[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]




    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

=======================================================================

                                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



                    U.S. GOVERNMENT PRINTING OFFICE
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                               __________


                    COMMITTEE ON ENERGY AND COMMERCE

                      JOE BARTON, Texas, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
RALPH M. HALL, Texas                   Ranking Member
MICHAEL BILIRAKIS, Florida           HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
JAMES C. GREENWOOD, Pennsylvania     FRANK PALLONE, Jr., New Jersey
CHRISTOPHER COX, California          SHERROD BROWN, Ohio
NATHAN DEAL, Georgia                 BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia             ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming               BART STUPAK, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES W. ``CHIP'' PICKERING,       KAREN McCARTHY, Missouri
Mississippi, Vice Chairman           TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania        TOM ALLEN, Maine
MARY BONO, California                JIM DAVIS, Florida
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
LEE TERRY, Nebraska                  HILDA L. SOLIS, California
MIKE FERGUSON, New Jersey            CHARLES A. GONZALEZ, Texas
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
JOHN SULLIVAN, Oklahoma

                      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           PETER DEUTSCH, Florida
CLIFF STEARNS, Florida                 Ranking Member
RICHARD BURR, North Carolina         DIANA DeGETTE, Colorado
CHARLES F. BASS, New Hampshire       TOM ALLEN, Maine
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
  Vice Chairman                      HENRY A. WAXMAN, California
MIKE FERGUSON, New Jersey            EDWARD J. MARKEY, Massachusetts
MIKE ROGERS, Michigan                JOHN D. DINGELL, Michigan,
JOE BARTON, Texas,                     (Ex Officio)
  (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)

  

 
    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.
    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 Disease 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 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.
    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:]

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 weight-loss 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 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.
    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. 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.
    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 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
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    \1\ The 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.
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    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
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    \2\ The 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,'' and Section 
12, which prohibits the false advertisement of ``food, drugs, devices, 
services or cosmetics.'' 15 U.S.C. 45, 52.
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    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
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    \3\ Source: 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.
    \5\ Source: Nutrition Business Journal (July 2002).
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    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
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    \6\ The 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: 
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    Commission law requires that claims about the safety and efficacy 
of any health-related 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 beyond the basic cease and desist orders in many cases, to 
require substantial monetary 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
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    \7\ See, 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. C-3926 (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.
    \8\ See, 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.
    \9\ See, 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).
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    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 
stepped-up 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
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    \10\ See Working Agreement Between FTC and FDA, 3 Trade Reg. Rep. 
(CCH)  9,859.01 (1971).
    \11\ See Federal Trade Commission Attacks $1 Billion in Deceptive 
Health Marketing Since December, FTC Press Release (July 10, 2003), 
available at .
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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.
---------------------------------------------------------------------------
    \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.
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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
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    \13\ See, e.g., Dietary Supplements: An Advertising Guide For 
Industry, Part B.5., available at .
    \14\ Last 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).
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    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 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
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    \15\ The 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.
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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
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    \16\ Attention Deficit-Hyperactivity Disorder Information Page, NIH 
National Institute of Neurological Disorders (Mar. 21, 2003), available 
at .
    \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.
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    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.
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    \18\ The Vital Basics case also challenged safety and efficacy 
claims for ``V-Factor,'' a supplement marketed as a male sexual 
performance enhancer.
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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 body-building 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 orders in both of these cases also required an 
additional warning for certain products that contained the powerful 
cardiovascular and central nervous system stimulant, ephedra, which has 
since been banned by the Food and Drug Administration.
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    \19\ Specifically 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.''
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    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.
---------------------------------------------------------------------------
    \20\ The 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.''
    \21\ The 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.
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    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
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    \22\ The 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
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    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 Commission 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.
---------------------------------------------------------------------------
    \23\ The 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 .
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \25\ FTC Consumer Feature, Promotions for Kids' Dietary Supplements 
Leave Sour Taste, (May 2000), available at .
---------------------------------------------------------------------------
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.

                               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) (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 Kids-Eeze 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 quality of life seen in recent decades will 
erode and more health-related 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 
research-based 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.
    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 children 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, 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 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.
    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 co-morbidities 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 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 state-of-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.

                               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. 
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 pseudo-science. 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 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 
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 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 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 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 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.
---------------------------------------------------------------------------
    \1\ PDR for Herbal Medicines, 2000 pp 779-782;
    \2\ McGuffin 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
---------------------------------------------------------------------------
    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 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.
    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.
    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.
    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 proceed 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.
    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 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.
    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 criminal 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?
    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 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 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 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 advertising 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.
    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 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 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.
    [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 ephedra-
containing 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.
    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?
    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?
    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?
    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.

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 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 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 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:]

   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 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 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 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 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 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 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 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 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 (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 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 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.
    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.''
    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.
    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----
    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----
    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.
    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.
    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.
    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?
    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 effective. 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?
    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.
    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?
    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 determined 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.
    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.
    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?
    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 
particular. 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?
    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.
    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?
    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.
    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----
    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?
    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----
    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.
    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''?
    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 
Administration. 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, 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?
    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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