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March 25, 2003
Mr. Dennis Gay
President and CEO
Basic Research LLC
402 West 5050
North Provo, UT 84604
Dear Mr. Gay:
The Committee on Energy and Commerce has jurisdiction over matters relating
to the regulation of food and drugs, advertising and marketing practices,
consumer protection and public health. Pursuant to this authority, the Committee
is undertaking a review of non-prescription dietary supplements and is
particularly interested in reviewing dietary supplements that have been, are
being, or may be developed, produced or marketed specifically for children. It
has come to our attention that you have developed and are selling a product
called "PediaLean." In various media outlets where you have advertised
this product, including on your website www.pedialean.com, you have stated that
this pill is for children from ages 6-16 years old that have a weight problem;
further, you have indicated that your product has been "clinically proven
safe" for children and has been tested successfully in a clinical trial
with children. However, it is our understanding that the active ingredient in
"PediaLean" is "Pediatropin," a substance that you state on
your website and in advertisements as being derived from "p.rivieri,"
the Latin name for a plant extract called the "konjac root." Further,
it is our understanding that "glucomannan," a bulk forming laxative,
is also derived from the "konjac root." This raises the question of
whether "Pediatropin" is simply a trademark name for glucommanan and,
if not, what the specific ingredients are in the "PediaLean" product
as a whole, as well as, in the "Pediatropin" component. It is our
understanding that glucomannan has never been tested for safety in the United
States on children.
In order to obtain additional information about this matter, we are
requesting that, pursuant to Rules X and XI of the U.S. House of
Representatives, you provide the Committee with the information requested below
by Tuesday, April 8, 2003.
- A listing of all ingredients and the amount of each ingredient contained
in the current marketed formulation of "PediaLean," and any other
formulations of the product marketed or tested in humans, as well as, all
records that relate to any research and/or testing of any and all
ingredients in the product, whether conducted by your company or any other
person or entity.
- Identify the person(s) responsible for determining the ingredients and
amount of each ingredient contained in "PediaLean." Include in
your response the name of the person, the most recent address and telephone
number, the name of the company with which the person is affiliated and
title within the company.
- Identify all ingredients that are in "Pediatropin" and their
scientific origins and explain the "method for micro-processing the
plant [p. rivieri] into a high molecular weight powder" that you refer
to on your website www.pedialean.com.
- Explain what the "proprietary micronization process" of
PediaLean is and how this process guarantees that "PediaLean" is
the "one and only weight-control compound designed, manufactured, and
clinically provide safe and effective for use by overweight children and
adolescents," as you represent on your website www.pedialean.com.
- All records relating to the development and marketing of "PediaLean."
- Provide a list of any other brand names under which the current or any
previous formulation of "PediaLean" is or has been marketed,
produced or sold by Basic Research LLC, a related firm, or supplied under
contract to an unrelated firm for marketing under their brand.
- State whether "PediaLean" (or any of its active or inactive
ingredients) has been tested for either safety or efficacy purposes in
children to whom it is being marketed -namely, children ages 6-16 years old.
Include in your response a description of the group that was tested (as well
as those who were excluded from such testing and the reasons therein), the
specific ingredient(s) that was tested and the duration and results of the
test(s). Provide all records that relate to such tests, including but not
limited to the clinical trial referenced on your website, www.pedialean.com.
- Provide a list of all physicians or scientists who were involved in the
development of "PediaLean" and include in your response the
following information:
- Name of the physician or scientist;
- Address and telephone number for the physician or scientist;
- Identification of States in which the physician is licensed to practice
medicine;
- Whether the physician or scientist received any compensation or benefit,
monetary or otherwise, for agreeing to speak on behalf of your product. If
the person received compensation, identify the type and amount and any and
provide all records that relate to such compensation or benefit,
including, but not limited to, any written contracts between the physician
or scientist and you or any corporate entity with which you are
affiliated;
- Whether the physician or scientist has prior experience in pediatric
care and if so, explain their medical credentials; and
- Provide all of the information about "PediaLean" that was
given to such physician or scientist.
- State whether you have received consumer complaints or notifications
concerning adverse health events associated with "PediaLean." If
so, for each year beginning when your product was first available for
consumption, provide the following information:
- The name of complainant; b.
- The date of complaint;
- A summary of consumer's adverse event(s);
- A summary of company's response to complaint;
- Whether any information about the complaint was reported to the Food and
Drug Administration ("FDA") or any other government entity, and
if so, a summary of the information that you provided; and
- All records relating to such complaints.
- State whether your company has reporting or tracking procedures for
adverse health events reported by consumers of your products. If so,
identify the entities to which these reports are made, the individual(s)
responsible for retaining such information, and describe the specific
procedures. Provide a copy of all procedures described in this question.
- State whether a customer has filed any lawsuits against your company
alleging health-related problems associated with taking "PediaLean."
If so, provide the following information:
- The name of complainant(s);
- The date the lawsuit was filed;
- A summary of health-related allegations of lawsuit; and
- The status of the lawsuit (i.e. pending, settled, verdict).
- Identify all corporate entities, whether for-profit or not-for-profit, in
which you are an officer or director, have a senior management position in
or are a founding member. Include in your response the name of the corporate
entity, the address, your position in the entity, and the dates of your
affiliation.
- Describe the corporate relationship between Basic Research LLC and
Klein-Becker usa. Provide all records that relate to the corporate
relationship of these companies.
- Provide a list of the names and titles of senior management in Basic
Research LLC and Klein-Becker usa, including those individuals involved in
developing and marketing "PediaLean" and any of the ingredients
used therein.
- From 1998 through the present, state the annual revenue for Basic Research
LLC, Klein-Becker usa and the amount of revenue per year generated from
sales of "PediaLean."
- Provide the name of the company(ies) producing and/or manufacturing "PediaLean"
and the name of the company(ies) distributing "PediaLean" in the
United States.
- For each year from 1998 through the present, identify and describe all
investigations by state or Federal agencies of your company (including
Klein-Becker usa) relating to your products, including but not limited to
"PediaLean." Include in your response the name of the product
being investigated; the identity of the investigating agency; the nature of
the investigation; and, if applicable, the resolution of the investigation.
Please note that for purposes of responding to this request, the terms
"records" and "relating" should be interpreted in accordance
with the attachment to this letter. The term "product" refers to
"PediaLean," unless otherwise noted; the term "you" or
"your" means Basic Research LLC or one or more of its divisions,
subsidiaries or affiliates, or related entities.
If you have any questions, please contact Kelli Andrews, Majority Counsel, at
(202) 226-2424, or David Nelson, Minority Investigator, at (202) 226-3400.
Sincerely,
W.J. "Billy" Tauzin Chairman
John D. Dingell Ranking Member
James C. Greenwood, Chairman Subcommittee on Oversight & Investigations
Peter Deutsch, Ranking Member Subcommittee on Oversight & Investigations
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