ERSP Decision: FLEXCIN INTERNATIONAL, INC.

BASIS OF INQUIRY

Direct response advertising for the Flexcin nutritional supplement was brought to the attention of the Electronic Retailing Self-Regulation Program (“ERSP”) pursuant to an anonymous challenge. The thirty-minute infomercial is presented in a radio talk-show format called the “Duke and Doctor,” featuring husband and wife team Dr. Jan McBarron and Duke Liberatore. The focus of the radio program is on arthritis and joint pain and how Flexcin works to ease their conditions. CEO and president of Flexcin International Inc., joins the Duke and the Doctor to discuss Flexcin and to explain why it was created and why it works on joint pain and other inflammatory muscle and joint diseases.

ERSP categorized the core claims communicated in the infomercial as follows:

1. Comparison to Drugs

  •  “…the drugs don’t work.”
  •  “It vs. prescriptions?”
  •  References to Vioxx such as “If your pain medication was recently withdrawn…”

2. Performance Claims

  •  “Soothes aching joints; super lubricates your joints; enhance joint flexibility; reconstructs and builds healthy cartilage; promotes health of existing tissue.”
  •  “…not just for health it’s for fibromyalgia … polymyalgia…any type of joint inflammatory disease.”
  •  “…pain free.”
  •  “This study shows…87.3% increase in joint function.”
  •  “Some people have seen results in as little as three days…in general three weeks.”

3. Testimonial Claims

  •  “…took away my pain.”
  •  “…perfectly, absolutely safe to take.”
  •  Sufferer of muscular dystrophy “…it did end pain considerably.”
  • “…see bone on bone six months ago…clearly space between the bones…cartilage…helps with cartilage building.”
  •  “…I didn’t have any pain.”
  • “…degenerative arthritis in my back…I don’t experience back pain…”
  •  “Somewhere around the fifth or sixth week I didn’t have any pain.”
  •  “Three to four weeks after taking it, my shoulder didn’t hurt…and be pain free.”

4. Safety Claim

  • “With no side effects.”

Further, ERSP was concerned about the lack of the disclosure of information that could be material to consumer understanding regarding the product. Moreover, the consumer testimonials do not contain “atypical” disclosures throughout the infomercial.

MARKETER’S POSITION

1. Comparison to Drugs

Flexcin International provided ERSP with news wire clips which stated that Bextra and Vioxx, two arthritis medications, were pulled off the market due to pressure from the Federal Drug Administration over heart risks. These articles, according to the marketer, confirm that their statements in regards to Vioxx and Bextra being pulled from the market were true. Specific statements regarding the effectiveness of the drugs were, according to the marketer, solely the opinions of the program host Dr. Jan McBarron.

2. Performance Claims

The marketer stated that the main ingredients in the Flexcin nutritional supplement were Cetyl Myristoleate, Glucosamine, M.S.M, Collagen Type II, Bromelain, and Enzymatic Blend.

The marketer cited to a randomized, double-blind, placebo-controlled parallel trial of Cetyl Myristoleate published in the Townsend Letter For Doctors and Patients in reference to the claim that testing “shows…87.3% increase in joint function.” Cetyl Myristoleate, according to Flexcin International, has been shown to have lubricating qualities, anti-inflammatory properties, functions as an immunomodulator to regulate hyper-immune responses, and works also as a pain reliever. In this 4 week study, 382 patients who had been diagnosed with degenerative joint disease or arthritis ailments were broken into three groups: Group A who received 10.8 grams of Cetyl Myristoleate, similar to the form found in Flexcin; Group B who received the same Cetyl Myristoleate plus “similar but less-effective” derivatives of Glucosamine hydrochloride, sea cucumber, and hydrolyzed cartilage; and Group C who received a placebo. The results indicated that group B (Cetyl Myristoleate and other additives), showed a rate of improvement of an average of 87% in the categories of Treatment Response, Doctor Assessment, Patient Assessment, and joint swelling, outperforming Group A which only showed a 63.3% average improvement and the placebo group which showed a 14.5% rate of improvement.

Addressing the differences in dosage between the study on Cetyl Myristoleate and the Flexcin nutritional supplement, the marketer stated that the nutritional supplement Flexcin contains 750mg of Cetyl Myristoleate per daily dosage, which is equivalent to 22.5g over a 4 week period, i.e., more than what was tested in this study.

In addition to a submitted article on the benefits of glucosamine in osteoarthritis patients and its ability to assist to reconstruct and rebuild healthy cartilage, Flexcin International also submitted a report of a double blind study on Methyl-Suflynly-Methane (M.S.M). Twelve patients were divided into two groups with eight patients given 2250mg dosages of M.S.M and four in the placebo group. However the placebo group was later divided again, resulting in 10 patients on M.S.M and 6 patients in the placebo group. The results from a self-reporting scale showed that after four weeks, the patients on M.S.M showed a 60 percent improvement which increased to 82% after six weeks. In contrast the placebo group reported a 20% improvement after 4 weeks and 18% after 6 weeks.

Another study on the effects of chicken type II collagen on rheumatoid arthritis, submitted by Flexcin International, showed a decrease in the number of swollen joints and tender joints. In the three month study, 59 patients with Rheumatoid arthritis were placed into two groups: 28 subjects fed chicken type II collagen and 31 patients in a placebo group. Among the collagen patients, 14% had complete resolution of the disease as compared to none in the placebo group. No side effects were noted during the duration of the study on the orally ingested type II collagen.

3. Consumer Testimonials

The marketer stated that before the beginning of the infomercial, the following disclosure appears in large type for 16 seconds:

“This Infomercial is a paid advertisement from Flexcin International, Inc. 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. Testimonial results are not typical. The dietary and other substances discussed in this Infomercial have not undergone evaluation and/or testing by the United States Food and Drug Administration or like agency of any other country. Risks that might be determined by such testing are unknown. Where customers experience a healing of any condition or relief of minor pain due to exercise or the normal changes of life, no claim is made that use of the product was a cure of disease. For severe or prolonged pain please consult your physician.”

This disclosure, according to the marketer, is sufficient to alert consumers to the fact that results may vary. Flexcin International also submitted written consumer testimonials used in the infomercial to ERSP along with releases for each testimonial appearance. These testimonials were the opinions of actual Flexcin users and described their own results using the Flexcin nutritional supplement.

4. Safety Claims

The marketer stated the beginning and end of the advertisement includes language expressly indicating that “Risks that might be determined by such testing are unknown.” The interpretation cited by the marketer, is that there are no known side effects. Further, according to Flexcin International, all ingredients included in the Flexcin product are found in an everyday health food store.

The specific claim that the Flexcin nutritional supplement is “absolutely safe to take” is made by a doctor and is that doctor’s professional opinion. Flexcin International contends that Flexcin as a company does not make any claims that the Flexcin nutritional supplement is perfectly safe to take but that all the ingredients are on the Generally Recognized as Safe (GRAS) list and is monitored by the Good Manufacturing Practices Institute. Flexcin and all of its ingredients are manufactured in a GMP Certified facility, with a certificate of the facility representing this fact.
ANALYSIS

1. Comparisons to Drugs

ERSP determined that although the statements indicating that, unlike Flexin, “…[prescription] drugs don’t work” may represent the opinion of a doctor, pursuant to the Federal Trade Commission Guide on Expert Endorsements:
“[W]here, 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 that, 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. Moreover, where the net impression created by the endorsement is that the advertised product is superior to other products with respect to any such feature or features, then the expert must in fact have found such superiority.
While the claim at issue may accurately represent the opinion of Doctor McBarron, in the absence of data supporting the representation, such statements are considered anecdotal. The fact that the endorsement reflects the opinion of the individual making the claim is no substitute for reliable competent evidence regarding the performance of the competitive product. ERSP therefore recommends that future advertising clearly and conspicuously put consumers on notice that the statements regarding the efficacy of prescription drugs are only the opinions of Doctor McBarron and should be interpreted as being attributable to Flexcin, International.

Although ERSP did agree that it was factually true that other pain medications such as Vioxx or Bextra had been pulled off the market, the context in which these factual statements were made could be interpreted by a reasonable consumer to be comparative performance statements in comparison to Vioxx, Bextra, or prescription medications. Accordingly an advertiser has the burden of supporting any reasonable interpretation of claims made in its advertising.

In addition, when these statements accompany claims such as “it vs. prescriptions?” and specific references to Vioxx such as “If your pain medication was recently withdrawn…,” ERSP determined that would be reasonable for consumers to be taking away an implied message regarding the advertised product’s superior efficacy versus prescription medications in a context that would require supporting evidence. In the absence of such evidence, ERSP recommends that the claims be discontinued or modified to remove any direct or implicit superiority references to prescription drugs.

2. Testimonials

Similar to the doctor’s opinion (cited in the Comparison to Drugs Analysis portion stated above), while ERSP appreciates that the testimonials used in the infomercial for the Flexcin nutritional supplement accurately depict the users’ experiences, they must also reflect what other consumers can expect to experience. Accordingly, all statements involving product claims made by the consumer in the advertisement are subject to direct substantiation. While the statements may be accurate that the claims reflect the truthful experience of the consumers, such statements are considered anecdotal and the fact that the testimonials reflect the individual opinion of the individual making the claim is no substitute for reliable competent evidence.

ERSP remained concerned about the lack of disclosures throughout the infomercial, and determined that the current advertising did not adequately or accurately communicate that these testimonials only represented isolated (i.e., atypical) instances of product performance and may not reflect what the average consumer might experience. Although ERSP appreciated the large disclosure shown at the beginning of the infomercial noted earlier, it states in the Dietary Supplements advertising Guide for Industry:

When the disclosure of qualifying information is necessary to prevent an ad from being deceptive, that information should be presented clearly and prominently so that it is actually noticed and understood by consumers. A fine-print disclosure at the bottom of a print ad, a disclaimer buried in a body of text, a brief video superscript in a television ad, or a disclaimer that is easily missed on an Internet web site, are not likely to be adequate. To ensure that disclosures are effective, marketers should use clear language, avoid small type, place any qualifying information close to the claim being qualified, and avoid making inconsistent statements or distracting elements that could undercut or contradict the disclosure. Because consumers are likely to be confused by ads that include inconsistent or contradictory information, disclosures need to be both direct and unambiguous to be effective.

Although the disclaiming language is present at the beginning of the program, ERSP recommends that further disclosures be placed conspicuously and in close proximity to the claim being qualified, i.e., the testimonials or the previous comparative statements made by the Doctor in the comparison to arthritis drugs.

3. Product Performance

ERSP appreciates the numerous studies and articles on the ingredients provided by the marketer, and determined that the ingredients contained in Flexcin may, in fact, provide several benefits to users. Therefore, ERSP does not object to specific qualified ingredient claims, placed in proper context.

However, ERSP is concerned with claims made about the Flexcin nutritional supplement as a whole. In the omission of reliable evidence, such as testing on the product itself, the marketer must be prepared to demonstrate that the individual ingredients of the product that were tested were of the same (or a similar) strength and quality as they are contained in the product. Particularly, when an advertiser or marketer is making health or safety claims, this is one standard generally used to determine whether the evidence can be considered “competent and reliable.” The studies submitted to ERSP, specifically the test on Cetyl Myristoleate that yielded the 87.3% increase in joint function was attributed to a product formulation with a different concentration of Cetyl Myristoleate and other ingredients deemed “similar but less-effective” by the marketer. Moreover, the marketer did not provide any information to confirm that the studies on M.S.M or type II collagen were at the same or similar levels contained in the Flexcin nutritional supplement.

ERSP was also troubled by the statement “Some people have seen results in as little as three days…in general three weeks.” As stated previously, no testing was submitted to ERSP on the Flexcin nutritional supplement as a whole. The specific time period represented in the Cetyl Myristoleate study (which as stated earlier was on a dosage different than the Flexcin nutritional supplement) was conducted over a four week period, the M.S.M study occurred over 4 week and 6 week periods, and finally the type II collagen study was conducted over a three month time period. Although the time period noted in the statement may accurately reflect the results of some unrepresentative Flexcin users, as stated (above in the Testimonial Claims analysis), the advertising must reflect what consumers can expect to experience. Accordingly, such a statement requires direct substantiation and should be discontinued until such a time as testing on the product can reflect what typical consumers may experience from use of the Flexcin nutritional supplement.

4. Safety Claims

ERSP determined he studies provided on the ingredients to ERSP all indicated that no adverse side effects were noted during the examination. Therefore ERSP did not object to the claim “With no side effects” made in the advertising.

CONCLUSION

ERSP determined that the comparative claims in the context of the subject advertisement could be reasonably interpreted by consumers as an implied performance comparison to prescription drugs and should be discontinued or modified to remove any direct or implicit references to the performance of prescription drugs. ERSP also determined that the specific statement made by the spokesperson on her opinion regarding the effectiveness of Flexin, should be qualified with additional language indicating that this was the opinion of the spokesperson herself. Further, ERSP did not agree that one disclosure at the beginning of the infomercial was adequate to reflect that the experiences of the Flexcin nutritional supplement in the infomercial were not typical. ERSP therefore recommended including further disclosures throughout the infomercial that were in close proximity to the testimonials in future advertising. Although ERSP agreed that the ingredients contained in the Flexcin nutritional supplement may have some benefits, ERSP recommended that specific product performance claims not specific to the ingredients should be discontinued until supported with either testing on the product itself or on the ingredients of the same or a similar level as those contained in the product. Lastly, ERSP did not object to the safety claim “With no side effects” made in the advertising.

MARKETER’S STATEMENT

“We are very happy to have participated in the ERSP program and in the spirit of voluntary self-regulation, will be making some of the recommended changes based on ERSP.

Some of the recommended changes are as follows based on ERSP suggestions:

1. A disclosure will be included throughout the advertisement to let the consumers know that results may not be typical.
2. Although we disagree that we do not make any comparisons to other drugs in the advertisement, we will take the ERSP’s recommendation into consideration and make modifications to certain parts of the advertisement. We would like to point out that we only tell the truth and show different headlines that were taken from newspapers across the country that show the recent pull and controversy of certain prescription drugs that were on the market. We not name any particular drugs.
3. We will consider adding a disclosure regarding the opinion of the spokesperson stating that this was the opinion of the spokesperson herself.
4. Flexcin International, Inc. will seriously consider the suggested recommendation regarding the 87.3% joint function claim that was mentioned on the Dr. Seimandi Study.”

Copyright 2005. Council of Better Business Bureaus, Inc.