A Model Critique for Industry
Paul M. Gross, PhD
November 10, 2008
Introduction
Published: Amagase H, Nance DM. A randomized, double-blind, placebo-controlled, clinical study of the general effects of a standardized Lycium barbarum (Goji) Juice, GoChi. Journal of Alternative and Complementary Medicine 2008 May; 14(4):403-12, sponsored by FreeLife International LLC, manufacturers of Himalayan Goji Juice and GoChi Juice. Both authors are affiliated with FreeLife.
This publication reports that daily consumption of 120 ml (4 oz.) of a wolfberry (goji, Lycium barbarum L.) juice blend with grape and pomegranate juices called GoChi Juice (1) has extensive effects on mood, energy, neurological functions and digestion. Publication of the article in a peer-reviewed journal supported by internet headlines and the FreeLife website trumpeting its results (1-3) may induce members of industry and consumers to accept the research.
When critiqued objectively, however, numerous deficiencies are detectable. The FreeLife GoChi Juice study raises general concerns as an example of low scientific quality applied in the design, conduct, interpretation and peer-review of work intended to describe physiological effects of a simple juice blend.
The intent is transparent -- in the masquerade of publication in a journal with questionable editorial practices, this report appears as a brazen marketing implement intended to induce purchases of the GoChi product, potentially persuading consumers in need of therapies to substitute GoChi juice instead of physician-prescribed medicines.
Against a template of federal guidance documents referenced below, this critique is an objective analysis of the GoChi study's unscientific suppositions and exposed weaknesses. The critique serves as vigilance on quality control for the consumer message about superfruit juices, a growing multibillion dollar global market widely influencing consumer dietary choices (4-7).
FreeLife GoChi Juice Study
The main conclusions of the FreeLife study were that consumption of 120 ml (~ 4 ounces) per day of the GoChi juice over a 2 week period caused a general 13-variable benefit summarized by:
1. increased feelings of well-being
2. improved neurological and psychological performance
3. improved gastrointestinal regularity
The FreeLife GoChi study can be tested for its underlying scientific substantiation using publicly available documents prepared by the US Federal Trade Commission (FTC, governs consumer advertising) and Food and Drug Administration (FDA, governs safety of dietary supplements).
Using the FreeLife GoChi study as an example in the superfruit juice industry allows analysis of how significant scientific agreement is an essential foreground of natural products research. The critique will show that FreeLife and the report's authors, Haru Amagese, PhD and Dwight Nance, PhD, ignored these guidelines and exaggerated the importance of both the undeveloped science on goji berries and interpretation of the study results.
Guidance documents for assessing scientific credibility of reports like the FreeLife GoChi study are:
a. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm
The Federal Trade Commission enforces laws governing unfair or deceptive advertising acts or practices, attempting to ensure that consumers have accurate information about dietary supplements allowing informed purchase decisions (8).
b. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html
For nutritional supplements like the FreeLife GoChi Juice, the FDA has a role in governing labeling. Combined with the FTC overview on advertising, it is appropriate to reference published regulatory documents to apply scientific scrutiny to the FreeLife GoChi report. Both agencies have the goal to ensure that claims stated or implied to consumers are presented truthfully and have adequate scientific support (9).
c. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html
This document presents the system of scientific standards needed in support of health claim petitions about the relationship between a food like FreeLife GoChi Juice and a disease or health-related condition (10, 11). Although the FreeLife publication was not part of a health claim application, its intent and interpretations address physiological changes subsequent researchers and consumers may expect from regular use of the juice. Examining the basis and interpretations of the study in light of whether it is established in significant scientific agreement provides a template for future research on superfruit juices.
Critique
Scientific substantiation is the backbone for validating concepts for product development and marketing product health claims. It reflects the consensus of expert scientific opinion leading to another benchmark for scientific acceptance -- totality of evidence (9,10).
Although the FreeLife GoChi study was discussed neither as an advertisement nor as a health claim petition, the intent seems obvious -- to assert its findings directly for marketing purposes used identically by FreeLife since the 2003 publication of the goji booklet by Mindell and Handel (12).
Conspicuous from the 13 primary results highlighted in Figure 1 of the report, Amagase and Nance make interpretations of the results indistinguishable from marketing claims for the FreeLife first-generation product, Himalayan Goji Juice (1,12). All these conclusions have no basis of significant scientific agreement (10) and are identical to unsupported marketing statements on the FreeLife website (1).
6 additional benefits are added, indicating the company's belief of enhanced immune and antioxidant functions from drinking the same dose of GoChi Juice over 30 days.
FreeLife claims the 19 total benefits are physiologically interrelated responses called the “GoChi Effect,” a concept having no basis in science or plausible biological significance.
What is scientific substantiation? It is defined in FTC case law as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has 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.” (8,9)
Reflecting the FTC and FDA guidance documents (8-11), this critique challenges the basis and conclusions of the FreeLife GoChi Juice study with five questions
1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994 (8)?
2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement (10) about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?
3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide early-stage clinical trials (13,14)?
4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?
5. Was the FreeLife GoChi study conducted mainly as a marketing tool in disguise as pseudoscience to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and potentially misleading about actual health benefits to consumers?
The critique will demonstrate that the FreeLife GoChi report misleads consumers to believe there are health benefits from drinking GoChi juice having no plausibility for a beneficial effect.
The six main findings of the 2008 FreeLife GoChi Study, contained in successive paragraphs in the report's Discussion, are listed below. The italicized terms are identical to those listed on page 5 of the 2003 booklet by Mindell and Handel (12) obtained in promotional material from a FreeLife distributor. According to Amagase and Nance, GoChi Juice:
Discussion in the Results section of the FreeLife GoChi report indicates the authors examined other potential benefits as postulated in the 2003 booklet by Mindell and Handel (12) -- increases sexual energy, relieves menstrual pain, improves quality of sleep, and increases feelings of happiness among other subjective benefits proclaimed in the 2003 booklet (bold italics indicate use of same benefits emphasized in FreeLife marketing).
None of these supposed effects of drinking GoChi Juice or Himalayan Goji Juice is supportable by current science. All of the investigational questions of the FreeLife GoChi Juice study derived from in vitro studies (published mainly in Chinese and translated only into English abstracts typically insufficient in detail to judge scientific quality), preliminary animal research or fabrications published in the original Mindell and Handel booklet.
For example, the company's long-held position restated in the FreeLife GoChi Juice report that polysaccharides of goji berries (identified in the report as Lycium barbarum polysaccharides or LBPs) are “master molecules” involved generally in human physiology (1,12) has no foundation in science. FreeLife claims itself as pioneer and world leader of goji science, the “driving force for international goji research ... to unlock goji’s secrets for the betterment of mankind,” especially for polysaccharides marketed as the most important ingredient of their two juice products, http://corporate.freelife.com/index.cfm?fuseAction=usa.CID_01_001_06
To this author’s knowledge, FreeLife personnel have never published scientific research on goji polysaccharides or any aspect of the fruit's properties. There also is no independent scientific evidence that goji polysaccharides are unique from any other fruit polysaccharides, nor that they can survive digestion chemically intact or have any biological significance in laboratory animals or humans.
In the Discussion of the FreeLife GoChi Juice report, the authors make leaps of interpretation from in vitro or animal results to conclusions about positive human behavioral outcomes which happen to be consistent with FreeLife marketing literature.
This report and FreeLife's marketing of misinformation would therefore appear to violate the FTC “truth in advertising” law which states (8) http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm
“The FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.”
A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances to their detriment.”
Accordingly, this may suggest that the FreeLife GoChi report and information on the company website represent deception, making “miracle” health claims about drinking GoChi Juice. This in turn could suggest that the publication falls into the category of consumer fraud as reported in (15) http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm
which states, “consumers may be spending billions of dollars a year on unproven, fraudulently marketed, often useless health-related products, devices and treatments. Why? Because health fraud trades on false hope. It promises quick cures and easy solutions to a variety of problems, from obesity to cancer and AIDS. But consumers who fall for fraudulent "cure-all" products don't find help or better health. Instead, they find themselves cheated out of their money, their time, and maybe even their health. Fraudulently marketed health products can keep people from seeking and getting treatment from their own healthcare professional.”
The FreeLife GoChi report needs to be subjected to scrutiny and skepticism, a screen that should have been applied before the project began in its design-planning stage, and especially by the editor and referees of the Journal of Alternative and Complementary Medicine during the article review process, as they are the final doorway to public media.
Summary of Expected Scientific Substantiation
Scientific substantiation: meaning of the claim. The FTC and FDA guidance documents (8-10) outline that a company, such as FreeLife, proclaiming health benefits from its product must clearly identify each implied and expressed claim, and that each interpretation of benefit must be substantiated scientifically.
From (9): “The firm's clear understanding of the meaning of the claim is useful in ensuring that the evidentiary basis for substantiation is appropriate for the claim. Understanding the claim's meaning will help identify the appropriate study hypotheses and measurable endpoints, which can be used to ensure that the firm has appropriate studies to substantiate the claim. For example, a firm making a claim that a dietary supplement "helps maintain blood vessel tone" or "supports healthy immune system" should have a clear understanding of the claim's meaning to develop endpoints that could be measured and replicated in studies used as a basis for substantiation.”
Assessing the FreeLife report and website information about GoChi juice, it is evident that neither the company nor the authors of the article have an understanding of scientific substantiation, as clear hypotheses and measurable physiological endpoints were not used, or at least have not been identified.
Absent of such rigorous background, consumers seeking information about goji berries or GoChi Juice (1-3) may come to the following conclusions about drinking just 120 ml (~ 4 ounces) of GoChi Juice daily for 2 weeks; also see article Figure 1 and corporate website, http://corporate.freelife.com/gochi/usa/19reasons.html
Based on the FTC truth-in-advertising law (8,15), it can be argued that not one of these benefits purported from taking GoChi juice meets scientific substantiation.
The following challenges about FreeLife's background for these claims can be itemized in bold below from the FDA guidance on scientific substantiation (9)
1. Have the studies specified and measured the exact dietary component of GoChi juice that is the subject of these results? No definitive ingredients list or components actually in the juice were demonstrated. The Nutrition Facts label for GoChi does not show it is anything other than barren of nutrient content (1).
2. Have the studies appropriately specified and measured the nutritional deficiency, structure/function or general well-being that is the subject of the GoChi Juice results? No specifications of nutritional deficiencies in the subjects were identified, and the results of “well-being” were merely subjective and testimonial in nature.
3. Do the results of the GoChi study accurately convey the extent, nature or permanence of the effect achieved and the level of scientific certainty for that effect? None of these study outcomes was satisfied. Weak design, unconvincing results and unscientific explanations create serious doubt that the study could be replicated by independent experts.
Scientific substantiation: relationship of quality and totality of evidence to the claim of benefits from drinking GoChi Juice.
What are the types of evidence that would substantiate the FreeLife GoChi juice claim of beneficial effects?
Although numerous aspects of the FreeLife study design are doubtful, a brief summary of critiques for this study can be drawn from the FDA document on substantiation for dietary supplements (9)
* bias and confounders. Design of the FreeLife GoChi study leaves open numerous weaknesses of experimental design replete with bias and confounders, including additional deficiencies below.
* lack of appropriate randomization and blinding. The subjects and authors were FreeLife employees already with knowledge and experience of the GoChi Juice; therefore, they were vulnerable to selection bias.
* inadequate number of subjects to assure inference to the general population.
* variables affecting reproducibility of the study were not controlled using rigorous selection criteria and independent subjects.
* primary variables concerning the subjects' diets and daily routines were inadequately controlled or explained. For example, food selection was unregulated, complicating nutritional conformity, and many subjects smoked during the study.
* dietary compliance in the protocol was subject to recall error
* the study did not involve a cross-over design and washout period that would have confirmed any true effect.
* the study interpretations are confounded by numerous factors, including the quantity and undefined content of the GoChi Juice ingredients, and other dietary factors that could have accounted for any results apart from those of the GoChi Juice.
Overall, substantial bias and numerous uncontrolled confounders of the FreeLife GoChi study prevent any measured outcomes from being attributed unequivocally to the GoChi juice. Yet the authors were still able to identify 13 benefits now used in a FreeLife promotional video entitled, New Goji Studies Released, http://corporate.freelife.com/gochi/usa/media.html
Consistent with this assessment, other FDA requirements to establish scientific substantiation, such as overall quality and totality of research evidence underlying the project hypothesis to be tested (9), were not met by the FreeLife GoChi study. Quoting the FDA document (9): “the mere fact that the study was published does not necessarily mean that the research was competent and reliable evidence adequate to substantiate a particular claim.”
By example of recently published FDA guidelines for dietary antioxidants (16,17), attributing GoChi polysaccharides or any other nutrient to the effects observed requires a) evidence the goji bioactives are available in the body, b) a defined mechanism of their biological action, and c) an established Dietary Reference Intake value. Contrary to what one might believe from FreeLife marketing material and the rationale for the GoChi Juice study, none of these qualifiers exists.
Reviewing Challenges to the Authors and FreeLife
1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994?
The study would seem to be a violation of these guidelines and good scientific practice, containing exaggerated statements and absent or misinterpreted science.
2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?
The study fails every qualification for significant scientific agreement, total body of evidence and scientific substantiation (9,10).
3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide clinical trials?
This study, at best, represents preliminary pilot work and therefore bears no resemblance to a well-controlled, expert-designed clinical trial (13,14).
4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?
The final obligation and responsibility to the industry and consumers for publication of such a study rests with the journal, its Editor and Editorial Board (18) who neglected rigorous scientific standards to allow publication of this article.
5. Was the FreeLife GoChi study conducted mainly as a marketing tool to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and misleading for providing actual benefits to consumers?
Given that the conclusions of the FreeLife GoChi Juice report support long-standing marketing statements by the company, one could surmise that the study conclusions were drawn up before the study was conducted. Members of the nutritional supplements industry or public not applying skepticism could be readily misled about the stated health benefits of GoChi Juice.
By consequence, the GoChi report, its authors, and FreeLife International appear vulnerable under the Federal Trade Commission Act which prohibits "unfair or deceptive acts or practices," and "any false advertisement" that is "misleading in a material respect." FDA's authority is embodied in the Federal Food, Drug, and Cosmetic Act which prohibits "labeling [that] is false or misleading in any particular” (13,19). http://www.ftc.gov/bcp/policystmt/ad-food.shtm and http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm
References
SOURCE: breathe.orgThis publication reports that daily consumption of 120 ml (4 oz.) of a wolfberry (goji, Lycium barbarum L.) juice blend with grape and pomegranate juices called GoChi Juice (1) has extensive effects on mood, energy, neurological functions and digestion. Publication of the article in a peer-reviewed journal supported by internet headlines and the FreeLife website trumpeting its results (1-3) may induce members of industry and consumers to accept the research.
When critiqued objectively, however, numerous deficiencies are detectable. The FreeLife GoChi Juice study raises general concerns as an example of low scientific quality applied in the design, conduct, interpretation and peer-review of work intended to describe physiological effects of a simple juice blend.
The intent is transparent -- in the masquerade of publication in a journal with questionable editorial practices, this report appears as a brazen marketing implement intended to induce purchases of the GoChi product, potentially persuading consumers in need of therapies to substitute GoChi juice instead of physician-prescribed medicines.
Against a template of federal guidance documents referenced below, this critique is an objective analysis of the GoChi study's unscientific suppositions and exposed weaknesses. The critique serves as vigilance on quality control for the consumer message about superfruit juices, a growing multibillion dollar global market widely influencing consumer dietary choices (4-7).
FreeLife GoChi Juice Study
The main conclusions of the FreeLife study were that consumption of 120 ml (~ 4 ounces) per day of the GoChi juice over a 2 week period caused a general 13-variable benefit summarized by:
1. increased feelings of well-being
2. improved neurological and psychological performance
3. improved gastrointestinal regularity
The FreeLife GoChi study can be tested for its underlying scientific substantiation using publicly available documents prepared by the US Federal Trade Commission (FTC, governs consumer advertising) and Food and Drug Administration (FDA, governs safety of dietary supplements).
Using the FreeLife GoChi study as an example in the superfruit juice industry allows analysis of how significant scientific agreement is an essential foreground of natural products research. The critique will show that FreeLife and the report's authors, Haru Amagese, PhD and Dwight Nance, PhD, ignored these guidelines and exaggerated the importance of both the undeveloped science on goji berries and interpretation of the study results.
Guidance documents for assessing scientific credibility of reports like the FreeLife GoChi study are:
a. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm
The Federal Trade Commission enforces laws governing unfair or deceptive advertising acts or practices, attempting to ensure that consumers have accurate information about dietary supplements allowing informed purchase decisions (8).
b. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html
For nutritional supplements like the FreeLife GoChi Juice, the FDA has a role in governing labeling. Combined with the FTC overview on advertising, it is appropriate to reference published regulatory documents to apply scientific scrutiny to the FreeLife GoChi report. Both agencies have the goal to ensure that claims stated or implied to consumers are presented truthfully and have adequate scientific support (9).
c. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html
This document presents the system of scientific standards needed in support of health claim petitions about the relationship between a food like FreeLife GoChi Juice and a disease or health-related condition (10, 11). Although the FreeLife publication was not part of a health claim application, its intent and interpretations address physiological changes subsequent researchers and consumers may expect from regular use of the juice. Examining the basis and interpretations of the study in light of whether it is established in significant scientific agreement provides a template for future research on superfruit juices.
Critique
Scientific substantiation is the backbone for validating concepts for product development and marketing product health claims. It reflects the consensus of expert scientific opinion leading to another benchmark for scientific acceptance -- totality of evidence (9,10).
Although the FreeLife GoChi study was discussed neither as an advertisement nor as a health claim petition, the intent seems obvious -- to assert its findings directly for marketing purposes used identically by FreeLife since the 2003 publication of the goji booklet by Mindell and Handel (12).
Conspicuous from the 13 primary results highlighted in Figure 1 of the report, Amagase and Nance make interpretations of the results indistinguishable from marketing claims for the FreeLife first-generation product, Himalayan Goji Juice (1,12). All these conclusions have no basis of significant scientific agreement (10) and are identical to unsupported marketing statements on the FreeLife website (1).
In recent additions to the FreeLife website, http://corporate.freelife.com/gochi/usa/19reasons.html
6 additional benefits are added, indicating the company's belief of enhanced immune and antioxidant functions from drinking the same dose of GoChi Juice over 30 days.
FreeLife claims the 19 total benefits are physiologically interrelated responses called the “GoChi Effect,” a concept having no basis in science or plausible biological significance.
What is scientific substantiation? It is defined in FTC case law as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has 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.” (8,9)
Reflecting the FTC and FDA guidance documents (8-11), this critique challenges the basis and conclusions of the FreeLife GoChi Juice study with five questions
1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994 (8)?
2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement (10) about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?
3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide early-stage clinical trials (13,14)?
4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?
5. Was the FreeLife GoChi study conducted mainly as a marketing tool in disguise as pseudoscience to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and potentially misleading about actual health benefits to consumers?
The critique will demonstrate that the FreeLife GoChi report misleads consumers to believe there are health benefits from drinking GoChi juice having no plausibility for a beneficial effect.
The six main findings of the 2008 FreeLife GoChi Study, contained in successive paragraphs in the report's Discussion, are listed below. The italicized terms are identical to those listed on page 5 of the 2003 booklet by Mindell and Handel (12) obtained in promotional material from a FreeLife distributor. According to Amagase and Nance, GoChi Juice:
1. increases endurance and energy; reduces fatigue
2. has effects on the brain and neuronal function, produces psychological and neurological effects; has anti-aging properties
3. facilitates recovery of red blood cells, so relates to increased endurance and decreased fatigue
4. may provide benefits to eye health and vision
5. modulates metabolism, improving physical performance and gastrointestinal function; contains polysaccharides, improving regularity
6. has anti-diabetic effects and in vivo antioxidant benefit, reducing blood glucose levels and DNA damage, elevating blood levels of superoxide dismutase, and so is beneficial for treatment of diabetes and metabolic diseases.
2. has effects on the brain and neuronal function, produces psychological and neurological effects; has anti-aging properties
3. facilitates recovery of red blood cells, so relates to increased endurance and decreased fatigue
4. may provide benefits to eye health and vision
5. modulates metabolism, improving physical performance and gastrointestinal function; contains polysaccharides, improving regularity
6. has anti-diabetic effects and in vivo antioxidant benefit, reducing blood glucose levels and DNA damage, elevating blood levels of superoxide dismutase, and so is beneficial for treatment of diabetes and metabolic diseases.
Discussion in the Results section of the FreeLife GoChi report indicates the authors examined other potential benefits as postulated in the 2003 booklet by Mindell and Handel (12) -- increases sexual energy, relieves menstrual pain, improves quality of sleep, and increases feelings of happiness among other subjective benefits proclaimed in the 2003 booklet (bold italics indicate use of same benefits emphasized in FreeLife marketing).
None of these supposed effects of drinking GoChi Juice or Himalayan Goji Juice is supportable by current science. All of the investigational questions of the FreeLife GoChi Juice study derived from in vitro studies (published mainly in Chinese and translated only into English abstracts typically insufficient in detail to judge scientific quality), preliminary animal research or fabrications published in the original Mindell and Handel booklet.
For example, the company's long-held position restated in the FreeLife GoChi Juice report that polysaccharides of goji berries (identified in the report as Lycium barbarum polysaccharides or LBPs) are “master molecules” involved generally in human physiology (1,12) has no foundation in science. FreeLife claims itself as pioneer and world leader of goji science, the “driving force for international goji research ... to unlock goji’s secrets for the betterment of mankind,” especially for polysaccharides marketed as the most important ingredient of their two juice products, http://corporate.freelife.com/index.cfm?fuseAction=usa.CID_01_001_06
To this author’s knowledge, FreeLife personnel have never published scientific research on goji polysaccharides or any aspect of the fruit's properties. There also is no independent scientific evidence that goji polysaccharides are unique from any other fruit polysaccharides, nor that they can survive digestion chemically intact or have any biological significance in laboratory animals or humans.
In the Discussion of the FreeLife GoChi Juice report, the authors make leaps of interpretation from in vitro or animal results to conclusions about positive human behavioral outcomes which happen to be consistent with FreeLife marketing literature.
This report and FreeLife's marketing of misinformation would therefore appear to violate the FTC “truth in advertising” law which states (8) http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm
“The FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.”
A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances to their detriment.”
Accordingly, this may suggest that the FreeLife GoChi report and information on the company website represent deception, making “miracle” health claims about drinking GoChi Juice. This in turn could suggest that the publication falls into the category of consumer fraud as reported in (15) http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm
which states, “consumers may be spending billions of dollars a year on unproven, fraudulently marketed, often useless health-related products, devices and treatments. Why? Because health fraud trades on false hope. It promises quick cures and easy solutions to a variety of problems, from obesity to cancer and AIDS. But consumers who fall for fraudulent "cure-all" products don't find help or better health. Instead, they find themselves cheated out of their money, their time, and maybe even their health. Fraudulently marketed health products can keep people from seeking and getting treatment from their own healthcare professional.”
The FreeLife GoChi report needs to be subjected to scrutiny and skepticism, a screen that should have been applied before the project began in its design-planning stage, and especially by the editor and referees of the Journal of Alternative and Complementary Medicine during the article review process, as they are the final doorway to public media.
* * * * *
Summary of Expected Scientific Substantiation
Scrutiny can be readily applied by the test of “scientific substantiation” of the FreeLife GoChi study as outlined by the FDA (9) using several criteria:
1. meaning of the claim being made
2. relationship of evidence to the claim
3. quality of the evidence
4. totality of the evidence
1. meaning of the claim being made
2. relationship of evidence to the claim
3. quality of the evidence
4. totality of the evidence
Scientific substantiation: meaning of the claim. The FTC and FDA guidance documents (8-10) outline that a company, such as FreeLife, proclaiming health benefits from its product must clearly identify each implied and expressed claim, and that each interpretation of benefit must be substantiated scientifically.
From (9): “The firm's clear understanding of the meaning of the claim is useful in ensuring that the evidentiary basis for substantiation is appropriate for the claim. Understanding the claim's meaning will help identify the appropriate study hypotheses and measurable endpoints, which can be used to ensure that the firm has appropriate studies to substantiate the claim. For example, a firm making a claim that a dietary supplement "helps maintain blood vessel tone" or "supports healthy immune system" should have a clear understanding of the claim's meaning to develop endpoints that could be measured and replicated in studies used as a basis for substantiation.”
Assessing the FreeLife report and website information about GoChi juice, it is evident that neither the company nor the authors of the article have an understanding of scientific substantiation, as clear hypotheses and measurable physiological endpoints were not used, or at least have not been identified.
Absent of such rigorous background, consumers seeking information about goji berries or GoChi Juice (1-3) may come to the following conclusions about drinking just 120 ml (~ 4 ounces) of GoChi Juice daily for 2 weeks; also see article Figure 1 and corporate website, http://corporate.freelife.com/gochi/usa/19reasons.html
1. have more energy, less fatigue, more capability for athletic performance
2. feel less stress, more calm, greater feeling of contentment, healthier and happier
3. experience better sleep, easier wake up, better focus and mental acuity
4. have improved gastrointestinal regularity
2. feel less stress, more calm, greater feeling of contentment, healthier and happier
3. experience better sleep, easier wake up, better focus and mental acuity
4. have improved gastrointestinal regularity
Based on the FTC truth-in-advertising law (8,15), it can be argued that not one of these benefits purported from taking GoChi juice meets scientific substantiation.
The following challenges about FreeLife's background for these claims can be itemized in bold below from the FDA guidance on scientific substantiation (9)
1. Have the studies specified and measured the exact dietary component of GoChi juice that is the subject of these results? No definitive ingredients list or components actually in the juice were demonstrated. The Nutrition Facts label for GoChi does not show it is anything other than barren of nutrient content (1).
2. Have the studies appropriately specified and measured the nutritional deficiency, structure/function or general well-being that is the subject of the GoChi Juice results? No specifications of nutritional deficiencies in the subjects were identified, and the results of “well-being” were merely subjective and testimonial in nature.
3. Do the results of the GoChi study accurately convey the extent, nature or permanence of the effect achieved and the level of scientific certainty for that effect? None of these study outcomes was satisfied. Weak design, unconvincing results and unscientific explanations create serious doubt that the study could be replicated by independent experts.
Scientific substantiation: relationship of quality and totality of evidence to the claim of benefits from drinking GoChi Juice.
What are the types of evidence that would substantiate the FreeLife GoChi juice claim of beneficial effects?
Although numerous aspects of the FreeLife study design are doubtful, a brief summary of critiques for this study can be drawn from the FDA document on substantiation for dietary supplements (9)
* bias and confounders. Design of the FreeLife GoChi study leaves open numerous weaknesses of experimental design replete with bias and confounders, including additional deficiencies below.
* lack of appropriate randomization and blinding. The subjects and authors were FreeLife employees already with knowledge and experience of the GoChi Juice; therefore, they were vulnerable to selection bias.
* inadequate number of subjects to assure inference to the general population.
* variables affecting reproducibility of the study were not controlled using rigorous selection criteria and independent subjects.
* primary variables concerning the subjects' diets and daily routines were inadequately controlled or explained. For example, food selection was unregulated, complicating nutritional conformity, and many subjects smoked during the study.
* dietary compliance in the protocol was subject to recall error
* the study did not involve a cross-over design and washout period that would have confirmed any true effect.
* the study interpretations are confounded by numerous factors, including the quantity and undefined content of the GoChi Juice ingredients, and other dietary factors that could have accounted for any results apart from those of the GoChi Juice.
Overall, substantial bias and numerous uncontrolled confounders of the FreeLife GoChi study prevent any measured outcomes from being attributed unequivocally to the GoChi juice. Yet the authors were still able to identify 13 benefits now used in a FreeLife promotional video entitled, New Goji Studies Released, http://corporate.freelife.com/gochi/usa/media.html
Consistent with this assessment, other FDA requirements to establish scientific substantiation, such as overall quality and totality of research evidence underlying the project hypothesis to be tested (9), were not met by the FreeLife GoChi study. Quoting the FDA document (9): “the mere fact that the study was published does not necessarily mean that the research was competent and reliable evidence adequate to substantiate a particular claim.”
To list a few among numerous elements of significant scientific agreement (10) missing from the FreeLife GoChi Juice report are
* an insufficient base of science to indicate plausibility of biological actions by the GoChi Juice polysaccharides or any ingredients
* a retrospective observational (testimonial) design, rather than an interventional design, for detecting subject responses
* biomarkers reliable for detecting specific biological responses supporting interpretations used in the Discussion
* research evidence allowing interpretation about a mechanism of action
* specificity of the proposed effects, such as by “dechallenging” the subjects (9)
* efficacy of the proposed effects, such as by using higher doses of the GoChi Juice to evoke greater responses.
* an insufficient base of science to indicate plausibility of biological actions by the GoChi Juice polysaccharides or any ingredients
* a retrospective observational (testimonial) design, rather than an interventional design, for detecting subject responses
* biomarkers reliable for detecting specific biological responses supporting interpretations used in the Discussion
* research evidence allowing interpretation about a mechanism of action
* specificity of the proposed effects, such as by “dechallenging” the subjects (9)
* efficacy of the proposed effects, such as by using higher doses of the GoChi Juice to evoke greater responses.
By example of recently published FDA guidelines for dietary antioxidants (16,17), attributing GoChi polysaccharides or any other nutrient to the effects observed requires a) evidence the goji bioactives are available in the body, b) a defined mechanism of their biological action, and c) an established Dietary Reference Intake value. Contrary to what one might believe from FreeLife marketing material and the rationale for the GoChi Juice study, none of these qualifiers exists.
Reviewing Challenges to the Authors and FreeLife
1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994?
The study would seem to be a violation of these guidelines and good scientific practice, containing exaggerated statements and absent or misinterpreted science.
2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?
The study fails every qualification for significant scientific agreement, total body of evidence and scientific substantiation (9,10).
3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide clinical trials?
This study, at best, represents preliminary pilot work and therefore bears no resemblance to a well-controlled, expert-designed clinical trial (13,14).
4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?
The final obligation and responsibility to the industry and consumers for publication of such a study rests with the journal, its Editor and Editorial Board (18) who neglected rigorous scientific standards to allow publication of this article.
5. Was the FreeLife GoChi study conducted mainly as a marketing tool to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and misleading for providing actual benefits to consumers?
Given that the conclusions of the FreeLife GoChi Juice report support long-standing marketing statements by the company, one could surmise that the study conclusions were drawn up before the study was conducted. Members of the nutritional supplements industry or public not applying skepticism could be readily misled about the stated health benefits of GoChi Juice.
By consequence, the GoChi report, its authors, and FreeLife International appear vulnerable under the Federal Trade Commission Act which prohibits "unfair or deceptive acts or practices," and "any false advertisement" that is "misleading in a material respect." FDA's authority is embodied in the Federal Food, Drug, and Cosmetic Act which prohibits "labeling [that] is false or misleading in any particular” (13,19). http://www.ftc.gov/bcp/policystmt/ad-food.shtm and http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm
References
1. FreeLife International website, Ingredients of GoChi Juice, FAQ, last item, http://corporate.freelife.com/gochi/usa/faq.html
2. Heller L. Goji berry juice improves energy, happiness -- study. NutraIngredients.com-Europe, July 22, 2008, http://www.nutraingredients.com/Research/Goji-berry-juice-improves-energy-happiness-study
3. Healthy living. Drink goji juice to your health. August, 2008. http://www.napsnet.com/articles/59022.html
4. Soft Drinks International, Focus - Soft drinks makers reap superfruit dividend, February 8, 2008, http://www.fda.gov/cder/guidance/7086fnl.htm
5. Associated Press, Exotic "super fruit" juice spawns $1B nutrition business for one company; experts doubtful, February 12, 2008, http://www.iht.com/articles/ap/2008/02/12/business/NA-FEA-FIN-US-Exotic-Juice-Claims.php
6. Sohn E. Superfruits, super powers? Los Angeles Times, March 10, 2008, http://www.latimes.com/features/health/la-hew-superfruit,0,5060388.story?page=1
7. Halliday J. Superfruits disturb the five-a-day balance, warns Datamonitor, FoodNavigator.com-Europe, August 4, 2008, http://www.foodnavigator.com/Financial-Industry/Superfruits-disturb-the-five-a-day-balance-warns-Datamonitor
8. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm
9. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html
10. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html
11. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 1, 1995, Dietary Supplement Health and Education Act of 1994, http://www.cfsan.fda.gov/~dms/dietsupp.html
12. Mindell, E., Handel, R. Goji -- The Himalayan Health Secret, VideoPlus Inc., Momentum Media Health Series, 2003, Lake Dallas, Texas, ISBN 0-9672855-2-6.
13. US Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies, Pharmacology/Toxicology, January, 2006, http://www.fda.gov/cder/guidance/7086fnl.htm
14. Wikipedia, Clinical trial design, http://en.wikipedia.org/wiki/Clinical_trial#Design
15. US Federal Trade Commission, Facts for Consumers, 'Miracle' Health Claims: Add a Dose of Skepticism, October, 2001, http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm
16. FDA Food Labeling; Nutrient Content Claims; Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods, Small Entity Compliance Guide, http://www.cfsan.fda.gov/~dms/hpotguid.html
17. Heller L. FDA issues guidance on antioxidants, NutraIngredients.com-USA, July 21, 2008, http://www.nutraingredients-usa.com/Regulation/FDA-issues-guidance-on-antioxidants
18. Editor-in-Chief, Journal of Alternative and Complementary Medicine, http://www.liebertpub.com/eboard.aspx?pub_id=26
19. US Federal Trade Commission, Enforcement Policy Statement on Food Advertising, May, 1994, Introduction, paragraph 2, http://www.ftc.gov/bcp/policystmt/ad-food.shtm
Dr. Paul is currently a consultant living in Ontario, Canada.
2. Heller L. Goji berry juice improves energy, happiness -- study. NutraIngredients.com-Europe, July 22, 2008, http://www.nutraingredients.com/Research/Goji-berry-juice-improves-energy-happiness-study
3. Healthy living. Drink goji juice to your health. August, 2008. http://www.napsnet.com/articles/59022.html
4. Soft Drinks International, Focus - Soft drinks makers reap superfruit dividend, February 8, 2008, http://www.fda.gov/cder/guidance/7086fnl.htm
5. Associated Press, Exotic "super fruit" juice spawns $1B nutrition business for one company; experts doubtful, February 12, 2008, http://www.iht.com/articles/ap/2008/02/12/business/NA-FEA-FIN-US-Exotic-Juice-Claims.php
6. Sohn E. Superfruits, super powers? Los Angeles Times, March 10, 2008, http://www.latimes.com/features/health/la-hew-superfruit,0,5060388.story?page=1
7. Halliday J. Superfruits disturb the five-a-day balance, warns Datamonitor, FoodNavigator.com-Europe, August 4, 2008, http://www.foodnavigator.com/Financial-Industry/Superfruits-disturb-the-five-a-day-balance-warns-Datamonitor
8. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm
9. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html
10. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html
11. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 1, 1995, Dietary Supplement Health and Education Act of 1994, http://www.cfsan.fda.gov/~dms/dietsupp.html
12. Mindell, E., Handel, R. Goji -- The Himalayan Health Secret, VideoPlus Inc., Momentum Media Health Series, 2003, Lake Dallas, Texas, ISBN 0-9672855-2-6.
13. US Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies, Pharmacology/Toxicology, January, 2006, http://www.fda.gov/cder/guidance/7086fnl.htm
14. Wikipedia, Clinical trial design, http://en.wikipedia.org/wiki/Clinical_trial#Design
15. US Federal Trade Commission, Facts for Consumers, 'Miracle' Health Claims: Add a Dose of Skepticism, October, 2001, http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm
16. FDA Food Labeling; Nutrient Content Claims; Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods, Small Entity Compliance Guide, http://www.cfsan.fda.gov/~dms/hpotguid.html
17. Heller L. FDA issues guidance on antioxidants, NutraIngredients.com-USA, July 21, 2008, http://www.nutraingredients-usa.com/Regulation/FDA-issues-guidance-on-antioxidants
18. Editor-in-Chief, Journal of Alternative and Complementary Medicine, http://www.liebertpub.com/eboard.aspx?pub_id=26
19. US Federal Trade Commission, Enforcement Policy Statement on Food Advertising, May, 1994, Introduction, paragraph 2, http://www.ftc.gov/bcp/policystmt/ad-food.shtm
Author: Paul M. Gross, PhD in physiology from the University of Glasgow, Scotland, has contributed science-based articles and conference presentations on superfruits since 2006. He is a founding member of the International Berry Health Association based in Oregon and currently sits on the steering committee.
As a scientist and expert on cardiovascular and brain physiology, Dr. Paul has done extensive award-winning, published research on the brain, cardiovascular system, bones and antioxidant drugs. The Karger Foundation of Switzerland recognized his research on brain blood vessels with their 1986 Memorial Award while the Heart and Stroke Foundation of Ontario appointed him as Research Scholar for 1987 -- 1992.
As a scientist and expert on cardiovascular and brain physiology, Dr. Paul has done extensive award-winning, published research on the brain, cardiovascular system, bones and antioxidant drugs. The Karger Foundation of Switzerland recognized his research on brain blood vessels with their 1986 Memorial Award while the Heart and Stroke Foundation of Ontario appointed him as Research Scholar for 1987 -- 1992.
Dr. Paul has published 85 peer-reviewed science reports over a 25-year career in medical research, and co-founded four nutritional supplement or biotechnology companies. He is the senior author of a 2006 book on the goji berry (Lycium barbarum L) entitled Wolfberry: Nature's Bounty of Nutrition and Health (Booksurge Publishing, Amazon.com). Two additional books are underway, both of which are focused in the antioxidant functional foods and phytochemical arena.
Awarded a First Dan black belt in the Korean martial art of Taekwondo at age 53, Dr. Paul maintains a high level of careful nutrition and physical fitness daily.
Awarded a First Dan black belt in the Korean martial art of Taekwondo at age 53, Dr. Paul maintains a high level of careful nutrition and physical fitness daily.
Dr. Paul is currently a consultant living in Ontario, Canada.
