Health Science International, Inc., et al.; Analysis of Proposed Consent Order to Aid Public Comment �09�09�09, 58303-58305 [E7-20277]
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Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
mailed or delivered to the following
address: Federal Trade Commission/
Office of the Secretary, Room 135-H,
600 Pennsylvania Avenue, NW.,
Washington, DC 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 as
part of or as an attachment to email
messages directed to the following email box: consentagreement@ftc.gov.
The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. All timely and responsive
public comments, whether filed in
paper or electronic form, will be
considered by the Commission, and will
be available to the public on the FTC
website, to the extent practicable, at
www.ftc.gov. As a matter of discretion,
the FTC makes every effort to remove
home contact information for
individuals from the public comments it
receives before placing those comments
on the FTC Web site. More information,
including routine uses permitted by the
Privacy Act, may be found in the FTC’s
privacy policy, at https://www.ftc.gov/
ftc/privacy.htm.
FOR FURTHER INFORMATION CONTACT:
Laura DeMartino (202) 326-3030,
Bureau of Consumer Protection, Room
NJ-2122, 600 Pennsylvania Avenue,
NW., Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to section 6(f) of the Federal Trade
Commission Act, 38 Stat. 721, 15 U.S.C.
46(f), and § 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
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).
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
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 October 5, 2007), on the
World Wide Web, at https://www.ftc.gov/
os/2007/10/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. 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 The
Green Willow Tree LLC, a limited
liability company, and Robert Burns,
individually and as a member and
manager of The Green Willow Tree
(together, ‘‘respondents’’).
The proposed consent order has been
placed on the public record for thirty
(30) days for reception 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 Progesta Care Plus,
EST, and Restored Balance, transdermal
creams that, according to their labels,
contain, among other ingredients,
natural progesterone. According to the
FTC complaint, respondents
represented that Progesta Care Plus,
EST, and Restored Balance: (1) Are
effective in preventing, treating, or
curing osteoporosis; (2) are effective in
preventing or reducing the risk of
estrogen-inducted endometrial (uterine)
cancer; and (3) do not increase the
user’s risk of developing breast cancer
and/or are effective in preventing or
reducing the user’s risk of developing
breast cancer. The complaint alleges
that respondents failed to have
substantiation for these claims. 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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
58303
reliable scientific evidence
substantiating claims that any
progesterone product or any other
dietary supplement, food, drug, device
or health-related service or program is
effective in preventing, treating, or
curing osteoporosis, in preventing or
reducing the risk of estrogen-induced
endometrial cancer or breast cancer, or
in the mitigation, treatment, prevention,
or cure of any disease, illness, or health
condition; that it does not increase the
user’s risk of developing breast cancer,
is safe for human use, or has no side
effects; or about its health benefits,
performance, efficacy, safety, or side
effects.
Part II of the proposed order prevents
respondents from misrepresenting the
existence, contents, validity, results,
conclusions, or interpretations of any
test, study, or research.
Part III 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; representations
for any medical device that are
permitted in labeling under any new
medical device application approved by
the FDA; and representations for any
product that are specifically permitted
in labeling for that product by
regulations issued by the FDA under the
Nutrition Labeling and Education Act of
1990.
Parts IV through VIII 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 and changes in
employment that might affect
compliance obligations under the order;
and to file compliance reports with the
Commission. Part IX 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. 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. E7–20272 Filed 10–12–07: 8:45 am]
[BILLING CODE 6750–01–S]
E:\FR\FM\15OCN1.SGM
15OCN1
58304
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
FEDERAL TRADE COMMISSION
[File No. 072 3145]
Health Science International, Inc., et
al.; Analysis of Proposed Consent
Order to Aid Public Comment
Federal Trade Commission.
Proposed Consent Agreement.
AGENCY:
ACTION:
sroberts on PROD1PC70 with NOTICES
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 November 7, 2007.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Health
Science International, File No. 071
3145,’’ 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,
NW, 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 as
part of or as an attachment to email
messages directed to the following email
box: consentagreement@ftc.gov.
The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. All timely and responsive
public comments, whether filed in
paper or electronic form, will be
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).
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
considered by the Commission, and will
be available to the public on the FTC
website, to the extent practicable, at
www.ftc.gov. As a matter of discretion,
the FTC 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 https://www.ftc.gov/
ftc/privacy.htm.
FOR FURTHER INFORMATION CONTACT:
Laura DeMartino (202) 326-3030,
Bureau of Consumer Protection, Room
NJ-2122, 600 Pennsylvania Avenue,
NW, Washington, D.C. 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to section 6(f) of the Federal Trade
Commission Act, 38 Stat. 721, 15 U.S.C.
46(f), and § 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 October 5, 2007), on the
World Wide Web, at https://www.ftc.gov/
os/2007/10/index.htm. A paper copy
can be obtained from the FTC Public
Reference Room, Room 130-H, 600
Pennsylvania Avenue, N.W.,
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 Health
Science International, Inc., a
corporation, and David Martin,
individually and as an officer of Health
Science International ( together,
‘‘respondents’’).
The proposed consent order has been
placed on the public record for thirty
(30) days for reception of comments by
interested persons. Comments received
during this period will become part of
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
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 Serenity for Women
Natural Progesterone Cream, a
transdermal cream that, according to its
label, contains, among other ingredients,
natural progesterone. According to the
FTC complaint, respondents
represented that Serenity for Women
Natural Progesterone Cream: (1) is
effective in preventing, treating, or
curing osteoporosis; (2) is effective in
preventing or reducing the risk of
estrogen-inducted endometrial (uterine)
cancer; and (3) does not increase the
user’s risk of developing breast cancer
and/or is effective in preventing or
reducing the user’s risk of developing
breast cancer. The complaint alleges
that respondents failed to have
substantiation for these claims. The
complaint also alleges that respondents
misrepresented that clinical testing
proved that Serenity for Women Natural
Progesterone is effective in preventing,
treating, or curing osteoporosis. 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 claims that any
progesterone product or any other
dietary supplement, food, drug, device
or health-related service or program is
effective in preventing, treating, or
curing osteoporosis, in preventing or
reducing the risk of estrogen-induced
endometrial cancer or breast cancer, or
in the mitigation, treatment, prevention,
or cure of any disease, illness, or health
condition; that it does not increase the
user’s risk of developing breast cancer,
is safe for human use, or has no side
effects; or about its health benefits,
performance, efficacy, safety, or side
effects.
Part II of the proposed order prevents
respondents from misrepresenting the
existence, contents, validity, results,
conclusions, or interpretations of any
test, study, or research.
Part III 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; representations
for any medical device that are
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
permitted in labeling under any new
medical device application approved by
the FDA; and representations for any
product that are specifically permitted
in labeling for that product by
regulations issued by the FDA under the
Nutrition Labeling and Education Act of
1990.
Parts IV through VIII 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 and changes in
employment that might affect
compliance obligations under the order;
and to file compliance reports with the
Commission. Part IX 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. 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. E7–20277 Filed 10–12–07: 8:45 am]
[BILLING CODE 6750–01–S]
FEDERAL TRADE COMMISSION
[File No. 072 3146]
Shelly Black, individually and doing
business as Progesterone Advocates
Network; Analysis of Proposed
Consent Order to Aid Public Comment
Federal Trade Commission.
Proposed Consent Agreement.
AGENCY:
sroberts on PROD1PC70 with NOTICES
ACTION:
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 November 7, 2007.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Progesterone
Advocates Network, File No. 071 3146,’’
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
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
following address: Federal Trade
Commission/Office of the Secretary,
Room 135-H, 600 Pennsylvania Avenue,
NW, 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 as
part of or as an attachment to email
messages directed to the following email
box: consentagreement@ftc.gov.
The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. All timely and responsive
public comments, whether filed in
paper or electronic form, will be
considered by the Commission, and will
be available to the public on the FTC
website, to the extent practicable, at
www.ftc.gov. As a matter of discretion,
the FTC 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 https://www.ftc.gov/
ftc/privacy.htm.
FOR FURTHER INFORMATION CONTACT:
Laura DeMartino (202) 326-3030,
Bureau of Consumer Protection, Room
NJ-2122, 600 Pennsylvania Avenue,
NW, Washington, D.C. 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to section 6(f) of the Federal Trade
Commission Act, 38 Stat. 721, 15 U.S.C.
46(f), and § 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
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).
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
58305
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 October 5, 2007), on the
World Wide Web, at https://www.ftc.gov/
os/2007/10/index.htm. A paper copy
can be obtained from the FTC Public
Reference Room, Room 130-H, 600
Pennsylvania Avenue, N.W.,
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 Shelly
Black, an individual trading and doing
business as Progesterone Advocates
Network (‘‘respondent’’).
The proposed consent order has been
placed on the public record for thirty
(30) days for reception 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 Nature’s Precise
Cream, a transdermal cream that,
according to its label, contains, among
other ingredients, natural progesterone.
According to the FTC complaint,
respondent represented that Nature’s
Precise Cream: (1) is effective in
preventing, treating, or curing
osteoporosis; (2) is effective in
preventing or reducing the risk of
estrogen-inducted endometrial (uterine)
cancer; and (3) does not increase the
user’s risk of developing breast cancer
and/or is effective in preventing or
reducing the user’s risk of developing
breast cancer. The complaint alleges
that respondent failed to have
substantiation for these claims. The
proposed consent order contains
provisions designed to prevent
respondent 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 claims that any
progesterone product or any other
dietary supplement, food, drug, device
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58303-58305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20277]
[[Page 58304]]
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 072 3145]
Health Science International, 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 November 7, 2007.
ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Health Science International, File No. 071
3145,'' 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, NW, 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 as part of or as an attachment to email messages
directed to the following email box: consentagreement@ftc.gov.
---------------------------------------------------------------------------
\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 FTC Act and other laws the Commission administers permit the
collection of public comments to consider and use in this proceeding as
appropriate. All timely and responsive public comments, whether filed
in paper or electronic form, will be considered by the Commission, and
will be available to the public on the FTC website, to the extent
practicable, at www.ftc.gov. As a matter of discretion, the FTC 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 https://
www.ftc.gov/ftc/privacy.htm.
FOR FURTHER INFORMATION CONTACT: Laura DeMartino (202) 326-3030, Bureau
of Consumer Protection, Room NJ-2122, 600 Pennsylvania Avenue, NW,
Washington, D.C. 20580.
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 October 5, 2007), on the World Wide Web, at https://www.ftc.gov/os/
2007/10/index.htm. A paper copy can be obtained from the FTC Public
Reference Room, Room 130-H, 600 Pennsylvania Avenue, N.W., 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 Health Science International, Inc., a corporation, and David
Martin, individually and as an officer of Health Science International
( together, ``respondents'').
The proposed consent order has been placed on the public record for
thirty (30) days for reception 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 Serenity for
Women Natural Progesterone Cream, a transdermal cream that, according
to its label, contains, among other ingredients, natural progesterone.
According to the FTC complaint, respondents represented that Serenity
for Women Natural Progesterone Cream: (1) is effective in preventing,
treating, or curing osteoporosis; (2) is effective in preventing or
reducing the risk of estrogen-inducted endometrial (uterine) cancer;
and (3) does not increase the user's risk of developing breast cancer
and/or is effective in preventing or reducing the user's risk of
developing breast cancer. The complaint alleges that respondents failed
to have substantiation for these claims. The complaint also alleges
that respondents misrepresented that clinical testing proved that
Serenity for Women Natural Progesterone is effective in preventing,
treating, or curing osteoporosis. 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 claims that any
progesterone product or any other dietary supplement, food, drug,
device or health-related service or program is effective in preventing,
treating, or curing osteoporosis, in preventing or reducing the risk of
estrogen-induced endometrial cancer or breast cancer, or in the
mitigation, treatment, prevention, or cure of any disease, illness, or
health condition; that it does not increase the user's risk of
developing breast cancer, is safe for human use, or has no side
effects; or about its health benefits, performance, efficacy, safety,
or side effects.
Part II of the proposed order prevents respondents from
misrepresenting the existence, contents, validity, results,
conclusions, or interpretations of any test, study, or research.
Part III 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; representations for any medical device
that are
[[Page 58305]]
permitted in labeling under any new medical device application approved
by the FDA; and representations for any product that are specifically
permitted in labeling for that product by regulations issued by the FDA
under the Nutrition Labeling and Education Act of 1990.
Parts IV through VIII 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
and changes in employment that might affect compliance obligations
under the order; and to file compliance reports with the Commission.
Part IX 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. 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. E7-20277 Filed 10-12-07: 8:45 am]
[BILLING CODE 6750-01-S]
