UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
In the Matter of
TrendMark Inc., also doing business as TrendMark International, a
corporation, William McCormack, individually and as an officer of the corporation, and E.
Robert Gates, individually and as an officer of the corporation.
FILE NO. 972 3255
AGREEMENT CONTAINING
CONSENT ORDER
The Federal Trade Commission has conducted an investigation of certain acts and
practices of TrendMark Inc. (TrendMark), also doing business as TrendMark
International, a corporation, and William McCormack and E. Robert Gates, individually and
as officers of the corporation (proposed respondents). Proposed respondents
are willing to enter into an agreement containing a consent order resolving the
allegations contained in the attached draft complaint. Therefore,
IT IS HEREBY AGREED by and between TrendMark Inc., a corporation, and William
McCormack and E. Robert Gates, individually and as an officers of the corporation, by
their duly authorized officers, and counsel for the Federal Trade Commission that:
1.a. Proposed respondent TrendMark is a Tennessee corporation with its principal office
or place of business at 3665 South Perkins, Suite 8, Memphis, TN 33183.
1.b.Proposed respondent William McCormack is an owner and officer of proposed
respondent TrendMark. Individually or in concert with others, he formulates, directs, or
controls the policies, acts, or practices of TrendMark. His principal office or
place of business is the same as that of TrendMark.
1. c. Proposed respondent E. Robert Gates is an owner and officer of proposed
respondent TrendMark. Individually or in concert with others, he formulates, directs, or
controls the policies, acts, or practices of TrendMark. His principal office or
place of business is the same as that of TrendMark.
2. Proposed respondents admit all the jurisdictional facts set forth in the draft
complaint.
3. Proposed respondents waive:
a. Any further procedural steps;
b. The requirement that the Commission's decision contain a statement of findings of
fact and conclusions of law; and
c. All rights to seek judicial review or otherwise to challenge or contest the validity
of the order entered pursuant to this agreement.
4. This agreement shall not become part of the public record of the proceeding unless
and until it is accepted by the Commission. If this agreement is accepted by the
Commission, it, together with the draft complaint, will be placed on the public record for
a period of sixty (60) days and information about it publicly released. The Commission
thereafter may either withdraw its acceptance of this agreement and so notify proposed
respondents, in which event it will take such action as it may consider appropriate, or
issue and serve its complaint (in such form as the circumstances may require) and decision
in disposition of the proceeding.
5. This agreement is for settlement purposes only and does not constitute an admission
by proposed respondents that the law has been violated as alleged in the draft complaint,
or that the facts as alleged in the draft complaint, other than the jurisdictional facts,
are true.
6. This agreement contemplates that, if it is accepted by the Commission, and if such
acceptance is not subsequently withdrawn by the Commission pursuant to the provisions of
Section 2.34 of the Commission's Rules, the Commission may, without further notice to
proposed respondents, (1) issue its complaint corresponding in form and substance with the
attached draft complaint and its decision containing the following order in disposition of
the proceeding, and (2) make information about it public. When so entered, the order shall
have the same force and effect and may be altered, modified, or set aside in the same
manner and within the same time provided by statute for other orders. The order shall
become final upon service. Delivery of the complaint and the decision and order to
proposed respondents by any means specified in Section 4.4 of the Commission's Rules shall
constitute service. Proposed respondents waive any right they may have to any other manner
of service. The complaint may be used in construing the terms of the order. No agreement,
understanding, representation, or interpretation not contained in the order or in the
agreement may be used to vary or contradict the terms of the order.
7. Proposed respondents have read the draft complaint and consent order. They
understand that they may be liable for civil penalties in the amount provided by law and
other appropriate relief for each violation of the order after it becomes final.
ORDER
DEFINITIONS
For purposes of this order, the following definitions shall apply:
1. Competent and reliable scientific evidence shall mean tests, analyses,
research, studies, or other evidence based on the expertise of professionals in the
relevant area, that has been conducted and evaluated in an objective manner by persons
qualified to do so, using procedures generally accepted in the profession to yield
accurate and reliable results.
2. Clearly and prominently shall mean as follows:
A. In an advertisement communicated through an electronic medium (such as television,
video, radio, and interactive media such as the Internet and online services), the
disclosure shall be presented simultaneously in both the audio and video portions of the
advertisement. Provided, however, that in any advertisement presented solely through video
or audio means, the disclosure may be made through the same means in which the ad is
presented. The audio disclosure shall be delivered in a volume and cadence sufficient for
an ordinary consumer to hear and comprehend it. The video disclosure shall be of a size
and shade, and shall appear on the screen for a duration, sufficient for an ordinary
consumer to read and comprehend it. In addition to the foregoing, in interactive media the
disclosure shall also be unavoidable and shall be presented prior to the consumer
incurring any financial obligation.
B. In a print advertisement, promotional material, or instructional manual, the
disclosure shall be in a type size and location sufficiently noticeable for an ordinary
consumer to read and comprehend it, in print that contrasts with the background against
which it appears. In multipage documents, the disclosure shall appear on the cover or
first page.
C. On a product label, the disclosure shall be in a type size and location on the
principal display panel sufficiently noticeable for an ordinary consumer to read and
comprehend it, in print that contrasts with the background against which it appears.
The disclosure shall be in all of the languages that are present in the advertisement.
Nothing contrary to, inconsistent with, or in mitigation of the disclosure shall be used
in any advertisement or on any label.
3. Unless otherwise specified, respondents shall mean TrendMark Inc., its
successors and assigns, and its officers William McCormack and E. Robert Gates,
individually and as an officers of TrendMark Corp., and each of the aboves agents,
representatives, and employees.
4. Commerce shall mean as defined in Section 4 of the Federal Trade
Commission Act, 15 U.S.C. § 44.
5. Drug shall mean as defined in Section 15 of the Federal Trade Commission
Act, 15 U.S.C. § 55.
6. Food shall mean as defined in Section 15 of the Federal Trade Commission
Act, 15 U.S.C. § 55.
I.
IT IS ORDERED that respondents, directly or through any corporation, subsidiary,
division, or other device, in connection with the manufacturing, labeling, advertising,
promotion, offering for sale, sale, or distribution of Neuro-Thin and
Lipo-Thin, or any other product or program in or affecting commerce, shall
not make any representation, in any manner, expressly or by implication, that:
A. Such product or program controls appetite;
B. Such product or program causes significant weight loss without a change in diet;
C. Such product or program causes long-term or permanent weight loss;
D. Such product or program prevents or helps prevent the absorption of
ingested fat;
E. Such product or program lowers LDL cholesterol or boosts HDL cholesterol;
F. Such product or program promotes healing of ulcers or lesions;
G. Such product or program helps prevent irritable bowel syndrome;
H. Such product or program reduces levels of uric acid in the blood; or
I. Such product or program helps improve cardiovascular health,
unless at the time it is made, respondents possess and rely upon competent and reliable
scientific evidence that substantiates the representation.
II.
IT IS FURTHER ORDERED that respondents, directly or through any corporation,
subsidiary, division, or other device, in connection with the manufacturing, labeling,
advertising, promotion, offering for sale, sale, or distribution of any product or program
in or affecting commerce, shall not represent, in any manner, expressly or by
implication, that the experience represented by any user testimonial or endorsement of the
product represents the typical or ordinary experience of members of the public who use the
product, unless:
A. At the time it is made, respondents possess and rely upon competent and reliable
scientific evidence that substantiates the representation; or
B. Respondents disclose, clearly and prominently, and in close proximity to the
testimonial or endorsement, either:
- what the generally expected results would be for users of the product, or
- the limited applicability of the endorsers experience to what consumers may
generally expect to achieve, that is, that consumers should not expect to experience
similar results.
For purposes of this Part, endorsement shall mean as defined in 16
C.F.R. § 255.0(b).
III.
IT IS FURTHER ORDERED that respondents, directly or through any corporation,
partnership, subsidiary, division, or other device, in connection with the manufacturing,
labeling, advertising, promotion, offering for sale, sale, or distribution of
Neuro-Thin or Lipo-Thin, or any other food, dietary supplement, drug, or
device, as food, drug, and device are defined
in Section 15 of the Federal Trade Commission Act, in or affecting commerce, shall not
make any representation, in any manner, expressly or by implication, about the health
benefits, performance, or efficacy of such product, unless, at the time the representation
is made, respondents possess and rely upon competent and reliable scientific evidence that
substantiates the representation.
IV.
IT IS FURTHER ORDERED that respondents, directly or through any corporation,
subsidiary, division, or other device, in connection with the labeling, advertising,
promotion, offering for sale, sale, or distribution of any product or program, in
or affecting commerce, shall not misrepresent, in any manner, expressly or by implication,
the existence, contents, validity, results, conclusions or interpretations of any test,
study, or research.
V.
IT IS FURTHER ORDERED that respondents, directly or through any corporation,
subsidiary, division, or other device, in connection with the labeling, advertising,
promotion, offering for sale, sale, or distribution of any product or program, in or
affecting commerce, shall disclose, clearly and prominently, a material connection, when
one exists, between a person providing an endorsement for any product or program, as
endorsement is defined in 16 C.F.R. § 255.0(b), and any respondent, or any
individual or entity labeling, advertising, promoting, offering for sale, selling, or
distributing such product or program. For purposes of this Part, material
connection shall mean any relationship that might materially affect the weight or
credibility of the endorsement and would not reasonably be expected by consumers.
VI.
Nothing in this order shall prohibit respondents from making any representation for any
drug that is permitted in the labeling for such drug under any tentative final or final
standard promulgated by the Food and Drug Administration, or under any new drug
application approved by the Food and Drug Administration.
VII.
Nothing in this order shall prohibit respondents from making any representation for any
product that is specifically permitted in labeling for such product by regulations
promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and
Education Act of 1990.
VIII.
IT IS FURTHER ORDERED that respondent TrendMark, and its successors and assigns, and
respondents William McCormack and E. Robert Gates shall, for five (5) years after the last
date of dissemination of any representation covered by this order, maintain and upon
request make available to the Federal Trade Commission for inspection and copying:
A. All advertisements and promotional materials containing the representation;
B. All materials that were relied upon in disseminating the representation; and
C. All tests, reports, studies, surveys, demonstrations, or other evidence in their
possession or control that contradict, qualify, or call into question the representation,
or the basis relied upon for the representation, including complaints and other
communications with consumers or with governmental or consumer protection organizations.
IX.
IT IS FURTHER ORDERED that, for a period of ten (10) years after the date of issuance
of this order, respondent TrendMark, and its successors and assigns, and respondents
William McCormack and E. Robert Gates shall deliver a copy of this order to all current
and future principals, officers, directors, and managers, and to all current and future
employees, agents, and representatives having responsibilities with respect to the subject
matter of this order, and shall secure from each such person a signed and dated statement
acknowledging receipt of the order. Respondents shall deliver this order to current
personnel within thirty (30) days after the date of service of this order, and to future
personnel within thirty (30) days after the person assumes such position or
responsibilities.
X.
IT IS FURTHER ORDERED that respondent TrendMark, and its successors and assigns shall
notify the Commission at least thirty (30) days prior to any change in the corporation(s)
that may affect compliance obligations arising under this order, including but not limited
to a dissolution, assignment, sale, merger, or other action that would result in the
emergence of a successor corporation; the creation or dissolution of a subsidiary, parent,
or affiliate that engages in any acts or practices subject to this order; the proposed
filing of a bankruptcy petition; or a change in the corporate name or address. Provided,
however, that, with respect to any proposed change in the corporation about which
respondents learn less than thirty (30) days prior to the date such action is to take
place, respondents shall notify the Commission as soon as is practicable after obtaining
such knowledge. All notices required by this Part shall be sent by certified mail to the
Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade
Commission, Washington, D.C. 20580.
XI.
IT IS FURTHER ORDERED that each of respondents William McCormack and E. Robert Gates,
for a period of five (5) years after the date of issuance of this order, shall notify the
Commission of the discontinuance of his current business or employment, or of his
affiliation with any new business or employment. The notice shall include respondent's new
business address and telephone number and a description of the nature of the business or
employment and his duties and responsibilities. All notices required by this Part shall be
sent by certified mail to the Associate Director, Division of Enforcement, Bureau of
Consumer Protection, Federal Trade Commission, Washington, D.C. 20580.
XII.
IT IS FURTHER ORDERED that respondent TrendMark, and its successors and assigns, and
respondents William McCormack and E. Robert Gates shall, within sixty (60) days after the
date of service of this order, and at such other times as the Federal Trade Commission may
require, file with the Commission a report, in writing, setting forth in detail the manner
and form in which they have complied with this order.
XIII.
This order will terminate twenty (20) years from the date of its issuance, or twenty
(20) years from the most recent date that the United States or the Federal Trade
Commission files a complaint (with or without an accompanying consent decree) in federal
court alleging any violation of the order, whichever comes later; provided, however, that
the filing of such a complaint will not affect the duration of:
A. Any Part in this order that terminates in less than twenty (20) years;
B. This order's application to any respondent that is not named as a defendant in such
complaint; and
C. This order if such complaint is filed after the order has terminated pursuant to
this Part.
Provided, further, that if such complaint is dismissed or a federal court rules that
the respondents did not violate any provision of the order, and the dismissal or ruling is
either not appealed or upheld on appeal, then the order will terminate according to this
Part as though the complaint had never been filed, except that the order will not
terminate between the date such complaint is filed and the later of the deadline for
appealing such dismissal or ruling and the date such dismissal or ruling is upheld on
appeal.
Signed this day of , 1998
TrendMark Corp.
By:
William McCormack
President
William McCormack,
individually and as an officer of TrendMark Inc.
E. Robert Gates,
individually and as an officer of TrendMark International
Ronald L. Waldman
Counsel for the Federal Trade Commission
APPROVED:
Michael Joel Bloom
Director
New York Regional Office
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
In the Matter of
TrendMark Inc., also doing business as TrendMark International, a
corporation, William McCormack, individually and as an officer of the corporation, and E.
Robert Gates, individually and as an officer of the corporation.
DOCKET NO.
COMPLAINT
The Federal Trade Commission, having reason to believe that TrendMark Inc., a
corporation, William McCormack, and E. Robert Gates, individually and as officers of the
corporation (respondents), have violated the provisions of the Federal Trade
Commission Act, and it appearing to the Commission that this proceeding is in the public
interest, alleges:
1. Respondent TrendMark Inc. (TrendMark) is a Tennessee corporation with
its principal office or place of business at 3665 South Perkins, Suite 8, Memphis, TN
33183.
2. Respondent William McCormack is an owner and officer of respondent TrendMark.
Individually or in concert with others, he formulates, directs, or controls the policies,
acts, or practices of TrendMark, including the acts or practices alleged in this
complaint. His principal office or place of business is the same as that of TrendMark.
3. Respondent E. Robert Gates is an owner and officer of respondent TrendMark.
Individually or in concert with others, he formulates, directs, or controls the policies,
acts, or practices of TrendMark, including the acts or practices alleged in this
complaint. His principal office or place of business is the same as that of TrendMark.
4. Respondents have manufactured, advertised, labeled, offered for sale, sold, and
distributed over-the-counter weight-loss products to the public called
Neuro-Thin and Lipo-Thin. Neuro-Thin and
Lipo-Thin are foods or drugs, within the meaning of
Sections 12 and 15 of the Federal Trade Commission Act.
5. The acts and practices of respondents alleged in this complaint have been in or
affecting commerce, as commerce is defined in Section 4 of the Federal Trade
Commission Act.
- Respondents have disseminated or have caused to be disseminated advertisements,
including but not necessarily limited to Exhibit A--a copy of a bulk e-mail sent to users
of America Online--which, among other things, directs the recipient to click on a
hyperlink which takes the recipient directly to TrendMarks website (excerpts from a
printout of the website are attached as Exhibit B). These advertisements contain the
following statements:
A. NEW ALL-NATURAL WEIGHT LOSS PRODUCT, NOW ON THE MARKET!!!
If youve heard about the new ?Phen/Fen Diet, and thought about trying
it..... DONT!!!
With the ALL NATURAL ?Thin-Thin Diet, you can achieve the same results,
without the dangerous side-effect of Drugs! Eat the foods you want, and STILL lose 10-12
pounds per month! Patent Pending Thin-Thin Diet works for you to lose weight and KEEP IT
OFF.
. . .
The Thin-Thin Diet Program is a Nutritional Breakthrough Program with a NO DIET, NO
WILL POWER, easy way to LOSE UP TO 20 POUNDS PER MONTH and KEEP IT OFF!!
(Exhibit A)
B. Read what a few of the THIN-THIN DIET users are saying:
. . . 'Because of the THIN-THIN Diet, I have reached my weight-loss goal and
my diabetes is much less of a problem!'
Toni H., Ohio
'After my husband died, I suffered from depression and gained 50 pounds. I tried
several diets, but just couldnt lose any of the weight. Ive lost 14 pounds
already on the THIN-THIN DIET and feel great!'
Kay M., Tennessee
NEURO-THIN turns your ?hunger switch off.
. . .
NEURO-THIN help[s] balance the levels of serotonin and dopamine in your
brain. The result? Food cravings and hunger pangs are eliminated . . . and . . .
youll be on the way to achieving your goal!
LIPO-THIN Features:
- Absorbs and binds fat.
- Inhibits LDL cholesterol and boosts HDL cholesterol.
- Promotes healing of ulcers and lesions.
. . .
- Helps prevent irritable bowel syndrome.
- Reduces levels of uric acid in the blood.
. . .
- Correlates with improved cardiovascular health.
LIPO-THIN eliminates fat before your body can absorb it.
Forbidden foods that you craved before beginning your THIN-THIN DIET can
still be eaten in moderation because the fat they contain is blocked by the chitin fiber
found in LIPO-THIN. This remarkable, naturally occurring ingredient acts like
a 'fat magnet' or a 'fat sponge' in your digestive tract. It forms a non-digestible gel
that binds with fat molecules and prevents their absorption into your body.
. . .
This program works. The THIN-THIN DIET is based on the latest scientific
studies. It stops cravings and blocks fat absorption.
(Exhibit B)
7. Through the means described in Paragraph 6, respondents have represented, expressly
or by implication, that:
- A. Neuro-Thin controls appetite.
-
- B. Taking Neuro-Thin and Lipo-Thin in combination causes significant weight
loss without a change in diet.
-
- C. Taking Neuro-Thin and Lipo-Thin in combination causes long-term or
permanent weight loss.
-
- D. Lipo-Thin helps prevent the absorption of ingested fat.
-
- E. Lipo-Thin lowers LDL cholesterol and boosts HDL cholesterol.
-
- F. Lipo-Thin promotes healing of ulcers and lesions.
-
- G. Lipo-Thin helps prevent irritable bowel syndrome.
-
- H. Lipo-Thin reduces levels of uric acid in the blood.
-
- I. Lipo-Thin helps improve cardiovascular health.
-
- J. Testimonials from consumers appearing in advertisements for the Thin-Thin Diet
reflect the typical or ordinary experience of members of the public who use
Neuro-Thin and Lipo-Thin.
8. Through the means described in Paragraph 6, respondents have represented, expressly
or by implication, that they possessed and relied upon a reasonable basis that
substantiated the representations set forth in Paragraph 7, at the time the
representations were made.
9. In truth and in fact, respondents did not possess and rely upon a reasonable basis
that substantiated the representations set forth in Paragraph 7, at the time the
representations were made. Among other reasons, the purported support which proposed
respondents did rely upon for the above claims--studies on individual components of
Neuro-Thin or Lipo-Thin-- did not relate adequately to their advertising
claims. For example, most of the studies that were submitted by the proposed respondents
as support were test tube studies and studies of rats. These studies cannot be used as
adequate support for the therapeutic effects of Neuro-Thin and Lipo-Thin in
human beings. Therefore, the representation set forth in Paragraph 8 was, and is, false or
misleading.
10. Through the means described in Paragraph 6, respondents have represented, expressly
or by implication, that scientific studies prove that Neuro-Thin and
Lipo-Thin cause significant weight loss.
11. In truth and in fact, scientific studies do not prove that Neuro-Thin
and Lipo-Thin cause significant weight loss. Therefore, the representation set forth
in Paragraph 10 was, and is, false or misleading.
12. Through the means described in Paragraph 6, respondents have represented that the
statements of Toni Holcomb, John Vaught, and Kay Morton appearing in website
advertisements are endorsements of Neuro-Thin and Lipo-Thin. Respondents have
failed to disclose adequately that these endorsers have a material connection with
individuals and entities marketing and profiting from the sales of Neuro-Thin and
Lipo-Thin. At the time of providing their endorsements, Toni Holcomb and John Vaught
were the spouses of independent distributors of Neuro-Thin and Lipo-Thin. At
the time of providing her endorsement, Kay Morton was an independent distributor of
Neuro-Thin and Lipo-Thin. These facts would be material to consumers in their
purchase or use decisions regarding Neuro-Thin and Lipo- Thin. The failure to
disclose adequately this fact, in light of the representation made, was, and is, a
deceptive practice.
13. The acts and practices of respondents as alleged in this complaint constitute
unfair or deceptive acts or practices, and the making of false advertisements, in or
affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission
Act.
THEREFORE, the Federal Trade Commission this day of , has issued this complaint against
respondents.
By the Commission.
Donald S. Clark
Secretary
SEAL:
ANALYSIS OF PROPOSED CONSENT ORDER
TO AID PUBLIC COMMENT
The Federal Trade Commission has accepted, subject to final approval, an agreement to a
proposed consent order ("proposed order") from TrendMark Inc., also doing
business as TrendMark International (TrendMark), and its principals, William
McCormack and E. Robert Gates.
The proposed order has been placed on the public record for sixty (60) days for receipt
of comments by interested persons. Comments received during this period will become part
of the public record. After sixty (60) days, the Commission will again review the
agreement and comments received and will decide whether it should withdraw from the
agreement or make final the agreement's proposed order.
This matter concerns weight loss products which were marketed by the proposed
respondents via unsolicited commercial e-mail sent to users of America Online. The e-mail
directed recipients to click on a hyperlink that would then take them to TrendMarks
website on the Internet. Both the e-mail and Internet website made various weight loss and
health-related claims about respondents Thin-Thin Diet which consisted of two
products--Neuro-Thin and Lipo-Thin.
The Commissions complaint alleges that proposed respondents engaged in deceptive
advertising in violation of Sections 5 and 12 of the FTC Act by making unsubstantiated
claims that: (1) Neuro-Thin controls appetite; (2) taking Neuro-Thin and
Lipo-Thin in combination causes significant weight loss without a change in diet;
(3) taking Neuro-Thin and Lipo-Thin in combination causes long-term or
permanent weight loss; (4) Lipo-Thin helps prevent the absorption of ingested fat;
(5) Lipo-Thin lowers LDL cholesterol and boosts HDL cholesterol; (6) Lipo-Thin
promotes healing of ulcers and lesions; (7) Lipo-Thin helps prevent irritable bowel
syndrome; (8) Lipo-Thin reduces levels of uric acid in the blood; (9)
Lipo-Thin helps improve cardiovascular health; and (10) testimonials from consumers
appearing in advertisements for the Thin-Thin Diet reflect the typical or ordinary
experience of members of the public who use Neuro-Thin and Lipo-Thin. The
complaint alleges that the proposed respondents did not have a reasonable basis for these
weight loss and health-related claims. In addition, the complaint alleges that
testimonials given by individuals on respondents website failed to disclose
adequately that these individuals had material connections with individuals marketing and
profiting from the sales off Neuro-Thin and Lipo-Thin.
The proposed respondents indicated that they neither possessed nor were aware of any
studies relating specifically to the Neuro-Thin or Lipo-Thin products.
Moreover, the purported support which proposed respondents did rely upon for the above
claims--studies on individual components of Neuro-Thin or Lipo-Thin-- did not
relate adequately to their advertising claims. For example, most of the studies that were
submitted by the proposed respondents as support were test tube studies and studies of
rats. These studies cannot be used as adequate support for the therapeutic effects of
Neuro-Thin and Lipo-Thin in human beings.
The complaint further alleges that proposed respondents made a false claim that
clinical evidence proves that Neuro-Thin and Lipo-Thin cause users to lose
significant weight.
The proposed order contains provisions designed to remedy the violations charged and to
prevent proposed respondents from engaging in similar acts in the future.
Paragraph I of the proposed order prohibits proposed respondents from claiming that
Neuro-Thin and Lipo-Thin or any other product or program: (1) controls
appetite; (2) causes significant weight loss without a change in diet; (3) causes
long-term or permanent weight loss; (4) prevents or helps prevent the
absorption of ingested fat; (5) lowers LDL cholesterol or boosts HDL cholesterol; (6) promotes
healing of ulcers or lesions; (7) helps prevent irritable bowel syndrome; (8) reduces
levels of uric acid in the blood; and (9) helps improve cardiovascular health,
unless, at the time the representation is made, proposed respondents possess and rely upon
competent and reliable scientific evidence that substantiates the representation.
Paragraph II of the proposed order states that the proposed respondents shall not
represent, in any manner, expressly or by implication, that the experience represented by
any user who gives a testimonial or endorsement of the product represents the typical or
ordinary experience of members of the public who use the product, unless: (a) at the time
it is made, the proposed respondents possess and rely upon competent and reliable
scientific evidence that substantiates the representation; or (b) the proposed respondents
disclose, clearly and prominently, and in close proximity to the testimonial or
endorsement, either: (1) what the generally expected results would be for users of the
product, or (2) the limited applicability of the endorsers experience to what
consumers may generally expect to achieve, that is, that consumers should not expect to
experience similar results.
Paragraph III of the proposed order prohibits proposed respondents from making any
representation for Neuro-Thin and Lipo-Thin or any other food, drug, dietary
supplement, drug, or device, about the health benefits, performance, or efficacy of such
product unless, at the time the representation is made, proposed respondents possess and
rely upon competent and reliable scientific evidence that substantiates the
representation.
Paragraph IV of the proposed order prohibits proposed respondents from misrepresenting
the existence, contents, validity, results, conclusions, or interpretations of any test,
study, or study.
Paragraph V of the proposed order requires the proposed respondents to disclose,
clearly and prominently, a material connection, when one exists, between a person
providing an endorsement for any product or program and any respondent, or any individual
or entity labeling, advertising, promoting, offering for sale, selling, or distributing
such product or program.
Paragraph VI of the proposed order provides that nothing in this order shall prohibit
proposed respondents from making any representation about any drug permitted by the Food
and Drug Administration.
Paragraph VII of the proposed order provides that nothing in this order shall prohibit
proposed respondents from making any representation for any product that is specifically
permitted in labeling for such product by regulations promulgated by the Food and Drug
Administration pursuant to the Nutrition Labeling and Education Act of 1990.
Paragraph VIII of the proposed order contains record keeping requirements for materials
that substantiate, qualify, or contradict covered claims and requires the proposed
respondents to keep and maintain all advertisements and promotional materials containing
any representation covered by the proposed order. In addition, paragraph IX requires
distribution of a copy of the consent order to current and future officers and agents
having responsibility with respect to the subject matter of the order. Further, Paragraph
X provides for Commission notification upon a change in the corporate respondent.
Paragraph XI requires proposed respondents William McCormack and E. Robert Gates to notify
the Commission when either of them discontinues his current business or employment and of
an affiliation by either of them with any new businesses or employment. Paragraph XII of
the proposed order requires the proposed respondents to file a compliance report. Finally,
paragraph XIII of the proposed order provides for the termination of the order after
twenty years under specified conditions.
The purpose of this analysis is to facilitate public comment on the proposed order. It
is not intended to constitute an official interpretation of the agreement and proposed
order or to modify in any way their terms.
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