[Federal Register Volume 79, Number 114 (Friday, June 13, 2014)]
[Notices]
[Pages 33919-33923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13886]



[[Page 33919]]

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FEDERAL TRADE COMMISSION

[File No. 122 3067]


i-Health, Inc. and Martek Biosciences Corporation; Analysis of 
Proposed Consent Order To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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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 Order 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 July 9, 2014.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/ihealthconsent online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write ``I-Health, Inc. and 
Martek Biosciences Corporation--Consent Agreement; File No. 122 3067'' 
on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/ihealthconsent 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: Keith Fentonmiller, Bureau of Consumer 
Protection, (202-326-2775), 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 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 June 9, 2014), on the World Wide Web, at 
http://www.ftc.gov/os/actions.shtm.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before July 9, 2014. 
Write ``I-Health, Inc. and Martek Biosciences Corporation--Consent 
Agreement; File No. 122 3067'' 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 Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a 
matter of discretion, the Commission tries to remove individuals' home 
contact information from comments before placing them on the Commission 
Web site.
    Because your comment will be made public, you are solely 
responsible for making sure that your comment does not include any 
sensitive personal information, like anyone'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, like medical records or other 
individually identifiable health information. In addition, do not 
include any ``[t]rade secret or any commercial or financial information 
which . . . is privileged or confidential,'' as discussed in Section 
6(f) of the FTC Act, 15 U.S.C. Sec.  46(f), and FTC Rule 4.10(a)(2), 16 
CFR 4.10(a)(2). In particular, do not include competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    If you want the Commission to give your comment confidential 
treatment, you must file it in paper form, with a request for 
confidential treatment, and you have to follow the procedure explained 
in FTC Rule 4.9(c), 16 CFR 4.9(c).\1\ Your comment will be kept 
confidential only if the FTC General Counsel, in his or her sole 
discretion, grants your request in accordance with the law and the 
public interest.
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    \1\ 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), 16 CFR 4.9(c).
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    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/ihealthconsent 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 Web site.
    If you file your comment on paper, write ``I-Health, Inc. and 
Martek Biosciences Corporation--Consent Agreement; File No. 122 3067'' 
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.
    Visit the Commission Web site 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 July 9, 2014. You can find more information, 
including routine uses permitted by the Privacy Act, in the 
Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

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 from against i-Health, Inc. and Martek Biosciences Corporation 
(hereafter ``the companies'').
    The proposed consent order (``proposed 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 or make final the 
agreement's proposed order.
    This matter involves the companies' advertising for the BrainStrong 
Adult

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dietary supplement containing algal docosahexaenoic acid (``DHA''), an 
omega-3 fatty acid. The Commission's complaint alleges that, based 
primarily on a randomized, controlled trial called the ``Memory 
Improvement with Docosahexaenoic Acid (DHA) Study'' (the ``MIDAS 
study''), the companies advertised that BrainStrong Adult improves 
memory and prevents cognitive decline in adults, and is clinically 
proven to improve memory in adults. Human cognitive function consists 
of at least five different types of memory, as well as non-memory 
abilities such as executive function, attention, processing speed, and 
reasoning. The MIDAS study objectively tested only two types of memory 
(episodic and working memory) and the cognitive ability of executive 
function, and was not designed to test DHA's effect on cognitive 
decline in aging adults.
    The complaint alleges that the companies violated Sections 5(a) and 
12 of the Federal Trade Commission Act by making the unsubstantiated 
representation that BrainStrong Adult improves memory in adults. 
According to the complaint, the MIDAS study did not show that 
BrainStrong Adult improves working memory or the cognitive ability of 
executive function. In addition, results from the tests of episodic 
memory did not yield a pattern of statistically and clinically 
significant improvement in the DHA group relative to the placebo group. 
For the same reasons, the complaint also alleges that the companies 
violated Sections 5(a) and 12 by making the false or misleading 
representation that BrainStrong Adult is clinically proven to improve 
memory in adults.
    Finally, the complaint alleges that the companies violated Sections 
5(a) and 12 by making the unsubstantiated representation that 
BrainStrong Adult prevents cognitive decline in adults. According to 
the complaint, a subject's performance on laboratory tasks that measure 
only one type of memory (i.e., episodic) does not fully capture the 
overall state of his or her cognitive function, which includes other 
types of memory and non-memory cognitive abilities. In the MIDAS study, 
subjects treated with DHA for twenty-four weeks performed worse than 
placebo on a task of executive function, a non-memory cognitive 
ability. Moreover, a twenty-four-week study is an insufficient duration 
to test the impact of DHA on cognitive decline. Because the placebo 
group in the MIDAS study showed no evidence of cognitive decline, the 
study could reach no conclusion about DHA's ability to prevent or slow 
that condition.
    The proposed order includes injunctive relief that prohibits these 
alleged violations and fences in similar and related violations. For 
purposes of the order, ``Covered Product'' means any dietary 
supplement, food, or drug promoted to prevent cognitive decline or 
improve memory, or containing DHA, including, but not limited to, 
BrainStrong Adult, except for infant formula or ingredients when sold 
specifically for use in infant formula. As additional fencing-in 
relief, the order requires the companies to follow appropriate 
recordkeeping and compliance reporting requirements, as well as 
document preservation requirements for human clinical studies that they 
conduct or sponsor on the Covered Product.
    Part I of the proposed order prohibits any representation that the 
Covered Product improves memory or prevents cognitive decline in 
adults, unless it is non-misleading and supported by competent and 
reliable scientific evidence. Such evidence must consist of human 
clinical testing that is sufficient in quality and quantity, based on 
standards generally accepted by experts in cognitive science, when 
considered in light of the entire body of relevant and reliable 
scientific evidence, to substantiate that the representation is true. 
The testing must have been conducted by qualified researchers, and have 
been randomized, double-blind, and placebo-controlled. In addition, the 
companies must maintain all underlying or supporting data that 
cognitive science experts generally would accept as relevant to an 
assessment of such testing.
    Part II of the proposed order prohibits any representation about 
the health benefits, performance, safety, or efficacy of the Covered 
Product, unless it is non-misleading and supported by competent and 
reliable scientific evidence that is sufficient in quality and quantity 
based on standards generally accepted in the relevant scientific 
fields, when considered in light of the entire body of relevant and 
reliable scientific evidence, to substantiate that the representation 
is true. For purposes of this Part, competent and reliable scientific 
evidence means tests, analyses, research, or studies that have been 
conducted by a qualified person in an objective manner and are 
generally accepted in the profession to yield accurate and reliable 
results. When that evidence consists of a human clinical trial, the 
companies must maintain all underlying or supporting data and documents 
that experts in the field generally would accept as relevant to an 
assessment of such testing.
    Part III of the proposed order prohibits the companies from 
misrepresenting, including through the use of a product name, word or 
phrase such as ``clinically shown'' or ``clinically proven,'' 
endorsement, depiction, illustration, trademark, or trade name, the 
existence, contents, validity, results, conclusions, or interpretations 
of any test, study, or research, including misrepresenting that the 
benefits of the product are clinically proven or that the product is 
clinically proven to improve memory in adults.
    Part IV of the proposed order provides a safe harbor for 
representations permitted under any tentative or final standard 
promulgated by the Food and Drug Administration (``FDA''), any new drug 
application approved by the FDA, or FDA regulations pursuant to the 
Nutrition Labeling and Education Act of 1990 or the FDA Modernization 
Act of 1997.
    Part V contains recordkeeping requirements for advertisements and 
substantiation relevant to representations covered by Parts I through 
III of the order.
    Triggered when the human clinical testing requirement in either 
Part I or II applies, Part VI of the proposed order requires the 
companies to 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 published in a peer-reviewed journal that was not 
conducted, controlled, or sponsored by any proposed respondent or 
supplier. Also, the published report must provide sufficient 
information about the test for experts in the relevant field to assess 
the reliability of the results.
    Parts VII through IX of the proposed order require the companies 
to: deliver a copy of the order to officers, employees, and 
representatives having managerial responsibilities with respect to the 
subject matter of the order; notify the Commission of changes in 
corporate structure that might affect compliance obligations under the 
order; and file compliance reports with the Commission.
    Part X 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 complaint or proposed order, or to

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modify the proposed order's terms in any way.

    By direction of the Commission, Commissioner Ohlhausen 
dissenting and Commissioner McSweeny not participating.
Donald S. Clark,
Secretary.

Statement of Chairwoman Edith Ramirez and Commissioner Julie Brill

    We write to explain our support for the complaint and order imposed 
against respondents i-Health, Inc. and Martek Biosciences Corporation 
(collectively, ``i-Health'') with respect to advertising claims that 
their BrainStrong Adult dietary supplement improves adult memory and is 
clinically proven to do so. Section 5 of the FTC Act requires that 
advertisers have a reasonable basis for the claims they make to ensure 
that their claims are truthful and non-deceptive.\1\ We have reason to 
believe that i-Health fell short of this standard.
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    \1\ FTC Policy Statement Regarding Advertising Substantiation, 
104 F.T.C. 839 (1984) (appended to Thompson Med. Co., 104 F.T.C. 648 
(1984)) (``Substantiation Statement'') (``[W]e reaffirm our 
commitment to the underlying legal requirement of advertising 
substantiation--that advertisers and ad agencies have a reasonable 
basis for advertising claims before they are disseminated.''), 
aff'd, 791 F.2d 189, 193 & 196 (D.C. Cir. 1986), cert. denied, 479 
U.S. 1086 (1987).
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    i-Health advertises a dietary supplement, BrainStrong Adult, 
containing docosahexaenoic acid (``DHA''), with broad and prominent 
claims that the product is ``[c]linically shown to improve memory.'' 
Its advertising also makes the general efficacy claim that BrainStrong 
improves memory. Consumers would likely have reasonably interpreted 
these claims broadly to include a wide variety of promises of real-life 
improvements in memory, such as the ability to remember the location of 
one's sunglasses or why one entered a room--which is the precise 
scenario depicted in i-Health's television ad.\2\ We do not believe 
that i-Health possessed the evidence necessary to back up such 
reasonable interpretations by consumers. Accordingly, we allege that i-
Health's efficacy claim was unsubstantiated and that its establishment 
claim was false and misleading.\3\
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    \2\ See FTC, Dietary Supplements: An Advertising Guide for 
Industry 3-4 (Apr. 2001) (``Dietary Supplements Guide''), available 
at http://business.ftc.gov/documents/bus09-dietary-supplements-advertising-guide-industry (``When an ad lends itself to more than 
one reasonable interpretation, the advertiser is responsible for 
substantiating each interpretation.''); see also id. at 12.
    \3\ The Commission also alleges that i-Health made the 
unsubstantiated claim that BrainStrong prevents cognitive decline in 
adults. Because the Commission has unanimously voted in favor of 
this allegation, we do not address it here.
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    i-Health's establishment claim that BrainStrong Adult is clinically 
proven to improve adult memory requires, by its own terms, a well-
controlled human clinical study.\4\ Its efficacy claim about its 
dietary supplement must be supported by competent and reliable 
scientific evidence.\5\ In support of these claims, i-Health relies 
primarily on a double-blind, placebo-controlled clinical study 
published in a peer-reviewed journal--the Memory Improvement with 
Docosahexaenoic Acid Study (``MIDAS study''). The study purports to 
show that DHA ``improves episodic memory'' and ``memory function.'' The 
MIDAS study's principal investigator and author was an employee of 
respondent Martek.\6\
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    \4\ Substantiation Statement at 839 (``When the substantiation 
claim is express (e.g., `tests prove,' `doctors recommend,' and 
`studies show'), the Commission expects the firm to have at least 
the advertised level of substantiation.''); Removatron Int'l Corp., 
111 F.T.C. 206, 297-99 (1988) (``If an advertisement represents that 
a particular claim has been scientifically established, the 
advertiser must possess a level of proof sufficient to satisfy the 
relevant scientific community of the claim's truth.''), aff'd, 884 
F.2d 1489 (1st Cir. 1989).
    \5\ Dietary Supplements Guide at 9.
    \6\ Karin Yurko-Mauro et al., Beneficial Effects of 
Docosahexaenoic Acid on Cognition in Age-Related Cognitive Decline, 
6 Alzheimer's & Dementia 456 (2010).
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    As an initial matter, regardless of the methodology and purported 
findings of the MIDAS study, the first question we ask is what the 
study was designed to measure and demonstrate. Stated differently, and 
more directly for our purposes, does the study, assuming it was well-
conducted, substantiate i-Health's broad claims that BrainStrong 
improves memory and that it was ``clinically shown'' to do so? Contrary 
to the view of Commissioner Ohlhausen, we do not think it does.
    As detailed in the complaint, there are several types of human 
memory, including episodic memory, sensory memory, working memory, 
semantic memory, and procedural memory. Importantly, the MIDAS study 
tested tasks associated with only two types of memory: episodic memory, 
the recollection of specific personal events linked to a time and 
place, such as where someone left her car keys; and working memory, the 
short-term mental manipulation of information, such as the ability to 
follow a story or discussion. Notably, the study reports only a very 
small improvement from BrainStrong in relation to episodic memory--the 
positive result was essentially limited to performance on a single test 
of one of three types of episodic memory that were measured 
(visuospatial). The study did not reveal any improvement in working 
memory. In light of the narrow scope of the study and its limited 
results, we have reason to believe that i-Health's marketing claims 
that BrainStrong improves ``memory'' broadly speaking would likely 
mislead consumers, as there is no basis to conclude that it has any 
impact whatsoever on other important facets of memory, such as the 
ability to remember the meaning of words (semantic memory) or to follow 
an exchange of dialogue (working memory). This alone would be reason 
enough for us to conclude that the MIDAS study does not adequately 
substantiate i-Health's general memory improvement claims.
    But our concerns extend even further. As we have also alleged in 
the complaint, the MIDAS study did not show a pattern of statistically 
and clinically significant improvements on the episodic memory tasks 
among subjects who took BrainStrong's DHA, relative to the placebo 
group. Specifically, it failed to show meaningful, statistically 
significant improvements on two of the three episodic memory tasks 
measured. Further, it failed to demonstrate that the very small, 
statistically significant improvement on one of those tasks that it did 
report correlates with improvements in memory tasks outside of the 
laboratory.\7\ We believe that reasonable consumers would likely be 
misled that BrainStrong will result in the kinds of real-life 
improvements depicted in i-Health's advertising.
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    \7\ See Dietary Supplements Guide at 12 (``Some results that are 
statistically significant may still be so small that they would mean 
only a trivial effect on consumer health.'').
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    It is correct, as Commissioner Ohlhausen notes in her dissent, that 
some of the statements made by the study's authors in the ``Results'' 
and ``Discussion'' sections of the MIDAS study use language similar to 
that in i-Health's memory improvement claims. However, we disagree that 
the Commission must accept at face value these statements as supportive 
of the claims in i-Health's advertising. Doing so would be inconsistent 
with the Commission's obligation to assess the quality and reliability 
of the scientific evidence underlying challenged advertising claims.\8\ 
Our conclusions are

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based on extensive consultations with experts in the cognitive science 
and biostatistics fields. Consistent with the requirements of Section 5 
and our past practice,\9\ we undertook an evaluation of the results of 
the MIDAS study to assess whether they substantiated i-Health's 
advertising claims and did not simply defer to the authors' 
interpretations of their results.\10\
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    \8\ Commissioner Ohlhausen also observes that the complaint does 
not take issue with how i-Health conducted the clinical testing 
component of the trial, i.e., that it was a large, multi-center 
trial that was randomized, placebo-controlled, and double-blinded. 
However, sometimes such studies ultimately yield inconclusive or 
weak findings, as was the case with the MIDAS study.
    \9\ See, e.g., Schering Corp., 118 F.T.C. 1030, 1084, 1095 
(1994). See also Unither Pharma, Inc., 136 F.T.C. 145, 161 (2003).
    \10\ In addition to the MIDAS study, our experts in the 
cognitive science and biostatistics fields also reviewed the 
totality of other evidence that i-Health proffered on DHA and 
memory, finding those results to be inadequate to back i-Health's 
claims as well.
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    For all of the foregoing reasons, we have reason to believe that i-
Health lacked adequate substantiation for the broad marketing claims 
that BrainStrong Adult improves adult memory, that i-Health's clinical-
proof claims are false and misleading, and that the relief set forth in 
the proposed order is appropriate.

Statement of Commissioner Maureen K. Ohlhausen, Dissenting in Part

    The Commission has long interpreted Section 5 of the FTC Act\1\ to 
require an advertiser to have a reasonable basis for making an 
objective claim about its product.\2\ As we execute this mandate, we 
must be mindful of what we are trying to accomplish, however. As former 
FTC Chairman Robert Pitofsky stated, the overall goal of evaluating 
advertising claims is not ``a broad, theoretical effort to achieve 
Truth, but rather a practical enterprise to ensure the existence of 
reliable data which in turn will facilitate an efficient and reliable 
competitive market process.''\3\
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    \1\ 15 U.S.C. 45(a).
    \2\ FTC Policy Statement Regarding Advertising Substantiation 
(appended to Thompson Med. Co., Inc., 104 F.T.C. 648, 840 (1984)).
    \3\ Robert Pitofsky, Beyond Nader: Consumer Protection and the 
Regulation of Advertising, 90 Harv. L. Rev. 661, 671 (1977).
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    I dissent in part from today's action because it imposes an unduly 
high standard of substantiation on a safe product. This unduly high 
standard not only risks denying consumers useful information in the 
present but may also, in the long term, diminish incentives to conduct 
research on the health effects of foods and dietary supplements and 
reduce the incentives of manufacturers to introduce such products.\4\ 
The majority's approach may ultimately undermine an efficient and 
reliable competitive market process and make consumers worse off. \5\
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    \4\ See Statement of Commissioner Maureen K. Ohlhausen, 
Dissenting in Part and Concurring in Part, In the Matter of 
GeneLink, Inc., et al., FTC Docket No. C4456, at 2 (Jan. 7, 2014) 
(``Although raising the requirement for both the number and the 
rigor of studies required for substantiation for all health- or 
disease-related claims may increase confidence in those claims, the 
correspondingly increased burdens in time and money in conducting 
such studies may suppress information that would, on balance, 
benefit consumers.'').
    \5\ See id. (``If we demand too high a level of substantiation 
in pursuit of certainty, we risk losing the benefits to consumers of 
having access to information about emerging areas of science and the 
corresponding pressure on firms to compete on the health features of 
their products.''); FTC Staff Comment Before the Food and Drug 
Administration In the Matter of Assessing Consumer Perceptions of 
Health Claims, Docket No. 2005N-0413, at 5-6 (2006) (noting the 
FTC's advertising enforcement seeks to avoid ``unduly burdensome 
restrictions that might chill information useful to consumers in 
making purchasing decisions.'') available at http://www.ftc.gov/be/V060005.pdf.
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    The complaint in this matter challenges the efficacy claim that 
BrainStrong Adult (a DHA supplement) improves memory in adults and the 
establishment claim that BrainStrong Adult is clinically proven to 
improve memory in adults.\6\ Advertisers must support claims of 
efficacy of dietary supplements with ``competent and reliable 
scientific evidence.''\7\ For establishment claims, where 
advertisements refer to a certain level of support, advertisers ``must 
be able to demonstrate that the assertion is accurate [and] have the 
level of support that they claim, expressly or by implication, to 
have.''\8\
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    \6\ The complaint also challenges the efficacy claim that 
BrainStrong Adult prevents cognitive decline. I agree with the 
majority that the proffered study does not support this claim.
    \7\ The FTC's Dietary Supplements: An Advertising Guide for 
Industry defines competent and reliable scientific evidence as 
``tests, analyses, research, studies, or other evidence based on the 
expertise of professionals in the relevant area, that have been 
conducted and evaluated in an objective manner by persons qualified 
to do so, using procedures generally accepted in the profession to 
yield accurate and reliable results.'' It further states that well-
controlled human clinical trials are the ``most reliable form of 
evidence.'' See Dietary Supplements: An Advertising Guide for 
Industry at 9 (``Dietary Supplements Guide''), available at http://business.ftc.gov/sites/default/files/pdf/bus09-dietary-supplements-advertising-guide-industry.pdf.
    \8\ Id.
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    In this matter, the defendant offers as the primary substantiation 
for its claims the MIDAS study, a placebo-controlled, randomized, 
double-blind, parallel, multi-center, six-month, peer-reviewed, 
journal-published study of 485 subjects with statistically significant 
results.\9\ Specifically, the MIDAS study concluded:
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    \9\ See Karin Yurko-Mauro et al., Beneficial Effects of 
Docosahexaenoic Acid on Cognition in Age-Related Cognitive Decline, 
6 Alzheimer's & Dementia 456 (2010) (``MIDAS study'').
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     ``This clinical study demonstrated that 900 mg/d of DHA 
supplementation improved episodic memory and learning in healthy, older 
adults with mild memory complaints. . . . The DHA effects are 
significant in that they represent an objective demonstration of 
improved memory in [age-related cognitive decline].''\10\
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    \10\ Id. at 461.
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     ``Our results are the first to clinically confirm that DHA 
significantly improves episodic memory and learning functions in 
healthy adults with [age-related cognitive decline].''\11\
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    \11\ Id. at 463.
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     ``Our study results demonstrate that DHA is well tolerated 
and may have significant positive effect on gradual memory loss. . . 
.''\12\
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    \12\ Id.
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    These conclusions match up well with the ``improves memory'' 
efficacy claim and the ``clinically proven to improve memory'' 
establishment claim.\13\ Thus, I believe this study, in the context of 
other supporting studies involving DHA and memory,\14\ provides a 
reasonable basis for the ``improves memory'' claims.\15\
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    \13\ BrainHealth Adult product packaging also included language 
stating, ``A recent clinical study showed that adults over 55 with a 
mild memory complaint who took 900mg/day of life's DHA for 6 months 
improved their short-term memory.''
    \14\ Martek cited many studies, including: a wide body of animal 
and cell culture studies that are consistent with the importance of 
DHA in cognitive function and suggest a potential mechanism for 
DHA's ability to support memory; numerous epidemiological studies 
identifying a correlation between DHA consumption and cognitive 
function; multiple clinical trials with generally supportive 
(although not wholly consistent) results; and seven reviews by 
independent expert bodies confirming the importance of DHA in 
supporting cognitive function. Not all of these studies are squarely 
on point, and some of them contain methodological weaknesses or 
inconclusive results. As such, their probity varies, but taken 
together they are supportive of DHA's positive role in brain 
function. The FTC must evaluate the well-conducted, statistically 
significant MIDAS study within the totality of this supportive 
evidence. See Dietary Supplements Guide at 14 (``Studies cannot be 
evaluated in isolation. The surrounding context of scientific 
evidence is just as important as the internal validity of individual 
studies.'').
    \15\ Because the claims at issue here closely parallel the 
conclusions of the MIDAS study, this case differs from others where 
companies possessed well-conducted clinical trials yielding 
statistically significant results but made claims beyond the trials' 
ability to support. Cf. Nestle HealthCare Nutrition, Inc., 151 
F.T.C. 1 (2011) (defendant claimed its product reduced the duration 
of acute diarrhea in children up to the age of thirteen; studies 
only applied to infants and could not be extrapolated to older 
children); Kellogg Co., FTC Docket No. C-4262 (2009) (defendant 
claimed that children who ate Frosted MiniWheats for breakfast were 
``nearly 20%'' or ``up to 18%'' more attentive three hours later 
than children who ate nothing; study calculated average increased 
attention as ~10% and over half of children showed no benefit from 
eating the cereal).
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    The complaint offers two reasons why the MIDAS study, despite being 
well-conducted and having statistically significant results, does not 
substantiate

[[Page 33923]]

Martek's claims for BrainStrong Adult. First, the complaint argues that 
the ``improves memory'' claim is unsubstantiated because the MIDAS 
study did not show that BrainStrong Adult improved performance for all 
types of memory. However, the MIDAS study did demonstrate a 
statistically significant improvement in performance on episodic memory 
tasks. An improvement in episodic memory is indeed an improvement in 
memory, and the claim accurately conveys the study's findings in 
consumer vernacular.
    Second, instead of criticizing the study's methodology, the 
complaint criticizes its conclusions. The complaint asserts that the 
MIDAS study ``did not yield a pattern of statistically and clinically 
significant improvement'' in memory.\16\ This conclusion is based on 
the opinion of experts retained by FTC staff. The eight MIDAS study co-
authors clearly disagree with this conclusion, as demonstrated by their 
own conclusions in the study.
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    \16\ It is undisputed that the MIDAS study's primary endpoint 
(the CANTAB Paired Associate Learning, or ``PAL,'' test) yielded 
statistically significant results, with a p-value of 0.032. As the 
Commission has stated, ``significance with a p-value that is less 
than or equal to 0.05 is the recognized standard to show that a 
study's hypothesis has been proven.'' POM Wonderful LLC, Opinion of 
the Commission, 2013 FTC Lexis 6 at *77 (2013). Furthermore, the 
MIDAS study demonstrated that the difference in PAL scores between 
the test group and the placebo group was equivalent to a net 3.4-
year improvement in performance, offering evidence of a clinically 
significant result.
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    The fact that some experts may disagree with the conclusions of a 
well-conducted study does not render that study unreliable or 
incompetent, nor make claims based on the study unsubstantiated. 
Specifically, Martek's reliance upon the MIDAS study, which was both 
well-conducted and consistent with other research, is not rendered 
unreasonable by the existence of some disagreement among experts. 
Indeed, ``some disagreement'' is the usual state of science.\17\
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    \17\ ``The game of science is, in principle, without end. He who 
decides one day that scientific statements do not call for any 
further test, and that they can be regarded as finally verified, 
retires from the game.'' Karl Popper, The Logic of Scientific 
Discovery 32 (Taylor & Francis Group, 2005).
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Concurring Statement of Commissioner Joshua D. Wright

    As set forth in the Commission's complaint, i-Health, Inc. and 
Martek Biosciences Corporation (i-Health) marketed a dietary supplement 
branded as BrainStrong Adult, which contains docosahexaenoic acid 
(DHA). In its advertising and marketing, i-Health represented, among 
other things, that BrainStrong Adult improves memory in adults.\1\
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    \1\ Complaint at ] 10.
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    As articulated in the complaint, these representations included a 
general memory improvement claim as well as a specific ``episodic'' 
memory improvement claim. I write separately to explain why, in my 
view, the Memory Improvement with Docosahexaenoic Acid Study (the MIDAS 
study) does not provide evidence sufficient to substantiate either of 
those claims.
    First, the MIDAS study was not designed to evaluate all the types 
of memory that would be encompassed within a general memory claim.\2\ 
As set forth in the complaint, there are several types of human memory, 
including episodic, sensory, working, semantic, and procedural. 
Although the MIDAS study included one test of working memory, which 
found no benefit from supplementation, the study's focus was episodic 
memory. Therefore, to the extent that consumers took away an 
understanding that BrainStrong Adult would improve general memory, 
rather than a single dimension of human memory, that claim was 
unsubstantiated.
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    \2\ Complaint at ]] 7 and 11.
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    Second, the MIDAS study does not adequately substantiate even a 
narrower claim of improving episodic memory--for example, that 
BrainStrong Adult would help consumers recall where they had just left 
their keys or the reason they left one room to walk into another room. 
It is correct the MIDAS study was a well-designed attempt to evaluate 
improvement in episodic memory.\3\ The shortcoming of the MIDAS study 
as it relates to substantiation is not study design or methodology but 
rather that, put simply, its results were inconsistent and 
insufficiently robust to support claims about noticeable improvement in 
everyday memory along the lines of the television ad.
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    \3\ The study was well designed in the sense that it was a 
randomized, double-blinded, placebo-controlled evaluation of 
multiple measures of episodic memory.
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    Episodic memory is a cognitive construct that encompasses the 
ability to recall specific autobiographical or personal events or 
``episodes,'' as well as the time and place those events occurred. 
Episodic memories have one or more components (e.g., visual, 
visuospatial, verbal, auditory, and temporal) and are formed in the 
brain's hippocampus after it interacts with one or more other brain 
regions. Identifying and isolating episodic memory can be especially 
difficult because of the potential influence of interactions with other 
brain regions, which may make it difficult to know whether and to what 
extent an improvement in test performance was due to changes to 
hippocampal function.
    Consequently, in order to assess changes in episodic memory, 
cognitive experts generally conduct studies employing multiple measures 
of episodic memory. Laboratory tests of episodic memory probe 
hippocampal function via different modalities (e.g., visual, auditory, 
verbal, and tactile) and cognitive tasks (pattern recognition, 
visuospatial memory, verbal recall). Cognitive experts then consider 
the results of the different tests together, which reduces the impact 
of the various confounding influences that are associated with each 
individual test. This standard approach reduces the likelihood that 
idiosyncrasies in the design or administration of any one test will 
lead to an erroneous conclusion.\4\
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    \4\ Michael S. Humphreys et al., Measuring Episodic Memory: A 
Novel Approach with an Indefinite Number of Alternative Forms, 24 
Appl. Cognit. Psychol. 1080, 1081 (2010) (``[t]he use of multiple 
tasks provides some insurance against the possibility that different 
neurological substrates are involved in at least some tasks commonly 
considered episodic.'') (citing Norman & O'Reilly, 2003).
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    Importantly, cognitive experts would generally accept that the 
observed effects from the intervention under study reflect changes to 
episodic memory rather than the influence of other neural pathways or a 
spurious correlation, when the multiple measures show a consistent 
trend in favor of treatment. By contrast, cognitive experts evaluating 
an intervention that generates a small but statistically significant 
effect for one task but not the other two would generally conclude the 
collective results are insufficient to demonstrate improved episodic 
memory.
    The MIDAS study properly employed three types of laboratory tasks 
to test different, but interrelated, aspects of episodic memory--
visuospatial memory, visual pattern recognition memory, and visual-
verbal memory.\5\ However, because the results of the three laboratory 
tasks, when evaluated together, did not consistently trend in support 
of improved episodic memory, the MIDAS study is not sufficient to 
substantiate i-Health's improved episodic memory claim.
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    \5\ Complaint at ] 11.

[FR Doc. 2014-13886 Filed 6-12-14; 8:45 am]
BILLING CODE 6750-01-P