Health Science International, Inc., et al.; Analysis of Proposed Consent Order to Aid Public Comment �09�09�09, 58303-58305 [E7-20277]

Download as PDF 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 http://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 http://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 http://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 http://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 http://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 http://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]]

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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 http://
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 http://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]