UNITED
STATES OF AMERICA
FEDERAL TRADE COMMISSION
In the Matter of
GLOBAL WORLD MEDIA CORPORATION,
a corporation, and
SEAN SHAYAN, individually and as officer of the
corporation.
FILE NO. 962-3210
AGREEMENT CONTAINING CONSENT
ORDER
The Federal Trade Commission has conducted an
investigation of certain acts and practices of Global
World Media Corporation, and Sean Shayan, individually
and as an officer of the corporation ("proposed
respondents"). Proposed respondents, having been
represented by counsel, 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
Global World Media Corporation, by its authorized
officers, and Sean Shayan, individually and as an officer
of the corporation, and counsel for the Federal Trade
Commission that:
1.a. Proposed respondent Global World Media
Corporation is a California corporation with its
principal office or place of business at 1501 Main
Street, Venice, California 90291.
1.b. Proposed respondent Sean Shayan is an officer of
the corporate respondent. Individually or in concert with
others, he formulates, directs, or controls the policies,
acts, or practices of the corporation, including the acts
or practices alleged in the draft complaint. His
principal office or place of business is the same as that
of Global World Media Corporation.
2. Proposed respondents admit all the jurisdictional
facts set forth in the 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 thirty
(30) 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 this 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. 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 a television or video advertisement, the
disclosure shall be presented simultaneously in both the
audio and video portions of the advertisement. 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.
B. In a radio advertisement or in telephone
conversations the disclosure shall be delivered in a
volume and cadence sufficient for an ordinary consumer to
hear and comprehend it.
C. In a print advertisement, the disclosure shall be
in a type size and in a location that are sufficiently
noticeable so that an ordinary consumer will see and read
it, in print that contrasts with the background against
which it appears. In multi-page documents, the disclosure
shall appear on the cover or the first page.
D. In an advertisement on any electronic media
received by consumers via computer, such as the
Internet's World Wide Web or commercial online computer
services, the disclosure shall be in a type size, and in
a location, that are sufficiently noticeable so that an
ordinary consumer will see it and read it, in print that
contrasts with the background against which it appears.
In multi-screen documents, the disclosure shall appear on
the first screen and on any screen containing ordering
information.
E. On a product label, the disclosure shall be in a
type size, and in a location on the principal display
panel, that are sufficiently noticeable so that an
ordinary consumer will see and read it, in print that
contrasts with the background against which it appears.
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 Global World Media Corporation, its successors
and assigns and its officers; Sean Shayan, individually
and as an officer of the corporation; and each of the
above's agents, representatives and employees.
4. "Ephedrine product(s)" shall mean foods,
drugs, dietary supplements, or other products intended
for internal use containing a source of any ephedrine
alkaloid, including but not limited to ephedrine,
pseudoephedrine, norephedrine, norpseudoephedrine,
N-methylephedrine, and N-methylpseudoephedrine, either
derived from natural sources such as Ephedra sinica (also
called Ma-Huang or Chinese Ephedra) or synthetically
produced.
5. "Purchaser for resale" shall mean any
purchaser of any ephedrine product(s) sold by respondents
(a) who is a distributor or operates a wholesale or
retail business selling any such product(s) or (b) who
orders one hundred (100) or more tablets, doses, or other
units of any such product(s) in any three (3) month
period.
6. "Commerce" shall mean as defined in
Section 4 of the Federal Trade Commission Act, 15 U.S.C.
44.
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 Ecstacy or Herbal Ecstacy tablets or any
other food, drug, or dietary supplement in or affecting
commerce, shall not:
- A. Represent in any manner, expressly or by
implication, that the use of such product is safe
or will cause no side effects; or
-
- B. Make any other representation, in any manner,
expressly or by implication, about the safety or
side effects of such product,
unless the representation is true and, 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 Ecstacy or Herbal Ecstacy tablets or any
other ephedrine product that is not a "drug" as
defined by the Federal Food, Drug and Cosmetic Act, 21
U.S.C. 321 as amended, in or affecting commerce, shall
not represent, in any manner, expressly or by
implication, that it is appropriate for users to take
such product in an amount that contains ephedrine
alkaloids or any other ingredient in excess of any level
for such ingredient in a dietary supplement as may be
established by the Food and Drug Administration (FDA)
under any applicable rule or regulation.
III.
IT IS FURTHER ORDERED that respondents shall make the
following disclosure, clearly and prominently, in any
advertisement, promotional material, package label, and
package insert for Ecstacy or Herbal Ecstacy tablets or
any other ephedrine product, and in any discussion
relating to dosage or use of any such product that
results from a communication via electronic mail or from
any call made by or on behalf of respondents or received
on their toll-free, pay-per-call number, or other
telephone lines.
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.
Provided, however, if the product is subject to
any FDA rule or regulation that requires a warning or a
disclosure about safety or health effects for labeling,
such warning or disclosure shall be required in lieu of
the disclosure set forth above.
IV.
IT IS FURTHER ORDERED that respondents shall not
provide the means and instrumentalities to, or otherwise
assist, any person who respondents know or have reason to
know is making any false or misleading representation or
deceptive material omission in connection with the
labeling, advertising, promotion, offering for sale,
sale, or distribution of Ecstacy or Herbal Ecstacy
tablets or any other ephedrine product.
"Assist" includes, but is not limited to,
selling Ecstacy or Herbal Ecstacy tablets or any other
ephedrine product to that person.
V.
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 in or affecting commerce
shall not misrepresent that any testimonial or
endorsement of the product reflects the actual experience
and current opinions, findings, beliefs, or experiences
of the testimonialist or endorser.
VI.
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 Ecstacy or Herbal Ecstacy tablets or any
other ephedrine product marketed as an alternative to an
illegal drug or for its euphoric, psychotropic, or sexual
effects, including through the use of the name Ecstacy,
Herbal Ecstacy, or Ecstasy, shall not disseminate or
employ for any such product advertising, marketing, or
other promotional activities directed to individuals
under the age of twenty-one (21) years.
For purposes of this Part, "advertising,
marketing, or other promotional activity directed to
individuals under the age of twenty-one (21) years"
shall include, but not be limited to:
A. Advertisements appearing in publications whose
readers younger than twenty-one (21) years of age
constitute fifty percent (50%) or more of the total
readership;
B. Advertisements appearing during or immediately
adjacent to television programs seen by audiences whose
viewers younger than twenty-one (21) years of age
constitute fifty percent (50%) or more of total viewers;
C. Advertisements appearing on a television or radio
station or channel at a time when its viewers or
listeners younger than twenty-one (21) years of age
constitute fifty percent (50%) or more of total viewers
or listeners;
D. Advertisements appearing on the same video as a
commercially prepared video whose viewers younger than
twenty-one (21) years of age constitute fifty percent
(50%) or more of total viewers; or preceding a movie
whose viewers younger than twenty-one (21) years of age
constitute fifty percent (50%) or more of total viewers;
E. Advertising or promotional activity at events such
as concerts that are attended by audiences whose members
younger than twenty-one (21) years of age constitute
fifty percent (50%) or more of the total audience; or
F. Advertising, marketing, or other promotional
activity, regardless of when or where it appears, is
disseminated, or takes place, whose audience members
younger than twenty-one (21) years of age constitute
fifty percent (50%) or more of the total audience.
VII.
IT IS FURTHER ORDERED that respondent Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan shall submit an analysis,
performed by an independent laboratory, of the level of
ephedrine alkaloids (including ephedrine,
pseudoephedrine, norephedrine, norpseudoephedrine,
N-methylephedrine, and N-methylpseudoephedrine) in
Ecstacy or Herbal Ecstacy tablets and any other ephedrine
product sold by them within sixty (60) days of service of
this order, and for the next five (5) years, once
annually during the month of the first submission
required by this Part.
VIII.
.
Nothing in this order shall be construed as permitting
respondents to market any ephedrine product:
- A. In a state where the sale of such products has
been banned;
-
- B. In a manner that is inconsistent with any
applicable state restrictions on their sale; or
-
- C. In a manner that is inconsistent with any
applicable FDA rule or regulation.
IX.
Nothing in this order shall prohibit respondents from
making any representation for any drug that is permitted
in 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.
X.
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.
XI.
IT IS FURTHER ORDERED that respondent Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan shall:
A. Send by first class certified mail or deliver in
person, an exact copy of the notice attached hereto as
Attachment A, without any other accompanying material, to
each person who makes or answers calls on respondents'
toll-free, pay-per-call number, or other telephone lines
maintained for providing information about Ecstacy or
Herbal Ecstacy or any other ephedrine product and each
person who provides such information via electronic mail.
Persons presently making or answering such calls and
electronic mail shall be sent the notice within thirty
(30) days after the date of service of this order.
Persons retained in the future to make or answer such
calls and electronic mail shall be given the notice prior
to being permitted to make or answer any such calls;
B. Notify any person who fails to return the signed
statement included in Attachment A within seven (7) days
of receipt that they will be terminated in the event that
they fail to return the signed statement;
C. Terminate any person who receives the notification
required by subpart B and fails to return the signed
statement within seven (7) days of receipt of the
notification, and terminate immediately any person who
fails to comply with the provisions of the notice
attached hereto as Attachment A; and
D. Institute a reasonable program of continuing
surveillance adequate to reveal whether each person who
makes or answers calls received on respondents'
toll-free, pay-per-call number, or other telephone lines
maintained for inquires about Ecstacy or Herbal Ecstacy
or any other ephedrine product, and each person who
provides information about such products via electronic
mail, is conforming to the requirements of this order.
XII.
IT IS FURTHER ORDERED that respondent Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan shall for five (5) years after the
receipt of the last correspondence required by Part XI
above, maintain and upon request make available for the
Federal Trade Commission for inspection and copying:
A. Copies of all notices sent to any person pursuant
to subpart A of Part XI of this order; and
B. Copies of all communications with any person who
receives the notification required by subpart B or is
terminated pursuant to subpart C of Part XI of this
order.
XIII
IT IS FURTHER ORDERED that respondent Global World
Media Corporation, and its successors and assigns, and
Sean Shayan shall:
A. Send an exact copy of the notice attached hereto as
Attachment B by first class certified mail, return
receipt requested within thirty (30) days after the date
of service of this order, to any purchaser for resale on
or after January 1, 1993. The mailing shall include no
other document;
B. For a period of three (3) years following the date
of service of this order, send an exact copy of the
notice attached hereto as Attachment B by first class
certified mail, return receipt requested, to any
purchaser for resale. The mailing shall include no
document other than Attachment B with the exception of an
invoice for the purchase of the product, and shall be
made prior to or simultaneously with the first shipment
of the product;
C. In the event respondents receive any information
that, subsequent to receipt of Attachment B, any
purchaser for resale is using or disseminating
advertisements or promotional materials that contain any
representation prohibited by this order, respondents
shall immediately notify such person that respondents
will cease to sell ephedrine products to such person if
the prohibited representations continue to be made; and
D. Terminate any purchaser for resale about whom
respondents receive any information that such person is
continuing to use advertisements or promotional materials
that contain any representation prohibited by this order
after receipt of the notice required by subpart C of this
Part.
XIV.
IT IS FURTHER ORDERED that respondent Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan shall for five (5) years after the
last correspondence to which they pertain, maintain and
upon request make available to the Federal Trade
Commission for inspection and copying:
A. Copies of all notification letters sent to persons
pursuant to subpart A or B of Part XIII; and
B. Copies of all communications received or sent
pursuant to subpart C or D of Part XIII.
XV.
IT IS FURTHER ORDERED that respondents Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan shall, for five (5) years after
the last date of dissemination of any representation
covered by this order, maintain and upon request make
available for 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, including complaints and other
communications with consumers or with governmental or
consumer protection organizations.
XVI.
IT IS FURTHER ORDERED that respondents Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan 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.
.XVII.
IT IS FURTHER ORDERED that Global World Media
Corporation and its successors and assigns shall notify
the Commission at least thirty (30) days prior to any
change in the corporation 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 respondent learns less than thirty (30) days prior
to the date such action is to take place, respondent
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.
XVIII.
IT IS FURTHER ORDERED that respondent Sean Shayan, for
a period of ten (10) years after the date of issuance of
this order, shall notify the Commission of (1) the
discontinuance of his current business or employment and
(2) his affiliation with any new business or employment
where such business or employment relates to the
manufacturing, advertising, promoting, offering for sale,
sale, or distribution of any food, drug, or dietary
supplement. 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.
IXX.
IT IS FURTHER ORDERED that respondents Global World
Media Corporation, and its successors and assigns, and
respondent Sean Shayan 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 that manner and form in which they have
complied with this order.
XX.
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;
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 respondent
did not violate any provision of this 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 , 19
GLOBAL WORLD MEDIA CORPORATION
By:
Sean Shayan
President
SEAN SHAYAN, individually and as an officer of the
corporation
WILLIAM H. DAILEY
Attorney for respondents
NANCY S. WARDER
Counsel for the Federal Trade Commission
MICHELLE K. RUSK
Counsel for the Federal Trade Commission
APPROVED:
C. LEE PEELER
Associate Director
Division of Advertising Practices
JOAN Z. BERNSTEIN
Director
Bureau of Consumer Protection
ATTACHMENT A
TO BE DELIVERED BY CERTIFIED MAIL OR IN PERSON
[To be printed on Global World Media Corporation
letterhead]
[date]
Dear [name]:
This letter is to inform you that Global World
Media Corporation ("GWMC") recently settled a
civil dispute with the Federal Trade Commission
("FTC") regarding certain alleged claims about
Ecstacy or Herbal Ecstacy tablets ("Ecstacy"). Although
we do not admit the violations alleged in the FTC
complaint, we have entered into this settlement with the
FTC to avoid litigation. As part of the settlement, we
are required to notify our employees and others who make
or receive calls about Ecstacy, or other
ephedrine-containing products sold by GWMC, to stop
making certain statements prohibited by the order and to
notify the caller of the potentially serious health risks
associated with taking these products.
Effective immediately, you must
comply with the following requirements when contacting
potential purchasers or responding by telephone, in
writing, or by any other means to any inquiry about
Ecstacy or any other ephedrine-containing product sold by
GWMC. These products include [list here by product name
any ephedrine-containing products other than Ecstacy sold
by GWMC as of the date of this notice]:
1. You must make the following
disclosure in your communications about Ecstacy or any
other ephedrine product:
- "I am required to give you the following
important information:
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."
[In the event any FDA rule or regulation requires a
different warning or disclosure in labeling about the
health and safety effects of such products, substitute
that warning or disclosure here.]
When given orally, this statement must be read prior
to any other discussion about the product and in a tone
of voice and at a speed that will permit the caller to
hear the disclosure and understand the seriousness of the
warning. When included in any written communication, this
statement must be presented clearly and prominently and
before any other information about the product. You must not
make any statement or other suggestion that could
contradict this statement.
2. You must not make any statement or
other suggestion about the number of tablets that users
can take, other than to repeat the dose information on
the product label.
Under the FTC order, we are required to get a signed
statement from you that you have read this letter and
intend to comply with its requirements. Accordingly, you
must sign and return the following statement to us.
Failure to sign and return the attached
statement promptly or to comply with the provisions of
this letter will result in your termination.
Your cooperation in complying with this letter is
appreciated. If you have any questions, please contact
William H. Dailey at (310) 458-0810 [in the event that he
no longer represents GWMC, the name and telephone number
of the acting attorney, or if none, an officer of GWMC,
may be substituted].
Sincerely,
Sean Shayan
President
Global World Media Corporation
[perforation for tear-away statement]
I have read this letter and understand it and will
keep a copy to refer to when answering consumer calls. In
the future I intend to comply with the provisions of the
letter. I understand that the failure to do so will
result in my termination.
[recipient's name] [date]
ATTACHMENT B
BY CERTIFIED MAIL, RETURN RECEIPT REQUESTED
[to be printed on Global World Media Corporation
letterhead]
[date]
Dear [name]
This letter is to inform you that Global World Media
Corporation ("GWMC") recently settled a civil
dispute with the Federal Trade Commission
("FTC") regarding certain alleged claims about
Ecstacy or Herbal Ecstacy tablets ("Ecstacy").
Although we do not admit to the violations alleged in the
FTC complaint, we have entered into this settlement with
the FTC to avoid litigation. As part of the settlement,
we are required to notify anyone who purchases for resale
Ecstacy or other ephedrine-containing products sold by
GWMC, including [list any ephedrine-containing products
sold by GWMC as of the date of this letter], to stop
using advertising or promotional materials that make any
of the representations prohibited by the settlement.
Allegations of the FTC Complaint
The FTC complaint alleges that GWMC claimed that the
use of Ecstacy in the recommended doses or other
reasonably foreseeable amounts is absolutely safe and
will cause no side effects. The complaint challenges
these claims as false and unsubstantiated, noting that
the use of products that contain ephedrine alkaloids,
such as Ecstacy, can have dangerous effects on the
central nervous system and heart. The complaint also
charges that GWMC's advertising for Ecstacy included
false endorsements from fictitious persons, including Dr.
Steven Jonson.
FTC Order Provisions
The order we entered into as part of our settlement
with the FTC requires us to comply with the following
provisions:
1. We are prohibited from making claims in
advertising, labeling and other promotions for Ecstacy,
or any other food, drug or dietary supplement, that such
product is absolutely safe or causes no side effects, or
from making any other claim about the product's safety or
lack of side effects, unless the claim is true and we
have competent and reliable scientific evidence to
support it.
2. We are prohibited in advertising, labeling, and
other promotions for Ecstacy or other products we sell
that contain ephedrine, including those listed above,
from recommending a dose that exceeds the maximum level
for ephedrine as established by FDA for dietary
supplements [insert FDA standard as of the date of this
letter].
3. We are prohibited in advertising, labeling, and
other promotions for any product from representing
falsely that any testimonial or endorsement of the
product reflects the actual experience and current
opinions, findings, beliefs or experiences of the
testimonialist or endorser.
4. We are required in all advertising, labeling, and
other promotions for Ecstacy and other
ephedrine-containing products to make the following
disclosure clearly and prominently:
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.
[In the event any FDA rule or regulation requires a
different warning or disclosure in labeling, about safety
or health effects of such products, substitute that
warning or disclosure here.]
5. Finally, we are prohibited from marketing Ecstacy
or any other ephedrine-containing product for its
euphoric, psychotropic, or sexual effects, through any
advertising, marketing, or other promotions directed at
an audience with 50% or more of its members under the age
of twenty-one.
As part of our settlement with the FTC, GWMC must take
steps (such as sending you this letter) to ensure that
people who purchase for resale Ecstacy or other
ephedrine-containing products sold by GWMC stop using any
advertising or promotional materials that do not fully
comply with the requirements described above. If you
continue to use materials that do not fully comply with
such requirements, we are required by the settlement with
the FTC to stop selling Ecstacy and other
ephedrine-containing products to you.
Thank you for your assistance. If you have any
questions, please contact William H. Dailey at (310)
458-0810 [in the event that he no longer represents GWMC,
the name and telephone number of the acting attorney, or
if none, an officer of GWMC, may be substituted].
Sincerely,
Sean Shayan
President
Global World Media Corporation
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
In the Matter of
GLOBAL WORLD MEDIA CORPORATION,
a corporation, and
SEAN SHAYAN, individually and as an officer of the
corporation.
DOCKET NO.
COMPLAINT
The Federal Trade Commission, having reason to believe
that Global World Media Corporation, a corporation, and
Sean Shayan, individually and as an officer of the
corporation ("respondents"), have violated
provisions of the Federal Trade Commission Act, and it
appearing to the Commission that this proceeding is in
the public interest, alleges:
1. Respondent Global World Media Corporation is a
California corporation with its principal office or place
of business at 1501 Main Street, Venice, California
90291.
2. Respondent Sean Shayan is an officer of the
corporate respondent. Individually or in concert with
others, he formulates, directs, or controls the policies,
acts, or practices of the corporation, including the acts
and practices alleged in this complaint. His principal
office or place of business is the same as that of Global
World Media Corporation.
3. Respondents have advertised, labeled, offered for
sale, sold, and distributed products to the public,
including Ecstacy or Herbal Ecstacy tablets
("Ecstacy"). The principal ingredient in
Ecstacy is Ma-Huang, a botanical source of ephedrine
alkaloids. Ecstacy also contains, among other things, the
following ingredients: guarana, ginseng, ginkgo biloba,
cola nut, and green tea extract. Ecstacy is a
"food" and/or "drug," within the
meaning of Sections 12 and 15 of the Federal Trade
Commission Act.
4. 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.
5. Respondents have disseminated or have caused to be
disseminated advertisements for Ecstacy, including but
not necessarily limited to the attached Exhibits A
through D, and oral representations as set forth in
subparagraph E below. In addition, respondents have
furnished the means and instrumentalities to third party
distributors to disseminate advertising on the World Wide
Web, including but not necessarily limited to the
attached Exhibits E and F. These advertisements and oral
representations contained the following statements:
A. ecstacy®
the world's first organic ecstacy (m.d.m.a.)
alternative
From Tokyo to South Africa to the United Kingdom to
Argentina, with over 2 million units sold in over 15
countries, a product known as herbal ecstacy®
is revolutionizing the way the world thinks of designer
drugs. Using 9 exotic botanicals imported exclusively for
this product, herbal ecstacy® has been
carefully formulated to produce a considerable range of
pleasurable effects.
"Reported effects last 4-8 Hours:
- highly increased energy levels
- increased sexual sensations
(a mild serotonin inhibitor)"
Dr. Janis Burton
New Psychology Magazine
Paris, France
"Developed by many of the same doctors who
created the chemical version, herbal ecstacy®
is 100% natural & absolutely safe. herbal
ecstacy® contains no chemicals or other
impurities. This product is synergistically blended in
order to maximize benefits and eliminate any possible
side effects."
Dr. Steven Jonson
Tel Aviv, Israel
(Exhibits A and B: Penthouse.)
B. 2 dosages (10 tablets) $19.99
12 dosages (60 tablets) $99.99
18 dosages (90 tablets) $149.99
40 dosages (200 tablets) $299.99
(Exhibit A: Penthouse.)
C. 2 doses (10 tablets) $19.99
10 doses (50 tablets) $69.99
20 doses (100 tablets) $99.99
(Exhibit B: Penthouse.)
D. toll free 24 hour 7 days
1 - 800 - 365 - 0000
(Exhibits A and B: Penthouse.)
E. Consumers calling respondents' toll-free
"800" number have been advised that if they
fail to achieve the advertised euphoric, psychotropic, or
sexual effects, they may ignore the dose suggested in
advertising and labeling for the product (such as one (1)
tablet every seventy-two (72) hours) and take more
Ecstacy tablets, including doses of seven or eight
tablets at one time.
F. Send Check or money order to:
Global World Media Corporation
. . . .
Distribution and wholesale inquiries
FAX (310) 581-4456
(Exhibits A and B: Penthouse.)
G. SPOKESWOMAN: Introducing Herbal Ecstacy.
[Various shots of young people dancing, playing drums,
embracing.]
SPOKESWOMAN: The world's first organic designer
experience. A sacred blend of nine exotic herbs that
produce a considerable range of pleasurable effects.
[SUPERSCRIPT: Satisfaction Guaranteed]
SPOKESWOMAN: Increased energy levels. Euphoric
sensations with absolutely no side effects. . . .Herbal
Ecstacy. The alternative. . . .
(Exhibit C: Nickelodeon, 1995)
H. MALE ANNCR.: Are you ready for this? Introducing
the world's first organic ecstasy alternative.
. . . .
MALE ANNCR.: Users reported keeping a clear head and a
sense of heightened perception all night long with no
side effects what so ever. So try the alternative, try
Herbal Ecstasy.
. . . .
MALE ANNCR.: The world's first organic ecstasy
alternative . . . .
(Exhibit D: Radio Commercial Transcript, 1995)
I. Herbal Ecstacy
. . . .
"A fantastically light headed, tingly happy,
happy buzz, with no side effects."
Herb Garden Magazine, UK.
"The effects of herbal ecstacy beyond smart drug
capacity include:
euphoric stimulation
highly increased energy levels
tingly skin sensations
enhanced sensory processing
increased sexual sensations
mood elevations
Dr. Janis Burton New Psychology Magazine
(Exhibit E: World Wide Web Site, March 27, 1996)
J. ecstacy
The Legal Alternative!
. . . .
" A fantastically light headed, tingly
happy-happy buzz, with no side effects."
Herb Garden Magazine, U.K.
"The effects of herbal ecstacy beyond smart
drug capacity include:
euphoric stimulation
highly increased energy levels
tingly skin sensations
enhanced sensory processing
increased sexual sensations
mood elevations"
Dr. Janis Burton - New Psychology Magazine
. . . .
10 tab pack - sug. dose 5 tabs.
(Exhibit F: World Wide Web Site, March 27, 1996)
6. Through the means described in Paragraph 5,
respondents have represented, expressly or by
implication, that use of Ecstacy in the doses recommended
or in other reasonably foreseeable amounts is absolutely
safe and will cause no side effects.
7 In truth and in fact, use of Ecstacy in the doses
recommended or in other reasonably foreseeable amounts is
not absolutely safe and may cause side effects. The
Ma-Huang in Ecstacy is a botanical source of various
chemicals including ephedrine alkaloids that can have
dangerous effects on the central nervous system and
heart. Therefore, the representation set forth in
Paragraph 6 was, and is, false or misleading.
8. Through the means described in Paragraph 5,
respondents have represented, expressly or by
implication, that they possessed and relied upon a
reasonable basis that substantiated the representation
set forth in Paragraph 6, at the time the representation
was made.
9. In truth and in fact, respondents did not possess
and rely upon a reasonable basis that the representation
set forth in Paragraph 6, at the time the representation
was made. Therefore, the representation set forth in
Paragraph 8 was, and is, false or misleading.
10. Through the means described in Paragraph 5,
respondents have represented, expressly or by
implication, that Dr. Steven Jonson of Tel Aviv, Israel,
provided an endorsement pertaining to the absolute safety
and the lack of side effects of Ecstacy, and that the
endorsement appearing in the advertisements for Ecstacy
accurately reflects his actual opinions, findings, and
beliefs.
11. In truth and in fact, Dr. Steven Jonson of Tel
Aviv, Israel, did not provide an endorsement pertaining
to the absolute safety and the lack of side effects of
Ecstacy. Dr. Jonson is a fictitious person and,
therefore, the endorsement appearing in the
advertisements for Ecstacy does not accurately reflect
the actual opinions, findings, or beliefs of Dr. Jonson.
12. In their advertising and sale of Ecstacy tablets,
including in media with a substantial youth audience such
as certain Nickelodeon and MTV cable
programming stations, respondents have represented that
Ecstacy tablets are a safe alternative to illegal drugs
to produce euphoric, psychotropic, or sexual enhancement
effects. Respondents have failed to disclose that use of
Ecstacy tablets in the doses recommended or in other
reasonably foreseeable amounts may present a significant
health or safety risk, including but not limited to
dangerous effects on the central nervous system and
heart. These facts would be material to consumers in
their purchase and use of Ecstacy tablets. This practice
was, and is, a deceptive act or 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 the day of , ,
has issued this complaint against respondents.
Donald S. Clark
Secretary
SEAL:
[Exhibits A-F attached to paper copies of complaint,
but not available in electronic form.]
Analysis of Proposed Consent
Order to Aid Public Comment
The Federal Trade Commission has accepted an agreement
to a proposed consent order from Global World Media
Corporation ("GWMC"), the marketer of Herbal
Ecstacy or Ecstacy ("Ecstacy"), and its owner,
Sean Shayan [hereinafter sometimes referred to as
respondents].
The proposed consent order has been placed on the
public record for sixty (60) days for reception of public
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 the comments received and will decide
whether it should withdraw from the agreement or make
final the agreement's proposed order.
The Commission's complaint in this matter concerns
safety claims respondents made in advertising for
Ecstacy, a dietary supplement that respondents promoted
as a natural "high" and expressly likened to
the illegal street drug MDMA. More specifically, the
complaint alleges that respondents represented that
Ecstacy, when taken in the recommended doses or other
reasonably foreseeable amounts, is absolutely safe and
has no side effects. The complaint explains that Ecstacy
contains a botanical source of ephedrine alkaloids, which
can have dangerous effects on the nervous system and
heart. Thus, according to the complaint, the claim that
Ecstacy is safe and side effect free is both false and
unsubstantiated.
In addition, the complaint charges that respondents
represented in their advertising for Ecstacy, including
in ads that ran on cable programming stations with
substantial youth audiences, such as Nickelodeon
and MTV, that Ecstacy is a safe
alternative to illegal drugs to produce euphoric,
psychotropic (mind-altering), or sexual enhancement
effects, but failed to disclose the health and safety
risks of using the product. According to the complaint
the undisclosed facts would be material to consumers and,
therefore, respondents' omission of the facts about the
health and safety risks of Ecstacy in their advertising
is alleged to be a deceptive practice.
Finally, the complaint challenges an endorsement of
Ecstacy's safety and lack of side effects contained in
respondents' advertising and attributed to a Dr. Steven
Jonson of Tel Aviv, Israel. According to the complaint,
the endorsement is false because Dr. Jonson is a
fictitious person.
The proposed consent order contains provisions
designed to remedy the violations charged and to prevent
respondents from engaging in similar acts and practices
in the future.
Part I of the order prohibits 1) claims that Ecstacy
or any other food, drug, or dietary supplement is safe or
will cause no side effects; or 2) any other safety or
side effects claims, unless the claim is true and
substantiated by scientific evidence.
Part II prohibits respondents from making any
representation for any food, drug, or dietary supplement
that contains ephedrine alkaloids that consumers can
appropriately take such product in an amount that exceeds
the level established by any regulation of the Food and
Drug Administration ("FDA") for ephedrine
alkaloids or any other ingredient in the product.
Part III requires the following clear and prominent
disclosure in all future advertising and labeling of, and
all consumer communications concerning, any
ephedrine-alkaloid-containing product sold by
respondents:
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.
Under Part III, if the product is subject to an FDA
rule or regulation that requires a labeling warning, that
warning is required in labeling in lieu of the warning
set forth above.
Part IV prohibits respondents from assisting others,
including by selling product to them, when respondents
have reason to believe that they are deceptively
promoting respondents' ephedrine-containing products.
Part V prohibits misrepresentations about endorsements
and testimonials.
Part VI prohibits respondents from directing to
individuals under the age of twenty-one advertising and
promotional activities for Ecstacy or any other ephedrine
product marketed as an alternative to an illegal drug or
for its euphoric, psychotropic, or sexual effects. Part
VI includes examples of prohibited activity, including
advertisements and promotions to audiences half or more
under twenty-one.
Part VII requires the respondents to conduct and
submit annual analyses of the levels of ephedrine
alkaloids in any ephedrine-containing product that they
sell for the next five (5) years.
Part VIII provides that nothing in the order permits
the respondents to market any product 1) in a state where
its sale has been banned; 2) in a manner that is
inconsistent with state restrictions on its sale; or 3)
in a way that is inconsistent with any applicable FDA
rule or regulation.
Parts IX and X provide safe harbors for claims
approved pursuant to FDA's regulation of the labeling for
drugs and foods, respectively.
Part XI requires respondents to send a letter
(Attachment A to the order) to anyone who provides the
public with information about any of respondents'
ephedrine-containing products. The letter advises the
recipient that the disclosure required by Part III of the
order must be made in all communications with consumers
concerning any of respondents' ephedrine-containing
products and that the only permissible statement about
the dose of any such product is the information on the
label. Part XII sets forth the record keeping and
surveillance requirements with respect to Part XI.
Part XIII requires respondents to send a letter
(Attachment B to the order) to distributors and
resellers, including any person who purchases more than
100 units of any of respondents' ephedrine-containing
products in any three (3) month period. The letter
describes the Commission's action in this case and
advises recipients to discontinue use of any promotional
materials that do not comply with the order. Part XIV
sets forth the record keeping and surveillance
requirements with respect to Part XIII.
The remaining parts of the order contain standard
provisions pertaining to record keeping, compliance,
sunsetting of the order, and similar matters.
The purpose of this analysis is to facilitate public
comment on the proposed order, and 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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