BASF SE and DIEM Labs; Analysis of Proposed Consent Orders To Aid Public Comment, 18285-18287 [2021-07217]

Download as PDF Federal Register / Vol. 86, No. 66 / Thursday, April 8, 2021 / Notices 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 public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551–0001, not later than May 10, 2021. A. Federal Reserve Bank of Kansas City (Porcia Block, Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Foote Financial Services, LLC, Hoxie, Kansas; to acquire Stanley Bank, Overland Park, Kansas. Board of Governors of the Federal Reserve System, April 5, 2021. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2021–07253 Filed 4–7–21; 8:45 am] BILLING CODE P FEDERAL TRADE COMMISSION [File No. 192 3088] BASF SE and DIEM Labs; Analysis of Proposed Consent Orders To Aid Public Comment Federal Trade Commission. Proposed consent agreement; request for comment. AGENCY: khammond on DSKJM1Z7X2PROD with NOTICES ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis of Proposed Consent Orders to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orders— SUMMARY: VerDate Sep<11>2014 16:53 Apr 07, 2021 Jkt 253001 embodied in the consent agreements— that would settle these allegations. DATES: Comments must be received on or before May 10, 2021. ADDRESSES: Interested parties may file comments online or on paper by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Please write ‘‘BASF SE; File No. 192 3088’’ on your comment, and file your comment online at https:// www.regulations.gov by following the instructions on the web-based form. If you prefer to file your comment on paper, 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: Janet Evans (202–326–2125), Bureau of Consumer Protection, Federal Trade Commission, 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 consent orders 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 agreements and the allegations in the complaint. An electronic copy of the full text of the consent agreement packages can be obtained 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 May 10, 2021. Write ‘‘BASF SE; File No. 192 3088’’ 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 https://www.regulations.gov website. Due to the COVID–19 public health emergency and the agency’s heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 18285 through the https://www.regulations.gov website. If you prefer to file your comment on paper, write ‘‘BASF SE; File No. 192 3088’’ on your comment and on the envelope, and mail it 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 website at https://www.regulations.gov, you are solely responsible for making sure your comment does not include any sensitive or confidential information. In particular, your comment should not include 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 your comment does not include 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, 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 https:// www.regulations.gov website—as legally E:\FR\FM\08APN1.SGM 08APN1 18286 Federal Register / Vol. 86, No. 66 / Thursday, April 8, 2021 / Notices required by FTC Rule 4.9(b)—we cannot redact or remove your comment from that 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 https:// www.ftc.gov to read this Notice and the news release describing the proposed settlement. 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 May 10, 2021. 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. khammond on DSKJM1Z7X2PROD with NOTICES Analysis of Proposed Consent Orders To Aid Public Comment The Federal Trade Commission (‘‘Commission’’) has accepted, subject to final approval, an agreement containing a consent order with BASF SE and BASF Corporation (‘‘BASF Respondents’’). It also has accepted, subject to final approval, an agreement containing a consent order with DIEM Labs, LLC, and others (‘‘DIEM Respondents’’). The proposed consent orders have been placed on the public record for 30 days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the agreements and the comments received, and will decide whether it should withdraw from one or both of the agreements and take appropriate actions, or make final the agreements’ proposed orders. This matter involves Respondents’ advertising for Hepaxa and Hepaxa PD capsules containing omega-3 fatty acids. The Commission’s proposed complaint alleges that advertising for the Hepaxa products represented that Hepaxa reduces liver fat in most adults with Nonalcoholic Fatty Liver Disease (‘‘NAFLD’’) within six months, and that Hepaxa PD reduces liver fat in most children with NAFLD within six months. The complaint further alleges that Respondents’ advertising represented that tests prove that Hepaxa reduces liver fat in adults with NAFLD and that tests prove that Hepaxa PD reduces liver fat in children with NAFLD. According to the proposed complaint, these claims are false or misleading, or were not substantiated at the time the representations were made, VerDate Sep<11>2014 16:53 Apr 07, 2021 Jkt 253001 in violation of Sections 5 and 12 of the FTC Act. The proposed orders include injunctive relief that prohibits these alleged violations and fences in similar and related conduct. The proposed orders against the BASF Respondents and DIEM Respondents are substantially similar. In both orders, ‘‘Covered Products’’ is defined as Hepaxa, Hepaxa PD, and any other Dietary Supplement, Food, or Drug that contains one or more omega-3 fatty acids or is promoted by a Respondent or its subsidiary to benefit cardiac, metabolic, or hepatic health or functions, including the prevention, mitigation, treatment, or cure of any disease of such systems. Part I of the orders prohibits Respondents from making any representation that a Covered Product reduces liver fat in adults or children with Non-alcoholic Fatty Liver Disease (NAFLD), or cures, mitigates, or treats any disease, including but not limited to liver disease, unless the representation is nonmisleading, including that, at the time such representation is made, they possess and rely upon competent and reliable scientific evidence that substantiates that the representation is true. For purposes of Part I, competent and reliable scientific evidence must consist of human clinical testing of the covered product, or of an essentially equivalent product, that is 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 be: (1) Randomized, double-blind, and placebo-controlled; and (2) conducted by researchers qualified by training and experience to conduct such testing. Part II prohibits Respondents from making any representation, other than representations covered under Part I, about the health benefits, performance, efficacy, safety, or side effects of any covered product, unless the representation is non-misleading, and, at the time of making such representation, they possess and rely upon competent and reliable scientific evidence that is 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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 For purposes of Part II, ‘‘competent and reliable scientific evidence’’ means tests, analyses, research, or studies that (1) 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, or of an essentially equivalent product, when such experts would generally require such human clinical testing to substantiate that the representation is true. Part III prohibits misrepresentations about tests and studies. Part IV provides Respondents a safe harbor for making claims approved by the Food and Drug Administration (‘‘FDA’’). Part V requires that, with regard to any human clinical test or study upon which Respondents rely to substantiate any claim covered by the orders, Respondents must secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of a test. Part VI provides for monetary relief, and Part VII describes the procedures and legal rights related those payments. Together, Respondents are paying the full amount of consumer injury, $416,914.00. DIEM Order Part VIII requires the company to provide sufficient customer information to enable the Commission to efficiently administer consumer redress to purchasers of Hepaxa and Hepaxa PD. DIEM Order Part IX and BASF Order Part VIII require Respondents to submit acknowledgments of receipts of the order. DIEM Order Part X and BASF Order Part IX require the filing of compliance reports with the Commission, including notification to the Commission of bankruptcy filings or changes in corporate structure that might affect compliance obligations. DIEM Order Part XI and BASF Order Part X contain recordkeeping requirements. DIEM Order Part XII and BASF Order XI contain other requirements related to the Commission’s monitoring of Respondents’ order compliance. Finally, DIEM Order Part XIII and BASF Order Part XII state that the orders will remain in effect for 20 years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the orders, and it is not intended to constitute an official interpretation of the complaint or orders, or to modify the orders’ terms in any way. E:\FR\FM\08APN1.SGM 08APN1 Federal Register / Vol. 86, No. 66 / Thursday, April 8, 2021 / Notices By direction of the Commission. April J. Tabor, Secretary. Use of Funds [FR Doc. 2021–07217 Filed 4–7–21; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Aging and Disability Resource Center/ No Wrong Door System COVID–19 Vaccine Access Supplemental Funding Announcement Type: Initial. Statutory Authority: The statutory authority for grants under this funding opportunity is contained in Title II of the Older Americans Act of 1965 (OAA) [as amended through P.L. 116–131] (42 U.S.C. 3012). Title II Section 202b(8), the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020, and the Coronavirus Response and Relief Supplemental Appropriations Act, 2021. The Centers for Disease Control and Prevention has the authority under Section 301 of the Public Health Service Act and Division M, Consolidated Appropriations Act, 2021, Public Law 116–260. Catalog of Federal Domestic Assistance (CFDA) Number: 93.048. DATES: The deadline for submission of the supplemental funding request is 11:59 p.m. EST April 9, 2021. khammond on DSKJM1Z7X2PROD with NOTICES I. Funding Opportunity Description This funding opportunity is to support a new effort to get the nation’s most vulnerable and at-risk seniors and people with disabilities vaccinated. Among some of the hardest to reach are seniors and people with disabilities who are unable to leave their home without assistance or are homebound, are socially isolated, live independently but are medically fragile, or have cognitive impairments. These individuals are at particular risk because they may depend on people coming into their homes to provide services, including personal care assistance. To assist in getting these particularly vulnerable and at-risk older adults and people with disabilities vaccinated, the Biden-Harris Administration has announced new funding to reach these important communities. The Administration for Community Living, in partnership with the Centers for Disease Control and Prevention, provides this supplemental funding opportunity specifically for current Aging and Disability Resource Center (ADRC)/No Wrong Door (NWD) COVID–19 CARES Act funding grantees. VerDate Sep<11>2014 16:53 Apr 07, 2021 Jkt 253001 These grants will provide assistance with scheduling vaccine appointments, transportation to vaccine sites, direct support services needed to attend vaccine appointments, connection to inhome vaccination options, and education about the importance of receiving the vaccine to older adults and people with disabilities. In addition, these grants will enable the aging and disability networks to identify people who are unable to independently travel to vaccination sites and to provide technical assistance to local health departments on improving access to vaccines for people with disabilities and older adults. This funding is specific to vaccine access support and is encouraged to support all ADRC/NWD partner agencies and community based organizations who may be able to reach the most at-risk individuals. Grantees are strongly encouraged to partner and coordinate with state and local agencies for this effort. Expected activities to be performed under this funding opportunity include: • Public outreach and education about COVID–19 vaccinations (e.g. public announcements, targeted marketing push, sharing information on ADRC/NWD website) including ways to address vaccination hesitancy. • Individual outreach and awareness (e.g., direct calls or in-person visits to individuals who may be eligible). • Vaccine registration support, including through statewide websites, 211 or in-person. • Transportation assistance to and from vaccination sites, including support during wait times at the vaccination site. • Support for unique vaccine distribution methods including arranging for in-home vaccinations for individuals enrolled in state funded long term services and supports (LTSS) programs who may have difficultly leaving the home. • Addressing accessibility needs at vaccination sites or post vaccination recovery needs (e.g., coordinating with AT programs.) Key requirements for grantees under this emergency FOA will include: • Grantees are expected to regularly participate in updates or touchpoints with all ADRC/NWD partners and subgrantees to discuss progress, challenges, and potential solutions related to vaccination access for older adults and people with disabilities. • Grantees will report to ACL on a semi-annual basis on challenges and successes that have been experienced by PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 18287 all partners and sub-grantees and will share ideas and receive technical assistance to address challenges. • Grantees will submit annual progress reports on the activities conducted, challenges, successes, and lessons learned and provide a written summary. • Grantees are expected to spend funds in reasonable timeframe. Grantees who have not drawn funds from the initial ADRC–COVID grant must explain how they will spend this supplemental funding in a prudent manner. II. Award Information 1. Funding Instrument Type These grants are discretionary, supplemental grants, authorized by the Centers for Disease Control and Prevention under Section 301 of the Public Health Service Act and Division M, Consolidated Appropriations Act, 2021, Public Law 116–260 and appropriated through the Coronavirus Response and Relief Supplemental Appropriations Act of 2021. 2. Anticipated Total Priority Area Funding per Budget Period The total available funding for this opportunity is $26,000,000. ACL intends to make available, under this program announcement, supplemental awards to ADRC–COVID grantees. The period of performance for these grants during which grant activities must occur is estimated to be April 1, 2021 and is projected to end on September 30, 2022. ADRC–COVID grantees are eligible to apply for and receive the amount of funding in the table below: State/territory AK ......................................... AL ......................................... AR ......................................... AS ......................................... AZ ......................................... CA ......................................... CM ........................................ CO ........................................ CT ......................................... DC ......................................... DE ......................................... FL .......................................... GA ......................................... GU ........................................ HI .......................................... IA .......................................... ID .......................................... IL ........................................... IN .......................................... KS ......................................... KY ......................................... LA ......................................... MA ........................................ MD ........................................ ME ........................................ E:\FR\FM\08APN1.SGM 08APN1 Available amount $159,812 395,251 238,292 159,812 578,369 1,572,442 159,812 395,251 238,292 159,812 159,812 1,572,442 892,287 159,812 159,812 238,292 159,812 892,287 578,369 238,292 395,251 395,251 578,369 395,251 159,812

Agencies

[Federal Register Volume 86, Number 66 (Thursday, April 8, 2021)]
[Notices]
[Pages 18285-18287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07217]


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

FEDERAL TRADE COMMISSION

[File No. 192 3088]


BASF SE and DIEM Labs; Analysis of Proposed Consent Orders To Aid 
Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement; request for comment.

-----------------------------------------------------------------------

SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices. The attached Analysis of Proposed Consent Orders to Aid 
Public Comment describes both the allegations in the draft complaint 
and the terms of the consent orders--embodied in the consent 
agreements--that would settle these allegations.

DATES: Comments must be received on or before May 10, 2021.

ADDRESSES: Interested parties may file comments online or on paper by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Please write ``BASF SE; File 
No. 192 3088'' on your comment, and file your comment online at https://www.regulations.gov by following the instructions on the web-based 
form. If you prefer to file your comment on paper, 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: Janet Evans (202-326-2125), Bureau of 
Consumer Protection, Federal Trade Commission, 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 consent orders 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 agreements and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement packages can be obtained 
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 May 10, 2021. 
Write ``BASF SE; File No. 192 3088'' 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 
https://www.regulations.gov website.
    Due to the COVID-19 public health emergency and the agency's 
heightened security screening, postal mail addressed to the Commission 
will be subject to delay. We strongly encourage you to submit your 
comments online through the https://www.regulations.gov website.
    If you prefer to file your comment on paper, write ``BASF SE; File 
No. 192 3088'' on your comment and on the envelope, and mail it 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 
website at https://www.regulations.gov, you are solely responsible for 
making sure your comment does not include any sensitive or confidential 
information. In particular, your comment should not include 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 your comment does not include 
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, 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 https://www.regulations.gov website--as legally

[[Page 18286]]

required by FTC Rule 4.9(b)--we cannot redact or remove your comment 
from that 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 https://www.ftc.gov to read this Notice and 
the news release describing the proposed settlement. 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 May 10, 2021. 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 Orders To Aid Public Comment

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an agreement containing a consent order with BASF SE 
and BASF Corporation (``BASF Respondents''). It also has accepted, 
subject to final approval, an agreement containing a consent order with 
DIEM Labs, LLC, and others (``DIEM Respondents''). The proposed consent 
orders have been placed on the public record for 30 days for receipt of 
comments from interested persons. Comments received during this period 
will become part of the public record. After 30 days, the Commission 
will again review the agreements and the comments received, and will 
decide whether it should withdraw from one or both of the agreements 
and take appropriate actions, or make final the agreements' proposed 
orders.
    This matter involves Respondents' advertising for Hepaxa and Hepaxa 
PD capsules containing omega-3 fatty acids. The Commission's proposed 
complaint alleges that advertising for the Hepaxa products represented 
that Hepaxa reduces liver fat in most adults with Nonalcoholic Fatty 
Liver Disease (``NAFLD'') within six months, and that Hepaxa PD reduces 
liver fat in most children with NAFLD within six months. The complaint 
further alleges that Respondents' advertising represented that tests 
prove that Hepaxa reduces liver fat in adults with NAFLD and that tests 
prove that Hepaxa PD reduces liver fat in children with NAFLD. 
According to the proposed complaint, these claims are false or 
misleading, or were not substantiated at the time the representations 
were made, in violation of Sections 5 and 12 of the FTC Act.
    The proposed orders include injunctive relief that prohibits these 
alleged violations and fences in similar and related conduct. The 
proposed orders against the BASF Respondents and DIEM Respondents are 
substantially similar. In both orders, ``Covered Products'' is defined 
as Hepaxa, Hepaxa PD, and any other Dietary Supplement, Food, or Drug 
that contains one or more omega-3 fatty acids or is promoted by a 
Respondent or its subsidiary to benefit cardiac, metabolic, or hepatic 
health or functions, including the prevention, mitigation, treatment, 
or cure of any disease of such systems.
    Part I of the orders prohibits Respondents from making any 
representation that a Covered Product reduces liver fat in adults or 
children with Non-alcoholic Fatty Liver Disease (NAFLD), or cures, 
mitigates, or treats any disease, including but not limited to liver 
disease, unless the representation is nonmisleading, including that, at 
the time such representation is made, they possess and rely upon 
competent and reliable scientific evidence that substantiates that the 
representation is true.
    For purposes of Part I, competent and reliable scientific evidence 
must consist of human clinical testing of the covered product, or of an 
essentially equivalent product, that is 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 be: (1) Randomized, double-blind, and 
placebo-controlled; and (2) conducted by researchers qualified by 
training and experience to conduct such testing.
    Part II prohibits Respondents from making any representation, other 
than representations covered under Part I, about the health benefits, 
performance, efficacy, safety, or side effects of any covered product, 
unless the representation is non-misleading, and, at the time of making 
such representation, they possess and rely upon competent and reliable 
scientific evidence that is 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.
    For purposes of Part II, ``competent and reliable scientific 
evidence'' means tests, analyses, research, or studies that (1) 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, or of an essentially equivalent product, when such experts 
would generally require such human clinical testing to substantiate 
that the representation is true.
    Part III prohibits misrepresentations about tests and studies. Part 
IV provides Respondents a safe harbor for making claims approved by the 
Food and Drug Administration (``FDA''). Part V requires that, with 
regard to any human clinical test or study upon which Respondents rely 
to substantiate any claim covered by the orders, Respondents must 
secure and preserve all underlying or supporting data and documents 
generally accepted by experts in the field as relevant to an assessment 
of a test.
    Part VI provides for monetary relief, and Part VII describes the 
procedures and legal rights related those payments. Together, 
Respondents are paying the full amount of consumer injury, $416,914.00. 
DIEM Order Part VIII requires the company to provide sufficient 
customer information to enable the Commission to efficiently administer 
consumer redress to purchasers of Hepaxa and Hepaxa PD.
    DIEM Order Part IX and BASF Order Part VIII require Respondents to 
submit acknowledgments of receipts of the order. DIEM Order Part X and 
BASF Order Part IX require the filing of compliance reports with the 
Commission, including notification to the Commission of bankruptcy 
filings or changes in corporate structure that might affect compliance 
obligations. DIEM Order Part XI and BASF Order Part X contain 
recordkeeping requirements. DIEM Order Part XII and BASF Order XI 
contain other requirements related to the Commission's monitoring of 
Respondents' order compliance. Finally, DIEM Order Part XIII and BASF 
Order Part XII state that the orders will remain in effect for 20 
years, with certain exceptions.
    The purpose of this analysis is to facilitate public comment on the 
orders, and it is not intended to constitute an official interpretation 
of the complaint or orders, or to modify the orders' terms in any way.


[[Page 18287]]


    By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2021-07217 Filed 4-7-21; 8:45 am]
BILLING CODE 6750-01-P
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