ERSP Decision: Accelis Weight Loss Supplement

 

IOVATE HEALTH SCIENCES, INC.

Accelis Weight Loss Supplement

 

BASIS OF INQUIRY

 

Direct response advertising for the Accelis weight loss supplement came to the attention of the Electronic Retailing Self-Regulation Program ("ERSP") pursuant to an anonymous challenge from a competitor. The core claims at issue originated from television, print, and online advertising. Based upon its review of the advertising campaign for Accelis, ERSP identified the following representative core claims that were communicated in the advertising regarding the general efficacy of the product:

 

Establishment Claims

 

"Clinical research has shown that the key ingredients in Accelis cause and accelerated weight loss."

. .[with a clinically proven ingredient you experience accelerated weight loss that you can see and feel!”

 "Clinically proven accelerated weight loss!"

"clinically proven to help you reach your weight-loss goals.

 

Performance Claims

 

..an amazing discovery in accelerated weights- new Accelis

"lose 10. 65 pounds fast.

"Just take one serving of two liquid, soft gel capsules daily and accelerate your weight loss.

"With Accelis, you can lose weight rapidly. "

"For noticeable weight loss with incredible results, get Accelis! 

“ACCELIS FACT: The key ingredient in Accelis can help you lose almost twice the weight."

"Goes to work immediately.”

"With fast-acting, rapid release liquid soft gel technology. "

 

Exclusivity Claims

 

"Breakthrough Soft Gel Technology"

"The rapid-release liquid technology is unlike any product on the market today and actually enhances the absorption of the weight-loss ingredients.”

"the world's first patented soft gel technology with corosolic acid.

"the worlds' first and only patented, rapid release, liquid, soft gel delivery technology.

"Accelis is liquid weight-loss formula. "

 

4. Testimonial and Endorsement Claims

 

"Proven Results; " "Lost 32lbs;” "I lost 32 pounds–fast!”

"I think it is one of the few products out there that has any

detail, which is a significant factor that people should look for

in a diet product. I think it is a well thought out

[Dr. Andrew Parkinson,             

“Effective weight loss from just one serving per day? In these 

Accelis case studies, you can see for yourself the extraordinary results" 

[Dr. Andrew Parkinson, MD)

"Dr. Andrew Parkinson, MD, endorses Accelis"

 

CHALLENGER'S POSITION

 

The challenger maintained that through its and television advertisement, Iovate claims that Accelis: causes rapid weight loss; causes consumers to lose 10.65 pounds; is "clinically proven"; doctor formulated; and; "supported by" doctors.

 

Conversely, according to the challenger, available clinical and scientific evidence (or lack thereof) regarding the ingredients found in Accelis strongly suggests that these claims cannot be substantiated. Moreover, it noted that the Federal Trade Commission's ("FTC")determinations that these types of claims are false and misleading.

 

According to the challenger, Accelis the supplement is an assortment of herbs contained in two soft-gel capsules which supply a 30 milligram dosage. However, the challenger contended that because the Accelis formula is declared a proprietary blend it is not possible to determine how much of each ingredient is supplied. In sum, the challenger argued that a review of the scientific evidence in support of Accelis' ingredients reveals that a 30 milligram serving is unlikely to facilitate weight loss.

 

1. Product Performance Claims

 

The challenger asserted that Iovate misleads consumers about the scientific efficacy of Accelis by stating that the product "helps regulate glucose levels and promote weight loss by stimulating the transport of glucose into the muscle cells where it can be used for energy instead of fat cells."  The Consumers are directed to a webpage titled the "Science behind Accelis" which provides a depiction of the five step "mechanism of action" of Accelis. The challenger argued that unless that illustration is predicated on competent and reliable scientific evidence demonstrating that Accelis does in fact function as represented, it is false and misleading.

 

Rapid Weight Loss Claims

 

The challenger asserted that the FTC has warned that "substantial weight loss in a short period is highly unlikely..  and referred to the 2002 publication entitled Tipping the Scales? Weight-Loss Ads Found Heavy on Deception as support. Accordingly, the challenger argued that unless Accelis has been the subject of a well-designed, double-blind, placebo-controlled, randomized human clinical trial demonstrating that the product will cause rapid, specific weight loss, the claims are false and misleading.

 

2. Establishment Claims

 

Moreover, it was alleged that Iovate explicitly states that the Accelis is supported by proven, clinical data. The challenger stated that these clinical claims lead consumers to mistakenly believe that a study has been conducted on the Accelis product itself. That notion is further promoted by including doctor formulated claims and an endorsement from a medical doctor who extols the competence of the science and compliments the company and product for having such evidence. Only upon close reading of the advertising might a consumer conclude that a study was not conducted by Iovate on Accelis and that reference is merely to a study conducted on an active ingredient found in Accelis rather than the finished product.

 

According to the challenger, the information provided on the Accelis website 

about the study is vague and unreliable. No information is provided about the number of 

participants in the study or whether the participants were male, female, or a combination 

of both.  The study description also fails to specify  amount of exercise or the limitation 

or the caloric intake. The challenger argued that pursuant to FTC regulations, any reference 

to a study must include all of the material information so that consumers will completely 

understand the scope and limitations of the study.

 

The challenger argued that, alternatively, even if ERSP were to take the position that the study is "scientifically acceptable," it is inapplicable to Accelis because the product contains six dietary ingredients in addition to its active ingredient, corosolic acid. Without a study on the actual finished product, it is impossible to determine whether consumers could expect the same results as those obtained with the active ingredient alone.

 

Exclusivity Claims

 

According to the challenger, Iovate also misleads consumers by claiming that Accelis is revolutionary (i.e., "Breakthrough Soft Gel Technology") because of the form of product administration. However, directly contrary to these claims, there are many weight loss products on the market dispensed in liquid form. For example, Nutrex’s Lipo 6 comes in liquid gel form, VPX Sports' RedLine comes in a liquid gel-form, JetFuel comes in a liquid capsule, Irwin Naturals' Green Tea Fat Burner comes in a liquid soft-gel, and The Lifestyles Group's XLA come in liquid capsule form.

 

Endorsements and Testimonials

 

The challenger also maintained that Iovate claims that Accelis will deliver specific weight loss results through consumer representations (i.e., "Lost 32lbs;” "I lost 32 pounds-fast!”).  However, FTC regulations require that specific result claims and testimonials be backed by competent and reliable scientific evidence. It is not enough that the testimonial represents the actual experience of the consumer. The challenger made reference to the Dietary Supplements: An Advertising Guide for Industry publication which requires that the results presented in an advertisement be typical and representative of what the average consumer can expect to achieve. Thus, the challenger argued, unless Accelis has been the subject of a well-designed, double-blind, placebo-controlled, randomized human clinical trial demonstrating that these results will be typically received by the average consumer, the claims are inaccurate.

 

Lastly, the challenger contended that Iovate implicitly claims that Accelis is "doctor formulated" and "approved". It argued that, based upon Dr. Parkinson's endorsement, most consumers would assume that he has evaluated the scientific basis for the product and has no financial interest in the product. Unless it is established that Dr. Parkinson reviewed the science using acceptable scientific review standards and disclosed whether or not he has been remunerated for his endorsements, claims are not properly supported.

 

MARKETER'S POSITION

 

The marketer explained that Accelis is a weight loss support supplement that has been commercially available since March 2006 and was designed to be used as part of an individual's diet and exercise plan. The primary ingredient in Accelis is corosolic acid (3%).

The marketer noted that corosolic acid has been the subject of a number of well-designed studies, on both animals and humans, several of which were submitted to ERSP. For example, one study examined the anti-diabetic effect of corosolic acid. Other studies examined the effects of corosolic acid compounds in inhibiting glycogen phosphorylase and on post-challenge plasma glucose levels in humans.

 

1. Performance Claims

 

According to Iovate, corosolic acid (3%) the key ingredient in Accelis, was the subject of a well-designed clinical study that demonstrated a significant weight loss benefit. In this eight-week, randomized, double-blind, placebo-controlled clinical trial (i.e., “the Judy study"), corosolic acid (3%)(which is also found in a patented product on the market called Glucotrim) was evaluated on twenty healthy volunteers who were administered a portion-controlled, balanced diet. Dr. Judy found that subjects in the group who consumed the test ingredient lost significantly more weight than the subjects in the group who consumed the placebo -- 10.65 pounds versus 5.87 pounds, respectively.

 

Moreover, 50 percent of the subjects in the test group lost 10 or more pounds compared to only 20 percent of the control group. Forty (40)percent of subjects in the test group lost more than 15 pounds and 20 percent lost more than 20 pounds over the eight-week period. Importantly, the study was designed to ensure that both groups (those who consumed the corosolic acid ingredient and those who consumed the placebo), had the same diet regimes so that any difference between groups could be attributed to the corosolic acid treatment and could not be attributed to diet alone.

 

The marketer stated that, in evaluating claims about the efficacy and safety of dietary supplements, the FTC and the National Advertising Division ("NAD”) apply a substantiation standard of "competent and reliable scientific evidence. " The FTC has defined "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 i n the profession to yield accurate and reliable results. "

 

In providing this information, both the regulatory agencies and the self-regulatory forum have recognized that “(i)n the absence of direct testing on a product, an advertiser can make claims that are supported in the scientific community and are clearly limited to the ingredients, but must be careful to avoid making any express or implied product claims.”   Moreover, the First Amendment protects an advertiser's right to disseminate advertising claims about a product ingredient based on competent and reliable testing so long as the claims are truthful and accurate, the claims do not imply that the product, rather than an ingredient, was tested, and where the product does not include other ingredients that would negate the claim or pose a material safety risk.

 

The marketer stated that the specific claim "ACCELIS FACT: The key ingredient in Accelis can help you lose almost twice the weight" is a mathematical calculation of the average weight loss amounts achieved by study subjects in the Judy study. Iovate referred to a prior ERSP matter regarding advertising for the Hydroxycut dietary supplement, in which ERSP found this type of mathematical calculation to be supportive of a similar claim. More specifically, ERSP agreed "an advertiser can determine a numerical superiority claim via a raw mathematical calculation." By dividing the amount of weight loss in the treatment group by what was lost by the placebo group -- that is, 10.65 pounds divided by 5.87 pounds, Iovate arrived at "twice the weight."

 

The marketer further maintained that the other "performance" claims that reference the ability of Accelis to enable consumers to lose weight are also substantiated by the well-designed Judy study described earlier. Moreover, the references to "rapid, " "accelerated," and “fast-acting” weight loss within this claim category are also supported by the Judy study and are given appropriate context via the temporal description in the study statement. The study demonstrated that subjects can achieve significant weight loss compared to placebo in just eight weeks. In addition, Accelis delivers its tested ingredient quickly via a soft-gel technology, which facilitates the "fast" results that can be' achieved by consumers.

 

In addition, a separate clinical study conducted by Dr. Judy was submitted to ERSP which, according to Iovate, demonstrated that this soft-gel technology increases the bioavailability of corosolic acid, thereby enhancing the speed of absorption of this weight loss ingredient.

 

The marketer also maintained that this research demonstrates that the key ingredient in Accelis "goes to work immediately."  It was explained that, to ensure efficient absorption of this ingredient and to provide immediate effect, Accelis features an absorption-enhanced delivery system. The increased bioavailability and efficacy of the technology is supported by an independent clinical study in which the technology was tested against a dry-powdered filled hard gelatin capsule formulation.

 

The marketer also maintained that the efficacy of corosolic acid's rapid onset of activity in blood glucose control is also supported by a recent human clinical study, which demonstrated that corosolic acid had glucose lowering effects following an oral glucose tolerance test and reached statistical significance at 90 minutes.

 

According to Iovate, these studies support the quick action of the key component of Accelis, corosolic acid, in its highly absorbable delivery system. This unique dosage form facilitates increased bioavailability of corosolic acid thereby supporting the claim that Accelis "goes to work immediately."

 

In response to concerns about the marketer's adherence to the position on claims of "rapid weight loss,"  the marketer stated that it carefully qualified all claims that can be construed as "rapid" to provide a temporal element. More specifically, the copy explains to consumers exactly how much time passed during the Judy study before the average weight loss results were achieved by study subjects. The Judy study demonstrated that subjects can achieve significant weight loss compared to placebo in just eight weeks.

 

With respect to the opinion that consumers would not view approximately 1.3 pounds per week of weight loss as "rapid," Iovate stated that communicating this average weight loss along with the temporal element provides consumers with realistic expectations, advocates a modest amount of weight loss consistent with FTC principles, and provides consumers with the appropriate context in which to understand the meaning of "rapid" and similar terms.

 

2. Establishment Claims

 

Iovate informed ERSP that the Judy study referred to above was conducted by an 

independent, third party researcher, following scientific standards well-accepted in the 

scientific community. It was a randomized, double-blind, controlled and conducted at an independent research facility. Importantly, consumers were directed to take Accelis 

in the same manner in which study subjects consumed the primary ingredient in the 

product - that is, consumers are directed to take two capsules before going to bed.

 

According to the marketer, the challenger's assertion that "a review of the evidence in support of certain of the ingredients reveals that a 30 milligram serving is unlikely to facilitate weight loss" is erroneous. The amount of corosolic acid in each serving of Accelis, 24 mg, is the exact same amount that subjects consumed in the study conducted by Dr. Judy, which demonstrated significant weight loss results. Iovate explained that, although Accelis contains small amounts of six additional ingredients, the product is functionally 

equivalent to the test product in the Judy study. Iovate took appropriate measures to ensure that the six additional ingredients in Accelis are safe for consumers and do not diminish the efficacy of the corosolic acid (3%)or any other ingredient.

 

Iovate scientists and third-party researchers reviewed the relevant literature about each of the individual ingredients in the product, including reports on safety, toxicology, dose-response relationships in humans, and related epidemiological and meta-analytical studies.

 

Regarding questions pertaining to sample size, the marketer explained that the study was conducted on a population size that yielded statistically significant results in terms of weight loss. Thus, the smaller population size does not diminish the applicability of the results to the general population. Further, it was noted that the test subjects' Body Mass Indices ("BMI"), which was over 30, is representative of the U.S. population.

 

In response to questions involving the average weight loss difference between the treatment and placebo groups, Iovate stated that a statistical analysis of baseline data for both the treatment and placebo groups demonstrates that there were no significant difference between groups for body weight. At baseline, the body weights of the treatment and placebo groups were an average of 224.42 and 211.73 pounds, respectively.

 

Iovate added that an analysis of intra-group data for the treatment group demonstrated significant, favorable, directional changes in various parameters including a reduction in BMI, body surface area ("BSA"), percent body fat, body fat, circumferences of body segments, and other changes such as a reduction in cholesterol but noted that because the only significant change compared to placebo was weight loss, advertising claims for Accelis were limited to weight loss only. The lack of significance between groups on the other parameters does not alter the statistical significance of the weight loss results between the treatment and placebo groups, nor does it undermine them in any way.

Iovate maintained that, similarly, the challenger's assertion that the advertising claims for Accelis "lead consumers to believe that a study has been conducted on Accelis itself" is either immaterial (in that, for all intents and purposes, the Judy study did test Accelis), or is grossly inaccurate (in that it ignores the plain language of the advertising copy). As noted earlier, it has been accepted that  “(i)n the absence of direct testing on a product, an advertiser can make claims that are supported in the community and are clearly limited to the ingredients, but must be careful to avoid making any express or implied product claims."

 

According to Iovate the establishment claims identified by ERSP in the subject advertising expressly describe the performance of the primary ingredient, which was the subject of a well-designed clinical study. Iovate stated that its print advertising clearly and conspicuously informs consumers of the weight loss achieved by study subjects who consumed the primary ingredients as part of their diet and exercise plan. More specifically, the marketer stated that a prominent disclosure, which is provided in close proximity to the triggering claims, states as follows:

 

“In an 8-week study, subjects using the key ingredient (3% corosolic acid) in Accelis lost an average of 10.65 lbs., as compared to subjects using a placebo, who lost an average of only 5.87 lbs. Both groups followed a calorie-controlled diet.”

 

Iovate added that a prominent disclosure is also included in each of the four short form television spots which states:

 

“Avg. weight loss 10.65 lbs. with the key ingredient in Accelis^TM

 vs. 5.87 lbs. with placebo in an 8-week study. Both groups 

followed a calorie-controlled diet.”

 

In the instant case, the aforementioned establishment claims should be considered together with these clear and conspicuous disclosures.

 

Iovate noted that it is significant that it recommends that viewers incorporate an exercise program as well. The print advertising includes a clear and conspicuous disclaimer stating: "Regular exercise and proper nutrition are essential for achieving your weight loss goals" while the television advertising includes a clear and conspicuous disclaimer stating: "Use Accelis with diet and exercise." Thus, consumers are clearly informed of the weight loss results they can expect to achieve from the primary ingredient in Accelis along with a diet program (as opposed to through diet alone) and are also encouraged to use the product as part of an overall diet and exercise routine.

 

The marketer stated that these disclosures are equivalent in clarity and conspicuousness and similar in wording to the disclosures used by Iovate in advertising for another one of its products, Hydroxycut, which was previously reviewed and found to be adequately substantiated by the ERSP.

 

3.    Exclusivity Claims

 

As noted above, Accelis has been marketed by Iovate to consumers since March 2006. Prior to the product launch, Iovate stated that it considered the other competing dietary supplements available in the market and there was no other dietary supplement that provided the combined benefits of a corosolic acid-based weight loss formula delivered via soft gel technology.

 

Regarding the claim "Accelis is the first liquid weight-loss formula," Iovate
explained to ERSP that this claim appeared in error in a single instance on the Accelis web site and was removed during the pendancy of the inquiry and will not be used in future advertising. [This single claim was replaced with the correct text, Accelis is the world’s first patented soft gel technology with corosolic acid.”]

 

4.   Testimonial Claims

 

The marketer disagreed with the challenger’s assertion that the testimonials by Dr. Parkinson are the equivalent of "Doctor Recommended" claims. It again referred to review of Hydroxycut advertising, which included similar testimonials from two doctors, wherein this issue was not raised and the testimonials provided by those doctors were treated as exactly that -- testimonials. The marketer maintained that Dr. Parkinson’s statements should be evaluated pursuant to the Guides Concerning Use of Endorsements and Testimonials in Advertising.

 

Consumer Testimonials

 

The marketer argued that the claims, "Proven Results, " "Lost 32 lbs. " and "I lost 32 pounds fast" along with the other testimonials identified by the challenger are substantiated. In accordance with the Endorsement Guides these testimonials are from bona fide users and reflect these users' honest opinions, findings, beliefs, and experiences. To confirm that these results were true and accurate, Iovate obtained affidavits from these individuals attesting to their personal results in using this product along with a diet and exercise program.

 

Although the challenger maintained that the “FTC requires that the results presented in an advertisement be typical and representative of what the average consumer can expect to achieve” the marketer contended that this is an incomplete reading of the Endorsement Guide.

 

Iovate stated that by advertising the personal experiences of these consumers, it has complied with these principles. As demonstrated in the Judy study, the Accelis endorsers' experiences are representative of what consumers reasonably can expect to achieve with the advertised product. Although the overall average weight loss of test subjects in the Judy study was 10.65 pounds, 20 percent of these subjects achieved a weight loss of greater than 20 pounds over the course of eight weeks, which is approximately 2.5 pounds per week. The testimonialist who lost 32 pounds did so in 12 weeks, which is roughly 2.66 pounds per week.

 

In addition, the other testimonials identified by the challenger demonstrated weight loss of approximately 2 pounds per week (24 pounds in 12 weeks, 23 pounds in 12 weeks, and 11 pounds in 5 weeks), which is comparative to the 40 percent of test subjects in the Judy study that lost 15 pounds or more in eight weeks (approximately 1.9 pounds per week).

 

Importantly, the advertisements clearly disclose to consumers the average results that were achieved by test subjects in the Judy study. Finally, for purposes of further clarification that an individual's results necessarily will be different than the average (some will be better, some will be worse) the advertisements in question clearly disclose that "Results will vary."

 

Expert Testimonial

 

The marketer asserted that the testimonials provided by Dr. Parkinson in support of Accelis are also substantiated. Iovate stated that Dr. Parkinson's medical training qualifies him to endorse Accelis, and Iovate stated that Dr. Parkinson conducted an extensive review and evaluation of the substantiation in support of Accelis as well as a thorough examination of the product. Iovate provided an affidavit from Dr. Parkinson in support of this review, which details the scientific literature that he reviewed. The marketer stated that the claims identified by ERSP are reflective and representative of this evaluation.

 

ANALYSIS

 

1.   General Product Performance Claims

 

ERSP determined that Iovate's general weight loss claims were supported by the Judy study. The key ingredient in Accelis is 3%corosolic acid. In addition to providing several studies on the various benefits of corosolic acid (on blood glucose levels, for example), the weight loss efficacy of the ingredient was demonstrated in this eight week, randomized double blind, placebo controlled study of subjects following a controlled diet based on body weight.

 

At the end of the eight weeks, subjects in the treatment group who consumed the 3% corosolic acid lost significantly more weight than the subjects in the control group. More specifically, the treatment group lost 10.7 pounds versus the almost 6 pounds that the control group lost.

ERSP was satisfied that the study was well-designed to ensure that both the control and treatment groups had the same diet regimens so that any difference between groups could be attributed to the corosolic acid and not to the diet regimen of the test subjects. The marketer also provided ERSP with assurances (i.e., affirmations of medical experts) that the additional non-primary ingredients in Accelis will not compromise the effectiveness of the corosolic acid ingredient. As such, because the marketer has demonstrated that its 3% corosolic acid product will result in increased weight loss as compared to diet alone, ERSP did not object to claims of product performance such as claims of "accelerated" weight loss, particularly in the context of a "diet and exercise" regimen.

 

ERSP was more concerned with claims such as "Lose 10.65 pounds fast" and "rapid weight loss." One point of distinction between the characterization of "rapid" or “fast”  weight loss with "accelerated" weight loss is that the term "accelerated"

would be more readily understood by consumers as being comparative (i.e., versus diet and exercise alone) while the terms “fast” and "rapid," especially in an unqualified context, may be interpreted more categorically. More specifically, ERSP was concerned that the modest amount of weight loss obtained by subjects in the main study being relied on by the marketer (approximately1.3 pounds per week) may not be consistent with consumer expectation of "rapid weight loss." The fact that the diet and exercise regimens of the subjects may have significantly contributed to this weight loss would seem to add to the uncertainty of the claim.

 

Moreover, in the context of these claims of "rapid" and “fast” weight loss, ERSP
was also concerned of misinterpretation of the claim that Accelis "Goes to work immediately."  It is a fundamental principle of advertising law that a marketer has the burden to support any reasonable interpretation of its advertising claims. Accordingly, ERSP determined that it would not be unreasonable for consumers to understand the concept of Accelis "working immediately" (particularly when the word "immediate" is communicated in conjunction with terms "rapid" and "fast") to mean that the product would result in significant weight loss within at least the first day or so of using the product. However, the data provided by Iovate (i.e., he Judy study) could not support such a take-away.

 

Similarly, the FTC has looked upon claims of "rapid" weight loss with a great deal of consternation. In fact, the FTC addressed the issue of rapid weight loss claims in its 2002 "Weight Loss Advertising: An Analysis of Current Trends" publication. In discussing such claims, the Commission noted that “… such results are not only unlikely, they would be accomplished at great risk to health. Rapid weight loss has been associated with an increased risk of developing gallstones. Consequently, responsible programs that offer proven means of rapid weight loss for obese patients such as coronary artery disease or Type II diabetes provide physician supervision while patients are actively losing weight.

 

ERSP recognizes the inherent subjectivity of phrases such as "rapid" and "fast," and appreciates the position that any consumer confusion would be alleviated considerably when the claim is communicated in a temporal context. Accordingly, in general, ERSP discourages the use of claims of "rapid" and "fast" weight loss because it may create unreal expectations in the mind of consumers with respect to product performance. Should the claim be presented in the clear and conspicuous context of and in close proximity to a defined time element  (i.e., "In an 8 week study…”),  as it is in the the present advertising at issue, ERSP agrees that consumers have sufficient information about the term to reach their own conclusions regarding whether or not such weight loss in such a time period is indeed "fast" or "rapid.”

 

2.       Establishment Claims

 

Although ERSP concluded that the Judy study provided adequate support for claims of general product performance, ERSP was not persuaded that this study alone provided the necessary evidence to support claims that the product or the primary ingredient has been "clinically proven" especially in the context of "rapid" or "accelerated" weight loss.

As ERSP has noted in past direct response advertising inquiries, claims that a product or its ingredients have been "clinically proven" communicate a very strong message to consumers and support for such claims are scrutinized very closely. In fact, many regulatory agencies often require more than one study to support "clinically proven" claims. This is not to say that one study is never enough to support an establishment claim. However, an advertiser or marketer relying on one study to support such a claim has a very high evidentiary burden to demonstrate that the study is clinically meaningful, robust and reproducible. While the marketer was correct in asserting the statistical significance of the data accumulated from the Judy study, ERSP determined that the Judy study would not suffice as the sole support for a "clinically proven" claim for Accelis or its primary ingredient for several reasons, including: a) the treatment group consisted of only 10 subjects; c) the population was limited to individuals with a body mass index above 30; d) the average weight of the subjects in the placebo group was 15 pounds less than the average weight in the treatment group, e) considering that the subjects with a body mass index above 30 were put on a regulated diet there was a concern if the weight loss was attributable more to the diet than the corosolic acid; and f) there were no instructions given to the subjects regarding exercise. While ERSP understands the marketer's position that none of these criticisms, when observed alone, would definitively be considered a fatal flaw in the study, it was determined that, when viewed collectively, there was sufficient concern to conclude that there was not sufficient reliable indicia of “clinical proof” that is consistent with both consumer and industry expectation regarding use of the term.

 

As such, ERSP recommended that the marketer discontinue claims that the product and/or its primary ingredient has been "clinically proven" to perform.

 

Exclusivity Claims

 

During the pendancy of the review, the marketer represented to ERSP that the claim that "Accelis is the first  liquid weight-loss formula” appeared in error in a single instance in the advertising and would not be used in the future.

 

While ERSP agrees with Iovate that its soft-gel technology is advantageous and unlike most other corosolic acid weight loss products the market, it was concluded that the claims at issue that position Accelis as the "only" soft- gel, corosolic acid based product could not be supported.

 

For example, it was confirmed a competitive 3% corosolic acid product, is also available in soft-gel and had been introduced into the market before Accelis.  As such, ERSP recommended that the marketer discontinue its claim (and similar statements).

 

Testimonial and Endorsement Claims

 

Although the challenger maintained that the claims of Dr. Parkinson could be considered a "doctors' recommendation" claim, ERSP did not agree. In the various forms of advertising at issue, it was clear that Dr. Parkinson was endorsing Accelis in his individual capacity and, in the absence of evidence indicating otherwise, ERSP did not believe that consumers would reasonably take away the message that Accelis was being recommended, collectively, by the medical community.

 

Regarding the endorsement of Dr. Parkinson, section 16 CFR 255.3 (B) of the FTC Guides concerning the Use of Endorsements and Testimonials in Advertising states that:

 

"Where, and to the extent that, the advertisement implies that the endorsement was based upon a comparison such comparison must have been included in his evaluation; and as a result of such comparison, he must have concluded with respect to those features on which he is expert and which are relevant and available to an ordinary consumer, the endorsed product is at least equal overall to the competitors' products."

 

Iovate submitted an affidavit from Dr. Parkinson to ERSP in support of his endorsement. In the affidavit, Dr. Parkinson confirms that he reviewed the research submitted by the marketer and the statements he makes in the commercial are factually accurate and reflect his honest opinions, findings and experiences.

 

As a result of his affirmation, ERSP did not object to the endorsement by Dr Parkinson.

 

Consumer testimonials

 

The advertising also included three consumer testimonials. In one, Nacia Barrett claims to have "lost 11 pounds in 5 weeks."  In another, Nicole Rueben states that she "lost 24 pounds and 6 inches of her waist" and, lastly, Mike Misola states that he
"lost 32 pounds and 6 inches of his waist."

 

As ERSP has noted in several recent dietary supplement reviews, section 255 of the FTC Endorsement Guides states that "unless the advertiser possesses and relies upon adequate substantiation for this representation, the advertisement should either clearly and conspicuously disclose what the generally expected would be in
the depicted circumstances or clearly and conspicuously disclose the limited applicability of the endorser's experience to what consumers may generally expect to achieve."

 

ERSP notes that though the Judy study does not provide adequate substantiation for these results, each testimonial (with a few isolated exceptions) in each form of advertising contains three important disclosures:1) "Individual results may vary"; 2) the weight loss was combined with diet and exercise and 3) "In an 8 week study subjects using the key ingredient (3 % corosolic acid) in Accelis an average of 20.65 pounds, as compared to subjects using a placebo, who lost an average of only 5.87 pounds.”

 

Accordingly, ERSP determined that the consumer claims were sufficient so long as the consumer testimonials are accompanied (clearly and conspicuously and in close proximity) with these three important disclosures in all of its advertising.

 

CONCLUSION

 

ERSP determined that general weight loss claims were supported by the eight-week, randomized, double blind, placebo controlled study of subjects following a controlled diet based on body weight. ERSP expressed its concerns 

 

with the marketer using unqualified "rapid" and “fast” weight loss claims, and concluded that it would not be unreasonable for consumers to understand the concept of Accelis "working immediately" to mean that the product would result in significant weight loss within at least the first few days or so of using the product and that the data provided by Iovate could not support such a take-away. ERSP was also not persuaded that the one study alone provided the necessary evidence to support claims that the product or the primary ingredient has been "clinically proven."

 

In addition, while it was concluded that the claims at issue which position Accelis as the only corosolic acid based product could not be supported.

 

Lastly ERSP did not object to the endorsement of Dr. Parkinson and or consider it a "doctors' recommendation" claim and determined that the consumer testimonials used in the advertising were sufficient so long as they are accompanied with the necessary disclosures.

 

MARKETER’S  STATEMENT

 

“Iovate appreciates ERSP's careful consideration of the relevant science and its conclusion that the principal weight loss claims for Accelis are substantiated by competent and reliable scientific evidence.  Iovate will closely consider ERSP's recommendations on the secondary claims and changes to future advertising that are consistent with this decision.”

 

Copyright 2006. Council of Better Business Bureaus, Inc.