board of Editors of the Journal of the American Dietetic Association for four years and was an outside reviewer for the Journal for 12 years

prior and I am very familiar with the evaluation of scientific research. During

this time, I have reviewed hundreds of proposed articles for publication in the

Journal about clinical trials conducted in the field of diet and health research.

• I am also on the advisory board of the Children’s Advertising Review Unit of the

National Advertising Review Board. In this capacity, I advise the Unit about

the accuracy and appropriateness of food advertising claims for foods targeted

for consumption by children.

I first learned about the ‘‘Skinny Pill for Kids’’ back in early December 2002, when

Barbara Hoffman, a reporter with The New York Post, asked if I’d heard of a new

diet pill being marketed to children 6-12 years old. At first I thought she’d misinterpreted a press release—because as a pediatric nutritionist, I could not imagine

someone coming up with a pill for young children that promised healthy, safe and

effective weight loss—but she referred me to a web site called ‘‘www.skinny.com’’

that had all the details about these supplements. I reviewed the website and was

both angry and disgusted by the information contained on the website about the

‘‘Skinny Pill for Kids.’’ The information was scientifically baseless, blatantly exploitative, and potentially very harmful to children. When Ms. Hoffman’s story ran in

the Post on December 6, 2002, the television media picked it up and I was invited

to debate the marketer of the pills, Edita Kaye, on NBC’s ‘‘The Today Show’’ the

following Monday, approximately the same time the product was to begin shipment.

I said on that program, and I will reiterate it today, the Skinny Pill for Kids, as

well as these other dietary supplements for children that the Committee has looked

at are ‘‘junk science.’’

Before I say a few words about the Skinny Pill for Kids, I would like to note that

I was extremely relieved that, due the pressure put upon Edita Kaye (the creator

and marketer of the pill) by the medical community and the media, the Pill was

pulled from the market before any child had actually taken it. Further, I also felt

vindicated in my efforts to counteract Ms. Kaye’s public claims about the product

on national television. And now, I’d like to summarize some concerns I had about

the ingredients in the product, as well as the marketing claims Ms. Kaye made:

• There is no scientific basis for ANY of the claims made about the Skinny Pill for

Kids on Ms. Kaye’s website. There is however, scientific evidence AGAINST

many of the claims she made. The pills were a concoction of a few vitamins and

65

minerals, along with fiber and herbs. A few examples of false claims, in my

opinion:

• ‘‘It contains a proprietary blend of safe natural vitamins, minerals, and fatfighting nutrients . . .’’In my opinion, these pills are not safe. They have never

been proven safe. They contain diuretic herbs that should never be given to

children.

• ‘‘It is formulated . . . to help children reduce their risk of obesity-related diseases such as heart disease, high blood pressure, and diabetes.’’ None of the

ingredients here will help reduce risk of these diseases. Children with these

diseases should be treated by physicians, not Ms. Kaye and desperate parents

should not be given a false sense of confidence that this pill is helping their

children in any way because it cannot help them. What it can do is to delay

consumers from seeking real treatments and healthier lifestyles to combat

obesity.

• ‘‘It offers very real weight-loss help through supplements that metabolically

assist children to burn more fat pounds and inches, block new fat deposits

and help regulate insulin levels to mitigate fat factors.’’ In my opinion, all of

these claims are absolutely false and without evidence to support them. No

studies have been shown to indicate that these claims are true for the ingredients in the Skinny Pill for Kids.

As for the vitamins, the amounts of niacin, folate, and vitamin B12 in the Skinny

Pill for Kids, can be obtained far more economically in any standard, over-thecounter multivitamin supplement that would also contain many other vitamins and

minerals. There is no need to take separate amounts of them. As for the herbal ingredients, she makes false, unproven claims about many of them, for example:

• Uva ursi: ‘‘Acts as a diuretic and helps diabetes. It has also been shown to

strengthen heart muscle.’’ She’s only right about it being a diuretic herb, and

that’s a huge concern. The Physicians’ Desk Reference for Herbs (a standard

reference text, well accepted by health professionals) stated, with scientific

backing, that uva ursi was CONTRAINDICATED for children under the age of

12 years—the very target population of these pills—as it has been associated

with liver damage.

• Glucommanan: ‘‘This substance actually picks up and removes fat from the colon

wall. It is good...for obesity because one of its primary functions is the removal

of fat. It has been recognized for normalizing blood sugar and it expands up to

sixty times its own weight and, in so doing, helps maintain a feeling of fullness

and curbs appetite.’’ Glucommanan is just a food thickener that has never been

proven safe or effective for weight loss.

• Buchu Leaf: ‘‘Aids in controlling diabetes and digestive disorders and fluid retention.’’ For weight loss, it has never been shown to be effective. It can however,

function as a diuretic and should not be given to children.

• Juniper Berry: ‘‘Helps regulate blood sugar and aids in fluid retention.’’ This is

another diuretic herb. Children who need diuretics should be under the care of

a physician, not Ms. Kaye.

One statement on her website was true regarding glucommanan: ‘‘It is important

to drink a large glass of water with this ingredient, as it can lodge in the throat

and expand thereby causing breathing problems.’’ This should be an indicator to the

Committee that this is an inappropriate supplement to give to children, especially

those 6 years of age. The issue is simple: the Skinny Pill for Kids should never have

been even thought about for children, let alone marketed to them.

Since fiber pills have not been shown to have much effect on weight loss, I am

also concerned about another supplement for overweight children called PediaLean.

Again, there is no scientific basis for the claims about this product, although the

marketers, Klein-Becker, seem to want you to believe otherwise. I have reviewed the

website for the product, www.pedialean.com, and have concerns about their purported ‘‘clinical evidence’’ for safety and efficacy.

These are a few comments I have about the cited ‘‘clinical evidence’’ that

PediaLean helps children lose weight:

• The study was not published in any journal I have ever heard of. I have been on

the Board of Editors of the Journal of the American Dietetic Association for several years. I read and review numerous manuscripts, good and bad, all the time.

I would never have had the chance to review this one however, because this

would never have made it to my desk. The associate editor or the editor-in-chief

would have screened this and rejected it out of hand and I am very grateful

that they do not waste my time with this type of study.

• This study was a single study, done in the early 90’s on a small number of children. The copy I received was translated from Italian and the full name of the

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journal was not revealed, only an abbreviation. This is highly unusual for a

translated study that being used to make specific claims, as it limits the ability

of the reader to verify the publication.

• There are not even any units assigned to the numbers associated with the claimed

weight loss. I have no idea if they are indicating pounds or kilos when they

refer to weight loss.

• The study has never been replicated. It has no controls. Without controls, I have

no idea if the results were due to the pills or to the fact that children had to

take two pills with a large glass of water before meals. Every researcher knows

you need controls to make your study meaningful. This is research 101. When

you do not include control groups, it suggests that you may not want the reader

to know the results. This is a study that suggests that the researchers didn’t

want the results to be accurate. They just wanted them Tuesday, so to speak.

For a company to rely on a study conducted in Italy over ten years ago, of such

poor quality and questionable conclusions, to support their marketing statements

that a product is safe and effective for a 6 year old, is disturbing.

The makers of Pedialoss also developed a pill with ingredients that promise but

cannot deliver weight loss. The ingredients in Pedialoss, inulin and lecithin, have

never been scientifically shown to aid in weight loss. Once again, this is a sham

product that cannot deliver what it promises because its claims are baseless and yet

another example of junk science.

Products like these should never exist. Even if they cause no harm that is reported, they serve only to exploit children and their caregivers by fostering the illusion that these products work, perhaps preventing them from seeking real solutions.

These supplements are also expensive. The Skinny Pill for Kids were to cost

$40.00 per month. PediaLean cost almost $80.00 a month. I’d rather see parents put

their hard earned money towards buying healthy food and taking their children for

healthy physical activities. Childhood overweight is a serious issue. It needs a serious solution. True lasting results to the obesity problems of children and adults are

not going to be found in over-the-counter supplements. If they are, then a body of

sound, scientific evidence should come before the claims. It is completely inappropriate to allow people to market ‘‘supplements’’ with no evidence that they work,

and then wait until there is a complaint or even harm, before they are investigated.

The loopholes in the laws that permit these types of supplements to be marketed

should be closed. They should be closed and nailed shut. My only regret in the judgment imposed on Ms. Kaye is that the multi-million dollar fines attached to the

judgment were forgiven for her lack of ability to pay. That makes for a rather weak

judgment. Only if she, and others of her ilk, were hit in their pocketbooks, where

they’d feel it most, and were held responsible for paying back the fine, even over

the course of many years, might they think twice about marketing junk supplements to vulnerable children and their families.

Thank you for you time and I am prepared to answer any questions you may have

on these or other matters.

Mr. GREENWOOD. Thank you, Mr. Ayoob. We appreciate your

joining us.

The Chair recognizes himself for 10 minutes for some questioning. I am going to start with you, Ms. Kaye.

And I can well imagine that you are thinking to yourself I never

sold one of these pills, why is everyone picking on me. But here is

the issue: Somebody else market this same market in the same

way tomorrow with the same concerns, raising the same concerns.

And so what we are here to do is to understand how this process

works so that we can act in the best interests of the American public.

So let me ask you this: In December 2002 you appeared on ‘‘The

Today Show’’ and other nationally televised shows promoting a

product you called Skinny Pill for Kids. The question is what scientific research did you do on the ingredients in the product before

you decided to market it to kids?

Ms. KAYE. I did due diligence, and I thought I acted in a prudent

manner by finding a facility, a lab, pharmaceutical company to

manufacture such a product and develop a formula that was safe

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and effective. My overall concern always was and continues to be

the problem of obesity in children, which is an ongoing problem

and appears to be getting worse.

As soon as I realized that there were concerns expressed about

the formula that was developed by this company on my behalf, I

immediately stopped the program and that is really what happened.

Mr. GREENWOOD. Well, were you driving the company to come up

with a formula? Your response would indicate that you simply, I

do not know whether your randomly chose this company or how

you chose this particular company based on its experience or its expertise or research that it had done that enabled you to have confidence that it would be able to do what apparently no one has ever

been able to do, according to all of our witnesses, and that is come

up with a pill that would actually help children to lose weight.

What made you think this company could do that for you, PAL

Labs?

Ms. KAYE. Well, PAL Labs assured me that they were an FDA

approved facility, that they also manufactured OTC products and

that they had high standards of quality control. And, I felt that

they were sound, that what they said was in fact correct.

Mr. GREENWOOD. Well, you hold yourself out to be America’s favorite nutritionist. Wouldn’t it make sense that as a nutritionist

with this self-proclaimed crusade to help children, that you would

have done some research, you would have looked into what kind of

ingredients might work rather than turning to PAL Labs and say

you come up with something?

Ms. KAYE. Sir, I am not a chemist or a formulator.

Mr. GREENWOOD. You’re a nutritionist?

Ms. KAYE. Hence, I searched for a company that could develop

a formula.

Mr. GREENWOOD. And what made you think this company could

do that?

Ms. KAYE. For the reasons I just cited.

Mr. GREENWOOD. Well, you said they are FDA approved. That

simply means that when they manufacture a product, in this case

one that does not have to be approved by FDA, the only thing that

matters is whether they’re using hygienically correct approaches

and there is no chance of a danger that is outside of the ingredients. That does not indicate that they have the tiniest bit of knowledge about what ingredients would actually be beneficial to people.

Did you ask them if they had ever——

Ms. KAYE. They——

Mr. GREENWOOD. Did you ask them if they had any experience

whatsoever in producing compounds that would help anyone lose

weight, particularly children?

Ms. KAYE. They had told me, and yes they did also in addition

to their OTC work, that they did develop formulas for nutritional

supplements. That, in addition to the fact that they were FDA certified, that they had a formulator——

Mr. GREENWOOD. You do not know or you are unaware of the fact

that nutritional supplements are not required to be able to demonstrate effectiveness before they are marketed?

Ms. KAYE. I am sorry, I do not understand.

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Mr. GREENWOOD. Nutritional supplements pursuant to Federal

law, makers of nutritional supplements are not required to demonstrate that they have any effectiveness whatsoever. Are you

aware of that?

Ms. KAYE. I am really not clear on what you are asking me.

Mr. GREENWOOD. Okay.

Ms. KAYE. I am not sure.

Mr. GREENWOOD. Okay. Do you know the difference between an

FDA process where you have to take a pharmaceutical product and

you have to go to the Food and Drug Administration and demonstrate that you have clinical trials that have demonstrated the

effectiveness and the safety of this product. And that after a very

long and sophisticated process, the FDA has to make a decision

whether the stuff actually works and whether it actually hurts people, whereas in the nutritional supplement field no such requirement exists. So therefore, PAL Labs could put peanut butter in a

capsule and call it a diet pill and you would come along and say,

well you are FDA approved, I guess you must be the experts. Do

you understand that?

Ms. KAYE. I think so. But I trusted their formulators that they

were a company that——

Mr. GREENWOOD. All right. I would like you to turn to that notebook right there to tab 13. Could you open that up to Tab 13, Ms.

Kaye? Now there you will find an email that you sent to Jerry

Rayman on the subject of Skinny Kids on November 7, 2002. Do

you see that?

Ms. KAYE. Yes, sir, I do.

Mr. GREENWOOD. Okay. Would you go down to No. 3 and would

you—what was your intent in sending this email?

What I would like you to do, it is tab 13 for the benefit of the

members of the committee. Would you just read for us beginning

with No. 3 where it says ‘‘This is a formula,’’ and read to the bottom of the page? Out loud, please.

Ms. KAYE. Yes. ‘‘This is a formula which was clearly stated to be

for children. What you have here in all your disclaimers is 12 years

plus. I might just as well put a different label on my far superior

existing Skinny Pill formula and sell it to 12 year old children and

plus. I need a formula for children 6 years old and up and that is

what we have been talking about for months.’’

Mr. GREENWOOD. Keep going.

Ms. KAYE. ‘‘Well I now have run out of time and I need this formula with price quotes by the end of business today, so please provide the following: A Skinny capsule: 2. For children 6 years of age

and older to be taken three times a day, two is better but I can

live with three that is also a thermic formula, and I need to be able

to say on the label that this is for children 6 years old and up.

Jerry, if I cannot get this, I am going to have to go to another formulator. I have an entire campaign built around the belief that you

could deliver this type of product for me. I do not want a me too

fiber formula like PediaLean, I want something that no one else

out there has and I need it by today. I do not mean to sound difficult, but I am very disappointed. Edita.’’

69

Mr. GREENWOOD. So you are clearly involved in the formulation

of this product. You were telling them what you want, is that

right? Could we not interpret that from your email?

Ms. KAYE. I was telling them that I would like them to come up

with a formula. I was not involved in that——

Mr. GREENWOOD. What is a thermic formula? You told them you

want a thermic formula, what does that mean?

Ms. KAYE. Something that helps with energy, that is what I had

meant.

Mr. GREENWOOD. Okay. And was there any indication that they

had ever done that before? Did you believe that they had ever been

able to come up with a thermic formula before?

Ms. KAYE. Well, I believed that they had developed formulas for

nutritional supplements for weight loss, that they were as they had

told me FDA approved, that they had formulators and that they

were confident that they could develop such a formula for children.

That was what I thought when we had conversations.

Mr. GREENWOOD. Okay. Let me ask Mr. Rayman, when did Edita

Kaye first contact PAL Labs about formulating a diet pill for kids?

Mr. RAYMAN. I do not remember the exact date.

Mr. GREENWOOD. Pull that microphone closer to you, please.

Mr. RAYMAN. I do not remember the exact day, but probably

sometime in that September/October prior to the actual——

Mr. GREENWOOD. Okay. Did she provide any instructions at that

time about the ingredients she wanted in the pills?

Mr. RAYMAN. We talked about a fiber pill. She talked about having a diuretic to get rid of the fiber in the system. And I conveyed

that information to——

Mr. GREENWOOD. You specifically remember her asking for a diuretic?

Mr. RAYMAN. Yes, I do.

Mr. GREENWOOD. Did she reject your fiber formulation?

Mr. RAYMAN. She rejected the first formulation, as it was apparent in that email that she sent to us.

Mr. GREENWOOD. Okay. And what was your sense of why she did

that?

Mr. RAYMAN. Based on what she said in the email is that she

thought that it wasn’t different enough from anything else that is

out there.

Mr. GREENWOOD. In any of these discussions did Ms. Kaye ever

express any concerns about the safety of the product for 6 year old

children?

Mr. RAYMAN. No, she did not.

Mr. GREENWOOD. Okay. My time has expired.

The gentlelady from Colorado.

Ms. DEGETTE. Thank you very much, Mr. Chairman.

Following up, Mr. Rayman, your title is Vice President of Domestic Sales and Marketing, correct?

Mr. RAYMAN. That is correct.

Ms. DEGETTE. Do you have any kind of a degree in biology or are

you a researcher?

Mr. RAYMAN. No, I am not.

Ms. DEGETTE. You are not in charge of formulating the products?

Mr. RAYMAN. No, I am not.

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Ms. DEGETTE. Now, to your knowledge has PAL Laboratories

ever formulated weight loss products before?

Mr. RAYMAN. We have made products that people may have marketed as weight loss, but by their direction. They tell us what ingredients they want us to put into a pill, and we put it into a pill.

Ms. DEGETTE. Okay. But Ms. Kaye did not tell you w hat ingredients to put in there, she simply said she wanted something that

was not just a fiber pill, right? And according to your written and

verbal testimony, she said she wanted something that was a diuretic, right?

Mr. RAYMAN. She wanted a diuretic added to her fiber product.

Ms. DEGETTE. Now were you her primary contact at PAL Labs?

Mr. RAYMAN. Yes.

Ms. DEGETTE. And what did you do when she came to you and

asked you for this product?

Mr. RAYMAN. I went to Jose de la Rocha and told him——

Ms. DEGETTE. And you told Mr. de la Rocha what she wanted,

right?

Mr. RAYMAN. That is correct.

Ms. DEGETTE. Mr. de la Rocha, what did you do then when you

learned of this request of Ms. Kaye’s through Mr. Rayman?

Mr. DE LA ROCHA. Yes. The first formula was——

Ms. DEGETTE. Could you hold that microphone up to your mouth.

Thank you.

Mr. DE LA ROCHA. Sorry.

The first formula was fiber formula for children 12 and over.

Ms. DEGETTE. That was what you understood that Ms. Kaye had

requested?

Mr. DE LA ROCHA. I understand that it was for—in my mind I

never thought for children 12 and—six and over.

Ms. DEGETTE. Now, have you ever developed dietary supplements before?

Mr. DE LA ROCHA. Yes, ma’am.

Ms. DEGETTE. What types of dietary supplements?

Mr. DE LA ROCHA. Vitamin C, vitamin E, simple formulas.

Ms. DEGETTE. And what is your educational background?

Mr. DE LA ROCHA. I’m a chemical engineer. I’m a doctor in technical science.

Ms. DEGETTE. A doctor of?

Mr. DE LA ROCHA. Technical science, that is like a similar or

Ph.D. or a master degree here in the States.

Ms. DEGETTE. And is your background in——

Mr. DE LA ROCHA. Chemical engineer.

Ms. DEGETTE. Is in development of dietary supplements?

Mr. DE LA ROCHA. No, ma’am.

Ms. DEGETTE. No. Okay. How long have you been involved in developing dietary supplements?

Mr. DE LA ROCHA. Normally I am not a formulator. I am a quality control guy.

Ms. DEGETTE. Oh, you’re a quality—okay. Do you have people at

PAL Labs who are in charge of developing the——

Mr. DE LA ROCHA. Right now, yes. Right now in this moment.

Ms. DEGETTE. Right now. But back with this product did you

have people in charge of developing some——

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Mr. DE LA ROCHA. We got a person in charge of developing, but

that person was not in the company in that moment.

Ms. DEGETTE. Right. So the answer is no?

Mr. DE LA ROCHA. No.

Ms. DEGETTE. Thank you.

Now, so you were in charge of—who asked you to be in charge

of developing?

Mr. DE LA ROCHA. Mr. Rayman.

Ms. DEGETTE. Mr. Rayman. Okay. And so he said Ms. Kaye

wants this weight loss product for children, and he told you to develop the formula, is that right?

Mr. DE LA ROCHA. That is correct.

Ms. DEGETTE. How did you figure out seeing as you have no

background in it, how to develop it?

Mr. DE LA ROCHA. Yes. I went to—I did my search and I——

Ms. DEGETTE. You did a search?

Mr. DE LA ROCHA. A search, and I see——

Ms. DEGETTE. On the Internet?

Mr. DE LA ROCHA. Yes. And in PDR and books. And I see a product that was full of fibers and it was approved for children already,

it was used in that moment for children. And I propose a similar

formula for her product.

Ms. DEGETTE. Now how did you figure out the—and that was for

children 12 and over.

Mr. DE LA ROCHA. Yes.

Ms. DEGETTE. How did you know that it should be for 12 and

over, from looking on the Internet?

Mr. DE LA ROCHA. I searched the PDR, Physician Desk Reference, to avoid problems and that is why I proposed 12 and over.

Ms. DEGETTE. Yes.

Mr. DE LA ROCHA. That was the first formula. Fibers for children

12 and over.

Ms. DEGETTE. Okay. But then at some point Mr. Rayman said

no, that is not what is Ms. Kaye wanted, right?

Mr. DE LA ROCHA. That is correct.

Ms. DEGETTE. And then you developed the new formulation that

was eventually used?

Mr. DE LA ROCHA. The second step was a formula with diuretic

but still 12 and over.

Ms. DEGETTE. Right. But how did you figure out how to put

these compounds together?

Mr. DE LA ROCHA. They—they almost—they will guide and they

say, okay——

Ms. DEGETTE. Who guides you?

Mr. DE LA ROCHA. Through Jerry Rayman. I do not know——

Ms. DEGETTE. What?

Mr. DE LA ROCHA. Jerry Rayman. It was——

Ms. DEGETTE. So Mr. Rayman told you—okay. Mr. Rayman, is

that true, did you tell Mr. de la Rocha amounts to put in in this

formula?

Mr. RAYMAN. Amounts? No. No.

Ms. DEGETTE. Okay. Go ahead, Mr. de la Rocha.

Mr. DE LA ROCHA. Yes, what diuretics, that is it. And I did the

second step, the second formula with——

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Ms. DEGETTE. But how did you figure out how much of the fiber

and how much of each diuretic to put into the formula?

Mr. DE LA ROCHA. Yes, that was using the Physician Desk Reference and what was in the market.

Ms. DEGETTE. I am sorry. The PDR, I mean I am not a scientist.

The PDR, that does not tell you what proportions of these various

compounds to put together, does it?

Mr. DE LA ROCHA. It has amounts safer and what is the drug

amount. They have some amount and some suggestions.

Ms. DEGETTE. Mr. Ayoob, I saw you shaking your head. What is

your view as to this proceed?

Mr. AYOOB. I am so glad you asked.

Ms. DEGETTE. I thought you might be.

Mr. AYOOB. Yes. If he had looked at the PDR, he would have

known that this is not to be given to people under 12 years of age.

And he may have, I do not know. He may have not intended it. I

do not know. But the PDR definitely says that can cause liver damage, it should not be given.

Ms. DEGETTE. It says what can cause liver damage?

Mr. AYOOB. I am sorry. Uva ursi.

Ms. DEGETTE. Okay.

Mr. AYOOB. That is the particular diuretic——

Ms. DEGETTE. What about the putting together of all of these

substances into the supplement? I mean, does the PDR address

that?

Mr. AYOOB. The PDR does not address it. It addresses individual

things.

Ms. DEGETTE. Right. Like it says a dose of X amount can cause

liver damage?

Mr. AYOOB. Exactly. Or at least in large amounts it can cause

liver damager, etcetera.

Ms. DEGETTE. Do you have a concern when you have a lab like

this putting together several different things, a fiber and these

diuretics, that there might be interactions between those?

Mr. AYOOB. It concerns me that there might be interactions between them. It also concerns me that it might have interactions

with prescription medications that children might be taking.

Also, it concerns me anytime there is any amount of a diuretic

herb in a over-the-counter supplement directed to very young children that says it is a diuretic and should not be given to them.

That is a very big concern for me.

Ms. DEGETTE. Okay.

Mr. AYOOB. In terms of——

Ms. DEGETTE. Now, Mr. de la Rocha, were you concerned about

the interaction of this supplement with children taking prescription

drugs?

Mr. DE LA ROCHA. Yes. In fact, this was a mistake in the moment

because what the original formula was for children 12 and over.

Ms. DEGETTE. Well, okay, I know. Early on I know you said that,

but the truth is the way it finally came—Ms. Kaye came back and

said she wanted it for kids six and older. And then Mr. Rayman,

you went back I assume and told Mr. de la Rocha we want it for

six and older, right?

Mr. RAYMAN. That is correct.

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Ms. DEGETTE. And so then what happened, Mr. de la Rocha?

Mr. DE LA ROCHA. Then I made a mistake.

Ms. DEGETTE. Okay. What was that mistake?

Mr. DE LA ROCHA. That I did not check the same ingredients for

children of that age.

Ms. DEGETTE. You just assumed they would be all right?

Mr. DE LA ROCHA. I just assumed if the client is asking for that

and according to Mr. Rayman the client was a nutritionist——

Ms. DEGETTE. It was really based on what the client wanted and

not any kind of scientific evidence at all, right?

Mr. DE LA ROCHA. Yes. I agree with you.

Ms. DEGETTE. Okay. Did you do any studies on kids before you

gave this formula to Ms. Kaye to market?

Mr. DE LA ROCHA. No. No.

Ms. DEGETTE. Mr. Ayoob, you are eager to say something else?

Mr. AYOOB. Thank you. I appreciate it.

This is sometimes perhaps what happens when you have somebody who is claiming to be a nutritionist who does not have any

qualifications. Somebody who did, might have been able to foresee

some of this problem.

I know in most States you have to be licensed or certified before

you can call yourself a nutritionist, and I am not sure that Ms.

Kaye is. And had she had some background and training, this

might have been preventable.

Ms. DEGETTE. Well——

Mr. AYOOB. I do not know.

Ms. DEGETTE. It might have been. And let me ask you, Ms.

Kaye, did you ever look at the PDR to see if these substances were

safe for children under 12? Did you ever do any kind of review of

the literature to see if this product was safe?

Ms. KAYE. I ready about fiber, which was something that I

thought would be a good thing since children do not get enough

fiber and need more. But as far as the actual ingredients in the

product and the quantities and so on, my concern was that this

company, this laboratory was formulators, as I thought, would develop a safe product. And that is——

Ms. DEGETTE. But you——

Ms. KAYE. [continuing] what I charged them to do.

Ms. DEGETTE. I saw you on national TV holding yourself out to

be a nutritionist. Now, you are not certified in nutrition?

Ms. KAYE. I am not a registered dietician, no.

Ms. DEGETTE. Right. See, I mean, I have two kids, 10 and 14.

I am worried about their fiber, too. I would never go out and try

to develop a dietary supplement. I am not—and—well—Mr. Chairman, I have a lot more questions which maybe I will ask at a second round. I will yield back.

Mr. GREENWOOD. The Chair thanks the gentlelady.

The gentleman from Florida.

Mr. STEARNS. Yes. Thank you, Mr. Chairman.

I am going to direct my questions to Mr. Barash and Regalado,

Mr. Regalado.

Mr. Barash, tell me what is your relationship with PediaLoss in

the past?

Mr. BARASH. I have no relationship with PediaLoss.

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Mr. STEARNS. In the past did you have any relationship?

Mr. BARASH. Yes. I guess it is easier to explain. Dynamic Health

placed a purchaser order with a company called Delta Body Systems, Brian Newsome who I had met in Bocoa Raton. He could not

fill that purchase order. I started up a company called DBS Laboratories, LLC.

Mr. STEARNS. Yes.

Mr. BARASH. Overtook the purchase order and was only involved

in—working with supplement manufacturing companies in delivering the product to Dynamic Health.

Mr. STEARNS. And what product was that?

Mr. BARASH. Well, PediaLoss was the product.

Mr. STEARNS. Okay. So you were involved with the marketing of

PediaLoss?

Mr. BARASH. No.

Mr. STEARNS. You were involved with the distribution of it?

Mr. BARASH. No.

Mr. STEARNS. Were you involved with the manufacturing of it?

Mr. BARASH. I was involved in the manufacturing process of

identifying a supplement contract manufacturer to produce the

product with the bottle makers, with the packaging and the label.

As far as putting the product together and delivering it to the Dynamic Health warehouse.

Mr. STEARNS. Where did the formula come from?

Mr. BARASH. The formula came from Brian Newsome and David

Wood.

Mr. STEARNS. Who is David Wood? Now you are saying you got

the formula from these people, and then you took this formula or

you got——

Mr. BARASH. No. The formula, the purchase order was done before I was in the picture. About 2 months before I got into the picture. That would be a question you would have refer over to Dynamic Health.

Mr. STEARNS. Okay. When you got the formula, what did you do

with the formula?

Mr. BARASH. Well, I had gotten one of several formulas. It was

my job to go out and find a supplement manufacturer company to

product the formula for Dynamic Health.

Mr. STEARNS. Yes. Are you aware of the claims that PediaLoss

makes in their website?

Mr. BARASH. I have seen the website, yes.

Mr. STEARNS. Yes. It says here——

Mr. BARASH. For packaging.

Mr. STEARNS. ‘‘This revolutionary new formula slows the absorption of carbohydrates allowing more to be burned for energy and

less to be stored as fat. This highly effective and natural dietary

supplement comes in berry flavor’’ and so forth.

Where is the justification in your mind coming from or came

from for this new all natural health product to deter child obesity?

Did——

Mr. BARASH. I am sorry.

Mr. STEARNS. Did David Wood provide this to you?

Mr. BARASH. No. I cannot comment on that.

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Mr. STEARNS. But you were involved with PediaLoss in the sense

that you took the formula and helped in the distribution of it?

Mr. BARASH. No. What I did was intercept a purchase order that

could not be fulfilled from a Brian Newsome Delta Body System

which Chabra International, Dynamic Health placed with him for

about 15 or 16 different products. They could not get him to deliver

product. So what I did is step into the picture and work with contract manufacturers in the—I would say the operations of getting

the product from the manufacturer to the warehouse.

Mr. STEARNS. Well, it is funny you mentioned that you do not

seem to have any relationship with PediaLoss, but the FTC has

charged you with false and misleading advertising for two products.

Mr. BARASH. That is correct.

Mr. STEARNS. One PediaLoss and, you know, this weight loss

supplement for kids and some product called an alleged female sexual enhancer. So you have been charged with false and misleading

advertising, yet you are saying to me today you do not seem to

have any relationship with PediaLoss, and you mentioned——

Mr. BARASH. I did not say I have no relationship—I have any

relationship——

Mr. STEARNS. Well, you seem to be equivocating of what you did

with PediaLoss. Do you think the FTC charges are groundless?

Mr. BARASH. As far as a concern with Jonathan Barash and——

Mr. STEARNS. That you have been charged with false and misleading advertising by the Federal Trade Commission for

PediaLoss, do you think that is true or not? Are these groundless

charges or do you accept these charges as fact? Just yes or no, I

mean tell me which one. Sorry.

Mr. BARASH. I am involved in a situation that would——

Mr. STEARNS. No, no. The question is do you think the charges

by the Federal Trade Commission are groundless? Yes or no. In

other words, are they false in your opinion? Is the Federal Trade

Commission wrong? Yes or no.

Mr. BARASH. No.

Mr. STEARNS. So you are saying that they are not false, so that

you accept them, that you did make false and misleading advertising of the PediaLoss product, that is what you just told me. Is

that true?

Mr. BARASH. No.

Mr. STEARNS. Well, you just said that the Federal Trade

Commission——

Mr. BARASH. If I could—if you could turn to this book to page

30—to the——

Mr. STEARNS. Well, I got tab 32 in front of me, and——

Mr. BARASH. How about 39?

Mr. STEARNS. [continuing] it talks about the product PediaLoss,

and it talks about the ingredients in it. And the question I have

for you is how did you come up with those ingredients for the tablets?

Mr. BARASH. I am the former President of DBS Laboratories,

LLC. If you have the PediaLoss packaging, you will find that my

company name and information is not on that product at all.

Mr. STEARNS. Well, who is David Wood?

76

Mr. BARASH. David Wood is a formulator or owns a manufacturing company in Ohio.

Mr. STEARNS. Did you have relationship with David Wood?

Mr. BARASH. I met him once.

Mr. STEARNS. And was he used as a credentialed person for the

product?

Mr. BARASH. Him and Brian Newsome of Delta Body——

Mr. STEARNS. Okay. So David would be used——

Mr. BARASH. [continuing] are the ones who formulated the product.

Mr. STEARNS. Yes. Okay. So David Wood formulate the product?

Mr. BARASH. Yes. That was formulated before I became—got into

the picture.

Mr. STEARNS. Yes. We cannot seem to get a hold of David Wood.

We have been unable to find him anywhere. So we had this dubious distinction that David Wood who formulated your product, we

cannot find him. We have no way to verify that the ingredients

that are in the product have been researched and yet we have a

list of products that the ingredients are being used in based upon

someone that we cannot find and has not been credentialed. Is that

accurate? Is that an accurate statement?

Mr. BARASH. I have no idea what——

Mr. STEARNS. Okay. When you met him, did you have the impression he was the authority for these ingredients?

Mr. BARASH. It was my understanding from Brian Newsome at

Delta Body Systems that the two of them had discussions in formulating this product for Dynamic Health and for the purchase order

that Dynamic Health placed with Delta Body Systems.

Mr. STEARNS. Okay.

Mr. Regalado, who wrote this ad that is here touting PediaLoss

as this great all natural product for a child obesity?

Mr. REGALADO. Erin Fox, a legal firm here in Washington, D.C.

Mr. STEARNS. Did you have anything to do with it at all?

Mr. REGALADO. No. I asked them what I was allowed to say.

They basically wrote the content.

Mr. STEARNS. Now you are part of Dynamic Health, are you?

Mr. REGALADO. Right. Was.

Mr. STEARNS. Was? And when you were with Dynamic Health,

did you do the distribution of this product and marketing?

Mr. REGALADO. Did the marketing and distribution. I was the

Vice President of Sales and Marketing, that is correct.

Mr. STEARNS. What do you think of the conversation I had relative to David Wood? Did you ever met David Wood?

Mr. REGALADO. No. I was not aware of the name or the person

or his function until Jonathan and I completed the questionnaire

requested from this Commission.

Mr. STEARNS. Did you ever question the ingredients or the credentials of David Wood who made up the formula for this?

Mr. REGALADO. No, I did not because rather than worrying about

David Wood from my perspective, I wanted to know about the product for marketing purposes. And we had a technical data abstract

and studies on the ingredients from a Dr. Guzman. And after reviewing that information, I felt that I had marketing materials to

work with. That information assured us that it was safe, it was efVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00084 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
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fective. And, in fact, one of the doctors that sat here did indicate

that there were ingredients in there that had possible weight loss

activities.

So based on reviewing that information, we felt that it was a viable product.

Mr. STEARNS. Do you have a medical degree?

Mr. REGALADO. No.

Mr. STEARNS. Mr. Barash, do you have a medical degree?

Mr. BARASH. No.

Mr. STEARNS. Are either one of you registered a dietician?

Mr. REGALADO. No.

Mr. STEARNS. Okay. Prior to arranging for this product to be advertized and sold on the market, did you give this formulation to

any medical doctor or registered dietician to review?

Mr. REGALADO. Well, that was Dr. Guzman. He reviewed it. He

gave us the technical abstracts, which was submitted to Kelli Andrews, a Ms. Kelli Andrews with the Commission.

Mr. STEARNS. Okay.

Mr. REGALADO. The technical data abstract and the studies were

submitted to the Commission.

Mr. STEARNS. Now this Dr. Guzman you said, did you ever check

Dr. Guzman’s credentials?

Mr. REGALADO. Not myself personally, no.

Mr. STEARNS. Did you, Mr. Barash?

Mr. BARASH. No, I did not. He was recommended from the manufacturer that I had selected.

Mr. STEARNS. To your knowledge did Dr. Guzman ever do a

study on this product?

Mr. BARASH. He did not do a study. He did the research reference on the ingredients.

Mr. STEARNS. And what does that mean?

Mr. BARASH. What he did was do detailed—he looked up detailed

information on each one of the ingredients and wrote a technical

abstract that was about 500 pages.

Mr. STEARNS. Were there any studies done on kids?

Mr. BARASH. For the formulation?

Mr. STEARNS. Yes.

Mr. BARASH. No.

Mr. STEARNS. Okay. So basically we really do not have, I think

it has been brought out by this testimony, Mr. Chairman, for this

particular product there is no credential to any information on

PediaLoss and everything that they claim on this website cannot

be corroborated.

And I yield back.

Mr. GREENWOOD. The Chair thanks the gentleman.

The gentleman from Oregon is recognized for 10 minutes.

Mr. WALDEN. Thank you, Mr. Chairman.

Mr. Rayman, Ms. Kaye had represented to the committee that

there was never Skinny Pill for Kids, there never was one. Could

you turn to tab 15 in the book? I will wait until you get there.

Mr. RAYMAN. That is the purchase order?

Mr. WALDEN. Yes. Does that evidence that a purchase order for

2,000 bottles of Skinny Pill for Kids was made?

78

Mr. RAYMAN. No. That is an order to make. We never made the

product.

Mr. WALDEN. Okay. So Ms. Kaye never purchased these pills

even though a check was written?

Mr. RAYMAN. That is correct.

Mr. WALDEN. What was the check for?

Mr. RAYMAN. The check was a down payment that—and the rest

of the payment will be made once we delivered the pill. But we

never manufactured the pill.

Mr. WALDEN. So did you refund the down payment then?

Mr. RAYMAN. I believe so, yes.

Mr. WALDEN. Were the pills ever in the process of being made?

Mr. RAYMAN. No, they never were.

Mr. WALDEN. Even when she was on national TV, they were not

being made?

Mr. RAYMAN. That is correct.

Mr. WALDEN. Never at PAL Labs?

Mr. RAYMAN. No.

Mr. WALDEN. Okay. Did you feel—I am going back to the email

that was sent by Ms. Kaye to PAL Labs saying, you know, time is

kind of running out, I want a formula, I want it now, I want a pill

targeted toward 6 year olds and up or I am going to go somewhere

else. What kind of pressure did you feel? I mean, what was your

response to that?

Mr. RAYMAN. As a sales person, you—you are exposed to threats,

and this I felt was a threat. I wanted to make a sale, needless to

say, but it was—I treated it as a threat that she might pull the

business, and we had put a lot of effort in conversation wise with

her.

Mr. WALDEN. And did you not end up, did your company not end

up putting together a formula for the pill? You have a chemist

here.

Mr. RAYMAN. We put together a formula, yes.

Mr. WALDEN. And did she sign off on the formula?

Mr. RAYMAN. I think that was signed off on the label, on I think

right before she went on air.

Mr. WALDEN. In that purchase order in tab 15 the date indicates

November 14, 2002 or 1 week after the email she sent. I thin that

was November 7, if I recall. With a delivery date of December 19.

What happened in the intervening time? When did you decide you

are not going to make the pills and why?

Mr. RAYMAN. Okay. The process was once we get a formula that

our customer approves and she signs off on it——

Mr. WALDEN. And that has happened in this case, right?

Mr. RAYMAN. Then we go ahead and we produce documents, supplemental facts box for the labeling which has to be signed off by

the customer as well.

Mr. WALDEN. And did she do that?

Mr. RAYMAN. She did not do that until December 6.

Mr. WALDEN. Okay. But that was done.

Mr. RAYMAN. That was done on December 6.

Mr. WALDEN. All right.

Mr. RAYMAN. All right. And then we—we would then go ahead

and start to order raw materials to manufacture the product.

79

Mr. WALDEN. What changed? What did you decide not to manufacture?

Mr. RAYMAN. Once we found out that there was a problem with

the uva ursi in the product, over that weekend, that is when we

decided as a company that we no longer wanted to manufacture

that product.

Mr. WALDEN. And that was your decision or was that Ms. Kaye’s

decision.

Mr. RAYMAN. Actually, it was Jose de la Rocha’s decision.

Mr. WALDEN. And when did that occur specifically, what day?

Mr. RAYMAN. That would probably—my best guess, somewhere

like that Monday or Tuesday, maybe the 8th or the 9th, or I do not

know the exact dates.

Mr. WALDEN. Was that before she went on national television?

Mr. RAYMAN. No, that was after she was on national TV.

Mr. WALDEN. Okay. So everybody’s agreed to the formula, she

goes on national television. You have got your order, which meant

a lot to you. You were being threatened. It is a $9,000 initial order,

right?

Mr. RAYMAN. Correct.

Mr. WALDEN. Mr. de la Rocha, why the change of heart?

Mr. DE LA ROCHA. Could you rephrase your question?

Mr. WALDEN. Why did you decide not to go ahead with the manufacture?

Mr. DE LA ROCHA. Because the product is not safe for children.

Mr. WALDEN. How did you determine that?

Mr. DE LA ROCHA. We—I determined that I came back from vacations. I checked the PDR. I checked what, the doctor, he was saying. He was correct. And I say this formula is not going on.

Mr. WALDEN. But who came up with the formula that you all

signed off on first?

Mr. DE LA ROCHA. Yes. I came on with the formula, but I was

guided through the whole process.

Mr. WALDEN. You were guided through the process?

Mr. DE LA ROCHA. Yes.

Mr. WALDEN. By whom?

Mr. DE LA ROCHA. Mr. Rayman. I do not have any contact with

Ms. Kaye.

Mr. WALDEN. And he is not a chemist?

Mr. DE LA ROCHA. No, but——

Mr. WALDEN. You are the chemist, but you do not usually do formulas?

Mr. DE LA ROCHA. Yes, I do not initially do formula——

Mr. WALDEN. Have you done any formulas since, are you currently doing any formulas like this? I mean——

Mr. DE LA ROCHA. No, not at all. I do not do formulas. Would you

ever formulate a pill for children?

Mr. DE LA ROCHA. No.

Mr. WALDEN. Had you ever done it before?

Mr. DE LA ROCHA. No.

Mr. WALDEN. You will not ever do it again?

Mr. DE LA ROCHA. For sure.

Mr. WALDEN. For sure.

Mr. Rayman, how come you are guiding him on the formula?

80

Mr. RAYMAN. I was not guiding him on the formula.

Mr. WALDEN. He says you were.

Mr. RAYMAN. I was giving him the instruction, they were coming

from my customer.

Mr. WALDEN. And your customer in this case was Ms. Ray—Ms.

Kaye, I’m sorry.

Mr. RAYMAN. Edita Kaye, yes.

Mr. WALDEN. But I thought she turned to your company for the

formula, is that not what you testified, Ms. Kaye, that you went

to an FDA approved lab because they had people that had formulas?

Ms. KAYE. Yes.

Mr. WALDEN. Turn on your mike, please, if you would. Yes,

thanks.

Ms. KAYE. They had formulators, that is what I believed, who

understood how to develop formulas. I am not a chemist——

Mr. WALDEN. Well, were you guiding Mr. Rayman? He says you

were. What did you tell him? Did you tell him what you wanted

in the concoction?

Ms. KAYE. I told him that I wanted a safe and effective product

for children.

Mr. WALDEN. Mr. Rayman, is that what you heard?

Mr. RAYMAN. That was part of what I heard.

Mr. WALDEN. What else did you hear?

Mr. RAYMAN. The first formula, which was all fiber, she rejected

and wanted additional products added to it.

Mr. WALDEN. I’m sorry, could you say that again?

Mr. RAYMAN. The first product that we suggested that she use

was a fiber product.

Mr. WALDEN. Okay. So she gave you specific instructions. How

specific were they when you say ‘‘fiber product,’’ did she get into

naming a specific type of fiber product?

Mr. RAYMAN. She did not.

Mr. WALDEN. So she just said give me a fiber product in here?

Mr. RAYMAN. She said she did not want just a fiber product.

Mr. WALDEN. What did she want besides that?

Mr. RAYMAN. That’s when she—in the email she said she wanted

a thermogenic and also through conversation she also said she

wanted an added diuretic.

Mr. WALDEN. So thermogenic and diuretic.

Is that true, Ms. Kaye? Is that what you told him?

Ms. KAYE. I told him about the thermogenic, which I believed

would add energy so that children could be more active.

Mr. WALDEN. Opps, that clicked off again. Sorry.

Ms. KAYE. The rest of the ingredients including the diuretic—the

fiber came because there was not in fact another product available

for sale that contained——

Mr. WALDEN. That’s the PediaLean, or whatever?

Ms. KAYE. Correct.

Mr. WALDEN. Okay.

Ms. KAYE. That contained fiber.

Mr. WALDEN. All right.

Ms. KAYE. And PAL Laboratories brought that product to my attention. I purchased that product. And in conversations it was deVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
81

termined that PAL Laboratories said it was a fiber formula and

that they could improve on it. And I said fine.

Mr. WALDEN. Is that your recollection, Mr. Rayman?

Mr. RAYMAN. I know we talked about a fiber product. I do not

have a recollection of improving upon it. I know as Edita was telling me that there were certain things that she wanted added to it.

Mr. WALDEN. But that is as specific as she got?

Mr. RAYMAN. The thermogenic and the diuretic.

Mr. WALDEN. Okay. And Mr. de la Rocha, is that what you heard

then from Mr. Rayman?

Mr. DE LA ROCHA. Yes, sir.

Mr. WALDEN. So it was very generic sort of put a thermogenic

in here and a diuretic, and some fiber?

Mr. DE LA ROCHA. Yes, sir.

Mr. WALDEN. Throw it together and give it to me for 6 year olds.

Do any of you every worry about the impact of this stuff on kids?

Mr. RAYMAN. Yes, sir. Certainly.

Mr. WALDEN. Then why would you create these formulas and go

along with it to the point of the client agreeing to the formula on

any—do you believe in clinical trials that are real?

Mr. DE LA ROCHA. Yes, sir.

Mr. WALDEN. You are all shaking your heads.

Do any of you today manufacture products that have not been

through clinical trials? Let us start right over here and work that

way. Any of you in companies make things today that have not

been through peer review clinical trials?

Mr. GAY. We do have food products that do not have trials.

Mr. WALDEN. You do?

Mr. GAY. Yes.

Mr. WALDEN. Okay. All right.

Mr. Gay, or Mr. Barash?

Mr. BARASH. I am not in the industry anymore.

Mr. WALDEN. You are not? Okay.

Mr. REGALADO. We do not manufacture any product. We are a

marketing company and we rely on the information given to us

from formulation companies.

Mr. WALDEN. All right.

Mr. REGALADO. And, in fact, the ingredients in most of what we

use have had clinical trials, the ingredients.

Mr. WALDEN. But not in that combination?

Mr. REGALADO. Correct.

Mr. WALDEN. And you know that when you are doing the marketing, because you do not really care about what is it in? You take

what they give you and you figure out how to spin it.

Mr. REGALADO. Well, it is not that we do not care. We trust the

people that we work with and those are GNP certified laboratories

with staff and so forth.

Mr. WALDEN. Right.

Let us go on down. Anybody else make dietary products that——

Mr. RAYMAN. Yes, we make dietary products.

Mr. WALDEN. [continuing] still that do not have real clinical

trials?

Mr. RAYMAN. Yes, that is correct.

Mr. WALDEN. Okay. All right.

82

Thank you, Mr. Chairman.

Mr. GREENWOOD. The Chair thanks the gentleman, and recognizes himself for 10 minutes for a second round.

This is the assessment then, the conclusion that I am coming to

from what I have heard so far. And that is that any scam artists

or group of scam artists who wants to get rich quick, preying on

the emotional pain of people suffering weight loss can go to a

phony laboratory, give a screwball list of ingredients that are not

proven to do a darn thing, put it in a pill, put the pill in a bottle,

put the bottle in a box and make a mint. That is my conclusion

from what I have heard today.

Now, I would like to know if anyone on the panel disagrees with

that conclusion? Okay. Mr. Gay, why do you not tell me what is

wrong with that conclusion?

Mr. GAY. I think that is, with all due respect, Congressman, I

think that is a generalization. We build our company on a completely different basis. Dr. Mowrey, worked with him, he has been

well published.

Mr. GREENWOOD. Okay. Well, let us talk about Dr. Mowrey, you

can feel free to jump in here as you like. Because you just said—

Mr. Gay, you said my conclusion is wrong because you rely on people like Mr. Mowrey.

Now, Mr. Mowrey is, as I understand it, has no—you have a degree is psychology, is that right, sir?

Dr. MOWREY. That is correct.

Mr. GREENWOOD. All right. So you have a degree in psychology.

And I also understand that you have never studied botany, is that

correct?

Dr. MOWREY. I have studied botany over the years. Yes, I have.

I have a degree in experimental psychology, I would like to clarify

that a little bit.

Mr. GREENWOOD. Okay. You have a degree in experimental——

Dr. MOWREY. So a scientific background then. Yes.

Mr. GREENWOOD. Okay. What is experimental psychology, Dr.

Mowrey?

Dr. MOWREY. Experimental psychology, if we were to differentiate with, say, from clinical psychological which deals with treating problems such as one would come in for counseling, that sort

of thing, experimental psychology deals more on a research

basis——

Mr. GREENWOOD. Okay. Let me stop you there. Let me stop you.

Mr. Gay, you just said you——

Dr. MOWREY. I’m sorry.

Mr. GREENWOOD. My assessment of this industry is not a good

one because you, for instance, rely on Dr. Mowrey to put together

your formulations. And after all, he has a degree in experimental

psychology.

Mr. GAY. He is well written.

Mr. GREENWOOD. And here is a quote from Mowrey from his

book the Scientific Validation of Herbal Medicine, ‘‘The scientific

method is a powerful tool, but it has its limits. Medical science in

America is a unique combination of economic and political factors

which fuse together almost religiously to promote synthesized,

highly active chemicals.’’ That is a quote from your expert.

83

Would you tell me how it is that you can rely on Dr. Mowrey who

does not know the first thing about how to help people lose weight

and yet you let him throw together your ingredients that you market, and what is his expertise to do that?

You know, there are lots of really qualified physicians in this

country, there are lots of qualified dieticians in this country to

whom you could turn to get some actual valid good information, but

you turn to Dr. Mowrey who has a degree in experimental psychology. Could you explain that?

Mr. GAY. Congressman, with all due respect, Dr. Mowrey is well

published in the herbal——

Mr. GREENWOOD. Anybody can be well published. All you have

to do is write a book and promote it. That does not mean you know

anything.

Your reliance on him is because he is well published, not because

he is well educated, not because he is skilled, not because he knows

anything?

Mr. GAY. He is a very well recognized in the dietary supplement

industry as being knowledgeable.

Mr. GREENWOOD. But what does the fact that he is very well recognized have to do with his qualifications?

Mr. GAY. Mr. Chairman——

Mr. GREENWOOD. Yes.

Mr. GAY. [continuing] it is not just Dr. Mowrey that we rely on.

Mr. GREENWOOD. Okay. Tell me who else you rely on?

Mr. GAY. Okay. I’ll finish talking about the company.

Mr. GREENWOOD. Okay.

Mr. GAY. We started off the company and decided that we were

going to build a company. We used Dr. Mowrey to review research

that has already been done by other people, other companies and

then we—after we assess that research, then we take that research

and turn it into a dietary supplement.

Mr. GREENWOOD. Like Zantrex-3?

Mr. GAY. Yes.

Mr. GREENWOOD. Zantrex-3. Okay. Main herbs in Zantrex-3 are

guarana, yerba mate and damiana coupled with caffeine, ginseng

and green tea. Right? Okay. Who is the expert that told you that

is a good way—is that a correct description of the ingredients of

Zantrex-3?

Mr. GAY. I believe it is.

Mr. GREENWOOD. Who is the expert that told you that is a good

way for people to lose weight ingesting those?

Mr. GAY. Congressman, I thought we are here to talk about children, overweight children and products for——

Mr. GREENWOOD. No. Actually we are here to talk about the entire industry. But I would like you to just—before I leave this, can

you tell me upon which expert you relied to determine that that is

a good formula to help people lose weight?

Mr. GAY. Mr. Mowrey and Dr. Chevreau.

Mr. GREENWOOD. Okay.

And Dr. Chevreau, let me turn to you. How did you formulate

these ingredients?

Ms. CHEVREAU. Based on my credential——

Mr. GREENWOOD. Which are?

84

Ms. CHEVREAU. My education. I am a Ph.D in chemistry, I have

a master’s in foods and nutrition and I am a registered dietician.

Mr. GREENWOOD. Okay.

Ms. CHEVREAU. So my qualification permits me to put products

or give me the knowledge to put products together like that.

Mr. GREENWOOD. Okay. And how did you come up with those ingredients?

Ms. CHEVREAU. Based on the review of scientific literature, that

is my job to look, review, study what has been published in the

peer review scientific literature and make recommendation of—on

ingredients.

Mr. GREENWOOD. And characterize that scientific literature,

which is peer reviewed clinical studies?

Ms. CHEVREAU. Yes, correct.

Mr. GREENWOOD. Okay.

Ms. CHEVREAU. Yes, peer reviewed clinical studies.

Mr. GREENWOOD. Okay. And why do you not just cite for me on

the ingredients in Zantrex and tell me about what you learned

from your peer reviewed clinical studies?

Ms. CHEVREAU. In Zantrex there is a combination of three ingredients, Yerba mate, guarana and damlana, which have been studied in clinical study in Denmark.

Mr. GREENWOOD. In Denmark.

Ms. CHEVREAU. It was the combination of those three together.

And our product exactly has the raw ingredients which were used

in that clinical——

Mr. GREENWOOD. Do you know how many patients were involved

in that clinical trial?

Ms. CHEVREAU. On top of my head, I do not remember.

Mr. GREENWOOD. Okay.

Dr. Ayoob, was I overly harsh in my characterization of this industry, particularly as it applies to children?

Mr. AYOOB. I’m sorry?

Mr. GREENWOOD. Was I overly harsh in my characterization of

this industry?

Mr. AYOOB. I think you were right on the money.

Mr. GREENWOOD. Tell me why you say that?

Mr. AYOOB. These companies have made false claims. They have

marketed what I have called junk science, which is making preposterous claims without enough evidence, and they do it to a very

vulnerable population. Perfect for getting money. Perfect. Okay. If

you want to get money out of people, you find what their weak spot

is and where they are most vulnerable, and you go right for it.

And people who are either ill or have physical problems or have

issues such as obesity or weight control or weight management

issues are prime suspects. These are a known desperate population.

They are ideally suited to giving up money to things that they

think will help them, and because it is a difficult process, they

think well I want a quick fix. And one of the tenants of junk

science is when it—if it sounds too good to be true, it probably is

or something that promises an incredible quick fix.

I certainly would never understand why a company would make

a dietary supplement based on one very, very, very flawed study

years ago that—I am talking about the one in PediaLean in parVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00092 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
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ticular. I would never even have reviewed this. It would have

never——

Mr. GREENWOOD. They may not even have consulted an experimental psychologist to get information on the ingredients——

Mr. AYOOB. Very possibly.

Mr. GREENWOOD. [continuing] would be good for your health.

Mr. AYOOB. And the—and, you know, that study was so flawed.

I can’t even—and I tell you, it was translated from Italian. I am

not sure that the study exists. There is no reference for it. It just

says the Journal and it says the year, it does not give a reference.

Highly unusual.

Mr. GREENWOOD. Mr. Gay, for how long have you sold

PediaLean?

Mr. GAY. Since early 2002.

Mr. GREENWOOD. Okay. Do you know what quantities you have

sold?

Mr. GAY. Off the top of my head, I do not.

Mr. GREENWOOD. Okay. Do you know what kind of profits you

have reaped from the sale of PediaLean Mr. GAY. As I stated in

my opening statement, PediaLean was part of an overall package

which included the website, a support program and that for parents. It is actually at a giant loss today of several hundred thousand dollars.

Mr. GREENWOOD. It is a giant loss?

Mr. GAY. Yes, the program.

Mr. GREENWOOD. The program was a giant loss?

Mr. GAY. That is correct.

Mr. GREENWOOD. And how about the product itself?

Mr. GAY. The product——

Mr. GREENWOOD. Did you make $580,270 in total net sales?

Mr. GAY. That is—that is gross income.

Mr. GREENWOOD. Okay. And you do not know what the profit

margin on this was?

Mr. GAY. I do not.

Mr. GREENWOOD. Okay. Why did you continue to sell it for 2

years at such a loss?

Mr. GAY. Primarily because of a representation, the reason we

are losing money on the product, in my opinion Congressman, is

because of a representation on the website when this committee

sent us a letter, they defined it as a designer steroid. And so we

have not continued to advertise it there. We feel like it is a good

product.

Congressman, I have nine children, me and my wife have nine

children, 18 grandchildren. And I do not have any problem giving

this product to my children. I love them dearly. So——

Mr. GREENWOOD. Do they take your products?

Mr. GAY. We had the—excuse me?

Mr. GREENWOOD. Do any of your nine children or 18 grandchildren ingest any of your products?

Mr. GAY. Absolutely. On a daily basis.

Mr. GREENWOOD. Okay. And including PediaLean, if that is not

too personal a question?

Mr. GAY. In some cases, yes.

Mr. GREENWOOD. Okay. And with what results?

86

Mr. GAY. I have not monitored that. They continue to take it, so

I assume they are seeing some benefit.

Mr. GREENWOOD. And do you believe—would you tell your children or grandchildren who are taking this that they could continue

to enjoy their favorite foods as long as they were taking

PediaLean?

Mr. GAY. With restricted—yes, because I do not think they’re

going to use very much when they take PediaLean.

Mr. GREENWOOD. Okay. And what studies have demonstrated

that?

Mr. GAY. I will let Dr. Mowrey speak to that.

Mr. GREENWOOD. Okay. Dr. Mowrey, could you share with us

what studies have demonstrated that PediaLean suppresses appetite?

Dr. MOWREY. The study that you are referring to undoubtedly,

Mr. Congressman, is the Italian study that has been introduced

here in conversation already. That study did not necessarily address appetite suppression. It is simply found that a group of children who were exposed to a normal caloric and exercise program,

and also took the recommended amount of the PediaLean equivalent, the exact same material that is in PediaLean, we will call it

Dicoman-5, they lost a greater percentage of their degree of overweight than did the children who were just doing the exercise

and——

Mr. GREENWOOD. Okay. My time has expired. But, Dr. Mowrey,

you have heard Dr. Ayoob and others in our first panel characterize

that study as pathetic.

Dr. MOWREY. Yes. Yes, I have.

Mr. GREENWOOD. Okay. And when you take into consideration

the smallness of the sample size, the fact that there were no controls, the fact that people dropped out of that study and that that

was not calculated into the results, you must know that that study

is laughable, is a laughable idea that you would base the sales of

products to marketing products to millions of children based on an

absurdly, grotesquely, inadequate, laughable—I cannot think of the

next adjective to describe that study. How can you in good conscience do that?

Dr. MOWREY. Mr. Chairman?

Mr. GREENWOOD. Yes.

Dr. MOWREY. Part of the job that I do as a consultant for Basic

Research is to review the world’s literature on these kinds of problems, especially related to——

Mr. GREENWOOD. And the world’s literature on this product consists of this one stupidly, ridiculously, inadequate study; that is the

world’s literature on this product? And on the basis of that you

would market it?

Dr. MOWREY. That is—the world’s literature on children’s weight

loss or children’s obesity is not very extensive in terms of actual

products that help out in this regard. This product——

Mr. GREENWOOD. Well, I am sure Dr. Ayoob will correct that

very briefly, and then I will yield.

Dr. MOWREY. This product is——

Mr. GREENWOOD. Dr. Ayoob?

Dr. MOWREY. This product—I am sorry.

87

Mr. GREENWOOD. Wait a minute. Let me just turn to Dr.

Ayoob——

Dr. MOWREY. Can I please answer your question, Mr. Congressman?

Mr. GREENWOOD. Well, you just made a statement and you said

that the world’s literature on——

Dr. MOWREY. I was answering your question. I am trying to answer your question. I am trying to answer your question on

why——

Mr. GREENWOOD. Well, you did answer my question.

Dr. MOWREY. On why——

Mr. GREENWOOD. I asked you on what research you based your

study, you told me it was the Italian research, which is laughable,

and that there is not much else out there in the world of literature

on childhood obesity. I am going to ask Dr. Ayoob is that a fair

statement.

Mr. AYOOB. No, it is not.

Mr. BURBAGE. May the record show that Mr. Mowrey was not allowed to answer the question. There were three questions posed.

Mr. GREENWOOD. Well, we have time constraints here. I am already 5 minutes over my time. But we will come back to Dr.

Mowrey.

The gentlelady from Colorado.

Ms. DEGETTE. Thank you, Mr. Chairman.

Mr. Gay, you said something that peaked my interest. You said

that you have a number of relatives who are on PediaLean, is that

right, or other supplements that your company makes?

Mr. GAY. Congresswoman, that implies to me that they’re actively on it. I see them take them.

Ms. DEGETTE. Okay. PediaLean is not intended as a permanent

dietary supplement, but rather a temporary weight loss tool, correct?

Mr. GAY. Along with diet and exercise.

Ms. DEGETTE. Along with diet and exercise.

Mr. GAY. Correct.

Ms. DEGETTE. So I guess I was interested when you said that

your relatives on are on this. Have you seen them lose any weight

from PediaLean?

Mr. GAY. Again, I have not monitored that.

Ms. DEGETTE. You do not know? You do not know if your own

relatives, which take PediaLean, have lost weight?

Mr. GAY. Again, I have not monitored that.

Ms. DEGETTE. Okay.

Dr. Chevreau, I want to talk to you a little bit about the clinical

basis for PediaLean, since you seem to be the only one with any

kind of scientific background here that might lend itself to develop

of dietary supplements.

As I understand it, PediaLean’s formula is based on, you say it

is based on clinical studies and so on. It is really based on the one

Italian study from 1992, correct?

Ms. CHEVREAU. Incorrect, to a ceratin extent.

Ms. DEGETTE. Okay. What other studies did you rely on in the

development of PediaLean?

88

Ms. CHEVREAU. I relied on—okay. Pedialean, let me back up for

a second. PediaLean is up of a very specific type of glucomannan.

Ms. DEGETTE. Yes.

Ms. CHEVREAU. In that type of glucomannan called Dicoman-5,

there are four adult study, four clinical study——

Ms. DEGETTE. And what are those four studies, please?

Ms. CHEVREAU. The name of them?

Ms. DEGETTE. Yes. Well, actually, Mr. Chairman, I would ask

unanimous consent to have Dr. Chevreau supplement her testimony just by giving us the titles and names of those studies, and

if possible copies of those studies. Would that be all right, Doctor?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. Thank you.

Ms. CHEVREAU. Absolutely.

Ms. DEGETTE. Now let me say, though, PediaLean is specifically

marketed to children, correct?

Ms. CHEVREAU. Yes. And four children study—I did not finish

sentence.

Ms. DEGETTE. There are also four children studies?

Ms. CHEVREAU. That is correct.

Ms. DEGETTE. Ah. What are those studies, please?

Ms. CHEVREAU. You mean the name of them?

Ms. DEGETTE. Yes.

Ms. CHEVREAU. The author?

Ms. DEGETTE. Yes, where they were conducted and what journal

they were published in?

Ms. CHEVREAU. The one we are referring to, the literary one——

Ms. DEGETTE. The Italian study from——

Ms. CHEVREAU. I would like to make the point——

Ms. DEGETTE. Well, we will talk about that in a minute. What

are the other three studies?

Ms. CHEVREAU. The name of the author—study I know, I do not

pronounce, it is an Italian author also. Another Italian——

Ms. DEGETTE. Okay. Where was that study published?

Ms. CHEVREAU. Oggi.

Ms. DEGETTE. And do we have a copy of that study? That is a

second study?

Ms. CHEVREAU. I think so.

Ms. DEGETTE. On children?

Ms. CHEVREAU. Correct.

Ms. DEGETTE. And when was that study conducted?

Ms. CHEVREAU. 1991/’92——

Ms. DEGETTE. The same time as the study that we have?

Ms. CHEVREAU. About.

Ms. DEGETTE. Okay. And the third study?

Ms. CHEVREAU. By Vito, V-I-T-O.

Ms. DEGETTE. Yes.

Ms. CHEVREAU. Italian study also.

Ms. DEGETTE. And where was that published?

Ms. CHEVREAU. Minerva—I will have to go back to the study.

Ms. DEGETTE. Okay. Doctor, would you please supplement if you

have copies of those studies, that would be great.

Ms. CHEVREAU. I do. I do.

89

Ms. DEGETTE. Now, do you know the sample sizes of each of

those studies?

Ms. CHEVREAU. Yes, I do.

Ms. DEGETTE. And how big are those sample sizes? So you relied

on four Italian studies done at approximately the same time about

12 years ago, correct?

Ms. CHEVREAU. That is correct.

Ms. DEGETTE. All right. And what were the sample sizes?

Ms. CHEVREAU. In order to be exactly accurate, I will have to get

my binder and look into it.

Ms. DEGETTE. Okay. Well, let us just talk about the main one

that we are talking about today, the one Libieri.

Ms. CHEVREAU. Correct.

Ms. DEGETTE. Actually, was Libieri involved in all those four

studies?

Ms. CHEVREAU. No.

Ms. DEGETTE. Okay. Now that study as 23 obese children, correct?

Ms. CHEVREAU. Complete the study, yes.

Ms. DEGETTE. Who completed the study? A number of children

dropped out of the study, right?

Ms. CHEVREAU. That is correct.

Ms. DEGETTE. Now, those children were never followed to see

why they dropped out, were they?

Ms. CHEVREAU. It is not indicated in the paper, correct.

Ms. DEGETTE. Okay. So you do not know? Now, that would be

a standard technique in a clinical study, right?

Ms. CHEVREAU. It is.

Ms. DEGETTE. To follow those and see why they dropped out? For

example, if you had 36 children who started in a study, 12 of them

dropped out because they had abdominal pain and discomfort. You

would want to know that, correct?

Ms. CHEVREAU. They indicated that a number of them who

dropped out because of abdominal——

Ms. DEGETTE. Right. Did that concern you?

Ms. CHEVREAU. No.

Ms. DEGETTE. Well, why not? It seems like about a third of the

children suffered some side effects from this root?

Ms. CHEVREAU. No, that is only five out of 30. That is not——

Ms. DEGETTE. Oh, I am sorry. Only five out of 30. Well, that is

still one-sixth, right?

Ms. CHEVREAU. That is—this is not uncommon on clinical trials.

Ms. DEGETTE. Dr. Ayoob, I would ask you is this a common occurrence in clinical trials?

Mr. AYOOB. I would say if this is the study that they are advertising on their website as clinical proof, it leaves something to be

desired. This is the study they are putting as their ‘‘best foot forward,’’ so to speak. I have a problem with a study that is so flawed.

Congressman Greenwood put right in the money. It was laughable.

And to say that—I think it was something like 14 percent of this

very small population dropped out because of abdominal pains, and

why the others dropped out we do not know.

Ms. DEGETTE. We do not know. It could have been——

90

Mr. AYOOB. It could have been the same thing. They just never

bothered to come back and report.

Ms. DEGETTE. It could have been esophageal obstruction.

Mr. AYOOB. Exactly. I mean, it——

Ms. DEGETTE. Yes, we just do not know.

And Dr. Chevreau, I want to ask you about that because Dr.

Hoppin talked a lot about this as well. One of the side effects, and

this was in this Italian study, was esophageal obstruction.

Ms. CHEVREAU. No.

Ms. DEGETTE. Oh, I am sorry. No. I am sorry. This is a side effect of this root that has been demonstrated in adult women, correct?

Ms. CHEVREAU. No. Your comment is incorrect. Certain type of

glucomannan has been associated with esophageal obstruction. The

specific grade of glucomannan that we are using in PediaLean has

not been associated with esophageal obstruction.

Ms. DEGETTE. The grade?

Ms. CHEVREAU. The grade.

Ms. DEGETTE. In other words, the amount to which it is ground?

Ms. CHEVREAU. Correct.

Ms. DEGETTE. Okay.

Ms. CHEVREAU. And purified.

Ms. DEGETTE. Now did you ever do any clinical trials? And I

know you are not required to under the law, but all of you are

holding yourselves up to a higher standard. So my question is did

you ever do any clinical trials on this particular grade of the substance?

Ms. CHEVREAU. I submitted—I wrote a grant, proposal to the

ASBIR program of NIH to request some money to do studies. Because as a small business and limited resources, we felt that we

would like to do a study.

Ms. DEGETTE. And you did not do a study, though, did you?

Ms. CHEVREAU. We did not get funding from NIH——

Ms. DEGETTE. So you did not do the study, right? Yes, I mean,

I did not ask you did you write a grant. I asked you did you do

a study, and the answer is no correct?

Ms. CHEVREAU. It is no.

Ms. DEGETTE. Now, did you try to—do you know of studies that

say this particular grade of the substance does not cause esophageal obstruction?

Ms. CHEVREAU. The four Italian study I am referring to use that

particular grade and none indicated esophageal obstruction.

Ms. DEGETTE. Right. But as Dr. Ayoob is pointing out, we do not

know why some of those kids left the study that you are putting

out on your website, why they left. I mean, it could have been for

this reason, we do not know one way the other, do we?

Ms. CHEVREAU. With due respect, we have talked to Dr. Libieri.

Ms. DEGETTE. Okay. But that is not a scientific technique. He

would put it in his paper, right?

Ms. CHEVREAU. He is a woman.

Ms. DEGETTE. Her, sorry. She would put it in her paper then,

right?

Ms. CHEVREAU. Excuse me?

91

Ms. DEGETTE. If she knew what happened to those people who

left the study, she would follow up and put it in her paper. That

is the science—I am not a scientist, but that would be part of the

study.

Ms. CHEVREAU. That is correct, yes.

Ms. DEGETTE. Well let me ask you then, you did not ever do any

tasks on this particular product, PediaLean, that was marketed to

children, correct?

Ms. CHEVREAU. Correct.

Ms. DEGETTE. Now, one of the things I am concerned, because

as described, I was a little bit relieved, frankly, to learn No. 1 your

product unlike some of these other products just contains fiber,

right?

Ms. CHEVREAU. Correct.

Ms. DEGETTE. And so it did not have the diuretics or stimulants

that some of these other substances have. And it is in a capsule

form, right?

Ms. CHEVREAU. Correct.

Ms. DEGETTE. so that made me feel like, well, you know maybe

it is not that unsafe. But then when I looked on the box a few minutes ago, and I talked about this before, it says ‘‘Special note: If

your child has difficulty swallowing capsules, do not worry. The

PediaLean formula can be sprinkled between a small piece of

bread, onto a spoonful of applesauce, peanut butter or yogurt, just

about any food.’’ And that makes me concerned because what is it

gets into the esophagus and expands? Have you ever done studies

sprinkling PediaLean on these breaks or putting them in these

foods?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. You did?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. Tell me about that study. How big was the sample?

Ms. CHEVREAU. It was not a clinical study, but we did do the

best.

Ms. DEGETTE. How did you do the test?

Ms. CHEVREAU. When the investigator came to Salt Lake City

back in March, I did to her a demonstration when I put PediaLean

in a glass of water and show it to her how long it took to become

a soft gelatinous mass.

Ms. DEGETTE. Right. That’s the capsule in the water, right?

Ms. CHEVREAU. No, no, no. The powder.

Ms. DEGETTE. The powder. Okay.

Ms. CHEVREAU. The actual powder. We put the powder, three

capsules, the content of three capsules in water in a glass of water,

a cup, and for 2 days she observed that. And at the end of 2 days

she still had a very soft gelatinous mass which in no way or shape

would cause obstruction?

Ms. DEGETTE. And that was the test you did? Now, the

investigator——

Ms. CHEVREAU. No, that was the test I did in front of the investigator.

Ms. DEGETTE. Okay, that was the investigator from the FTC?

Ms. CHEVREAU. It was the lady——

92

Ms. DEGETTE. Investigator from the committee, this young

woman sitting here?

Ms. CHEVREAU. Yes. Yes.

Ms. DEGETTE. And that was after you were already marketing

PediaLean?

Ms. CHEVREAU. That is correct.

Ms. DEGETTE. Yes. Yes. Did you do any tests on bread or applesauce before?

Ms. CHEVREAU. Yes, I did.

Ms. DEGETTE. Tell me about that.

Ms. CHEVREAU. I am a bench chemist from training. I have tried

all the different compilation of mixing, of different medium whether it was in vinegar to mimic the stomach acid or making more alkaline to observe——

Ms. DEGETTE. Was this documented? Did you write it down, the

results? Did you measure how long it took to dissolve?

Ms. CHEVREAU. Or to gel, yes.

Ms. DEGETTE. Yes, you—with the vinegar and the break and the

applesauce?

Ms. CHEVREAU. I do not recall on the top of my head but I would

suspect it is my lab books.

Ms. DEGETTE. Did you mix this with applesauce? Now, I want

to tell you, and I do not say this to be threatening in anyway. I

do not want to make you go into a trap, okay.

Did you test this substance with applesauce?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. And did you test it with peanut butter?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. And did you sprinkle on a piece of bread?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. And then what did you do?

Ms. CHEVREAU. I observed it over some period of time to see

what was the reaction, whether it was going to become a hard gel.

Ms. DEGETTE. All right. Now, did you ever feed it to children?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. Okay. How many children did you feed it to?

Ms. CHEVREAU. I used my neighbor’s children.

Ms. DEGETTE. How many of them?

Ms. CHEVREAU. Three.

Ms. DEGETTE. And you fed it to them on bread, on peanut butter,

okay?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. And is this all documented in your lab books? I

want you to really think hard about these answers. I am not trying

to put you into a trap, okay.

Ms. CHEVREAU. I will have to go back to my lab book and——

Ms. DEGETTE. Would you be willing to give us that lab book?

Ms. CHEVREAU. Yes.

Ms. DEGETTE. Okay. Now, by the way, did your neighbor’s children lose weight?

Ms. CHEVREAU. No. We did it a couple of times.

Ms. DEGETTE. Okay.

Ms. CHEVREAU. It was not intended for them to take that on a

daily basis.

93

Ms. DEGETTE. It was not, as Mr. Greenwood fairly points out, it

was not efficacy, it was for safety?

Ms. CHEVREAU. Correct.

Ms. DEGETTE. And was that all the children you tested it on, or

did you test it on other children?

Ms. CHEVREAU. No. I did not test on other children.

Ms. DEGETTE. Thank you.

Mr. Chairman, thank for your comment.

Mr. GREENWOOD. Thank you.

The Chair recognizes himself for 10 minutes.

Mr. Gay, I may have cut you off a little short when you were

talking about different experts on which you rely. You talked about

Mowrey and Dr. Chevreau. My understanding is you rely on Dr.

Friedlander as well, on his—Mr. Friedlander. I’m sorry. You rely

on Friedlander?

Mr. GAY. Not for the science.

Mr. GREENWOOD. Pardon me?

Mr. GAY. Not for the science.

Mr. GREENWOOD. But then for what?

Mr. GAY. Primarily as a marketing consultant.

Mr. GREENWOOD. Okay. And describe what Mr. Friedlander does

for your company as a marketing consultant.

Mr. GAY. Helps prepare, consults with Dr. Mowrey, Dr. Chevreau

and other doctors that particular formulations and kinds of products and marketing strategies.

Ms. KAYE. Excuse me. May I be excused for about 2 minutes?

Mr. GREENWOOD. Yes, you may.

Ms. KAYE. Thank you.

Mr. GREENWOOD. Just bear with me, please.

Look at tab 87, Mr. Gay. Do you see that. It says at the top

‘‘Twenty-fourth story of level 2 printed in full format,‘‘ do you see

that?

Mr. GAY. Yes.

Mr. GREENWOOD. Okay. It says ‘‘A man accused of making millions by selling worthless mail order cures for ills from impotency

to baldness to obesity has been banished from living and working

in Florida. Mitchell Friedlander, the 38 year old owner of Robertson Taylor Company entered pleas of no contest Tuesday to 13

charges of operating a scheme to defraud.’’ Is that the same Mr.

Friedlander upon whom you rely for your marketing expertise?

Mr. GAY. I believe it is.

Mr. GREENWOOD. Okay. Again, Mr. Gay, I do not know if I was

overly harsh about describing your industry as one in which scam

artists can make a lot of money preying on the emotions of people.

For instance, I guess is it Mr. Friedlander who put together this

ad which ran in Redbook, ‘‘If your child is overweight and it is destroying both your lives, European breakthrough gives hope to you

and your overweight child.’’ Did Mr. Friedlander—I will ask you directly Mr. Friedlander, did you put together this advertisement?

Mr. FRIEDLANDER. I was involved with putting it together, yes.

I was involved in putting it together. Yes, sir.

Mr. GREENWOOD. Okay. And so when you say ‘‘the European

breakthrough,’’ what did you mean when you wrote the words ‘‘European breakthrough’’?

94

Mr. FRIEDLANDER. The studies were conducted in Italy and——

Mr. GREENWOOD. Oh, that study? That is the European breakthrough?

Mr. FRIEDLANDER. As far as that study. Dr. Ayoob suggested that

the study might exist. It is available on the Pubmed, which is the

national—the data base for the National Library of Medicine. Anybody who wanted to look for the study could find it.

Mr. GREENWOOD. Well, you have heard that story. You have

heard the way people who know what they are talking about describe that, people who understand scientific studies have describe

this study as laughable.

Mr. FRIEDLANDER. Well——

Mr. GREENWOOD. You disagree with that?

Mr. FRIEDLANDER. Yes, I do, sir. With all due respect the study

was a published peer review clinical trial. It means that other expects in the area of pediatrics reviewed the study——

Mr. GREENWOOD. Who conducted the study?

Mr. FRIEDLANDER. Dr. Libieri.

Mr. GREENWOOD. Okay.

Mr. FRIEDLANDER. He conducted the study.

Mr. GREENWOOD. And what are his credentials?

Mr. FRIEDLANDER. Excuse me?

Mr. GREENWOOD. What are his credentials?

Mr. FRIEDLANDER. Doctor—it is a she, and she is an M.D., a pediatric doctor.

Mr. GREENWOOD. Okay. And the fact that the study had no control group——

Mr. FRIEDLANDER. No, it did have a control group, at least a control group as defined by the Food and Drug Administration. They

list the number of controls and the type of controls that are used

in clinical trials. This is a concurrent control. It was a substance

that was tested up against diet and exercise alone. That is what

was done. To say that it was not controlled is silly.

The other thing that you said——

Mr. GREENWOOD. Well, let us go back to Dr. Ayoob again. Mr.

Friedlander is actually going to defend the value of this study, so

would you respond to his defense?

Mr. AYOOB. Yes. In terms of the controls, those controls were not

placebo controlled. That means that they are not particularly valid.

What you are doing is you are testing, giving these pills to kids to

or three times a day against not giving them. And you are attributing the results to the actual ingredient in the pill.

What a good placebo controlled trial would have done is given a

placebo pill with the same amount of water to an equally matched

group of children.

Also with that—as I said——

Mr. GREENWOOD. That is pretty much clinical control 101?

Mr. AYOOB. Oh, yes. Yes.

Mr. GREENWOOD. That is as fundamental as it gets?

Mr. AYOOB. Absolutely.

Mr. GREENWOOD. Is he wrong, Mr. Friedlander?

Mr. FRIEDLANDER. Well, he might not be wrong and you might

not be wrong. But if I am wrong, so is the Food and Drug AdminisVerDate 11-MAY-2000 09:15 Sep 01, 2004 Jkt 000000 PO 00000 Frm 00102 Fmt 6633 Sfmt 6602 95442.TXT HCOM1 PsN: HCOM1
95

tration. And I refer to 21 CFR 314.126 which lists the type of controls that are available to use in clinical trials.

I know you are very emotional, but——

Mr. GREENWOOD. Address your questions to the committee

please, Mr. Friedlander.

Mr. FRIEDLANDER. I’m sorry. But let’s not blow this out proportion. There are other controls besides a double-blinded placebo controlled trial. As a matter of fact, Hoffman-LaRoche just released a

study that was done all—on children that was—the study protocol

was exactly the same as the Libieri study. It was just in the newspapers just the other day. And——

Ms. DEGETTE. Would the chairman yield?

Mr. GREENWOOD. I will yield to the gentlelady from Colorado.

Ms. DEGETTE. I have got to say, Mr. Friedlander——

Mr. FRIEDLANDER. Excuse me.

Ms. DEGETTE. [continuing] if a clinical trial using this methodology were submitted to the FDA for a drug, which is what they,

you know, approve; they do not approve dietary supplements in the

same way, this would have been laughed out of the FDA. And I

think you now that as well as anybody.

This clinical trial was loose, at best. Thank you.

Mr. FRIEDLANDER. Again, Ms. DeGette, I am sorry that I have

to disagree with you, but—and I will get you the statute. This was

an awfully robust clinical trial. The p-value or the confidence value

was .005. There is a statute—.0005. There is a statute in the FDA

regulation—in the FDA Act which provides that studies with that

robust of result only require one clinical trial, as long as there

other supporting evidence that suggests that the trial was done

correctly.

Mr. GREENWOOD. Well, reclaiming my time.

Mr. Gay, Mr. Friedlander seems like a nice guy, but he is also

pled no contest to a long string of charges that had to do with selling worthless mail order cures for ills. Of all the experts in the

world, why would you choose someone, how would you expect to

build the credibility of your company by choosing someone with

that background? I understand that he is—he had a suspended 1

year jail term, they put him on probation for 5 years and barred

him from doing business or living in Florida. Why would this be—

Dr. Mowrey is your expert on science, Dr. Friedlander is your expect on marketing.

Mr. FRIEDLANDER. I am not a doctor, sir.

Mr. GREENWOOD. I am sorry. Mr. Friedlander. This troubles us

that these are the experts with whom you surrounded yourself and

you are sitting here trying to convince us that you are legitimate

business.

Mr. GAY. Actually, I am not trying to convince you of anything.

You asked me here.

Mr. GREENWOOD. Right.

Mr. GAY. I am telling you the facts.

Mr. GREENWOOD. Right.

Mr. GAY. And the facts are this supplement that we are talking

about in PediaLean, it is a food product. We eat it in ice cream.

We eat it in cookies. We eat it imitation crab on a regular basis.

And to say that it causes kinds of problems and they are outside,

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it has not been studied for safety; it is something we ingest on a

regular basis. It is a food product.

The thing that is revolutionary about this is the way it was applied.

Mr. GREENWOOD. Well, why did you not test it yourself? Why

would you rely on——

Mr. GAY. I did test it myself.

Mr. GREENWOOD. No. In a clinical study?

Mr. GAY. No.

Mr. GREENWOOD. Well, what do you mean you tested it yourself?

Mr. GAY. Because that is not our business model. We think that

the American public, that is our business model——

Mr. GREENWOOD. Which is what is your business model?

Mr. GAY. Deserves the right to food markets that are out there

in the marketplace that can be used to benefit them and with basic

research. And that is what this is, is basic research. It is not a

drug.

Mr. GREENWOOD. And you do not have any qualms about using

that same business plan to products that are marketed to 6 year

old children?

Mr. GAY. The business plan had a study that was peer reviewed,

published in a journal for studies. I used to Friedlander for marketing ideas. I used Dr. Chevreau primarily, Dr. Mowrey secondarily on this particular product to review the studies, are there to

make sure we did not have—that we were within the guidelines

that we needed to be——

Mr. GREENWOOD. I am a little confused about the four studies.

Your advertisement only talks about one study. What are the other

studies?

Mr. GAY. Those are the studies that Dr. Chevreau promised to

offer to Congresswoman DeGette. She talked about them earlier.

Mr. GREENWOOD. Wait a minute. Which studies? Giving her next

door neighbor’s children your——

Mr. GAY. No.

Mr. GREENWOOD. Oh, these four——

Mr. GAY. Yes.

Mr. GREENWOOD. Okay. Well, why did you not say four studies

in your ads? I am a little confused about that?

Mr. GAY. Did not need to. Felt like we had the substantiation.

Mr. GREENWOOD. Okay. At one point you had on your website

BBB Online Reliability Program. BBB normally stands for Better

Business Bureau. And then you took it off your website. Two different versions. Is there reason for that?

Mr. GAY. Yes.

Mr. GREENWOOD. What is the reason?

Mr. GAY. We are no longer a member of the BBB.

Mr. GREENWOOD. Why is that? I thought that would be helpful

in gaining confidence in your consumers, would it not?

Mr. GAY. Maybe. But we restructured the company a couple of

years ago. When we restructured the company we had to go back

to the BBB and get reapproved for——

Mr. GREENWOOD. So this is the Better Business Bureau?

Mr. GAY. That is correct.

Mr. GREENWOOD. Okay. And you had to get approved and what?

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Mr. GAY. We just have not done that. Did not see a need for it.

Mr. GREENWOOD. Did not see a need for it?

Mr. GAY. Correct.

Mr. GREENWOOD. Okay. Saw a need for it originally, but then did

not see a need for it more recent.

Is there any reason to think that you might have difficulty getting the Better Business Bureau’s approval?

Mr. GAY. No. Just I think the cost and expense of going through

the process for the different entities for different product lines.

Mr. GREENWOOD. Okay.

My time has expired.

The gentlelady from Colorado?

Ms. DEGETTE. I do not have anymore questions, Mr. Chairman.

Mr. GREENWOOD. Okay. We thank the witnesses for your appearance today, and you are excused.

And the hearing is adjourned.

[Whereupon, at 1:54 p.m., the hearing was adjourned.]

[Additional material submitted for the record follows:]

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