UNITED STATES OF AMERICA
FEDERAL TRADE
COMMISSION
In the Matter of
UNITHER PHARMA, INC.,
and
UNITED THERAPEUTICS CORPORATION. |
FILE NO. 022 3036
AGREEMENT CONTAINING CONSENT
ORDER |
The Federal Trade Commission has conducted an investigation
of certain acts and practices of Unither Pharma, Inc. and
United Therapeutics 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 Unither Pharma, Inc., United Therapeutics Corporation,
their duly authorized officers, and counsel for the Federal
Trade Commission that:
1. a. Proposed respondent Unither Pharma,
Inc. ("Unither Pharma") is a Delaware corporation with its
principal office or place of business at 1110 Spring St.,
Silver Spring, Maryland 20910. Unither Pharma is a wholly
owned subsidiary of Unither Pharmaceuticals, Inc., which
is wholly owned by respondent United Therapeutics Corporation.
b. Proposed respondent United Therapeutics
Corporation ("United Therapeutics") is a Delaware corporation
with its principal office or place of business at 1110
Spring St., Silver Spring, Maryland 20910.
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 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 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' address
as stated in this agreement by any means specified in Section
4.4(a) 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. Unless otherwise specified, "respondents"
shall mean United Therapeutics Corporation, Unither Pharma,
Inc., and their successors, assigns, officers, agents, representatives
and/or employees.
3. "Commerce" shall mean as defined in
Section 4 of the Federal Trade Commission Act, 15 U.S.C.
§ 44.
4. "Food" and "drug" shall mean as defined
in Section 15 of the Federal Trade Commission Act, 15 U.S.C.
§ 55, and "over-the-counter" shall mean available without
a prescription.
5. "L-Arginine product" means any food,
over-the-counter drug, medical food, or dietary supplement
which contains as an ingredient the amino acid L-arginine.
I.
IT IS 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 HeartBar, HeartBar
Plus, HeartBar Sport (collectively "HeartBar"), or any other
L-Arginine product used in or marketed for: (1) the treatment,
cure, or prevention of cardiovascular disease, or (2) the
improvement of cardiovascular or vascular function, in or
affecting commerce, shall not make any representation, in
any manner, expressly or by implication, that such product:
A. substantially decreases leg pain for
people with cardiovascular disease;
B. reverses damage or disease to the
heart caused by high cholesterol, smoking, diabetes, estrogen
deficiency, or any other medical condition or health risk;
C. prevents age-related vascular problems,
including "hardening of the arteries" and plaque formation,
or reduces the risk of developing cardiovascular disease;
D. reduces or eliminates the need for
surgery, such as a coronary bypass or angioplasty, or for
medications, such as nitroglycerin, in patients with cardiovascular
disease; or
E. improves endurance, circulation, and
energy for the general population;
unless, at the time the representation 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 food, medical food, or dietary supplement used in or
marketed for: (1) the treatment, cure, or prevention of cardiovascular
disease, or (2) the improvement of cardiovascular or vascular
function, 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.
III.
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 food, medical food, or dietary supplement used in or
marketed for: (1) the treatment, cure, or prevention of cardiovascular
disease, or (2) the improvement of cardiovascular or vascular
function, shall not misrepresent, in any manner, expressly
or by implication, the existence, contents, validity, results,
conclusions, or interpretations of any test, study, or research.
IV.
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.
V.
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.
VI.
IT IS FURTHER ORDERED that respondents
shall, within thirty (30) days after the date of service of
this order, send by first class certified mail, return receipt
requested, to each distributor, seller, or purchaser for resale
of any HeartBar product with whom respondents, or their agents,
successors, or assigns, have done business since January 1,
2001, notice of this order in the form attached as Attachment
A. The mailing shall not include any other documents.
In the event that respondents receive any
information that, subsequent to its receipt of notice of this
order, any distributor, seller, or purchaser for resale is
using or disseminating any advertisement or promotional material
containing claims about HeartBar prohibited by Parts I, II,
or III of this order, respondents shall: (1) immediately send
such distributor, seller, or purchaser for resale a letter
requesting that it stop using or disseminating any such advertisement
or promotional material and notifying it that any such use
or dissemination will be reported to the Commission; and (2)
within thirty (30) days notify the Associate Director for
Advertising Practices, Bureau of Consumer Protection, Federal
Trade Commission, in writing, of the identity of such distributor,
seller, or purchaser for resale and its use or dissemination
of any advertisement or promotional material containing claims
about HeartBar prohibited by Parts I, II, or III of this order.
VII.
IT IS FURTHER ORDERED that respondents,
and their successors and assigns, 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 including videotape
recordings of all such broadcast advertisements;
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.
VIII.
IT IS FURTHER ORDERED that respondents,
and their successors and assigns, shall deliver a copy of
this order to all current and future officers, directors,
and managers, and to all current and future employees, and
agents 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, for a period of five (5) years after the date
of service of this order, to future personnel within thirty
(30) days after the person assumes such position or responsibilities.
IX.
IT IS FURTHER ORDERED that respondents,
and their 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 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, 600 Pennsylvania
Avenue, NW, Washington, D.C. 20580.
X.
IT IS FURTHER ORDERED that respondents,
and their successors and assigns, 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.
XI.
IT IS FURTHER ORDERED that 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 ________, 2003
FOR UNITED THERAPEUTICS CORPORATION
By:
PAUL A. MAHON
Senior Vice President and General Counsel
FOR UNITHER PHARMA, INC.
By:
__________________________________
YU-LUN LIN
President and Chief Operating Officer
_________________________________
DANIEL FERREL McINNIS
AKIN, GUMP, STRAUSS, HAUER & FELD, L.L.P.
Counsel for United Therapeutics Corporation and Unither Pharma,
Inc.
MATTHEW DAYNARD
Counsel for the Federal Trade Commission
APPROVED:
MARY ENGLE
Associate Director
Division of Advertising Practices
J. HOWARD BEALES, III
Director
Bureau of Consumer Protection
ATTACHMENT A
BY CERTIFIED MAIL,
RETURN RECEIPT REQUESTED
[To be printed on
letterhead of Unither Pharma, Inc. or United Therapeutics
Corporation]
[date]
Dear [distributor, seller, or purchaser
for resale]:
We write to announce Unither Pharma's new
advertising policy for HeartBar related products. As you may
be aware, on ___________, 2003, the Federal Trade Commission
("FTC") announced a settlement and consent agreement with
Unither Pharma, Inc. and United Therapeutics Corporation related
to the marketing of HeartBar products. This agreement requires
that the claims we make when marketing HeartBar products must
be accurate and grounded in competent and reliable scientific
evidence.
We are committed to obeying fully the requirements
of this settlement agreement with the FTC, while, at the same
time, vigorously supporting sales of HeartBar products. To
better explain how this advertising policy change may affect
you, we briefly summarize the agreement with the FTC and ask
for your full cooperation in ensuring that HeartBar products
are sold in a manner consistent with this policy.
The Settlement Agreement
In its complaint accompanying the consent
order, the FTC alleged, among other things, that our advertisements
made unsubstantiated claims that: (1) HeartBar substantially
decreases leg pain for people with cardiovascular disease;
(2) HeartBar reverses damage or disease to the heart caused
by high cholesterol, smoking, diabetes, or estrogen deficiency;
(3) HeartBar prevents age-related vascular problems, including
"hardening of the arteries" and plaque formation, and reduces
the risk of developing cardiovascular disease; (4) HeartBar
reduces or eliminates the need for surgery, such as a coronary
bypass or angioplasty, and medications, such as nitroglycerin,
in patients with cardiovascular disease; and (5) HeartBar
Sport improves endurance and energy for the general population.
The FTC's complaint further alleged that
our advertisements falsely claimed that clinical studies,
research, and/or trials show that: (1) HeartBar decreases
angina pain, including by as much as 70% within two weeks;
(2) HeartBar decreases leg pain while walking or exercising,
including by as much as 66% within two weeks, for people with
peripheral artery disease; (3) HeartBar reverses the effects
of high cholesterol, smoking, diabetes, and estrogen deficiency
on the heart; and (4) HeartBar Sport improves endurance and
energy for the general population.
We deny the FTC's complaint allegations
and do not admit to any wrongdoing or violation of law. However,
in order to resolve this matter, Unither Pharma, Inc. and
United Therapeutics Corporation have entered into a settlement
agreement with the FTC. Pursuant to the consent agreement,
Unither Pharma, Inc. and United Therapeutics Corporation are
required to request that our distributors and sellers stop
using or distributing advertisements, packaging, or promotional
materials containing claims challenged by the FTC. We are
sending you this letter, because you are one of our distributors,
sellers, or purchasers for resale.
Unless we have competent and reliable scientific
evidence to support our claims, the consent agreement prohibits
us from representing that any HeartBar product:
- substantially decreases leg pain
for people with cardiovascular disease;
- reverses damage or disease to
the heart caused by high cholesterol, smoking, diabetes,
estrogen deficiency, or any other medical condition or health
risk;
- prevents age-related vascular
problems, including "hardening of the arteries" and plaque
formation, or reduces the risk of developing cardiovascular
disease;
- reduces or eliminates the need
for surgery, such as a coronary bypass or angioplasty, or
for medications, such as nitroglycerin, in patients with
cardiovascular disease; or
- improves endurance, circulation,
and energy for the general population.
The consent agreement also prohibits us
from misrepresenting the existence, contents, validity, results,
conclusions, or interpretations of any test, study, or research
regarding any HeartBar product.
Our Commitment
Unither Pharma, Inc. and United Therapeutics
Corporation are committed to the continued study of the health
benefits of the HeartBar product and L-arginine through scientifically
valid, well-controlled clinical testing. It is the companies'
hope that such testing will produce competent and reliable
scientific evidence necessary to support additional claims
that supplemental L-arginine provides certain health benefits.
However, Unither Pharma, Inc. and United Therapeutics Corporation
wish to emphasize that it is critically important that claims
made pertaining to such health benefits only be made based
upon such competent and reliable scientific evidence.
Your Assistance
We request your assistance in complying
with the consent agreement. Please discontinue using, distributing,
or relying on any of our advertising or promotional material,
including packaging, for any HeartBar product that makes any
of the claims mentioned above. Please also notify any of your
customers who resell these products and who may have such
materials to discontinue using such promotional materials.
If we receive information that you are continuing to use materials
that do not comply with the consent agreement, we will notify
the FTC of your failure to comply with this request.
We very much look forward to our mutual
continued success and thank you very much for your assistance.
Sincerely,
[name]
President
Unither Pharma, Inc./United Therapeutics Corporation
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