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Correspondence The Committee on Energy and Commerce W.J. "Billy" Tauzin, Chairman Energy and Commerce Leaders Expand Investigation of Skinny Pill for Kids May 7, 2003 Mr. Roger Lopez Dear Mr. Ruiz: The Committee on Energy and Commerce has jurisdiction over matters relating
to the regulation of food and drugs, advertising and marketing practices and
consumer protection, generally. Pursuant to this authority, the Committee is
undertaking a review of non-prescription dietary supplements marketed to
children. We have learned that you are involved in the development of a product
called "Skinny Pill for Kids" and that you have worked with Ms. Edita
Kaye to develop and promote this product. For example, on December 9, 2002, a
scientist employed by PAL Laboratories ("PAL"), Jose De La Rocha,
appeared on "Connie Chung Tonight" to discuss the formulation of the
"Skinny Pill for Kids" and its safety for children. During this
television appearance, Mr. De La Rocha, who was identified as "director of
quality control and formulation" at PAL Laboratories, described some of the
ingredients in the "Skinny Pill for Kids" stating that it is
"mainly a fiber product" and that a "few milligrams" of uva
ursi, a diuretic, are found in each pill in the "Skinny Pill for Kids"
formulation. When questioned about whether this product is dangerous for young
people, Mr. De La Rocha relies on the fact that the product is a "fiber
product" and that it is proven that children and adults will feel full from
fiber and thus, will eat less. Further, after a discussion about the ingredients
in the "Skinny Pill for Kids," Mr. De La Rocha endorses the product as
safe for children by noting that he would give his children this product. In
response to questioning concerning why the "Skinny Pill for Kids" was
not tested on children, Mr. De La Rocha made clear that PAL Laboratories
"are only the manufacturers.we are not involved in the marketing of the
product." Given Mr. De La Rocha's statements concerning the formulation of the
"Skinny Pill for Kids," as well as his statement on national
television that imply this is a safe product for children, the Committee is
requesting additional information from PAL concerning this product. As you know,
several doctors, including one that specializes in pediatric obesity, have
questioned not only the efficacy of the pill, but more importantly, the safety
of some herbs contained in the "Skinny Pill for Kids." These issues
raise concerns about whether you are formulating a cocktail of unregulated herbs
that has not been tested for its safety, either in content or amount, for
children. In order to obtain additional information about this matter, we are
requesting that, pursuant to Rule X and XI of the U.S. House of Representatives,
you provide the Committee with the information requested below by Wednesday, May
21, 2003. State when and by whom you were first contacted
about developing and/or manufacturing a product known as "Skinny Pill
for Kids" and explain the development process of this product. Provide
all records that relate to your engagement as the manufacturer or
prospective manufacturer of this product, including all internal or external
communications, or any other records relating to developing, manufacturing,
promoting or marketing this product. If the documents requested in Question 1 do not
provide a complete record of oral commitments between PAL and Ms. Edita Kaye
or her corporate entities, including an entity known as "The Skinny
Pill," including expected dates of delivery and other salient
information, provide a statement detailing the terms of such obligations. Identify all products that you are, have been
or will be manufacturing for Ms. Edita Kaye, a corporate entity known as
"The Skinny Pill" or any corporate entity owned or operated by Ms.
Edita Kaye. For each product identified, include a description of the
product, the date that you first manufactured the product, the amount of the
product that you have manufactured to date, and the company for whom you are
manufacturing the product. A listing of all ingredients and the amount of
each ingredient contained in the formulation or proposed formulation(s) of
the "Skinny Pill for Kids," and 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 the
"Skinny Pill for Kids." Include in your response the name of the
person, the most recent address and telephone number, and the name of the
company with which the person is affiliated. State whether the "Skinny Pill for
Kids" (or any of its active or inactive ingredients) has been tested
for either safety or efficacy purposes on children to whom it is being
marketed -namely, children ages 6-12 years old. Include in your response a
description of the group that was tested and the duration and results of the
test(s). Provide all records that relate to such tests. Explain the difference between the ingredients
and/or the amount of ingredients in "The Skinny Pill" (for adults)
and the "Skinny Pill for Kids." Provide all records comparing,
directly or indirectly, the two products. State whether PAL received any payment for its
efforts to manufacture or promote the "Skinny Pill for Kids" and
if so, the amount of the payment made to PAL to date. State whether PAL is involved in the
manufacturing or development of other dietary supplement products designed
for use by persons sixteen (16) years of age or younger. If so, identify the
name of the product, name and corporate affiliation of the person(s) with
whom or for whom PAL is developing or manufacturing the product, name of the
person(s) at PAL that is involved in the development and/or manufacture of
the product, name of the person(s) with expert knowledge of pediatric
medicine or nutrition that are involved in the product development and/or
manufacturing, the date the product was or will be available for public
consumption, and a summary description of the product and what its designed
use is for children. Identify the person(s) and their agents (if
any) responsible for promoting or negotiating Mr. Jose De La Rocha's
appearance on "Connie Chung Tonight," December 9, 2002. Include
the name of the person(s), the company that he/she works for, the person's
title at the company and the most recent contact information. Provide a curriculum vitae of Mr. Jose De La
Rocha, including but not limited to, his educational background, employment
history, and background or experience in science, nutrition (including
pediatric nutrition) or medicine. 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 the
Skinny Pill for Kids, unless otherwise noted; the term "you" or
"your" means PAL Laboratories 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 John D. Dingell James C. Greenwood, Chairman Peter Deutsch, Ranking Member Related Documents The
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