[Federal Register Volume 68, Number 118 (Thursday, June 19, 2003)]
[Notices]
[Pages 36797-36798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15500]


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FEDERAL TRADE COMMISSION

[File No. 022 3036]


Unither Pharma, Inc., et al.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices or unfair methods of competition. The attached Analysis to 
Aid Public Comment describes both the allegations in the draft 
complaint that accompanies the consent agreement and the terms of the 
consent order--embodied in the consent agreement--that would settle 
these allegations.

DATES: Comments must be received on or before July 14, 2003.

ADDRESSES: Comments filed in paper form should be directed to: FTC/
Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580. Comments filed in electronic form should be 
directed to: [email protected], as prescribed in the 
Supplementary Information section.

FOR FURTHER INFORMATION CONTACT: Mary Engle or Matthew Daynard, FTC, 
Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580, (202) 326-3161 or 326-3291.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Section 2.34 
of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby 
given that the above-captioned consent agreement containing a consent 
order to cease and desist, having been filed with and accepted, subject 
to final approval, by the Commission, has been placed on the public 
record for a period of thirty (30) days. The following Analysis to Aid 
Public Comment describes the terms of the consent agreement, and the 
allegations in the complaint. An electronic copy of the full text of 
the consent agreement package can be obtained from the FTC Home Page 
(for June 12, 2003), on the World Wide Web, at ``http://www.ftc.gov/os/2003/06/index.htm.'' A paper copy can be obtained from the FTC Public 
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, 
DC 20580, either in person or by calling (202) 326-2222.
    Public comments are invited, and may be filed with the Commission 
in either paper or electronic form. Comments filed in paper form should 
be directed to: FTC/Office of the Secretary, Room 159-H, 600 
Pennsylvania Avenue, NW., Washington, DC 20580. If a comment contains 
nonpublic information, it must be filed in paper form, and the first 
page of the document must be clearly labeled ``confidential.'' Comments 
that do not contain any nonpublic information may instead be filed in 
electronic form (in ASCII format, WordPerfect, or Microsoft Word) as 
part of or as an attachment to email messages directed to the following 
email box: [email protected]. Such comments will be considered 
by the Commission and will be available for inspection and copying at 
its principal office in accordance with Section 4.9(b)(6)(ii) of the 
Commission's Rules of Practice, 16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission has accepted, subject to final 
approval, an agreement containing a consent order from Unither Pharma, 
Inc. and its parent company, United Therapeutics Corporation 
(collectively ``Unither'').
    The proposed consent order has been placed on the public record for 
thirty (30) days for receipt of comments by interested persons. 
Comments received during this period will become part of the public 
record. After thirty (30) days, the Commission will again review the 
agreement and the comments received, and will decide whether it should

[[Page 36798]]

withdraw from the agreement or make final the agreement's proposed 
order.
    This matter involves allegedly misleading representations about 
Unither's HeartBar products, chewy food bars and powders enriched with 
L-Arginine, vitamins, and minerals. HeartBar's labeling describes the 
product as the only ``medical food'' for the dietary management of 
heart and vascular disease.
    According to the FTC complaint, Unither failed to have 
substantiation for the claims that HeartBar: (1) Substantially 
decreases leg pain for people with cardiovascular disease; (2) reverses 
damage or disease to the heart caused by high cholesterol, smoking, 
diabetes, or estrogen deficiency; (3) prevents age-related vascular 
problems, including ``hardening of the arteries'' and plaque formation, 
and reduces the risk of developing cardiovascular disease; (4) 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) improves endurance and energy for the 
general population. Among other reasons, several of the representations 
are not supported by any clinical studies on humans. Other 
representations are based on results reported in studies that suffer 
from various flaws, including the failure to account for the placebo 
effect and extremely small sample sizes, such that the experience of a 
single or a few subjects account for the benefits purportedly 
experienced by the active group as a whole.
    The complaint further alleges that, contrary to Unither's claims, 
clinical studies, research, and/or trials do not show that HeartBar: 
(1) Decreases angina pain, including by as much as 70% within two 
weeks; (2) decreases leg pain while walking or exercising, including by 
as much as 66% within two weeks, for people with peripheral artery 
disease; (3) reverses the effects of high cholesterol, smoking, 
diabetes, and estrogen deficiency on the heart; or (4) improves 
endurance and energy for the general population.
    The proposed consent order contains provisions designed to prevent 
the Unither from engaging in similar acts and practices in the future.
    Part I of the order prohibits claims that HeartBar (HeartBar, 
HeartBar Plus, or HeartBar Sport), or any other L-Arginine product used 
in or marketed for the treatment, cure, or prevention of cardiovascular 
disease, or the improvement of cardiovascular or vascular function: (1) 
Substantially decreases leg pain for people with cardiovascular 
disease; (2) reverses damage or disease to the heart caused by high 
cholesterol, smoking, diabetes, estrogen deficiency, or any other 
medical condition or health risk; (3) prevents age-related vascular 
problems, including ``hardening of the arteries'' and plaque formation, 
or reduces the risk of developing cardiovascular disease; (4) 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 (5) improves endurance, circulation, 
and energy for the general population, unless the claims are 
substantiated by competent and reliable scientific evidence.
    Part II of the order requires that Unither possess competent and 
reliable scientific evidence to support any future claims about the 
health benefits, performance, or efficacy 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. For the same products covered in 
Part II, Part III of the order prohibits Unither from misrepresenting 
the existence, contents, validity, results, conclusions, or 
interpretations of any test, study, or research.
    Parts IV and V of the order permit drug claims permitted in 
labeling under any tentative final or final standard promulgated by the 
FDA, or under any new drug application approved by the FDA, and any 
representation for any product permitted in labeling by the FDA 
pursuant to the Nutrition Labeling and Education Act of 1990.
    Part VI of the order mandates that the respondents notify their 
distributors as to the claims the Commission has challenged and report 
to the Commission any distributors who continue to make claims that the 
Commission's order prohibits.
    Parts VII, VIII, IX, and X of the order require Unither to keep 
copies of relevant advertisements and materials substantiating claims 
made in the advertisements, to provide copies of the order to certain 
of its personnel, to notify the Commission of changes in corporate 
structure, and to file compliance reports with the Commission. Part XI 
provides that the order will terminate after twenty (20) years under 
certain circumstances.
    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.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 03-15500 Filed 6-18-03; 8:45 am]
BILLING CODE 6750-01-P