Basic Research LLC, et al., 28865-28867 [E6-7533]

Download as PDF Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices V, has applied to become a bank holding company. B. Federal Reserve Bank of Dallas (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 752012272: 1. First National Bank Group, Inc.,, Edinberg, Texas; to acquire 9.90 percent of Southside Bancshares, Inc., Tyler, Texas, and indirectly acquire Southside Delaware Financial Corporation, Dover, Delaware, and Southside Bank, Tyler, Texas. C. Federal Reserve Bank of San Francisco (Tracy Basinger, Director, Regional and Community Bank Group) 101 Market Street, San Francisco, California 94105-1579: 1. Silver State Bancorp, Henderson, Nevada; to acquire 100 percent of the voting shares of Choice Bank, Scottsdale, Arizona. Board of Governors of the Federal Reserve System, May 12, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6–7499 Filed 5–17–06; 8:45 am] BILLING CODE 6210–01–S FEDERAL RESERVE SYSTEM wwhite on PROD1PC61 with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained VerDate Aug<31>2005 17:06 May 17, 2006 Jkt 208001 from the National Information Center Web site at https://www.ffiec.gov/nic/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 12, 2006. A. Federal Reserve Bank of Boston (Richard Walker, Community Affairs Officer) P.O. Box 55882, Boston, Massachusetts 02106-2204: 1. Coastal Affiliates, MHC, , Yarmouth Port, Massachusetts; to become a bank holding company by acquiring Cape Cod Co-operative Bank, Yarmouth Port, Massachusetts. B. Federal Reserve Bank of Chicago (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: 1. Kujawa Family Holdings, Inc., Berlin, Wisconsin; to become a bank holding company by acquiring 100 percent of the voting shares of Farmers & Merchants Bank, Berlin, Wisconsin. 2. RAC Inc., Kohler, Wisconsin; to become a bank holding company by acquiring 100 percent of the voting shares of Ridgestone Financial Services, Inc., Brookfield, Wisconsin, and thereby indirectly acquire Ridgestone Bank, Brookfield, Wisconsin. C. Federal Reserve Bank of St. Louis (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: 1. F &M Bancshares, Inc., Trezevant, Tennessee; to acquire 100 percent of the voting shares of Citizens City & County Bank, Trenton, Tennessee. D. Federal Reserve Bank of Kansas City (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: 1. Emprise Financial Corporation, Wichita, Kansas; to acquire 100 percent of the voting shares of Prairie Capital, Inc., and thereby indirectly acquire Prairie State Bank, both in Augusta, Kansas. Board of Governors of the Federal Reserve System, May 15, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6–7577 Filed 5–17–06; 8:45 am] BILLING CODE 6210–01–S FEDERAL TRADE COMMISSION 28865 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 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 June 12, 2006. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to ‘‘Basic Research LLC, Docket No. 9318,’’ 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, 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 e-mail 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 Web site, to the extent practicable, at https://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 [Docket No. 9318] Basic Research LLC, et al.; Analysis of Agreement Containing Consent Order To Aid Public Comment Federal Trade Commission. Proposed consent agreement. AGENCY: ACTION: PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 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). E:\FR\FM\18MYN1.SGM 18MYN1 28866 Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices Privacy Act, may be found in the FTC’s privacy policy, at https://www.ftc.gov/ ftc/privacy.htm. FOR FURTHER INFORMATION CONTACT: Laureen Kapin (202–326–3237), Bureau of Consumer Protection, 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 § 3.25(f) of the Commission Rules of Practice, 16 CFR 3.25(f), 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 May 11, 2006), on the World Wide Web, at https://www.ftc.gov/ os/2006/05/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. wwhite on PROD1PC61 with NOTICES Analysis of Agreement Containing Consent Order To Aid Public Comment The Federal Trade Commission (‘‘Commission ‘‘) has accepted an agreement containing a consent order, subject to final approval, with Basic Research L.L.C. (‘‘Basic Research’’) and five other limited liability companies (‘‘Corporate Respondents’’), as well as with Dennis Gay, Daniel Mowrey, and Mitchell Friedlander (‘‘Individual Respondents’’), all of whom were named as Respondents in the Complaint issued by the Commission on June 15, 2004. The agreement and consent order settle charges that the Corporate Respondents and the Individual Respondents (together ‘‘Respondents’’) violated sections 5 and 12 of the Federal Trade Commission Act, 15 U.S.C. 45 and 52, by advertising and selling dietary supplements and drugs with unsubstantiated claims for fat loss and/ or weight loss, falsely representing that some of these products were clinically VerDate Aug<31>2005 17:06 May 17, 2006 Jkt 208001 proven to be effective, and falsely representing that Respondent Mowrey was a medical doctor. On February 27, 2006, the case was withdrawn from adjudication, so that the Commission could consider the proposed consent order. The proposed consent order has been placed on the public record for thirty (30) days to receive comments from interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will review the agreement and any comments received, and decide whether to withdraw from the agreement or to make final the proposed order. The purpose of this analysis is to facilitate comment on the proposed consent order. This analysis does not constitute an official interpretation of the agreement and proposed order and does not modify their terms in any way. The Complaint Allegations According to the Commission’s Complaint, Individual Respondents Dennis Gay, Daniel Mowrey (also doing business as American Phytotheraphy Research Laboratory), and Mitchell K. Friedlander all worked from the same Salt Lake City, Utah facility as Corporate Respondents Basic Research, L.L.C., A.G. Waterhouse, L.L.C., Klein-Becker usa, L.L.C., Nutrasport, L.L.C., Sovage Dermalogic Laboratories, L.L.C., and BAN, L.L.C., who have operated as a common enterprise to advertise and sell a broad line of topical gels and dietary supplements. The Commission’s Complaint alleges that these Respondents engaged in deceptive practices in advertising and selling topical fat-loss gels (DermalinAPg, Cutting Gel, and Tummy Flattening Gel), weight-loss and fat-loss dietary supplements for ‘‘significantly overweight’’ adults containing ephedrine, caffeine and aspirin (Anorex and Leptoprin), and a weight-loss dietary supplement for children containing glucomannan (PediaLean). Specifically, the Commission’s Complaint challenges the following claims as unsubstantiated: • That Dermalin-APg, Cutting Gel, and Tummy Flattening Gel cause rapid and visibly obvious fat loss in areas of the body to which they are applied; • That Leptoprin and Anorex cause weight loss of more than 20 pounds in significantly overweight users and that those products cause loss of substantial, excess fat in significantly overweight users; and • That PediaLean causes substantial weight loss in overweight or obese PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 children. Additionally, the Complaint challenges the following claims as false: • That published, clinical testing proves that Cutting Gel and Tummy Flattening Gel cause rapid and visibly obvious fat loss in areas of the body to which they are applied; • That clinical testing proves that Leptoprin causes weight loss of more than 20 pounds, including as much as 50, 60, or 147 pounds, in significantly overweight users; and that clinical testing proves that Leptoprin causes loss of substantial, excess fat in significantly overweight users; • That clinical testing proves that PediaLean causes substantial weight loss in overweight or obese children; and • That Respondent Mowrey is a medical doctor. The Proposed Consent Order The proposed consent order contains provisions designed to prevent Respondents from continuing the illegal conduct alleged in the Complaint, and from engaging in future practices similar to those previously alleged. The proposed order’s specific provisions are as follows: The core prohibitions appear in Paragraphs I through IV. Paragraph I prohibits Respondents from making any unsubstantiated representations that Dermalin-APg, Cutting Gel, Tummy Flattening Gel, Anorex, Leptoprin, PediaLean, or any substantially similar product, cause weight loss or fat loss. At the time that any Respondents make weight loss or fat loss claims for any of those products, Respondents must possess and rely upon a reasonable basis for such claims, which shall consist of competent and reliable scientific evidence. Paragraph II of the proposed order prohibits Respondents from making any unsubstantiated representations that any food, drug, or dietary supplement has an effect on any disease, on the structure or function of the human body, or other health benefits or weight loss benefits. At the time that any Respondents make any such claims, Respondents must possess and rely upon a reasonable basis for those claims, which shall consist of competent and reliable scientific evidence. The proposed consent order also prohibits the Respondents from making misrepresentations concerning any test, study, or research (Paragraph III of the proposed order), or concerning the profession, expertise, training, education, experience or qualifications of Respondent Mowrey or any other endorser (Paragraph IV of the proposed order). E:\FR\FM\18MYN1.SGM 18MYN1 28867 Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices As defined in the proposed order, ‘‘competent and reliable scientific evidence’’ means 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. A ‘‘substantially similar product’’ means any product that is substantially similar in ingredients, composition, and properties to any of the six products challenged in the Complaint. Paragraph V provides that Basic Research will pay the sum of three million dollars ($3,000,000), on behalf of all Respondents, to the Commission. In the discretion of the Commission, these funds may be used to provide redress to purchasers of any of the products challenged in the Complaint and to pay the attendant administrative costs. If the Commission determines, in its sole discretion, that redress to product purchasers is wholly or partially impracticable or is otherwise unwarranted, any funds not used will be paid to the U.S. Treasury. The proposed order allows Respondents to engage in various forms of legitimate conduct. The order does not prohibit Respondents from making any claim for any drug that is permitted in labeling for that drug under any tentative final or final standard established by the Food and Drug Administration (‘‘FDA’’), or under any new drug application approved by the FDA (Paragraph VI of the proposed order). The order also does not prohibit Respondents from making any claim for any product that is specifically permitted in labeling for that product under FDA regulations made under the Nutrition Labeling and Education Act of 1990 (Paragraph VII of the proposed order). Additionally, Paragraphs VIII, IX, X, and XI provide for various compliance reports and notifications by the Respondents. Paragraph XII obligates the Respondents to cooperate in certain ways with any Commission inquiry into their compliance with the order. The proposed order will expire in 20 years. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E6–7533 Filed 5–17–06; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [60Day–06–06BG] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Longitudinal Follow-up of Youth with Attention-Deficit/Hyperactivity Disorder (ADHD) Identified in Community No. of respondents wwhite on PROD1PC61 with NOTICES Health Risk Behavior Survey (Parent Report) ................................................. Health Risk Behavior Survey (Youth Report) .................................................. Demographics and Family History Survey (Parent) ........................................ Treatment and Services Survey ...................................................................... VerDate Aug<31>2005 17:06 May 17, 2006 Jkt 208001 Background and Brief Description Centers for Disease Control and Prevention Respondents PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 Settings: Examining Health Status, Correlates, and Effects Associated with Treatment for ADHD—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). This project will collect data from proxy respondents and youths with and without Attention-Deficit/Hyperactivity Disorder (ADHD). This program addresses the Healthy People 2010 focus area of Mental Health and Mental Disorders, and describes the prevalence, incidence, long-term outcomes, treatment(s), select co-morbid conditions, secondary conditions, and health risk behavior of youth with ADHD relative to youth without ADHD. In FY 2002–FY 2005 two cooperative agreements (transitioned to extramural research) were awarded to conduct community-based epidemiological research on ADHD among elementaryaged youth, known as the Project to Learn about ADHD in Youth (PLAY Study Collaborative, OMB# 0920–0584, expired on March 31, 2006). These studies provided community-based prevalence, rates of co-morbidity, and rates of health risk behaviors among elementary-age youth with and without ADHD as determined by a rigorous case definition developed by the principal investigators in collaboration with CDC scientists. The purpose of this program is to study the long-term outcomes and health status for children with ADHD identified and treated in community settings through a systematic follow-up of the subjects who participated in the PLAY Study Collaborative. There is considerable interest in the long-term outcomes of youth with ADHD as well as the effects of treatment, lack of treatment, and quality of care in average U.S. communities, emphasizing the public health importance of longitudinal research in this area. There are no costs to the respondents other than their time. Estimated Annualized Burden Hours Average burden per response (in hrs.) No. of responses per respondent 980 980 980 980 E:\FR\FM\18MYN1.SGM 1 1 1 1 18MYN1 10/60 10/60 15/60 10/60 Total burden hours 163 163 245 163

Agencies

[Federal Register Volume 71, Number 96 (Thursday, May 18, 2006)]
[Notices]
[Pages 28865-28867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7533]


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

FEDERAL TRADE COMMISSION

[Docket No. 9318]


Basic Research LLC, et al.; Analysis of Agreement Containing 
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 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 June 12, 2006.

ADDRESSES: Interested parties are invited to submit written comments. 
Comments should refer to ``Basic Research LLC, Docket No. 9318,'' 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, 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 e-mail messages directed to the 
following e-mail 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 Web site, to the extent 
practicable, at https://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

[[Page 28866]]

Privacy Act, may be found in the FTC's privacy policy, at https://
---------------------------------------------------------------------------
www.ftc.gov/ftc/privacy.htm.

FOR FURTHER INFORMATION CONTACT: Laureen Kapin (202-326-3237), Bureau 
of Consumer Protection, 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 Sec.  3.25(f) 
of the Commission Rules of Practice, 16 CFR 3.25(f), 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 May 11, 2006), on the World Wide Web, at https://www.ftc.gov/os/
2006/05/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 (``Commission ``) has accepted an 
agreement containing a consent order, subject to final approval, with 
Basic Research L.L.C. (``Basic Research'') and five other limited 
liability companies (``Corporate Respondents''), as well as with Dennis 
Gay, Daniel Mowrey, and Mitchell Friedlander (``Individual 
Respondents''), all of whom were named as Respondents in the Complaint 
issued by the Commission on June 15, 2004.
    The agreement and consent order settle charges that the Corporate 
Respondents and the Individual Respondents (together ``Respondents'') 
violated sections 5 and 12 of the Federal Trade Commission Act, 15 
U.S.C. 45 and 52, by advertising and selling dietary supplements and 
drugs with unsubstantiated claims for fat loss and/or weight loss, 
falsely representing that some of these products were clinically proven 
to be effective, and falsely representing that Respondent Mowrey was a 
medical doctor. On February 27, 2006, the case was withdrawn from 
adjudication, so that the Commission could consider the proposed 
consent order.
    The proposed consent order has been placed on the public record for 
thirty (30) days to receive comments from interested persons. Comments 
received during this period will become part of the public record. 
After thirty (30) days, the Commission will review the agreement and 
any comments received, and decide whether to withdraw from the 
agreement or to make final the proposed order.
    The purpose of this analysis is to facilitate comment on the 
proposed consent order. This analysis does not constitute an official 
interpretation of the agreement and proposed order and does not modify 
their terms in any way.

The Complaint Allegations

    According to the Commission's Complaint, Individual Respondents 
Dennis Gay, Daniel Mowrey (also doing business as American 
Phytotheraphy Research Laboratory), and Mitchell K. Friedlander all 
worked from the same Salt Lake City, Utah facility as Corporate 
Respondents Basic Research, L.L.C., A.G. Waterhouse, L.L.C., Klein-
Becker usa, L.L.C., Nutrasport, L.L.C., Sovage Dermalogic Laboratories, 
L.L.C., and BAN, L.L.C., who have operated as a common enterprise to 
advertise and sell a broad line of topical gels and dietary 
supplements.
    The Commission's Complaint alleges that these Respondents engaged 
in deceptive practices in advertising and selling topical fat-loss gels 
(Dermalin-APg, Cutting Gel, and Tummy Flattening Gel), weight-loss and 
fat-loss dietary supplements for ``significantly overweight'' adults 
containing ephedrine, caffeine and aspirin (Anorex and Leptoprin), and 
a weight-loss dietary supplement for children containing glucomannan 
(PediaLean). Specifically, the Commission's Complaint challenges the 
following claims as unsubstantiated:
     That Dermalin-APg, Cutting Gel, and Tummy Flattening Gel 
cause rapid and visibly obvious fat loss in areas of the body to which 
they are applied;
     That Leptoprin and Anorex cause weight loss of more than 
20 pounds in significantly overweight users and that those products 
cause loss of substantial, excess fat in significantly overweight 
users; and
     That PediaLean causes substantial weight loss in 
overweight or obese children. Additionally, the Complaint challenges 
the following claims as false:
     That published, clinical testing proves that Cutting Gel 
and Tummy Flattening Gel cause rapid and visibly obvious fat loss in 
areas of the body to which they are applied;
     That clinical testing proves that Leptoprin causes weight 
loss of more than 20 pounds, including as much as 50, 60, or 147 
pounds, in significantly overweight users; and that clinical testing 
proves that Leptoprin causes loss of substantial, excess fat in 
significantly overweight users;
     That clinical testing proves that PediaLean causes 
substantial weight loss in overweight or obese children; and
     That Respondent Mowrey is a medical doctor.

The Proposed Consent Order

    The proposed consent order contains provisions designed to prevent 
Respondents from continuing the illegal conduct alleged in the 
Complaint, and from engaging in future practices similar to those 
previously alleged. The proposed order's specific provisions are as 
follows:
    The core prohibitions appear in Paragraphs I through IV. Paragraph 
I prohibits Respondents from making any unsubstantiated representations 
that Dermalin-APg, Cutting Gel, Tummy Flattening Gel, Anorex, 
Leptoprin, PediaLean, or any substantially similar product, cause 
weight loss or fat loss. At the time that any Respondents make weight 
loss or fat loss claims for any of those products, Respondents must 
possess and rely upon a reasonable basis for such claims, which shall 
consist of competent and reliable scientific evidence.
    Paragraph II of the proposed order prohibits Respondents from 
making any unsubstantiated representations that any food, drug, or 
dietary supplement has an effect on any disease, on the structure or 
function of the human body, or other health benefits or weight loss 
benefits. At the time that any Respondents make any such claims, 
Respondents must possess and rely upon a reasonable basis for those 
claims, which shall consist of competent and reliable scientific 
evidence.
    The proposed consent order also prohibits the Respondents from 
making misrepresentations concerning any test, study, or research 
(Paragraph III of the proposed order), or concerning the profession, 
expertise, training, education, experience or qualifications of 
Respondent Mowrey or any other endorser (Paragraph IV of the proposed 
order).

[[Page 28867]]

    As defined in the proposed order, ``competent and reliable 
scientific evidence'' means 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. A ``substantially 
similar product'' means any product that is substantially similar in 
ingredients, composition, and properties to any of the six products 
challenged in the Complaint.
    Paragraph V provides that Basic Research will pay the sum of three 
million dollars ($3,000,000), on behalf of all Respondents, to the 
Commission. In the discretion of the Commission, these funds may be 
used to provide redress to purchasers of any of the products challenged 
in the Complaint and to pay the attendant administrative costs. If the 
Commission determines, in its sole discretion, that redress to product 
purchasers is wholly or partially impracticable or is otherwise 
unwarranted, any funds not used will be paid to the U.S. Treasury.
    The proposed order allows Respondents to engage in various forms of 
legitimate conduct. The order does not prohibit Respondents from making 
any claim for any drug that is permitted in labeling for that drug 
under any tentative final or final standard established by the Food and 
Drug Administration (``FDA''), or under any new drug application 
approved by the FDA (Paragraph VI of the proposed order). The order 
also does not prohibit Respondents from making any claim for any 
product that is specifically permitted in labeling for that product 
under FDA regulations made under the Nutrition Labeling and Education 
Act of 1990 (Paragraph VII of the proposed order).
    Additionally, Paragraphs VIII, IX, X, and XI provide for various 
compliance reports and notifications by the Respondents. Paragraph XII 
obligates the Respondents to cooperate in certain ways with any 
Commission inquiry into their compliance with the order. The proposed 
order will expire in 20 years.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E6-7533 Filed 5-17-06; 8:45 am]
BILLING CODE 6750-01-P