ERSP Decision: Cylaris Weight-Loss Supplement

 IOVATE HEATH SCIENCES INTERNATIONAL, INC.

Cylaris Weight-Loss Supplement

 

BASIS OF INQUIRY

 

Direct response advertising for the Cylaris weight-loss supplement (“Cylaris”), manufactured by Iovate Health Sciences International, Inc., (“Iovate”) was brought to the attention of the Electronic Retailing Self-Regulation Program (“”ERSP”) by WellNx Life Sciences (“WellNx”), a manufacturer of competing weight loss supplements. ERSP identified the group of core claims stated below (accompanied by representative claims) as the basis of inquiry:

 

Establishment Claims

 

“Introducing new Cylaris, a clinical breakthrough that can help you lose a significant amount of weight”; “A new clinical breakthrough”;  “The new standard in clinical-strength weight loss has been set”

 “Clinical studies show that Cylaris can help you lose up to 32 pounds in 8 weeks.”

“Lose 287% the weight compared to placebo” 

“In one 8-week clinical study, participants who used Cylaris lost an average of 14.52 lbs., whereas those in the placebo group only lost an average of 5.06 lbs. In the same study, 10 percent of subjects lost up to 32.78 lbs. in 8 weeks.”

 “In the same study measuring changes in percent body fat and BMI (body mass index), the results showed noticeable decreases for these anthropomorphic measures. If Cylaris can work this well on its own, just imagine how much weight you could lose if you also paired it with a healthy diet and exercise plan!”

“Cylaris is supported by an 8-week research study . This study showed a significant decrease in subjects' weight loss as well as decreases in body fat percentage and BMI, regardless of a calorie-controlled diet.”

 

Performance Claims

 

“Lose up to 32 lbs. in 8 Weeks!”

“Supports Healthy Cholesterol Levels”

3.   Superiority Claims

 

“Cylaris - World's Strongest Weight-loss Formula”

“Clinical breakthroughs of this magnitude and scope do not happen regularly, which is why Cylaris is undoubtedly the best weight-loss product on the market today.”

“No other product on the market can deliver the same results due to Cylaris' unique proprietary formula.”

 

CHALLENGER’S POSITION

 

Establishment Claims

 

WellNx argued that the information provided on the website about the science behind Cylaris is deceptive. According to the challenger, Iovate also does not cite to any competent and reliable scientific evidence to support any of their claims, in contravention of the FTC requirements, For example. WellNx maintained that there is a vast amount of information lacking on the parameters of the clinical study cited.  No information was provided concerning the number of participants in the study, the age of the participants, or whether the participants were male or female or a combination of both. According to the challenger, Iovate also did not point out the health status of the subjects involved in this study (i.e. whether they were obese/overweight).  

 

WellNx stated that based on some of the claims being made by Iovate, consumers may also assume that a medical doctor has evaluated the scientific basis for the safety and efficacy of the product.  It has been noted in past ERSP cases that the opinions and expertise of doctors are given great weight by consumers in their evaluations of products or advertisements due to their expertise on health related matters.  If Cylaris has been “Doctor-Researched, Formulated and Approved”, Iovate has provided no proof that such a review of safety and efficacy exists.  Iovate neither demonstrated the basis of this claim, nor did they provide qualifying information to the consumer as to the credentials of the doctor cited.   

 

WellNx also contended that the term “clinical breakthrough” is being used incorrectly in Iovate’s advertising for Cylaris.  According to the challenger, the clinical breakthrough was based on only one clinical trial performed on Cylaris which contained a multitude of design flaws. Also, this study was published in an on-line journal that was purportedly peer reviewed and available without subscription or payment for individual papers. In terms of design, the challenger  maintained that the study was performed on both obese and overweight individuals without proper blinded controls in each group. The trial was performed mainly on morbidly obese West Africans whose BMI exceeded 30, and whose weight exceeded 200lbs. at the onset of the study.   The placebo group was obese, there was no overweight placebo group, and, furthermore, the overweight group was used for general comparison with the obese groups.   The challenger also contended that data for this study showed extremely high standard deviations and all data is shown as percentage change rather than being expressed in absolute terms, implying that the researchers needed to transform the data drastically in order to reach levels of significance.  

 

The challenger maintained that the advertising does not point out that the individuals who lost this weight were morbidly obese with waist circumferences up to 142cm and bodyweights up to approximately 300lbs.  Even after the 8 weeks of weight-loss, the average obese individual would still weigh approximately 195 lbs. The placebo group (who were classified as obese) lost 5.06 and the obese group receiving Cylaris lost 14.52.  There is a difference of 9.46lbs between these groups, and not stating this directly in advertisement is deceptive.  WellNx argued that bodyweight fluctuations between 5 and 10lbs. are not unusual over an 8 week period for obese individuals.  The challenger argued that withholding this sort of information concerning the health status of subjects, along with not disclosing certain information concerning exact amount of weight loss, is inaccurate.

 

The challenger questioned the assertion of Iovate that Cylaris was formulated by Dr. Marvin Heuer, the chief scientific advisor for Iovate Health Sciences Inc. WellNx made this assertion based upon the marketer’s representation that the Cissus quandrangularis extract (“Cissus”) and soy albumin are provided by Gateway Health Alliances (GHA), although the marketer also maintained that the “The Cissus clinical studies were conducted prior to Iovate’s contact with GHA…”.  Thus, the challenger asked, if Cylaris was actually formulated by Dr. Heuer, then it is unclear how the clinical trial was conducted on a product with the exact ingredient combination (other than caffeine) prior to Iovate’s involvement with GHA—the supplier of two key ingredients. The Cissus studies were performed by Dr. Julius Oben, which leads a reasonable person to believe that it was either Dr. Oben or GHA who came up with the Cylaris blend used in the study.

 

Moreover, WellNx noted that the methods outlined in product formula study  (“Study 1”) state that subjects were given two daily 514 mg doses of the Cylaris formula (excluding caffeine which was added to the commercially available Cylaris).  The Supplement Facts panel for Cylaris states that each serving (2 caplets) contains 522mg of the proprietary weight loss blend (including caffeine).  This difference only leaves a total of 8mg for the addition of caffeine in the commercially available Cylaris product compared to the Cylaris used in the Study 1.  Caffeine is the first ingredient listed on the Supplement Facts panel under the “Weight Loss Proprietary Blend” for the commercially available product, which means that it is included at a greater quantity than all other ingredients in that blend.   Iovate has already stated that each serving of Cylaris supplies 150mg of Cissus, and Cissus is listed directly below caffeine on the Supplement Facts panel.  This means that caffeine must be included at a rate greater than 150mg/serving, although there is only a weight difference of 8mg between the Cylaris used in the Cissus Formula study and the commercially available Cylaris.  WellNx maintained that this discrepancy was not fully explained by Iovate, and indicates that the key ingredient combination in the commercially available Cylaris is not the same as the combination used in Study 1.  

 

The challenger raised several criticisms (including both design flaws and conflicts of interest) regarding the Iovate research. More specifically, WellNx called ERSP’s attention to the fact that Julius Oben, the primary author on the two Cissus studies, has a financial interest in the success of these studies as a patent holder on Cissus quadrangularis, the primary ingredient in Cylaris. The challenger also informed ERSP that studies were published only in an online journal and its description as a “peer reviewed journal” is highly circumspect due to its anonymous, on-line submission of potential peer reviewers, the significant processing fee and the relatively short time (i.e., 50 days) between submission to a journal and publication. 

 

With respect to significant design flaws in the study, WellNx noted that:

 

all the subjects included in the Study 1 are West African which differ from Cylaris’ North American consumer.  Iovate cannot supply assume that the Cissus formulation would initiate the same results in a North American subject base. 

the weight of the obese subjects in Study 1 is significantly higher than the average North American consumer. The average baseline weight is over 200 lbs in Study 1.

the placebo group used was classified as obese, and had a higher standard deviation with respect to weight (approximately 31 lbs.) when compared to the formulation groups (17.6 lbs and 20 lbs.).  

the placebo group also had a lower fat percentage than the other groups, thereby possibly confounding the study results.  The researchers do not mention if the differences reached statistical significance, and only noted that “…none of the baseline differences between the groups was clinically significant.”  

there was no exercise control either limiting activity or prescribing a specific regimen. Without controlling for exercise, it becomes possible to manipulate the study’s results and it is generally accepted by experts that it is impossible to determine the effectiveness of the weight loss formula versus the exercise.

 

the lack of clinical assessment methods to monitor the type and amount of food consumed results in difficulty determining the effectiveness of the supplement.

 

the magnitude of weight loss indicated in the study is unlikely to occur without exercise because of the restricted diet in the Cissus calories formulation group of to 2100-2200 calories/day which is incompatible with calorie differential required for weight loss.  Furthermore, Study 1 did not report the baseline caloric intake of the subjects, nor was it an inclusion factor for this study.  Therefore, it is impossible to know if the so called “calorie reduced” diet was indeed calorie reduced for the subjects in this study.

the treatment formula used in Study 1 reveals that it does not contain a sufficient amount of caffeine or EGCGs to have a significant thermogenic effect at the prescribed dose.  

 

the BMI of obese test subjects presented an extremely large range in weight loss. The challenger also contended that the BMI of test subjects should have been disclosed in the advertising. 

 

2. Performance Claims

 

WellNx contended that Iovate is inaccurately claiming that by taking Cylaris, consumers can rapidly lose substantial amounts of weight (up to 32 pounds in eight weeks); that its product is stronger than any other weight-loss formula on the planet; and that there is appropriate clinical and scientific evidence to support these representations.  According to its website, Iovate markets its Cylaris product in caplet form, and the product contains the following ingredients in its weight loss blend: caffeine anhydrous, Cissus quadrangularis extract, green tea extract, and soy albumin extract. The Supplement Facts also show the percent Daily Value of Vitamin B6, Folic Acid, Vitamin B12, Selenium, and Chromium.

 

According to the challenger, more specifically, the advertisement for Cylaris implies that users can lose vast amounts of weight without the help of diet or exercise.  WellNx stated that Iovate is implying that the changes in bodyweight reported were the result of taking Cylaris alone, a fact demonstrated by additional language in the advertisement stating “…just imagine how much weight you could lose if you also paired it with a healthy diet and exercise plan!”  

 

According to the challenger, these claims clearly exceed the criteria referred to by the Federal Trade Commission (“FTC”) in its Red Flag – Bogus Weight Loss Claims guide, as the product causes weight loss of greater than two-pounds per week for more than a month without dieting or exercise.  WellNx argued that Iovate inconspicuously stated in its disclaimer that “Regular exercise and proper nutrition are essential for achieving your weight-loss goals” however, they have not disclosed that “regular exercise and proper nutrition” are essential for Cylaris to be effective; nor have they demonstrated that Cylaris plus diet and exercise, were more effective than diet and exercise alone.  

 

The challenger also maintained that the disclaimer statement that “In the same study, 10% of subjects lost up to 32.78 lbs in 8 weeks” is meaningless as the data to which they refer could be one individual whom presumably lost 32.78 lbs and has been grouped in the top 10th percentile, rather than the average or minimal result of the top 90th percentile.  WellNx contended that this is deceptive to consumers who may interpret this statement to mean that 10% of study subjects lost 30 lbs or more, rather than one individual whom presumably lost the unusually high amount of 32.78 lbs.  The challenger noted that Iovate does not cite to any competent and reliable scientific evidence that the average consumer would expect as support for these claims nor has it indicated that this result is typical.

 

WellNx informed ERSP that the FTC requires that the results presented in an advertisement be typical and representative of what the average consumer can expect to achieve.  Although Iovate provided an “average of 14.52 lbs.” weight-loss in subjects using the key ingredient, it failed to clearly and prominently disclose all of the qualifying conditions under which these subjects achieved their results, including whether or not diet and exercise were used in conjunction with Cylaris. Furthermore, even if a highly scrutinizing consumer were to interpret this advertisement as meaning that the weight-loss results were achieved in conjunction with “regular exercise and proper nutrition”, these claims would still be considered “too good to be true” according to the FTC, as they infer that consumers can safely lose more than 3 lbs per week for a period of greater than 4 weeks – a Red Flag claim.  In this regard, Iovate is clearly disseminating misleading “Red Flag” claims that are not only false and deceptive, but also pose a health risk to consumers taking Cylaris. The challenger asserted that Iovate has provided no data to support these claims, and requested that these claims be discontinued.

 

WellNx called ERSP’s attention to the fact that Iovate has stated that Cissus quadrangularis has never before been studied in the context of weight loss.  Traditionally, Cissus quadrangularis is used for the treatment of bone fractures, gastric ulcers and other ailments that have nothing to do with weight loss.  Cissus quadrangularis was not studied as a component of a dietary supplement, however, Iovate is heralding Cissus quadrangularis as an outstanding new tool for weight loss.  There is only the one aforementioned study which shows that a blend of products including Cissus quadrangularis results in weight loss.  The challenger asserted that the study using Cylaris as the supplement is not sufficient scientific evidence that weight loss was indeed a direct effect of the Cissus quadrangularis as there are a number of other ingredients in Cylaris. 

 

As such, the challenger stated that until a randomized, placebo-controlled, double blinded study is performed on the direct effect of Cissus quadrangularis on weight loss, it is inaccurate to advertise that it is the new breakthrough in weight loss as it may not have been at all involved in the perceived weight loss in the single study cited.  The challenger maintained that scientific substantiation for the mechanism of action for the other constituents of Cylaris should also be provided, otherwise these claims are misleading and should be removed from advertising.

 

The challenger also pointed to contradictory statements made by Iovate during the challenge, more specifically that it “… does not base its weight loss claims on the presence of Cissus alone.  Rather, Iovate bases its claims for Cylaris on the ingredients studied in the Cissus Formula Study, which match exactly the key ingredients in the Cylaris formula.”  However, in contrast to this statement, Iovate later goes onto to state that “... all of the Cylaris weight loss claims are expressly based on Cissus as the key ingredient, in the exact concentrations studied in the clinical trial.  Iovate does not make any performance claims on the basis of the supporting ingredients, such as caffeine”. According to WellNx, these two statements are incompatible. 

 

If the claims were, in fact, based solely on the inclusion of the “key ingredients” as used in Study 1, a reasonable consumer would think that there would be no added benefit or need to include caffeine in the formula, let alone to include it at the highest weight amount and have it listed as the first ingredient under the heading of “Proprietary Weight Loss Blend”.  The challenger contended that there has been no direct scientific study which measures the weight loss effects of Cissus and caffeine under the same parameters, therefore stating that the statement that Cissus is the primary weight loss ingredient in Cylaris is erroneous.

 

WellNx also noted that the green tea used in Study1 is not standardized for active ingredients in the same manner as the green tea used in the commercially available Cylaris.  Study 1 clearly indicates that the green tea was standardized for 22% EGCG and 40% caffeine, whereas the Supplement Facts Panel for Cylaris reveals that the green tea in the product is standardized for 90% polyphenols and 45% EGCG with no mention of standardization for caffeine.  Therefore, the challenger contended, the statements that Iovate continually makes throughout the Cylaris report such as “…Cissus formulation also included green tea, soy albumin, chromium polynicotinate, selenium, B-vitamins—the exact amounts of which also appear in the Cylaris product” are inconsistent.

 

Furthermore, according to WellNx, Iovate’s statement that it’s “up to” claim is substantiated based on the percentage of individuals quoted (10%) is misleading. This percentage, in fact, only equates to 3 individuals as the Cissus formulation/no diet group consisted of 31 individuals.  Weight loss of this magnitude in only 3 subjects does not represent “an appreciable number of consumers” nor is it “under circumstances normally and expectably encountered by consumers.” WellNx referred to the FTC’s cautions in similar cases where it noted that “the advertised result should be one that the average consumer can reasonably expect to achieve.”  

 

3.    Superiority Claims

 

WellNx maintained that Iovate expressly claims that its Cylaris product is superior to all other dietary supplements on the market. It noted that the FTC evaluates comparative advertising in the same manner as it evaluates all other advertising, requiring that an advertiser possess competent and reliable scientific evidence to support any claims. The challenger objected because Iovate does not cite to any competent and reliable scientific evidence to support any of its claims, and, thus, does not meet the FTC requirement.  WellNx noted that Iovate also used the same weight loss amount and percentage claims to advertise its RapidSlim SX product as the “World’s fastest weight loss solution”.  It maintained that advertising these products with identical claims of expected results and calling one of them “World’s Strongest” and one of them “World’s Fastest” is also confusing to consumers and creates ambiguity in the marketplace. Therefore, the lack of competent and reliable scientific evidence results in all-inclusive superlative claims such as Cylaris being the “World’s Strongest weight-loss Formula” is false and misleading, and therefore should be discontinued.  

 

WellNx informed ERSP that there are a number of other weight loss products on the market with the same complex of “key ingredients” on which these claims are said to be based. There are at least 5 competing products on the market that contain the same “key ingredients” as found in Cylaris, including Iovate’s own RapidSlim product along with the SoyLabs CardioTrim products including a Women’s formula, Men’s Formula, Active Formula, and Diabetic formula. Accordingly, the failure of the marketer to conduct a comparative analysis of these products would render its superiority claim unsupported.

 

MARKETER’S POSITION

 

The marketer explained that Cylaris is a dietary supplement designed to help consumers reach their weight loss goals in conjunction with a healthy lifestyle. The product includes a number of essential vitamins and a specially formulated, proprietary weight loss blend. 

 

The marketer maintained that all claims about Cylaris are substantiated by competent and reliable scientific evidence demonstrating the product’s efficacy. The primary ingredient in the Cylaris weight loss formula is Cissus quadrangularis, which has been the subject of multiple clinical trials over the last 50 years. Iovate submitted two published, peer reviewed studies, in particular, which it maintained demonstrated the efficacy of Cissus in reducing body fat, weight loss and supporting healthy cholesterol levels.

 

Establishment and Performance Claims

 

The marketer stated that Cylaris is formulated with a clinically-tested and proven weight loss ingredient, Cissus, that has also been proven effective as part of a formula containing green tea, soy albumin, chromium polynicotinate, selenium, B-vitamins. According to Iovate, studies on Cissus show that consumers may safely and effectively lose weight based upon the action of the product’s clinically proven ingredient.

 

Iovate maintained that the establishment clams for Cylaris are supported by two published, peer reviewed studies. More specifically, in Study 1, 123 subjects were divided into 3 groups: 31 subjects were placed on a 2100-2200 kilocalorie per day diet and treated daily with 1028 mg of a formula containing Cissus; Two groups each comprising 31 subjects who ingested the Cissus formula and maintained normal eating habits; and 30 subjects who ingested a placebo. The results demonstrated a statistically significant net reduction in weight and body fat in each group, including the group that did not restrict their diet. 

 

The marketer also stated that Study 1 supported the claim that Cylaris helps support healthy a cholesterol level. The study showed a statistically significant  result in improved blood cholesterol. More specifically, the group that ingested the Cissus formula (without dietary restrictions) lost an average of 14.52 lbs, while the placebo group following the same protocol lost 5.06 lbs. Additionally, Iovate informed ERSP that the study also showed significant (i.e., 50.5%) increases among the Cissus formula-treated subjects in (good) HDL cholesterol levels and decreases (i.e., 18.4%) in LDL (bad) cholesterol. Total cholesterol was also reduced by 27 percent in the Cissus group versus a 3.1% decrease in placebo. These percentage values reflect the change from baseline (week 0) to the end of the study period (Week 8).

 

The marketer noted that in the same study, 10% of the subjects lost up to 32.78 pounds over 8 weeks. The data is statistically significant  and demonstrated the effectiveness of the product ingredient. Iovate also referred to previous NARC cases stating that if an advertiser uses a percentage claim, it must continue to emphasize the specific study results in conjunction with that claim in a manner that will ensure that reasonable consumers do not misunderstand the product’s expected performance. Accordingly, Iovate discloses the percentage of subjects that that lost up to 32.78 lbs. in just 8 weeks. These cases have also noted that the FTC has held that claims involving the phrase “up to” require that the maximum level of performance claimed can be achieved by an appreciable number of consumers under circumstances normally and expectably encountered by consumers.

 

Study 2 was a six-week randomized, double-blind, placebo controlled study. 68 subjects were divided into a placebo group and a group that ingested 300 mg of the Cissus daily ingredient. The mean weight loss in the formula-treated group was 10.56 pounds (with a reduction in body fat percentage and body mass index); the placebo group experienced a mean weight gain of 2.64 pounds. Similar to the results of Study 1, Study 2 also showed significant increases among the Cissus formula-treated subjects in (good) HDL cholesterol levels and decreases in (bad) LDL cholesterol.

 

Contrary to the challenger’s suggestions, the marketer stated that the identical amount of active chromium (as Chromate) appears in the commercially available product as was tested in the study. Iovate also confirmed that while the milligram amount and concentration percentage of green tea appears to differ, they are standardized to identically match the amount of the active compound EGCG from the study to the product. 

 

The marketer noted that despite including Cissus at a dosage shown to provide weight loss benefits, Iovate does not base its weight loss claims on the presence of Cissus alone.  Rather, Iovate bases its claims for Cylaris on the ingredients studied in the Cissus formula which matches the key ingredients in the formula. Iovate added that a discussion of the results of Study 1 is clearly communicated to consumers on the current Cylaris label.

 

With respect to the challenger’s argument that Iovate should be precluded from making weight loss efficacy claims for Cylaris on the basis of Study 2 because Iovate has used that study as substantiation for a different product (i.e., RapidSlim ) formulated with the same ingredient, the marketer contended that such an argument is untenable. The Cylaris formula contains Cissus in the same concentration and dosage as the amount studied in the clinical trial and it is clearly disclosed that the clinical trial used in support of the claims was performed on a key ingredient in Cylaris, as opposed to the entire product “matrix.” It added that ERSP has found weight loss claims made for two different products with same principal ingredients to be acceptable.

 

Iovate also addressed the allegation of WellNx that Dr. Heuer could not have been the developer of Cylaris because the clinical trial was conducted on a product with the exact ingredient combination (other than caffeine) prior to Iovate’s involvement with GHA—the supplier of two key ingredients. The marketer responded by noting that Dr. Heuer reviewed the published, peer-reviewed research and additionally, pursuant to his independent review of the substantiation for the individual ingredients, he developed the commercially available product that is Cylaris. The marketer clarified its position by noting that Cylaris is a combination of the clinical ingredients in Study 1, as well as additional supporting ingredients included as part of Dr. Heuer’s formulation effort.

 

The marketer also disputed any conflict of interest between the author of Study 1 and the owners of the Cylaris formula (which license the formula exclusively to Iovate) and objected to the challenger’s suggestion that the disclosure of such information was relevant or material to consumers.

 

Caffeine Promotes Thermogenic Effects

 

According to Iovate, clinical trials have generally indicated that caffeine is well tolerated and produces no adverse effects in adults. Cylaris contains 200 mg of caffeine per serving. The marketer cited to a study of 300 mg of encapsulated caffeine on exercise trained individuals versus untrained individuals which showed significant increases from baseline in both groups. 

 

Iovate also referred to a double-blind placebo-controlled trial in which 3 different doses of caffeine (100 mg, 200 mg, 300 mg) were administered to examine its thermogenic effects. According to the indirect calorimetric measurements, a 100 mg dose of caffeine significantly increased thermogenesis above the placebo.

 

Polynicotinate Promotes Weight Loss 

 

The marketer explained that chromium is an essential dietary mineral and is primarily utilized in the maintenance of carbohydrate and lipid metabolism. Cylaris contains 150 units of elemental chromium per serving (300 units in a daily serving). Iovate maintained that its studies demonstrate chromium’s role in weight loss and cited to one study in which 43 subjects were divided into 4 groups. The group of subjects consuming 400 units of chromium polynicotinate per day showed a significant reduction in body weight and insulin at various time points as compared to subjects consuming a placebo.

 

The marketer added that in thirty years of studies on chromium (of up to 1 mg per day), there have been no documented signs of chromium toxicity. 

 

In responding to the criticisms of WellNx, the marketer noted that it has provided a detailed explanation of the conclusions reached in the two main studies with regard to their effects on weight loss. It maintained that WellNx’s argument that Cissus wasn’t studied alone is false and disregards the conclusions reached by the authors in Study 2.  

 

The marketer also emphasized that Study 1 conformed to the preferred scientific protocol of randomization, double-blinding and placebo controls in clinical trial design. The marketer maintained that the size and duration of the study not only meet conventional weight loss study parameters, but it exceeds them. Despite the focus of the challenger on the average baseline of the participating subjects, Iovate noted that Study 1 was designed to test the efficacy of a weight loss ingredient for an appropriate population, which will necessarily consist of exclusively overweight individuals. 

 

In rebuttal to the criticism of Iovate’s peer reviewed study, the marketer asserted that the Journal in which the study appeared is an open access, peer reviewed, online journal that publishes articles on all aspects of lipids, including a synthesis of new lipid compounds and their role in health and disease.

 

Finally, Iovate disputed the challenger’s allegation that it deliberately failed to disclose that its testing was conducted on obese as well as overweight individuals, noting that the Food and Drug Administration (“FDA”) specifically caution dietary supplement manufacturers from implying that a dietary supplement can treat obesity, which the FDA recognizes as a disease.

 

2. Superiority  Claims

 

Iovate stated that before introducing Cylaris, it conducted a comprehensive “Product Comparison Market Analysis” of claims made by all other leading manufacturers of weight loss supplements, as well as the substantiation cited in support of these claims. According to Iovate, this Analysis, which was provided to ERSP along with all relevant back-up materials, demonstrated that there is no publicly available data cited by any other manufacturer that shows a stronger weight loss supplement than Cylaris.  Iovate asserted that the Analysis was comprehensive, and accounted for all leading weight loss supplements that make up more than 90 percent of total sales in the weight loss supplement market. It added that the challenger has not identified a single clinical study offered in support of any competitive products that disprove the marketer’s claims.

 

In addition, Iovate utilizes a disclosure in all advertising for Cylaris stating that “In reviewing all available public research on other diet products, the results support the remarkable conclusion that there is no other weight loss supplement available stronger than Cylaris.”  Because no other competitive product on the market contains the ingredients evaluated in Study 1, and is marketed for weight loss, and because the disclosure qualified that the claim is based upon publicly available data, the marketer maintained that the claim is accurate and substantiated. 

 

Iovate stated that the fact that Cylaris contains the same key ingredient as other Iovate products (i.e., RapidSlim) in no way detracts from their exclusivity and superiority claims. Both products rely on the same study for their core claims but each is positioned independently on the market. 

 

The marketer noted that the comparative sources submitted by WellNx to refute Iovate’s superiority claims were below the average weight loss reported in the two main studies it relies on. The challenger’s argument that the marketer’s claims are unsubstantiated because another manufacturer also uses Cissus for three products was also characterized as unfounded because, unlike Cylaris, those products are marketed to retirement communities and not the general public.

 

ANALYSIS

 

Iovate explained to ERSP that the primary ingredient in Cylaris (i.e., Cissus qudrangularis) is the same primary ingredient found in RapidSlim (a companion weight loss supplement marketed by Iovate) and that the ingredient’s presence in the two products in the form of the proprietary weight loss blends is identical. The only difference between Cylaris and RapidSlim is that RapidSlim contains trace amounts of three other tea extracts as well as white pepper powder, hoodia, and white willow extract. 

 

ERSP notes that a recent inquiry involving RapidSlim brought by WellNx included many of the same (or similar) claims at issue in this matter. The marketer also relied on the same testing to support it claims for Cylaris as it did for RapidSlim.  In so much as ERSP has already evaluated the adequacy of Iovate’s two tests in the RapidSlim inquiry, when applicable, we will simply refer to our relevant determination in that inquiry in order to avoid being duplicative in our analysis.

 

Establishment Claims

 

In the RapidSlim decision, ERSP commented on the prevalence of “doctor formulated,” “scientific breakthrough,” and similar types of claims in the dietary supplement industry, and noted that Iovate used these types of claims throughout its advertising, in varying contexts. In advertising for Cylaris, claims are disseminated in the context of the product being “doctor researched, formulated and approved” and that Cylaris represents a “clinical breakthrough.”

 

In the RapidSlim inquiry, ERSP agreed with Iovate that in the advertised context, it was not inappropriate for the marketer to describe the product as a “scientific breakthrough.”  It was also noted that it can be difficult to evaluate what messages consumers are taking away from these claims in the absence of consumer perception data. ERSP made reference to the dictionary meaning of  “breakthrough” as “any significant or sudden advance, development, achievement, or increase, as in scientific knowledge” and determined that the combined proprietary blend of ingredients in RapidSlim was unlike any other product currently on the market that leads to quantifiable weight loss. In this context, ERSP agreed that use of the term “scientific breakthrough” was not inappropriate. In the subject inquiry, ERSP determined that the substitution of the word “clinical” for “scientific” was of little distinction to consumers in their interpretation of the “breakthrough” claim.

 

ERSP also previously determined that the consumer take-away of the claim that RapidSlim is “Doctor formulated” may be difficult to establish. The marketer indicated that Dr. Marvin Heuer developed the RapidSlim (and, in this case, the Cylaris formula) by reviewing the results of the research on Cissus  quadrangularis. Thus, in a literal context, RapidSlim and Cylaris were both, in fact, formulated a by a doctor and the “doctor formulated” claim is not inaccurate. As such, ERSP sees no reason to conclude differently in this challenge.

 

However, ERSP believes that the claim that Cylaris is “Doctor approved” as disseminated on the product packaging and in the context of certain print advertisements was more problematic. Although ERSP was not persuaded by WellNx’ contention in RapidSlim that a “doctor formulated” claim could be interpreted analogously with a “Doctor recommended” claim, with regard to a “doctor approved” claim, ERSP noted that this interpretation (in certain advertised contexts) may be more tenable.

 

First, with respect to product packaging, the claim “Doctor researched, formulated and approved” appears prominently on the face of the package and, on some versions of packaging, is accompanied by a small triangular reference symbol. However, the triangular reference symbol is displayed in two different contexts on the side panels of the Cylaris product packaging. In one context, this symbol directs consumers to the DSHEA disclaimer that “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat cure, or prevent any disease.” The disclosure in this context does not appear relevant to the Doctor researched, formulated and approved” claim. However, in the second (and separate) disclosure, the assessment of Dr. Richard Margolin (who also appears in various contexts in almost all of the advertising for Cylaris) is referenced and his statement is directly pertinent to the “doctor approved” claim upon which the marker bases the "doctor approved" claim. Accordingly, ERSP recommends that the marketer reconcile this discrepancy on future product packaging.

 

With respect to the print advertising, the context of the claim in varies although, in almost all of the print advertisements, the Cylaris product packaging (including the claim that Cylaris is “Doctor Researched, Formulated and Approved”) is depicted prominently. 

 

One print advertisement features a woman named Blakely Smart and it is indicated that she lost 30 pounds in 18 weeks. In this advertisement, the product packaging is shown on the right-hand side of the ad and a side-bar box containing a photo and accompanying statement of  Dr. Richard Margolin is on the opposite side of the page.  For purposes of clarity, ERSP recommends that Iovate use consistent triggering symbols to correspond to the relevant disclosures for various claims made, such as “Dr. Formulated.”   

 

ERSP determined that, as it is a basic principle of advertising law that a marketer has the burden of supporting any reasonable interpretation of its claims. Without any clear reference connection to the particular doctor to whom the claim may be attributed, consumers could interpret the “doctor approved” claim much more broadly to a larger group of doctors who have purportedly recommended the product (i.e., pursuant to a comprehensive survey of doctors). However, no such evidence has been produced by Iovate to support such an interpretation.

 

Conversely a second print advertisement is less ambiguous. It feature a full page photograph of Dr. Richard Margolin (again accompanied by the Cylaris product packaging) and a statement with various triggering symbols make it much clearer that the “doctor approved” claim is limited to the personal assessment of this one doctor. ERSP agreed that in this context (in the absence of consumer perception evidence) that the claim is less ambiguous.

 

The establishment claim that by using Cylaris consumers can “Lose 287% of the weight versus the placebo,” reflects a typical pattern the marketer has used in the advertising of other dietary supplement products to quantify the percentage of difference between a test and control product. Notwithstanding that ERSP has consistently noted the claim is literally accurate and supported by the marketer’s testing, we have opined on this advertising technique in previous cases where we questioned the meaningfulness of communicating the efficacy of the product in this manner. 

 

While ERSP does recognize that in almost all presentations of the claim the marketer does provide specific information (in the form of disclosures) about the study results being used as support for its claim, considering that the target audience for this advertisement includes individuals with BMIs and body weight that may not parallel the physical characteristics of the group of test subjects who had a comparative weight loss of 287% versus the placebo, ERSP concluded that the claim is not entirely accurate in its present context.  As such, ERSP recommends that the marketer use a less dramatic comparative statement in the advertisement in future advertising and also make it clear to consumers that the accuracy of the quantified claim quantified claim was limited to those individuals in the test group that shared similar BMI and weight characteristics as the placebo group.

 

Accordingly, in addition to including the results of the overweight group in the presentation of the claim, we again recommend that Iovate consider using a less dramatic comparative statement in the advertisement in future advertising which we believe provides consumers with a better understanding of distinction being made by the marketer. 

 

Lastly, taking into consideration the inclusion of the overweight group in its overall weight loss calculation, ERSP determined that the establishment claims which specified the results of the marketer’s 8 weeks study were merely literal articulations of the results obtained in those studies and, when disclosed in this way, are accurately communicated in the advertising. However, ERSP did find the study results as disclosed in the television advertising to be difficult to read and recommends that Iovate make the text of the disclosure larger in future advertisements.

 

Performance Claims

 

The claim that consumers can “lose up to 32 lbs. in 8 weeks” is essentially the same claim that was at issue in RapidSlim (“Lose up to 30lbs. or more – FAST”) and was based upon the same two studies. Moreover, the context of the claim in the Cylaris advertising (Lose up to 32 pounds in 8 weeks”) was also similar, insomuch that it would not materially change ERSP’s determination in this matter.

 

Similar to ERSP’s analysis in RapidSlim, on its face, the marketer’s testing supported the claim that users can “Lose up to 32 lbs or more in 8 week.” It was also noted that in the previous cases, it has been held that 10% of test subjects which have met the maximum number in an “up to” claim can sometimes be understood to be a significant and sufficient number to support the claim. Nevertheless, ERSP had several reservations about this claim as based upon the two tests submitted by Iovate. 

 

First, it appeared to ERSP that any weight loss achieved by test subjects to this extent (i.e., 30 lbs or more) may have been predicated on a diet and exercise regimen. It seems notable that except in the one study group (i.e., obese subjects on a regulated diet), the test subjects were not prescribed a diet and exercise regimen. However, this should not be construed to mean that subjects did not diet and exercise, in fact, it appeared as if the opposite were true. For example, there were several subjects in the placebo groups of the two Iovate studies who lost more than 15 pounds in 8 weeks which, because of the placebo treatment they received, may have occurred as a result of a significant change in diet and exercise. As such, while Iovate contended that the study subjects were directed to maintain their normal diet and exercise regimens, ERSP determined that the variables of diet and exercise were not fully accounted for in the study and, thus, it was difficult to ascertain the specific amount of weight loss that was attributable solely to the test product (i.e., and not from diet and exercise). We agree that the disclosure “Regular exercise and proper nutrition are essential for achieving you weight loss goals” sends a useful message to consumers.  In addition to this disclosure, Iovate should consider including qualifying language informing consumers that the results obtained were not due to product use alone. 

 

In a previous case, ERSP also stated that the fact that the amount of weight loss claimed in the advertisement (30 lbs in 8 weeks or 3.75 pounds per week) exceeds the amount of safe weight loss articulated in the FTC’s Red Flag Guide on Deceptive Weight Loss claims could not be overlooked. More specifically, it was noted that the Red Flag Guide suggests that consumers should be wary of claims communicating that they can safely lose more than three pounds per week for a period of more than four weeks and, in the print advertising, the average weight loss of less than two pounds per week is clearly and conspicuously disclosed proximate to the “up to” claim. Although the marketer agued that it was intent of the FTC to target advertisers making express safety representations along with weight loss of three pounds per week or more in four weeks and that the average weight loss of less than two pounds per week is clearly and conspicuously disclosed in proximity to the “up to” claim, there is clearly an inference (based on the lack of disclosures indicating otherwise) that the amount of weight loss stated in the subject claim can be achieved safely. Similarly, regardless of the fact that this weight loss result may have only been applicable to 10% of the test subjects, the fact remains that this is an overt claim being made by the marketer that is arguably in contravention to a statement deemed misleading by the FTC. 

 

With respect to the claim that Cylaris “Supports Healthy Cholesterol Levels,” ERSP agreed that the results of Study 2 which demonstrated a significant decrease in total cholesterol (i.e., an 18% decrease in total cholesterol, a 26.9% decrease in LDL-cholesterol and a 21.1% increase in HDL-cholesterol) provided a reasonable basis for the claim.

 

Superiority Claims

 

Iovate’s claim that Cylaris is “the world’s strongest weight loss formula” is qualified in all forms of advertising as based upon “available published studies on other diet products.” ERSP reviewed an almost identical claim (and disclosure) in RapidSlim (“the world fastest weight loss solution”) that was based on the same evidence that was submitted by Iovate to support its “strongest” claim. Although the superiority claim is couched in a different performance context, it did not alter ERSP’s analysis of the data and, more specifically, did not alleviate the concerns regarding the reliability of extrapolating data from tests using different methodology and protocol.

 

As ERSP stated in RapidSlim, it is a fundamental principal in advertising law that a marketer making an unqualified, comparative superiority claim has the burden of testing a significant number of products on the marketplace, particularly the best selling brands (many of which were identified by Iovate in its comparative data). 

 

Most of the products identified by Iovate in its analysis were not compared with Cylaris for “strength” because no relevant, published data was available for these products and (as was the case in RapidSlim) with the omission of such data, it is recommended that the marketer discontinue the communication of this claim in its advertised context in any vehicle of commercial dissemination including, for example, in language accompanying search engine results. 

 

The television advertising for RapidSlim submitted by Iovate also included this superiority claim in several unqualified contexts. More specifically, the claim is made at the end of the broadcast and is unaccompanied by any relevant disclosure. Even when the claim is first presented in the television advertisement and the purported disclosure (“based on available published studies on other diet products”) appears, the exact language in the disclosure could not be read by ERSP. 

 

Moreover, based upon the evidence presented, ERSP was also troubled by the “world’s strongest” claim even in a qualified context. Although ERSP does recognize the marketer’s good faith attempt in providing the basis for its claims, the comparison of dietary supplement products based upon “available public research” is not a reliable comparison of the claim in its advertised context because of the different variables inherent in the four published studies. First, the amount of publicly available research on weight loss products is extremely limited. Moreover, only two of the four studies were even of the same duration as the study being relied on by Iovate in this inquiry and the information regarding the number of participants, the diet and exercise regimens and the baseline weights of the subjects was different from the study used to support Cylaris claims. As such, (and as was noted in RapidSlim) extrapolating results from these studies to support the superiority claim at issue would be erroneous and set a dubious precedent for other advertisers interested in making a similar claim in this context.

 

ERSP also notes that a “world’s strongest” claim (particularly in the dietary supplement category) is of great significance to consumers and the burden to support such a claim, even in qualified context, should be a substantial one. 

 

In sum, ERSP determined that marketer’s data did not support the claim that RapidSlim is the “World’s Strongest Weight Loss Formula” in either a qualified or unqualified context and it is recommended that the marketer discontinue this claim unless it can be fully qualified to in a way that is consistent with this decision and clearly communicates to consumers the basis of the comparison in a truthful and non-misleading way.

 

With respect to the alleged superiority claim that “Clinical breakthroughs of this magnitude and scope do not happen regularly, which is why Cylaris is undoubtedly the best weight-loss product on the market today,” ERSP noted that the claim was made in an isolated instance on the Cylaris website and, as such, cannot be considered a primary or core claim in the advertising and is, thus, not within ERSP ’s jurisdictional purview. Nevertheless, insomuch as this superiority claim is predicated upon the proceeding sentence (i.e., “Cylaris is not only the world’s strongest weight loss formula, but also an amazing product for fast weight loss and overall wellness.”) which ERSP deemed inaccurate, the self-regulatory forum hopes the marketer will consider revising this claim accordingly.

 

Lastly, the claim that “No other product on the market can deliver the same results due to Cylaris' unique proprietary formula” also appeared only once – on the Cylaris website – and, similarly, cannot be considered a core advertising claim and isoutside the scope of ERSP’s jurisdiction. 

 

CONCLUSION

 

ERSP agreed with the marketer that its use of the term “clinical breakthrough” was not inappropriate, nor was the claim that Cylaris is “doctor formulated”. Conversely, ERSP determined that in some contexts of Iovate’s advertising the claim that Cylaris is “doctor approved” (i.e., without any clear reference connection to a particular doctor) could be interpreted more broadly to a larger group of doctors who have recommend the product and that the marketer could not support the claim in such a context.

 

With respect to the “Lose 287% the Weight Compared to Placebo” claim, ERSP did not dispute the literal accuracy of the claim as it pertained to the group in the testing that most clearly mirrored the placebo control, but recommended that the marketer use a less dramatic comparative statement in the advertisement in future advertising and also make it clear to consumers that the accuracy of the quantified claim was limited to those individuals in the test group that shared similar BMI and weight characteristics as the placebo group.  

 

ERSP also concluded that, on its face, the marketer’s testing supported the claim “Lose up to 32 lbs in 8 weeks,” although it expressed several reservations about this claim, including its adherence to the FTC’s Red Flag Guide. In addition, ERSP determined that Iovate provided a reasonable basis for its claim that Cylaris  “Supports Healthy Cholesterol Levels.”  

 

Lastly, ERSP determined Iovate’s data did not support the claim that Cylaris is the “World’s Strongest Weight-Loss Formula” in either the qualified or unqualified context it was presented in the advertisement.

 

MARKETER’S STATEMENT

 

“Iovate is pleased that ERSP found the general product performance claims for Cylaris to be substantiated by two randomized, double-blind, placebo-controlled trials conducted by Dr. Julius Oben.  These studies, which were peer-reviewed and published in the Journal of Lipids in Health and Disease, establish that (1) Cylaris “contains proven, clinical-strength ingredients” and (2) Cylaris is “clinically proven” to promote weight loss and “support healthy cholesterol levels.”  Iovate also appreciates ERSP’s finding that the Cylaris establishment claims are accurately communicated in the advertising.

  

Iovate is pleased that ERSP found the “doctor formulated” and “clinical breakthrough” claims substantiated and notes that ERSP considers the use of qualifiers in conjunction with appropriate triggering symbols adequate to support Iovate’s “doctor approved” claim.  Iovate carefully follows Federal Trade Commission guidance in the advertising of its products, as is reflected in the ERSP Decision, particularly in ERSP’s analysis of the disclosures that appear in Iovate’s advertising.   

 

ERSP also found that Iovate followed applicable precedent in substantiating the “lose up to 32 pounds” claim, but nonetheless recommended that the claim be modified. While Iovate disagrees with ERSP’s reasoning on this issue, out of deference to this forum, Iovate will modify the principal claim to ensure that there can be no doubt that an appreciable number of consumers realized the maximum benefit a substantial amount of the time.  In fact, 29 percent of the test subjects lost 24 pounds over the eight-week period – well beyond the ten percent that is typically required when using an “up to” claim in advertising. 

    

Finally, ERSP concluded that Iovate’s “Lose 287% the Weight Compared to Placebo” was accurate but included certain recommendations regarding the associated disclosure.  Iovate will consider ERSP’s recommendations in its future advertising and will also ensure that the “doctor approved” and “world’s strongest weight-loss formula” claims are qualified in a manner that is consistent with this decision.   With regard to the latter, Iovate notes that the "world's strongest" claim is literally accurate based on the extensive cross-study analysis of clinical studies that was submitted.  Neither the challenger nor ERSP was able to find a single clinical study that demonstrated superior weight loss in a controlled setting. 

 

Iovate appreciates ERSP’s careful attention to this matter and will continue to support ERSP’s efforts to promote truthful and accurate advertising of dietary supplements”

 

Copyright 2007. Council of Better Business Bureaus, Inc.