[Federal Register Volume 73, Number 193 (Friday, October 3, 2008)]
[Notices]
[Pages 57625-57627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23328]


=======================================================================
-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

[File No. 082 3095]


Bioque Technologies, Inc., et al.; Analysis of Proposed Consent 
Order to Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

-----------------------------------------------------------------------

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 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 October 17, 2008.

ADDRESSES: Interested parties are invited to submit written comments. 
Comments should refer to ``Bioque Technologies, File No. 082 3095,'' to 
facilitate the organization of comments. A comment filed in paper form 
should include this reference both in the text and on the envelope, and 
should be mailed or delivered to the following address: Federal Trade 
Commission/Office of the Secretary, Room 135-H, 600 Pennsylvania 
Avenue, N.W., Washington, D.C. 20580. Comments containing confidential 
material must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with Commission Rule 4.9(c). 16 CFR 
4.9(c) (2005).\1\ The FTC is requesting that any comment filed in paper 
form be sent by courier or overnight service, if possible, because U.S. 
postal mail in the Washington area and at the Commission is subject to 
delay due to heightened security precautions. Comments that do not 
contain any nonpublic information may instead be filed in electronic 
form by following the instructions on the web-

[[Page 57626]]

based form at (http://secure.commentworks.com/ftc-BioqueTechnologies). 
To ensure that the Commission considers an electronic comment, you must 
file it on that web-based form.
---------------------------------------------------------------------------

    \1\ The comment must be accompanied by an explicit request for 
confidential treatment, including the factual and legal basis for 
the request, and must identify the specific portions of the comment 
to be withheld from the public record. The request will be granted 
or denied by the Commission's General Counsel, consistent with 
applicable law and the public interest. See Commission Rule 4.9(c), 
16 CFR 4.9(c).
---------------------------------------------------------------------------

    The Federal Trade Commission Act (``FTC Act'') and other laws the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives, 
whether filed in paper or electronic form. Comments received will be 
available to the public on the FTC website, to the extent practicable, 
at (http://www.ftc.gov/os/publiccomments.shtm). As a matter of 
discretion, the Commission makes every effort to remove home contact 
information for individuals from the public comments it receives before 
placing those comments on the FTC website. More information, including 
routine uses permitted by the Privacy Act, may be found in the FTC's 
privacy policy, at (http://www.ftc.gov/ftc/privacy.shtm)

FOR FURTHER INFORMATION CONTACT: Richard Cleland, FTC Bureau of 
Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 
20580, (202) 326-3088.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec.  2.34 of 
the Commission 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 September 18, 2008), on the World Wide Web, at http://www.ftc.gov/os/2008/09/index.htm. A paper copy can be obtained from the FTC Public 
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington, 
D.C. 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. All comments should be filed as 
prescribed in the ADDRESSES section above, and must be received on or 
before the date specified in the DATES section.

Analysis of Agreement Containing Consent Order to Aid Public Comment

    The Federal Trade Commission (``FTC'' or ``Commission'') has 
accepted, subject to final approval, an agreement containing a consent 
order from Bioque Technologies, Inc., Vittorio A. Bonomo, and Christine 
A. Guilman (together, ``Respondents'').
    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 
withdraw from the agreement or make final the agreement's proposed 
order.
    This matter involves the advertising and promotion of Serum GV, a 
topical serum that, according to its label, contains, among other 
ingredients, extract of annona muricata, also known as graviola, 
derived from the soursop or guanabana tree. According to the FTC 
complaint, Respondents represented that Serum GV is an effective 
treatment for skin cancer, including melanoma, and that it prevents 
melanoma. The complaint alleges that Respondents failed to have 
substantiation for these claims. Also according to the FTC complaint, 
Respondents represented that Serum GV is recognized by the medical 
profession as an effective treatment for skin cancer and that it is 
clinically proven to prevent or treat melanoma. The complaint alleges 
that these claims are false and misleading because Serum GV is not 
recognized by the medical profession as an effective treatment for skin 
cancer and is not clinically proven to prevent or treat melanoma. The 
proposed consent order contains provisions designed to prevent 
Respondents from engaging in similar acts and practices in the future.
    Part I of the proposed order requires Respondents to have competent 
and reliable scientific evidence substantiating any claims that a 
covered product or service is an effective treatment for skin cancer, 
including melanoma; prevents melanoma; is recognized by the medical 
profession as an effective treatment for skin cancer; or is clinically 
proven to prevent or treat melanoma. The provision further requires 
that such claims be true and non-misleading. A ``covered product or 
service'' is defined in the order as ``any health-related service or 
program; or any food, dietary supplement, device, or drug, including, 
but not limited to, Serum GV.''
    Part II of the proposed order requires the Proposed Respondents to 
possess competent and reliable scientific evidence for any claims about 
the absolute or comparative benefits, performance, efficacy, safety, or 
side effects of any covered product or service. The claims also must be 
truthful and non-misleading.
    Part III of the proposed order prohibits Respondents from making 
future misrepresentations about the existence, contents, validity, 
results, conclusions, or interpretations of any test or study.
    Part IV of the proposed order provides that the order does not 
prohibit Respondents from making representations for any drug that are 
permitted in labeling for the drug under any tentative final or final 
Food and Drug Administration (``FDA'') standard or under any new drug 
application approved by the FDA and representations for any product 
that are specifically permitted in labeling for that product by 
regulations issues by the FDA under the Nutrition Labeling and 
Education Act of 1990.
    Part V of the proposed order requires Respondents to provide the 
FTC with a list of all consumers that they know purchased Serum GV and 
prohibits Respondents from using or disclosing the consumer 
information, except to a law enforcement agency or as required by law.
    Part VI of the proposed order requires Respondents to send to the 
consumers identified in Part V a notification letter drafted by the FTC 
to inform them about the consent agreement.
    Part VII of the proposed order provides for the payment of 
$9,035.85, the full amount of sales of the product, to the Commission.
    Parts VIII through XII of the proposed order require Respondents to 
keep copies of relevant advertisements and materials substantiating 
claims made in the advertisements; to provide copies of the order to 
certain of their personnel; to notify the Commission of changes in 
corporate structure (for the corporate respondent) and changes in 
employment (for the individual respondents) that might affect 
compliance obligations under the order; and to file compliance reports 
with the Commission. Part XIII 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.

[[Page 57627]]

    By direction of the Commission.

Donald S. Clark
Secretary
[FR Doc. E8-23328 Filed 10-2-08; 8:45 am]
BILLING CODE 6750-01-S