I-Health, Inc.

Text (OCR of the scan at left; may contain errors)

IN THE MATTER OF I-HEALTH, INC.

AND MARTEK BIOSCIENCES CORP.

CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTIONS 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket No. C-4486; File No. 122 3067 Complaint, August 21, 2014 – Decision, August 21, 2014 This consent order addresses i-Health, Inc.’s and Martek Biosciences Corporation’s advertising for the BrainStrong Adult dietary supplement containing algal docosahexaenoic acid (“DHA”), an omega-3 fatty acid. 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 and prevents cognitive decline in adults. The consent order prohibits any representation about the health benefits, performance, safety, or efficacy of any dietary supplement, food, or drug promoted to prevent cognitive decline or improve memory, or containing DHA, 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.

Participants For the Commission: Victor DeFrancis, Keith Fentonmiller, and Edwin Rodriguez.

For the Respondents: Charles Dickinson, Martin Hahn, and Corey Roush, Hogan Lovells US LLP; Jason Stephans, In-House Counsel.

COMPLAINT The Federal Trade Commission (“FTC” or “Commission”), having reason to believe that i-Health, Inc. and Martek Biosciences Corporation (“Respondents”), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:

VOLUME 158 Complaint 1. Respondent i-Health, Inc. is a Delaware corporation with its principal office or place of business at 55 Sebethe Drive, Cromwell, Connecticut 06416. i-Health, Inc. was formerly known as Amerifit Brands, Inc. (also known as Amerifit, Inc.). 2. Respondent Martek Biosciences Corporation is a Delaware corporation with its principal office or place of business at 6480 Dobbin Road, Columbia, Maryland 21045. On June 30, 2012, Martek Biosciences Corporation merged into its successor, DSM Nutritional Products, LLC. DSM Nutritional Products, LLC is a Delaware corporation with its principal office or place of business at 45 Waterview Boulevard, Parsippany, New Jersey 07054.

3. Since at least March 2011, Respondents have together labeled, advertised, promoted, offered for sale, sold, and distributed to consumers throughout the United States a dietary supplement branded as BrainStrong Adult, which contains, among other ingredients, docosahexaenoic acid (“DHA”), an Omega-3 fatty acid, from algal triglyceride oil. BrainStrong Adult is either a “food” or a “drug” as defined in Section 15 of the FTC Act, 15 U.S.C. § 55.

4. The acts and practices of Respondents, as alleged herein, have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act. BrainStrong Adult 5. BrainStrong Adult is formulated for adults with a recommended dose of 900 mg of DHA per day and is marketed at a wide range of major retail stores, including, but not limited to, CVS Pharmacy, Walmart, Walgreens, and Rite Aid. BrainStrong Adult is also marketed through online vendors, such as www.drugstore.com and www.amazon.com. The retail price is approximately $30 for a thirty-day supply. 6. Respondents have disseminated or caused to be disseminated advertisements for BrainStrong Adult, including, but not limited to, the attached Exhibits A through D. These advertisements contain the following statements and depictions, among others:

I-HEALTH, INC. 265 Complaint a. Product Packaging: BrainStrong Adult 90-Count Bottle VOLUME 158 Complaint b. Product Packaging: BrainStrong Adult 120-Count Bottle I-HEALTH, INC. 267 Complaint c. Internet Website: www.brainstrongdha.com (Exhibit A) JUST SAY “NO” TO THE LOSS OF MEMORY.

* * * THE MIDAS STUDY Losing your memory as you age may be natural. But improving your memory can also be natural. New BrainStrong™ with life’sDHA™, is safe, natural and clinically shown to help protect against normal, cognitive decline as we age.† THE STUDY THAT PROVED IT.

Adults 55+: The Memory Improvement with Docosahexaenoic Acid (DHA) Study, or MIDAS, was the first large, randomized and placebo-controlled study demonstrating the benefits of DHA in maintaining and improving brain health in older adults. The study indicated that the use of DHA improves learning and memory recall in healthy aging adults with mild memory complaints.

IN OTHER WORDS:

MIDAS found that healthy people with memory complaints who took 900 mg/day algal DHA capsules for six months had almost double the reduction in errors on a test that measures learning and memory performance versus those who took a placebo, a benefit roughly equivalent to having the learning and memory skills of someone three years younger. * * * Conclusions:

 900 mg/day algal DHA supplementation for 6 months resulted in a significant decrease of memory VOLUME 158 Complaint errors on a memory test as well as significant increases to verbal recognition memory scores.

* * * A BATTLE PLAN:

We now have clinical evidence to indicate that 900 mg/day of algal DHA improves memory in aging adults.

†A recent clinical study showed that adults over 55 with a mild memory complaint, who took 900mg/day of life’sDHA™ for 6 months, improved their short-term memory.

* * * BrainStrong Adult is a daily brain health supplement for adults of all ages containing 900mg/serving of a DHA omega-3 fatty acid, which helps protect the brain against normal cognitive decline as we age. d. Television Advertisement: “Forget Me Not” (Exhibit B: CD and storyboard excerpt) I-HEALTH, INC. 269 Complaint e. Internet Website: Facebook (Exhibit C) (DSM-FTC- 1100) “BrainStrong Adult is a new daily brain health supplement for adults containing 900mg/serving of a DHA omega-3 fatty acid, which helps protect the brain against normal cognitive decline as we age.” f. Internet Advertisements: Twitter i. Tweets from December 18, October 24, and August 21, 2012 ii. Exhibit D (DSM-FTC-1030) 31 Mar [BrainStrong Twitter image] BrainStrong DHA @BrainStrongDHA Did you know you can continue learning into your 80s? And BrainStrong has been shown to increase memory in adults 55+! #BrainStrongChamp VOLUME 158 Complaint 7. There are several types of human memory. Episodic memory is the recollection of specific personal events linked to a time and place. It can be verbal, as in remembering a conversation or a list of grocery items, or nonverbal, as in recalling a major life event (e.g., the birth of a child) or where one left an object. Episodic memory can be of short (minutes) or long (years) duration. The scenario depicted in Exhibit B (a woman not recalling the reason she entered a room – to find her sunglasses) is an example of an episodic memory failure over a short duration. Humans also possess sensory memory (e.g., residual sensory impressions of visual stimuli or sounds), working memory (the short-term mental manipulation of information, such as numbers), semantic memory (general knowledge about the world, such as facts, concepts, and vocabulary), and procedural memory (learned skills, like riding a bike). 8. Human cognitive function includes not only the different types of memory, but also non-memory abilities such as executive function, attention, processing speed, and reasoning. 9. The MIDAS study referred to in Exhibit A objectively tested only two types of memory – episodic and working – and the cognitive ability of executive function. In addition, according to the authors of the MIDAS study, the study “was not designed to assess long term effects of DHA on cognitive decline rates,” and although “DHA is potentially beneficial for prevention of cognitive decline[, it] will need confirmation with long-term prevention trials.”

Count I Unsubstantiated Memory Improvement Claim 10. In connection with the advertising, promotion, offering for sale, or sale of BrainStrong Adult, Respondents have represented, directly or indirectly, expressly or by implication, that BrainStrong Adult improves memory in adults. 11. The representation set forth in Paragraph 10 was not substantiated at the time the representation was made. The MIDAS study did not show that BrainStrong Adult improved performance on non-episodic memory tasks. In addition, the MIDAS study employed three types of laboratory tasks to test I-HEALTH, INC. 271 Complaint different, but interrelated, aspects of episodic memory – visuospatial memory, visual pattern recognition memory, and visual-verbal memory. Results from these tasks did not yield a pattern of statistically and clinically significant improvement in the DHA group relative to the placebo group. Whether analyzed separately or as a composite, the effect size of any statistically significant, between-group difference was trivial, and no evidence showed that any such difference correlated with improvement in everyday episodic memory tasks outside the laboratory, such as the ability to remember the location of one’s sunglasses or why one entered a room.

Count II Unsubstantiated Prevention of Cognitive Decline Claim 12. In connection with the advertising, promotion, offering for sale, or sale of BrainStrong Adult, Respondents have represented, directly or indirectly, expressly or by implication, that BrainStrong Adult prevents cognitive decline in adults. 13. The representation set forth in Paragraph 12 was not substantiated at the time the representation was made. 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 MIDAS showed no evidence of cognitive decline, the study could reach no conclusion about DHA’s ability to prevent or slow that condition. Count III False Establishment Claim about Memory Improvement 14. In connection with the advertising, promotion, offering for sale, or sale of BrainStrong Adult, Respondents have represented, directly or indirectly, expressly or by implication, that BrainStrong Adult is clinically proven to improve memory in adults.

VOLUME 158 Complaint 15. In fact, BrainStrong Adult is not clinically proven to improve memory in adults. Therefore, the representation set forth in Paragraph 14 was, and is, false or misleading. Violations of Sections 5 and 12 16. The acts and practices of Respondents as alleged in this Complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce, in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

THEREFORE, the Federal Trade Commission, this twentyfirst day of August, 2014, has issued this complaint against the Respondents.

By the Commission, Commissioner Ohlhausen dissenting and Commissioner McSweeny not participating. I-HEALTH, INC. 273 Complaint Exhibit A DHA for Aduigs 55+ | De Cmege-d for Brain & Memory Hesith | BrainStong brainstrong , Products “Expectant Moms [NURSES gas adults Adults DHA FOR ADULTS 55+ a pee a Sen lice Up tm ase treat your tienes DHA FOR ADULTS 554+ The, a (LIKE BOWES NEED CALCIUM, BRAINS NEED DHA. THE MIDAS STUDY =| JUST SA¥ “NO* TO THE LOSS OF MEMOAY.

BRATINSTRONG ADULT Yes, a certain degree of memory loss and deciine In cognitive function Hife'sDHA: WHAT'S THE imay be conekdered a normal part of aging. And brain health, Including STory? memory, ik odten Ested as one of the top health-related concerns of aging populations In the U.S. ard other countries. (ut DHA & brain nutrition, And since aur bodies don't: efichntly mails IDHA, we need to consume: It through food, beverages or supplements fo keep our brains dunctioning to the best of their ability. ‘Yet most American adults age S54 consume less than 100 mg of DHA dally, which & mot enough.

@ The U3. beets of Medione recommends adults tke op oo 180 mgday OHA +ERA dinky for genera! health Morersus studies on safety and efficacy of DA speciically at doses manghg fom 25-2900 mgtay have shows Ao adverse effests.

Assuming you want bo stay ahead, the question is mow to linprave your imemory? Will you change your diet by adding DHA-rkh food or wie you fake 2 DHA supplement? Healthcare Professionals Clinical Research © Contact Wz About |-Mealth Follow BrainStrong f © I-Hemith, Inc. 2013, All rights meerved. Use of this site signifies your agreement to the Terms of Use | Wew our Privacy Policy. “These statements have nat been awaluabed by the PDA. This product is mot Intended to diagnose, treat, cure or prevent any disease Exhibit A http: |/orainstronpdha.comyadults/da_for_adults[2 2/2013 9:21:03 AM) VOLUME 158 Complaint ‘he MIDAS Study | Memory Improvement with OHA Shady | DMA and Memory Loss THE MIDAS STUDY GRAIHSTRONS Bt facebook OM PACKROGH © I-Haaith, Inc. 2013. All rights reserved. THE MIDAS STUDY Losing your memory as you age may be natural. But improving your memory can also be natural. New BrainStrong™ with WiestHa™, bs safe, natural and clinically shown to help protect against normal, cognitive declins as we age. + THE STUDY THAT PROVED IT.

Adults 554: The Memory Improvement wkh Docosahexaenoic Ack (DHA) Study, or MIDAS, was the first lange, randomized and placebocontroiad study demonstrating the benefits of CHA In maintaining and improving Geain Pealth In older adults. The study indicated that the usa of CHA Improves learning and memory recall In healthy aging aduls WEN miki mamory complaints.

IN OTHER WORDS:

MIDAS. found that Pealiny people skh memory complaints wre book 900 mg/day algal DHA capsules for she months had almost double the reduction In errors on a best that measures learming and memory Performance wersus those who took & place, a benefit nowghly equivalent to having the learning and memory skis of someone thren years younger The CHA was well-tolerated and subjects taking the DHA also ei perienced a lower heart rate, providing 2 significant cardiovascular Benafit.

Conclusions:

+ S00 mgfday algal DHA supplementation for 6 months resulted in a significant decrease of memory errors on a memory test as well as significant Increases to verbal recognition mmncey scores. + DRA suppiomEentation doubled plasma DHA levis. Higher plasma: and red blood! cell levels of GHA ane associated with better cognitive function.

+ DRA supplementation significantly decreased Maart rate compared ‘te placebo over the 24-week supplementation, providing a candivascular benefit consistent with previously published studles in humans.

A BATTLE PLAN:

‘We now have clinical evidence to indicate that 900 mg/day of algal DHA Improves memory lin aging adults.

"A neoent clic! study showed that adults over 55 with a mid memory compinnt, who took S00mgiday of We'sDHA™ for & montis, improved their short-term memory.

Exhibit A tens were brainstrongd ha comyadulsy the_midas_shady[1/4/2013 4:52:28 Pe] I 26 poopie Ihe his, Sign Ups to C4 sabe what your friends Iie.

I-HEALTH, INC. 275 Complaint Bey BrainStrong Adult OHA Omega-3 Products | Memory Imocawvement Supplements brainstrong , Products SBAINSTRONG PRENATAL BRAINETRO! Health Benefit DHA Is Important for healthy brain and eye development and function® and fas been shown to support Peart health from infancy through aduithood.* 5 4 Jest as calcium is eesential for building stromg bones, OHA entures that the oaiis In the brain, retina, heart, and other parts of the nervous system: Gevelog and function property. In order to ensure optimal development and function, me must continuously mplenish the OHA in our bockes by getting enough of this Important fatty ackd In our diets. Healthcare Professionals Clinical Research = Contact Us| About |Health i i-Heaath, Inc. 2013. All rights reserved. Il 119 people Ike this. Sign a Up to see what your fetnete tke ordinstrong ADULT CLINICALLY SHOWN TO IMPROVE MEMORW*t BrainStromg Adult is a dally brain Meath supeiensant toe adults of al apes containing S00mg/serving of a DHA omaga-3 fatty ack, which meips protect the brain against movmal cognitive decline at we age" BrainStrong Adult contains Ife'S0HA4, the premium DHA, the only brand of DHA shown lina Clinkeal shes bo limerava inemory.*? TA recent clinical study showed that adutts over 55 with aml memory compinint, whe foo 900g day of hfe SOHA™ for 6 martha, imoroved phar short-term mernary.

More Information Eroduct Facts and Directions for Ue Fiori Asher Custer Follow Brainstrong | f Use off this site signifies your agreement to the Terms of Use | View our Privacy Policy. “These statements hawt nat been avaluabed by the ADA. This prodiect is mot intended to diagnose, treat, cure of prewant any disease Exhibit A http: rene. brainstrongdha com/products"brainstrong_adulk{1/4/2013 4:50:15 PM] VOLUME 158 Complaint Exhibit B BrainStrong pe SrrOng ACUVI Leg | ze 37 of 38 j arith, 1 leairstrong sider wine pedo inthe alban beni ereers, hiere Rirsintionng adiiecia nee phot tn thee album Breieoona Decks, March 2044 February 2011 January 2001 Becember 200 Deceiver 2 tetQsn Dirmartstecng priates Steir shits. Beqeriier 14 Seaton ackioc! amare phat tothe albu ee nstrany I-HEALTH, INC.

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itp: femur trairmtongdhacon! Procacis rere, woeder* Welrgare 1s raider DHA Exhibit C Proprietary and Confidential DSM Nutritional Products 142002 12-30 Pe DSM-FTC-1100 VOLUME 158 Complaint Exhibit D I-HEALTH, INC. 279 Decision and Order DECISION AND ORDER The Federal Trade Commission (“Commission”) having initiated an investigation of certain acts and practices of the respondents named in the caption hereof, and the respondents having been furnished thereafter with a copy of a draft complaint that the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge the respondents with violation of the Federal Trade Commission Act, 15 U.S.C. § 45 et seq.; and The respondents, their attorneys, and counsel for the Commission having thereafter executed an agreement containing a consent order (“consent agreement”) that includes: a statement that the agreement is for settlement purposes only and does not constitute an admission that the law has been violated as alleged in the draft complaint, or that the facts as alleged in the draft complaint, other than the jurisdictional facts, are true; and waivers and other provisions as required by the Commission’s Rules; and The Commission having thereafter considered the matter and having determined that it has reason to believe that the respondents have violated the Federal Trade Commission Act, and that a complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such consent agreement on the public record for a period of thirty (30) days for the receipt and consideration of public comment, and having duly considered the comments filed thereafter by interested persons pursuant to Commission Rule 2.34, 16 C.F.R. § 2.34, now in further conformity with the procedure prescribed in Commission Rule 2.34, the Commission hereby issues its complaint, makes the following jurisdictional findings, and enters the following order: 3. Respondent i-Health, Inc. is a Delaware corporation with its principal office or place of business at 55 Sebethe Drive, Cromwell, Connecticut 06416. 4. Respondent Martek Biosciences Corporation was a Delaware corporation with its principal office or place of business at 6480 Dobbin Road, Columbia, Maryland 21045. On June 30, 2012, Martek Biosciences VOLUME 158 Decision and Order Corporation merged into its successor, DSM Nutritional Products, LLC. DSM Nutritional Products, LLC is a Delaware corporation with its principal office or place of business at 45 Waterview Boulevard, Parsippany, New Jersey 07054.

5. The Commission has jurisdiction of the subject matter of this proceeding and of the respondents, and the proceeding is in the public interest.

ORDER DEFINITIONS For purposes of this order, the following definitions shall apply:

A. Unless otherwise specified, “Respondents” means i- Health, Inc. and Martek Biosciences Corporation, and their successors and assigns.

B. DSM Nutritional Products, LLC is a successor of Martek Biosciences Corporation.

C. “Commerce” means as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44. D. “Covered Product” means any dietary supplement, food, or drug promoted to prevent cognitive decline or improve memory, or containing docosahexaenoic acid (“DHA”), including, but not limited to, BrainStrong Adult. Covered Product does not include infant formula or ingredients when sold specifically for use in infant formula.

E. “Dietary supplement” means:

1. any product labeled as a dietary supplement or otherwise represented as a dietary supplement; or 2. any pill, tablet, capsule, powder, softgel, gelcap, liquid, or other similar form containing one or I-HEALTH, INC. 281 Decision and Order more ingredients that are a vitamin, mineral, herb or other botanical, amino acid, probiotic, or other dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above, that is intended to be ingested, and is not represented to be used as a conventional food or as a sole item of a meal or the diet.

F. “Endorsement” means as defined in 16 C.F.R. § 255.0. G. “Food” and “drug” mean as defined in Section 15 of the FTC Act, 15 U.S.C. § 55.

H. The term “including” in this order means “without limitation.”

I. The terms “and” and “or” in this order shall be construed conjunctively or disjunctively as necessary, to make the applicable phrase or sentence inclusive rather than exclusive.

J. “Reliably Reported,” for a human clinical test or study (“test”), means a report of the test has been published in a peer-reviewed journal, and such published report provides sufficient information about the test for experts in the relevant field to assess the reliability of the results.

I.

Prohibited Memory and Cognitive Decline Claims IT IS ORDERED that Respondents and their officers, agents, representatives, and employees, directly or through any corporation, partnership, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, including through the use of a product name, endorsement, VOLUME 158 Decision and Order depiction, illustration, trademark, or trade name, that such product:

A. improves memory in adults; or B. prevents cognitive decline in adults, unless the representation is non-misleading and, at the time of making such representation, Respondents possess and rely upon competent and reliable scientific evidence to substantiate that the representation is true. For purposes of this Section, competent and reliable scientific evidence shall 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. Such testing shall be randomized, double-blind, and placebo-controlled; and be conducted by researchers qualified by training and experience to conduct such testing. In addition, all underlying or supporting data and documents generally accepted by experts in cognitive science as relevant to an assessment of such testing, as set forth and described in the Part of this Order entitled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies, must be available for inspection and production to the Commission. II.

Prohibited Health Benefit Claims IT IS FURTHER ORDERED that Respondents and their officers, agents, representatives, and employees, directly or through any corporation, partnership, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, including through the use of a product name, endorsement, depiction, illustration, trademark, or trade name, other than representations covered under Part I of this order, about the health benefits, performance, safety, or efficacy of any Covered Product, unless the representation is non-misleading, and, at the time of making such representation, the Respondents I-HEALTH, INC. 283 Decision and Order possess and rely upon 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 (1) have been conducted and evaluated in an objective manner by qualified persons; (2) are generally accepted in the profession to yield accurate and reliable results; and (3) as to which, when they are human clinical tests or studies, all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of such testing, as set forth in the Part of this Order entitled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies, are available for inspection and production to the Commission. III.

Prohibited Representations Regarding Tests or Studies IT IS FURTHER ORDERED that Respondents and their officers, agents, representatives, and employees, directly or through any corporation, partnership, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, including through the use of a product name, word, phrase such as “clinically shown” or “clinically proven,” endorsement, depiction, illustration, trademark, or trade name: A. The existence, contents, validity, results, conclusions, or interpretations of any test, study, or research; or B. That any benefits of such Covered Product are scientifically or clinically proven, including, but not limited to, that the Covered Product is clinically proven to improve memory in adults.

VOLUME 158 Decision and Order IV.

FDA Approved Claims IT IS FURTHER ORDERED that nothing in this order shall prohibit Respondents from making any representation for: A. Any drug that is permitted in labeling for such drug under any tentative or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration; or B. Any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990 or permitted under Sections 303-304 of the Food and Drug Administration Modernization Act of 1997. V.

Record Keeping Requirements IT IS FURTHER ORDERED that Respondents shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon request make available to the Commission for inspection and copying: A. All advertisements, labeling, packaging, and promotional materials containing the representation; B. All materials that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, qualify, or call into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations.

I-HEALTH, INC. 285 Decision and Order VI.

Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies IT IS FURTHER ORDERED that, with regard to any human clinical test or study (“test”) upon which Respondents rely to substantiate any claim covered by this Order, Respondents shall 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, including, but not necessarily limited to: A. All protocols and protocol amendments, reports, articles, write-ups, or other accounts of the results of the test, and drafts of such documents reviewed by the test sponsor or any other person not employed by the research entity;

B. All documents referring or relating to recruitment; randomization; instructions, including oral instructions, to participants; and participant compliance;

C. Documents sufficient to identify all test participants, including any participants who did not complete the test, and all communications with any participants relating to the test, all raw data collected from participants enrolled in the test, including any participants who did not complete the test; source documents for such data; any data dictionaries; and any case report forms;

D. All documents referring or relating to any statistical analysis of any test data, including, but not limited to, any pretest analysis, intent-to-treat analysis, or between-group analysis performed on any test data; and E. All documents referring or relating to the sponsorship of the test, including all communications, including contracts, between any sponsor and the test’s researchers.

VOLUME 158 Decision and Order Provided, however, the preceding preservation requirement shall not apply to a Reliably Reported test, unless the test was conducted, controlled, or sponsored, in whole or in part (1) by any Respondent, or by any person or entity affiliated with or acting on behalf of any Respondent, including officers, agents, representatives, and employees, or by any other person or entity in active concert or participation with any Respondent (“Respondent’s affiliates”), (2) by the supplier or manufacturer of the product at issue, or (3) by a supplier to any Respondent, to Respondent’s affiliates, or to the product’s manufacturer of any ingredient contained in such product.

For any test conducted, controlled, or sponsored, in whole or in part, by Respondents, Respondents must establish and maintain reasonable procedures to protect the confidentiality, security, and integrity of any personal information collected from or about participants. These procedures shall be documented in writing and shall contain administrative, technical, and physical safeguards appropriate to Respondents’ size and complexity, the nature and scope of Respondents’ activities, and the sensitivity of the personal information collected from or about the participants. VII.

Order Acknowledgements IT IS FURTHER ORDERED that Respondents shall deliver a copy of this order to all current and future principals, officers, and directors, and to all current and future employees, agents, and representatives having managerial responsibilities with respect to the subject matter of this order. Respondents shall secure from each such person a signed and dated statement acknowledging receipt of the order. Respondents shall deliver this order to such current personnel within thirty (30) days after the date of service of this order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities. VIII.

Compliance Notification IT IS FURTHER ORDERED that Respondents shall notify the Commission at least thirty (30) days prior to any change in the corporations that may affect compliance obligations arising under I-HEALTH, INC. 287 Decision and Order this order, including, but not limited to, a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor entity; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the business or corporate name or address. Provided, however, that, with respect to any proposed change in the corporation(s) about which Respondents learn less than thirty (30) days prior to the date such action is to take place, Respondents shall notify the Commission as soon as is practicable after obtaining such knowledge. Unless otherwise directed by a representative of the Commission, all notices required by this Part shall be sent by overnight courier (not the U.S. Postal Service) to the Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580, with the subject line i-Health, Inc., FTC File No. 122-3067. Provided, however, that, in lieu of overnight courier, notices may be sent by first class mail, but only if electronic versions of such notices are contemporaneously sent to the Commission at [email protected].

IX.

Compliance Reporting IT IS FURTHER ORDERED that Respondents, within one hundred twenty (120) days after the date of service of this order, shall file with the Commission a true and accurate report, in writing, setting forth in detail the manner and form of their compliance with this order. Within ten (10) days of receipt of written notice from a representative of the Commission, they shall submit additional true and accurate written reports. X.

Order Termination This order will terminate on August 21, 2034, or twenty (20) years from the most recent date that the United States or the Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of: VOLUME 158 Concurring Statement A. Any part in this order that terminates in less than twenty (20) years;

B. This order’s application to any Respondent that is not named as a Respondent in such complaint; and C. This order if such complaint is filed after the order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that Respondents did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that the order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. By the Commission, Commissioner Ohlhausen dissenting and Commissioner McSweeny not participating. 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. 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 I-HEALTH, INC. 289 Concurring Statement 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 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 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).

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. 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 Intl 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.

VOLUME 158 Concurring Statement 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 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 6 Karin Yurko-Mauro et al., Beneficial Effects of Docosahexaenoic Acid on Cognition in Age-Related Cognitive Decline, 6 Alzheimer’s & Dementia 456 (2010).

I-HEALTH, INC. 291 Concurring Statement 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.

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 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 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.”).

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). VOLUME 158 Concurring Statement 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 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. 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.

I-HEALTH, INC. 293 Dissenting Statement Separate Statement of Commissioner Maureen K. Ohlhausen Dissenting in Part The Commission has long interpreted Section 5 of the FTC Acti 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 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 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). 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 VOLUME 158 Dissenting Statement 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 In this matter, the defendant offers as the primary substantiation for its claims the MIDAS study, a placebocontrolled, randomized, double-blind, parallel, multi-center, sixmonth, peer-reviewed, journal-published study of 485 subjects with statistically significant results.9 Specifically, the MIDAS study concluded:

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.

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/bus09dietary-supplements-advertising-guide-industry.pdf. 8 Id.

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”).

I-HEALTH, INC. 295 Dissenting Statement  “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 [agerelated cognitive decline].”10  “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  “Our study results demonstrate that DHA is well tolerated and may have significant positive effect on gradual memory loss….”12 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 10 Id. at 461.

11 Id. at 463.

12 Id.

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’sDHA 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, VOLUME 158 Dissenting Statement The complaint offers two reasons why the MIDAS study, despite being well-conducted and having statistically significant results, does not substantiate 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 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 wellconducted 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).

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. I-HEALTH, INC. 297 Dissenting Statement staff. The eight MIDAS study co-authors clearly disagree with this conclusion, as demonstrated by their own conclusions in the study.

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 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). VOLUME 158 Concurring Statement 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 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.

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 1 Complaint at ¶ 10.

2 Complaint at ¶¶ 7 and 11.

3 The study was well designed in the sense that it was a randomized, doubleblinded, placebo-controlled evaluation of multiple measures of episodic memory.

I-HEALTH, INC. 299 Concurring Statement 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. 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 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 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).

VOLUME 158 Concurring Statement 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. 5 Complaint at ¶ 11.

I-HEALTH, INC. 301 Analysis to Aid Public Comment ANALYSIS OF 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 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 nonmemory 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) VOLUME 158 Analysis to Aid Public Comment 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 I-HEALTH, INC. 303 Analysis to Aid Public Comment 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.

VOLUME 158 Analysis to Aid Public Comment 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 peerreviewed 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 modify the proposed order’s terms in any way.

ACTAVIS PLC 305 Complaint