Telomerase Activation Sciences, Inc. and Noel Thomas Patton; Analysis To Aid Public Comment, 8672-8674 [2018-04025]

Download as PDF 8672 Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices Changes in estimates: There is no change of hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This universe of respondents remains the same. The changes in costs are due to inflation and an increase in wages for respondents, rounded to 3 significant figures. Courtney Kerwin, Director, Regulatory Support Division. [FR Doc. 2018–04055 Filed 2–27–18; 8:45 am] BILLING CODE 6560–50–P FEDERAL MARITIME COMMISSION Notice of Agreement Filed The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. A copy of the agreement is available through the Commission’s website (www.fmc.gov) or by contacting the Office of Agreements at (202) 523–5793 or tradeanalysis@ fmc.gov. Agreement No.: 012442–001. Title: Miami Marine Terminal Conference Agreement. Parties: Port of Miami Terminal Operating Company, L.C. and South Florida Container Terminal, LLC. Filing Party: David F. Smith; Cozen O’Connor; 1200 19th Street NW, Washington, DC 20036. Synopsis: The amendment revises Article 3 of the Agreement to correct the name of one of the Agreement Parties, the Port of Miami Terminal Operating Company, L.C. By Order of the Federal Maritime Commission. Dated: February 23, 2018. Rachel E. Dickon, Secretary. [FR Doc. 2018–04080 Filed 2–27–18; 8:45 am] BILLING CODE 6731–AA–P FEDERAL TRADE COMMISSION sradovich on DSK3GMQ082PROD with NOTICES [File No. 142 3103] Telomerase Activation Sciences, Inc. and Noel Thomas Patton; Analysis To Aid Public Comment Federal Trade Commission. Proposed consent agreement. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of SUMMARY: VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 federal law prohibiting unfair or deceptive acts or practices. 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 March 23, 2018. ADDRESSES: Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: ‘‘In the Matter of Telomerase Activation Sciences, Inc., et al.’’ on your comment, and file your comment online at https:// ftcpublic.commentworks.com/ftc/ telomeraseconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ‘‘In the Matter of Telomerase Activation Sciences, Inc., et al.’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC–5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Andrew Wone (202–326–2934), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW, Washington, DC 20580. SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 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 February 21, 2018), on the World Wide Web, at https:// www.ftc.gov/news-events/commissionactions. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before March 23, 2018. Write ‘‘In the Matter of Telomerase Activation PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 Sciences, Inc., et al.’’ on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission website, at https://www.ftc.gov/policy/publiccomments. Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ telomeraseconsent by following the instructions on the web-based form. If this Notice appears at http:// www.regulations.gov/#!home, you also may file a comment through that website. If you prefer to file your comment on paper, write ‘‘In the Matter of Telomerase Activation Sciences, Inc., et al.’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC–5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Because your comment will be placed on the publicly accessible FTC website at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else’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. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including in particular competitively sensitive information such as costs, E:\FR\FM\28FEN1.SGM 28FEN1 Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. 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). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request. Visit the FTC website at http:// www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that 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 on or before March 23, 2018. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/ privacy-policy. Analysis of Proposed 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 as to Telomerase Activation Sciences, Inc. and Noel Thomas Patton (collectively ‘‘respondents’’). The proposed consent order (‘‘order’’) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 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 order. This matter involves respondents’ advertising for TA–65MD, a product that comes in capsule and powder forms, and TA–65 for Skin (‘‘TA–65 Skin’’), a topical cream product. The VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 complaint alleges that respondents violated Sections 5(a) and 12 of the FTC Act by making false or unsubstantiated health or performance claims that: TA– 65MD and TA–65 Skin reverse aging; TA–65MD prevents and repairs DNA damage; TA–65MD restores aging immune systems; TA–65MD increases bone density; TA–65MD reverses the effects of aging, including improving skin elasticity, increasing energy and endurance, and improving vision; TA– 65MD prevents or reduces the risk of cancer; TA–65 Skin reverses the effects of aging, including improving skin elasticity; and TA–65 Skin decreases recovery time of the skin after medical procedures. The complaint also alleges that respondents claimed that some of the above performance claims were clinically or scientifically proven. The complaint further alleges that respondents misrepresented that a 2012 paid-for segment on The Suzanne Show featuring TA–65MD was independent, educational programming and not paid commercial advertising. Additionally, the complaint alleges that respondents deceptively represented that consumers appearing in advertisements were independent users of TA–65MD, expressing their impartial views of satisfaction. According to the complaint, respondents failed to disclose that these consumer endorsers received compensation, including free TA– 65MD. Finally, the complaint alleges that by providing promotional materials that had false or unsubstantiated health or performance claims to marketers of other products containing TA–65MD, respondents provided these other marketers the means and instrumentalities to engage in deceptive acts and practices. The order includes injunctive relief that prohibits these alleged violations and fences in similar and related violations. The order applies to marketing claims for any covered product, defined as TA–65MD and TA– 65 Skin or any other drug, food, dietary supplement, or cosmetic. As additional fencing-in relief, the order requires respondents to provide a notice to all of its licensees authorized to advertise, market, or sell any covered product, monitor certain high-selling licensees, and follow appropriate recordkeeping, compliance reporting, and document preservation requirements. Provision I prohibits any representation that a covered product reverses human aging; prevents or repairs DNA damage; restores aging immune systems; increases bone density; reverses the effects of aging, including improving skin elasticity, increasing energy and endurance, and PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 8673 improving vision; decreases recovery time of the skin after medical procedures; prevents or reduces the risk of cancer; or cures, mitigates, or treats any disease unless the representation is non-misleading and respondents possess and rely upon competent and reliable scientific evidence that substantiates that the representation is true. The definition of competent and reliable scientific evidence in Provision I specifies human clinical testing and requires that the testing be sufficient in quality and quantity, based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing must (1) be randomized, double-blind, and placebo-controlled; and (2) be conducted by researchers qualified by training and experience to conduct such testing. In addition, respondents must maintain all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of such testing. Provision II prohibits representations regarding the health benefits, performance, efficacy, safety, or side effects of any covered product unless the representation is non-misleading and respondents possess and rely upon competent and reliable scientific evidence to substantiate that the representation is true. Provision II defines competent and reliable scientific evidence as tests, analyses, research, or studies: (1) That have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; (2) that are generally accepted by such experts to yield accurate and reliable results; and (3) that are randomized, double-blind, and placebo-controlled human clinical testing of the covered product, when such experts would generally require such human clinical testing to substantiate that the representation is true. When such tests or studies are human clinical tests or studies, respondents must maintain all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of such testing. Provision III prohibits misrepresentations that any covered product is clinically or scientifically proven to reverse human aging, prevent or repair DNA damage, restore aging immune systems, or increase bone density. Provision III also prohibits any misrepresentation that the performance E:\FR\FM\28FEN1.SGM 28FEN1 sradovich on DSK3GMQ082PROD with NOTICES 8674 Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices or benefits of any product are scientifically or clinically proven or about the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Provision IV is a provision for FDAapproved claims. Provision V prohibits misrepresentations in connection with the marketing, advertising, or promoting of any product, service, or program that paid commercial advertising is independent programming. Provision VI prohibits any representation about any user, consumer, or endorser of a covered product without disclosing, clearly and conspicuously, and in close proximity to that representation, any unexpected material connection between such endorser and (1) any respondent; or (2) any other individual or entity affiliated with the product. ‘‘Unexpected material connection’’ means any relationship that might materially affect the weight or credibility of the testimonial or endorsement and that would not reasonably be expected by consumers. Provision VII prohibits misrepresentations regarding the status of any endorser or person providing a review of a product, including a misrepresentation that the endorser or reviewer is an independent or ordinary user of the product. Provision VIII prohibits respondents from providing the means and instrumentalities to make any false or misleading statement of material fact, including the representations prohibited by Provisions I to III. ‘‘Means and instrumentalities’’ mean any information, document, or article referring or relating to any covered product, including any advertising, labeling, promotional, or purported substantiation materials, for use by a licensee to market or sell any covered product. Provision IX, triggered when the human clinical testing requirement in Provisions I or II applies, requires that respondents secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of the test, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test’s researchers. There is an exception for a reliably reported test (defined as a test that is published in a peer-reviewed journal) that was not conducted, controlled, or sponsored by, with, or on behalf of any respondent or by any supplier or manufacturer of the product. Also, the published report must provide sufficient information about the test for experts in the relevant VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 field to assess the reliability of the results. Provision X mandates that respondents acknowledge receipt of the order, distribute the order to principals, officers, and certain employees and agents, and obtain signed acknowledgments from them. Provision XI requires that respondents submit compliance reports to the FTC 60 days after the order’s issuance and submit notifications when certain events occur for 10 years. Provision XII requires that respondents create and retain certain records for 10 years. Provision XIII provides for the FTC’s continued compliance monitoring of respondents’ activities during the order’s effective dates. Provision XIV requires that respondents notify their licensees, monitor their highest-selling licensees’ advertising to ensure compliance with Provisions I through III, and suspend any licensee who makes any prohibited claims. Respondents must terminate any licensee who continues to make prohibited claims. There are two limited exceptions to the monitoring requirement: (1) Representations during private consultations between a licensee and one of the licensee’s patients about the potential safety, health benefits, performance, efficacy, or side effects of a covered product; and (2) representations about the potential safety, health benefits, performance, efficacy, or side effects of a covered product by a licensee who has purchased a covered product solely for incorporation into the licensee’s own product and markets that product without any involvement by respondents. Provision XV requires that respondents send a notice to all customers who purchased directly from them TA–65MD or TA–65 Skin within one year prior to the issuance of the order or through a currently active enrollment in a continuity or autoship program. Provision XVI provides that, with exceptions, the order will terminate in 20 years. The purpose of this analysis is to facilitate public comment on the order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order’s terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2018–04025 Filed 2–27–18; 8:45 am] BILLING CODE 6750–01–P PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Request for Information Regarding Patient-Reported Outcome Measures Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for information. AGENCY: AHRQ is seeking information submissions from the public. Information is being solicited to inform our work on patient-reported outcomes (PROs). Access to information regarding physical function PRO measure use will assist the selection of measures for AHRQ’s efforts to develop and implement user-friendly technical tools to collect and integrate PRO data in electronic health records or other health information technology products. DATES: Submission must be received by April 1, 2018. ADDRESSES: Electronic responses are preferred and should be addressed to Janey.hsiao@ahrq.hhs.gov. Nonelectronic responses will also be accepted. Please mail to: Janey Hsiao, Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, Mailstop: 06E73A. FOR FURTHER INFORMATION CONTACT: Janey Hsiao, Health Scientist Administrator, Center for Evidence and Practice Improvement, Janey.hsiao@ ahrq.hhs.gov, (301) 427–1335. SUPPLEMENTARY INFORMATION: AHRQ plans to conduct a Challenge Competition in Fall 2018 to develop user-friendly technical tools to collect and integrate patient-reported outcome (PRO) data in electronic health records or other health information technology products. The technical tools will be intended for use in ambulatory care settings including primary care and specialty care. For this competition, AHRQ will choose a physical function PRO measure as a use case for the tool development. More information about the Challenge Competition is available at https://www.gpo.gov/fdsys/pkg/FR2017-12-26/pdf/2017-27663.pdf. AHRQ will also conduct another project to pilot test whether the specified standards used in the Challenge Competition can be adapted for data collection utilizing other PRO measures or domains. AHRQ is interested in learning what physical function PRO measures are being used, and about experiences with these measures in clinical practice. We are also interested in methods used to collect these PROs, including computer adaptive testing SUMMARY: E:\FR\FM\28FEN1.SGM 28FEN1

Agencies

[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Notices]
[Pages 8672-8674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04025]


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FEDERAL TRADE COMMISSION

[File No. 142 3103]


Telomerase Activation Sciences, Inc. and Noel Thomas Patton; 
Analysis 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. 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 March 23, 2018.

ADDRESSES: Interested parties may file a comment online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``In the Matter of 
Telomerase Activation Sciences, Inc., et al.'' on your comment, and 
file your comment online at https://ftcpublic.commentworks.com/ftc/telomeraseconsent by following the instructions on the web-based form. 
If you prefer to file your comment on paper, write ``In the Matter of 
Telomerase Activation Sciences, Inc., et al.'' on your comment and on 
the envelope, and mail your comment to the following address: Federal 
Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, 
Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment 
to the following address: Federal Trade Commission, Office of the 
Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 
5610 (Annex D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Andrew Wone (202-326-2934), Bureau of 
Consumer Protection, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 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 February 21, 2018), on the World Wide Web, 
at https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before March 23, 2018. 
Write ``In the Matter of Telomerase Activation Sciences, Inc., et al.'' 
on your comment. Your comment--including your name and your state--will 
be placed on the public record of this proceeding, including, to the 
extent practicable, on the public Commission website, at https://www.ftc.gov/policy/public-comments.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/telomeraseconsent by following the instructions on the web-based 
form. If this Notice appears at http://www.regulations.gov/#!home, you 
also may file a comment through that website.
    If you prefer to file your comment on paper, write ``In the Matter 
of Telomerase Activation Sciences, Inc., et al.'' on your comment and 
on the envelope, and mail your comment to the following address: 
Federal Trade Commission, Office of the Secretary, 600 Pennsylvania 
Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580, or deliver 
your comment to the following address: Federal Trade Commission, Office 
of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, 
Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your 
paper comment to the Commission by courier or overnight service.
    Because your comment will be placed on the publicly accessible FTC 
website at https://www.ftc.gov, you are solely responsible for making 
sure that your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else'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. You are also 
solely responsible for making sure that your comment does not include 
any sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs,

[[Page 8673]]

sales statistics, inventories, formulas, patterns, devices, 
manufacturing processes, or customer names.
    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). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the public FTC website--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC website, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC website at http://www.ftc.gov to read this Notice and 
the news release describing it. The FTC Act and other laws that 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 on or before March 23, 2018. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Proposed 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 as to Telomerase Activation Sciences, Inc. and Noel Thomas Patton 
(collectively ``respondents'').
    The proposed consent order (``order'') has been placed on the 
public record for 30 days for receipt of comments by interested 
persons. Comments received during this period will become part of the 
public record. After 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 order.
    This matter involves respondents' advertising for TA-65MD, a 
product that comes in capsule and powder forms, and TA-65 for Skin 
(``TA-65 Skin''), a topical cream product. The complaint alleges that 
respondents violated Sections 5(a) and 12 of the FTC Act by making 
false or unsubstantiated health or performance claims that: TA-65MD and 
TA-65 Skin reverse aging; TA-65MD prevents and repairs DNA damage; TA-
65MD restores aging immune systems; TA-65MD increases bone density; TA-
65MD reverses the effects of aging, including improving skin 
elasticity, increasing energy and endurance, and improving vision; TA-
65MD prevents or reduces the risk of cancer; TA-65 Skin reverses the 
effects of aging, including improving skin elasticity; and TA-65 Skin 
decreases recovery time of the skin after medical procedures. The 
complaint also alleges that respondents claimed that some of the above 
performance claims were clinically or scientifically proven.
    The complaint further alleges that respondents misrepresented that 
a 2012 paid-for segment on The Suzanne Show featuring TA-65MD was 
independent, educational programming and not paid commercial 
advertising. Additionally, the complaint alleges that respondents 
deceptively represented that consumers appearing in advertisements were 
independent users of TA-65MD, expressing their impartial views of 
satisfaction. According to the complaint, respondents failed to 
disclose that these consumer endorsers received compensation, including 
free TA-65MD. Finally, the complaint alleges that by providing 
promotional materials that had false or unsubstantiated health or 
performance claims to marketers of other products containing TA-65MD, 
respondents provided these other marketers the means and 
instrumentalities to engage in deceptive acts and practices.
    The order includes injunctive relief that prohibits these alleged 
violations and fences in similar and related violations. The order 
applies to marketing claims for any covered product, defined as TA-65MD 
and TA-65 Skin or any other drug, food, dietary supplement, or 
cosmetic. As additional fencing-in relief, the order requires 
respondents to provide a notice to all of its licensees authorized to 
advertise, market, or sell any covered product, monitor certain high-
selling licensees, and follow appropriate recordkeeping, compliance 
reporting, and document preservation requirements.
    Provision I prohibits any representation that a covered product 
reverses human aging; prevents or repairs DNA damage; restores aging 
immune systems; increases bone density; reverses the effects of aging, 
including improving skin elasticity, increasing energy and endurance, 
and improving vision; decreases recovery time of the skin after medical 
procedures; prevents or reduces the risk of cancer; or cures, 
mitigates, or treats any disease unless the representation is non-
misleading and respondents possess and rely upon competent and reliable 
scientific evidence that substantiates that the representation is true. 
The definition of competent and reliable scientific evidence in 
Provision I specifies human clinical testing and requires that the 
testing be sufficient in quality and quantity, based on standards 
generally accepted by experts in the relevant disease, condition, or 
function to which the representation relates, when considered in light 
of the entire body of relevant and reliable scientific evidence, to 
substantiate that the representation is true. Such testing must (1) be 
randomized, double-blind, and placebo-controlled; and (2) be conducted 
by researchers qualified by training and experience to conduct such 
testing. In addition, respondents must maintain all underlying or 
supporting data and documents generally accepted by experts in the 
field as relevant to an assessment of such testing.
    Provision II prohibits representations regarding the health 
benefits, performance, efficacy, safety, or side effects of any covered 
product unless the representation is non-misleading and respondents 
possess and rely upon competent and reliable scientific evidence to 
substantiate that the representation is true. Provision II defines 
competent and reliable scientific evidence as tests, analyses, 
research, or studies: (1) That have been conducted and evaluated in an 
objective manner by experts in the relevant disease, condition, or 
function to which the representation relates; (2) that are generally 
accepted by such experts to yield accurate and reliable results; and 
(3) that are randomized, double-blind, and placebo-controlled human 
clinical testing of the covered product, when such experts would 
generally require such human clinical testing to substantiate that the 
representation is true. When such tests or studies are human clinical 
tests or studies, respondents must maintain all underlying or 
supporting data and documents generally accepted by experts in the 
field as relevant to an assessment of such testing.
    Provision III prohibits misrepresentations that any covered product 
is clinically or scientifically proven to reverse human aging, prevent 
or repair DNA damage, restore aging immune systems, or increase bone 
density. Provision III also prohibits any misrepresentation that the 
performance

[[Page 8674]]

or benefits of any product are scientifically or clinically proven or 
about the existence, contents, validity, results, conclusions, or 
interpretations of any test, study, or research.
    Provision IV is a provision for FDA-approved claims.
    Provision V prohibits misrepresentations in connection with the 
marketing, advertising, or promoting of any product, service, or 
program that paid commercial advertising is independent programming.
    Provision VI prohibits any representation about any user, consumer, 
or endorser of a covered product without disclosing, clearly and 
conspicuously, and in close proximity to that representation, any 
unexpected material connection between such endorser and (1) any 
respondent; or (2) any other individual or entity affiliated with the 
product. ``Unexpected material connection'' means any relationship that 
might materially affect the weight or credibility of the testimonial or 
endorsement and that would not reasonably be expected by consumers.
    Provision VII prohibits misrepresentations regarding the status of 
any endorser or person providing a review of a product, including a 
misrepresentation that the endorser or reviewer is an independent or 
ordinary user of the product.
    Provision VIII prohibits respondents from providing the means and 
instrumentalities to make any false or misleading statement of material 
fact, including the representations prohibited by Provisions I to III. 
``Means and instrumentalities'' mean any information, document, or 
article referring or relating to any covered product, including any 
advertising, labeling, promotional, or purported substantiation 
materials, for use by a licensee to market or sell any covered product.
    Provision IX, triggered when the human clinical testing requirement 
in Provisions I or II applies, requires that respondents secure and 
preserve all underlying or supporting data and documents generally 
accepted by experts in the field as relevant to an assessment of the 
test, such as protocols, instructions, participant-specific data, 
statistical analyses, and contracts with the test's researchers. There 
is an exception for a reliably reported test (defined as a test that is 
published in a peer-reviewed journal) that was not conducted, 
controlled, or sponsored by, with, or on behalf of any respondent or by 
any supplier or manufacturer of the product. Also, the published report 
must provide sufficient information about the test for experts in the 
relevant field to assess the reliability of the results.
    Provision X mandates that respondents acknowledge receipt of the 
order, distribute the order to principals, officers, and certain 
employees and agents, and obtain signed acknowledgments from them.
    Provision XI requires that respondents submit compliance reports to 
the FTC 60 days after the order's issuance and submit notifications 
when certain events occur for 10 years.
    Provision XII requires that respondents create and retain certain 
records for 10 years.
    Provision XIII provides for the FTC's continued compliance 
monitoring of respondents' activities during the order's effective 
dates.
    Provision XIV requires that respondents notify their licensees, 
monitor their highest-selling licensees' advertising to ensure 
compliance with Provisions I through III, and suspend any licensee who 
makes any prohibited claims. Respondents must terminate any licensee 
who continues to make prohibited claims. There are two limited 
exceptions to the monitoring requirement: (1) Representations during 
private consultations between a licensee and one of the licensee's 
patients about the potential safety, health benefits, performance, 
efficacy, or side effects of a covered product; and (2) representations 
about the potential safety, health benefits, performance, efficacy, or 
side effects of a covered product by a licensee who has purchased a 
covered product solely for incorporation into the licensee's own 
product and markets that product without any involvement by 
respondents.
    Provision XV requires that respondents send a notice to all 
customers who purchased directly from them TA-65MD or TA-65 Skin within 
one year prior to the issuance of the order or through a currently 
active enrollment in a continuity or autoship program.
    Provision XVI provides that, with exceptions, the order will 
terminate in 20 years.
    The purpose of this analysis is to facilitate public comment on the 
order, and it is not intended to constitute an official interpretation 
of the complaint or order, or to modify the order's terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018-04025 Filed 2-27-18; 8:45 am]
 BILLING CODE 6750-01-P