NBTY, Inc.; Analysis of Proposed Consent Order To Aid Public Comment, 79377-79378 [2010-31823]

Download as PDF Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices Board of Governors of the Federal Reserve System, December 15, 2010. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2010–31851 Filed 12–17–10; 8:45 am] BILLING CODE 6210–01–P FEDERAL TRADE COMMISSION [File No. 102 3080] NBTY, Inc.; Analysis of Proposed Consent Order To Aid Public Comment Federal Trade Commission. Proposed Consent Agreement. AGENCY: ACTION: 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. SUMMARY: Comments must be received on or before January 14, 2011. ADDRESSES: Interested parties are invited to submit written comments electronically or in paper form. Comments should refer to ‘‘NBTY, File No. 102 3080’’ to facilitate the organization of comments. Please note that your comment—including your name and your State—will be placed on the public record of this proceeding, including on the publicly accessible FTC Web site, at http://www.ftc.gov/os/ publiccomments.shtm. Because comments will be made public, they should not include any sensitive personal information, such as an individual’s Social Security Number; date of birth; driver’s license number or other State identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, comments should not include any ‘‘[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential * * *.,’’ as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled jlentini on DSKJ8SOYB1PROD with NOTICES DATES: VerDate Mar<15>2010 17:18 Dec 17, 2010 Jkt 223001 ‘‘Confidential,’’ and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c).1 Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please consider submitting your comments in electronic form. Comments filed in electronic form should be submitted by using the following Web link: https:// ftcpublic.commentworks.com/ftc/nbty and following the instructions on the Web-based form. To ensure that the Commission considers an electronic comment, you must file it on the Webbased form at the Web link: https:// ftcpublic.commentworks.com/ftc/nbty. If this Notice appears at http:// www.regulations.gov/search/index.jsp, you may also file an electronic comment through that Web site. The Commission will consider all comments that regulations.gov forwards to it. You may also visit the FTC Web site at http:// www.ftc.gov/ to read the Notice and the news release describing it. A comment filed in paper form should include the ‘‘NBTY, File No. 102 3080’’ 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 H–135 (Annex D), 600 Pennsylvania Avenue, NW., Washington, DC 20580. 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. The Federal Trade Commission Act (‘‘FTC Act’’) and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives, whether filed in paper or electronic form. Comments received will be available to the public on the FTC Web site, to the extent practicable, at http://www.ftc.gov/os/ publiccomments.shtm. As a matter of discretion, the Commission makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC 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 FTC Rule 4.9(c), 16 CFR 4.9(c). PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 79377 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.shtm. FOR FURTHER INFORMATION CONTACT: Devin Domond (202–326–2610), 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 § 2.34 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 December 13, 2010), on the World Wide Web, at http:// www.ftc.gov/os/actions.shtm. 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 NBTY, Inc., NatureSmart LLC, and Rexall Sundown, Inc. (collectively, ‘‘Respondents’’). The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement’s proposed order. This matter involves the advertising and promotion of the following products in Respondents’ Disney/ E:\FR\FM\20DEN1.SGM 20DEN1 jlentini on DSKJ8SOYB1PROD with NOTICES 79378 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices Marvel line of children’s multivitamin and mineral dietary supplements: (1) Disney Princess Complete; (2) Disney Princess Gummies; (3) Disney Pixar Cars Gummies; (4) Disney Winnie the Pooh Gummies; (5) Disney Tigger & Pooh Gummies; (6) Disney Pixar Finding Nemo Gummies; (7) Disney Pixar WallE Gummies; (8) Disney Pixar Toy Story Gummies; (9) Marvel Heroes Complete; and (10) Marvel Heroes Gummies (collectively, the ‘‘NBTY Products’’). According to the FTC complaint, Respondents represented, in advertisements, that the NBTY Products contained a significant amount of DHA (docosahexaenoic acid, a polyunsaturated Omega-3 fatty acid) or an amount comparable to 100 mg of DHA. The complaint alleges that this claim is false or misleading because, in fact, a daily serving of the NBTY products only contained either 0.1 mg of DHA (which is one thousandth of 100 mg) or 0.05 mg of DHA (which is five ten-thousandths of 100 mg). The Commission also charges that Respondents represented that the DHA provided by a daily serving of the NBTY Products promoted healthy brain and eye development in children two years of age and older. The FTC alleges that this claim is false or misleading because Respondents failed to have evidence to substantiate it. 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 prohibits Respondents from misrepresenting that any product contains a specific ingredient or specific numerical amount of any ingredient. Part II of the proposed order prohibits Respondents from making any representations in advertising for any product about the health benefits, performance, or efficacy of the product, unless the representation is true and non-misleading. In addition, Respondents must possess competent and reliable scientific evidence sufficient in quality and quantity, when considered in light of the entire body of relevant and reliable scientific evidence, to support such claims as true. Part III of the proposed order states that the order does not prohibit Respondents from making representations for any drug that are permitted in labeling for that drug under any tentative or final standard promulgated by the FDA, or under any new drug application approved by the FDA. This part of the proposed order also states that the order does not prohibit Respondents from making representations for any product that are VerDate Mar<15>2010 17:18 Dec 17, 2010 Jkt 223001 specifically permitted in labeling for that product by regulations issued by the FDA under the Nutrition Labeling and Education Act of 1990. Part IV of the proposed order requires Respondents to pay two million, one hundred thousand dollars ($2,100,000) to the Commission to be used for equitable relief, including restitution, consumer redress, and any attendant expenses for the administration of such equitable relief. Parts V through VIII of the proposed order require Respondents to keep copies of relevant advertisements and materials substantiating claims made in the advertisements; to provide copies of the order to certain personnel; to notify the Commission of changes in corporate structure 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, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify their terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2010–31823 Filed 12–17–10; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0420] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on FDA-Regulated Products Used in Animals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 19, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–New and title ‘‘Testing Communications on FDA– Regulated Products Used in Animals.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7651, Juanmanuel.vilela@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Testing Communications on FDA– Regulated Products Used In Animals— (OMB Control Number 0910–New) FDA’s Center for Veterinary Medicine (CVM) has authorization under section 903(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational and public information programs relating to the safety of CVM-regulated products. Further, CVM is authorized to conduct this needed research to ensure that these programs have the highest likelihood of being effective. Thus, CVM concludes that improving communications about the safety of regulated animal drugs, feed, food additives, and devices will involve many research methods, including individual in-depth interviews, mallintercept interviews, focus groups, selfadministered surveys, gatekeeper reviews, and omnibus telephone surveys. The information collected will serve three major purposes. First, as formative research, it will provide critical knowledge needed about target audiences to develop messages and campaigns about the use of animal drugs, feed, food additives, and devices. Knowledge of both the consumer and the veterinary professional decisionmaking processes will provide a better understanding of target audiences that FDA will need in order to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using regulated animal drugs, feed, food additives, and devices by providing users with a better context in which to place risk information more E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79377-79378]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31823]


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FEDERAL TRADE COMMISSION

[File No. 102 3080]


NBTY, Inc.; 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 January 14, 2011.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form. Comments should refer to ``NBTY, File 
No. 102 3080'' to facilitate the organization of comments. Please note 
that your comment--including your name and your State--will be placed 
on the public record of this proceeding, including on the publicly 
accessible FTC Web site, at http://www.ftc.gov/os/publiccomments.shtm.
    Because comments will be made public, they should not include any 
sensitive personal information, such as an individual's Social Security 
Number; date of birth; driver's license number or other State 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. Comments also 
should not include any sensitive health information, such as medical 
records or other individually identifiable health information. In 
addition, comments should not include any ``[t]rade secret or any 
commercial or financial information which is obtained from any person 
and which is privileged or confidential * * *.,'' as provided in 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 
4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which 
confidential treatment is requested must be filed in paper form, must 
be clearly labeled ``Confidential,'' and must comply with FTC Rule 
4.9(c), 16 CFR 4.9(c).\1\
---------------------------------------------------------------------------

    \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 FTC Rule 4.9(c), 16 CFR 
4.9(c).
---------------------------------------------------------------------------

    Because paper mail addressed to the FTC is subject to delay due to 
heightened security screening, please consider submitting your comments 
in electronic form. Comments filed in electronic form should be 
submitted by using the following Web link: https://ftcpublic.commentworks.com/ftc/nbty and following the instructions on 
the Web-based form. To ensure that the Commission considers an 
electronic comment, you must file it on the Web-based form at the Web 
link: https://ftcpublic.commentworks.com/ftc/nbty. If this Notice 
appears at http://www.regulations.gov/search/index.jsp, you may also 
file an electronic comment through that Web site. The Commission will 
consider all comments that regulations.gov forwards to it. You may also 
visit the FTC Web site at http://www.ftc.gov/ to read the Notice and 
the news release describing it.
    A comment filed in paper form should include the ``NBTY, File No. 
102 3080'' 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 H-135 (Annex D), 600 
Pennsylvania Avenue, NW., Washington, DC 20580. 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.
    The Federal Trade Commission Act (``FTC Act'') and other laws the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives, 
whether filed in paper or electronic form. Comments received will be 
available to the public on the FTC Web site, to the extent practicable, 
at http://www.ftc.gov/os/publiccomments.shtm. As a matter of 
discretion, the Commission makes every effort to remove home contact 
information for individuals from the public comments it receives before 
placing those comments on the FTC 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.shtm.

FOR FURTHER INFORMATION CONTACT: Devin Domond (202-326-2610), 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.  2.34 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 December 13, 2010), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. 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 NBTY, Inc., NatureSmart LLC, and Rexall Sundown, Inc. 
(collectively, ``Respondents'').
    The proposed consent order has been placed on the public record for 
thirty (30) days for receipt of comments by interested persons. 
Comments received during this period will become part of the public 
record. After thirty (30) days, the Commission will again review the 
agreement and the comments received, and will decide whether it should 
withdraw from the agreement and take appropriate action or make final 
the agreement's proposed order.
    This matter involves the advertising and promotion of the following 
products in Respondents' Disney/

[[Page 79378]]

Marvel line of children's multivitamin and mineral dietary supplements: 
(1) Disney Princess Complete; (2) Disney Princess Gummies; (3) Disney 
Pixar Cars Gummies; (4) Disney Winnie the Pooh Gummies; (5) Disney 
Tigger & Pooh Gummies; (6) Disney Pixar Finding Nemo Gummies; (7) 
Disney Pixar Wall-E Gummies; (8) Disney Pixar Toy Story Gummies; (9) 
Marvel Heroes Complete; and (10) Marvel Heroes Gummies (collectively, 
the ``NBTY Products'').
    According to the FTC complaint, Respondents represented, in 
advertisements, that the NBTY Products contained a significant amount 
of DHA (docosahexaenoic acid, a polyunsaturated Omega-3 fatty acid) or 
an amount comparable to 100 mg of DHA. The complaint alleges that this 
claim is false or misleading because, in fact, a daily serving of the 
NBTY products only contained either 0.1 mg of DHA (which is one 
thousandth of 100 mg) or 0.05 mg of DHA (which is five ten-thousandths 
of 100 mg).
    The Commission also charges that Respondents represented that the 
DHA provided by a daily serving of the NBTY Products promoted healthy 
brain and eye development in children two years of age and older. The 
FTC alleges that this claim is false or misleading because Respondents 
failed to have evidence to substantiate it.
    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 prohibits Respondents from misrepresenting 
that any product contains a specific ingredient or specific numerical 
amount of any ingredient.
    Part II of the proposed order prohibits Respondents from making any 
representations in advertising for any product about the health 
benefits, performance, or efficacy of the product, unless the 
representation is true and non-misleading. In addition, Respondents 
must possess competent and reliable scientific evidence sufficient in 
quality and quantity, when considered in light of the entire body of 
relevant and reliable scientific evidence, to support such claims as 
true.
    Part III of the proposed order states that the order does not 
prohibit Respondents from making representations for any drug that are 
permitted in labeling for that drug under any tentative or final 
standard promulgated by the FDA, or under any new drug application 
approved by the FDA. This part of the proposed order also states that 
the order does not prohibit Respondents from making 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.
    Part IV of the proposed order requires Respondents to pay two 
million, one hundred thousand dollars ($2,100,000) to the Commission to 
be used for equitable relief, including restitution, consumer redress, 
and any attendant expenses for the administration of such equitable 
relief.
    Parts V through VIII of the proposed order require Respondents to 
keep copies of relevant advertisements and materials substantiating 
claims made in the advertisements; to provide copies of the order to 
certain personnel; to notify the Commission of changes in corporate 
structure 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, with certain 
exceptions.
    The purpose of this analysis is to facilitate public comment on the 
proposed order, and it is not intended to constitute an official 
interpretation of the agreement and proposed order or to modify their 
terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2010-31823 Filed 12-17-10; 8:45 am]
BILLING CODE 6750-01-P