ERSP Decision: OHT Peptide-3 Anti-Aging Formula

 1-800 PHARMACY, INC.

OHT Peptide-3 Anti-Aging Formula

 

BASIS OF INQUIRY

 

Direct response advertising for the OHT Peptide-3 anti-aging formula, marketed by 1-800 Pharmacy came to the attention of the Electronic Retailing Self-Regulation Program (“ERSP”) pursuant to an anonymous competitive challenge. The following express core claims in the online advertising have been delineated as follows:

 

Performance Claims Regarding Product Technology

 

“targeted, multi-layered dermal therapy”;

“OHT Peptide-3 contains three patented peptides that target both upper and lower layers of the skin, reducing wrinkles and repairing stretch marks.”;

 “… repair[s] stretch marks”

 

Establishment Claims

 

Acetyl Hexypeptide-3 is “clinically proven” to smooth wrinkles by relaxing tense facial muscles.

“… contains the exact, clinically tested dosage of each ingredient.  This potency ensures that OHT Peptide-3 delivers efficacious results.”

 

Comparative Claims

 

“Experience OHT Peptide-3’s Safe, Botox®-like Effects”;

“Surpasses the Hottest Skin Care Product in the World”;

“surpasses the leader”

 

CHALLENGER’S POSITION

 

I.          Performance Claims Regarding Product Technology

 

The challenger maintained that 1-800 Pharmacy is currently marketing an anti-aging moisturizer that uses three patented peptides, among other ingredients, to allegedly target both upper and lower layers of the skin by virtue of a “multi-layered dermal therapy,” thereby “reducing” wrinkles and “repairing” stretch marks. The challenger argued that these reduction and repair representations amount to performance claims requiring substantiation. 

 

The challenger argued that by making claims that the OHT Peptide-3

technology “repairs” stretch marks, the marketer is making an express permanent repair claim requiring adequate substantiation evidence in the form of well controlled, well designed scientific studies over a long-term period to establish that the technology permanently, repairs typical problems associated with aging skin, including the appearance of stretch-marks. The challenger added that if 1-800 Pharmacy could substantiate claims of long-lasting effectiveness and results are achieved through repeated use of the product, such information is material to consumers and should be disclosed in the advertisement.

 

The challenger stated that it is highly unlikely the OHT Peptide-3

 Technology is able to bring about permanent change for the same reasons that collagen injections into the dermis do not permanently “repair” wrinkles or stretch marks – that is the resulting “plumping up” effect is only a temporary phenomenon because the injected collagen will eventually downgrade.

 

Lastly, the challenger also maintained that, even assuming OHT Peptide-3

 can prove the technology targets both the upper and lower layers of the skin, it is unlikely OHT Peptide-3 will be able to prove that this technology will “repair” stretch-marks. Moreover, the challenger disputed the characterization of the results of a four-week study on Siegesbeckia Oreintalis Extract, an ingredient in the OHT Peptide-3 moisturizer, more particularly, that test results demonstrate that the ingredient will “correspond to restructuring of the tissue.” The challenger noted that the marketer has explicitly acknowledged that no studies have ever been performed to establish such effect. 

 

II. Establishment Claims

 

The challenger noted the limited data regarding the effectiveness of acetyl-hexypeptide-3, which the marketer maintained was “clinically proven” to smooth wrinkles, was insufficient to serve as an appropriate substantiating basis for the claim. The challenger also disputed the reliability of the one study which the marketer submitted as the clinical proof for the effectiveness of acetyl-hexypeptide-3 and referred to “other commentators” who have questioned the sufficiency of the clinical studies.

 

Moreover, the challenger asserted that there is little or no data articulating the various factors required to establish reliable and well controlled scientific protocols including the methodology of the test; the sample size, whether the results have been peer reviewed and whether the results are contradicted by other bodies of evidence. 

 

The challenger also stated there has been no assertion given by the marketer that OHT Peptide-3 contains the same quantity of any particular ingredient as the amount referenced in the applicable tests and that “clinically proven” claims must held to a higher degree of scrutiny than general performance claims because of the heightened expectations communicated by such claims to consumers.

 

III.` Comparative Claims

 

The challenger stated that an advertiser must support all reasonable interpretations of its advertising and argued that the advertising at issue conveys a strong message to consumers that that OHT Peptide-3 technology surpasses, or is better than, other competitive cosmetic anti-aging skin care products, and is superior to medical procedures like Botox.  The challenger also noted that the marketer makes an ingredient comparison against the “leading brand” without disclosing the identity of comparative brand. The challenger objected to the comparison because it does not provide the requisite amount of reliable scientific data required to substantiate a superiority claim of this sort, particularly against an industry leader.

 

The challenger also contended that in order to support its comparative performance claims versus professional treatments like Botox, 1-800 Pharmacy should be required to demonstrate that the effects of the product lasts longer than the named competitor. The challenger further relied on the basic principle of advertising law that when making unqualified comparative product performance claims, an advertiser has the burden of providing reliable performance data against all or a significant portion of competitive products on the market.

 

MARKETER’S POSITION

 

        Establishment Claims Regarding Product Effectiveness Technology

 

The marketer explained to ERSP that the technology of OHT Peptide-3 is based on the clinical effectiveness of four main ingredients in the product, more specifically, acetyl-hexypeptide-3; Palmitoyl Oligopeptide-3; Palmitoyl Tetrapeptide-3 and Biopeptide-CL. 

As support for the advertised claims of the clinical effectiveness of the ingredients, the marketer provided information from the respective clinical studies on each ingredient.

For example, the marketer explained that Palmitoyl Pentapeptide-3 is a synthetic protein that is a fragment of the C-terminal portion of collagen I (the most common type of the nineteen forms of collagen) combined with palmitic acid to make it more lipophillic, to improve its stability and to enhance its affinity towards human skin. The intention of the research behind Palmitoyl Pentapeptide-3 was to find a short peptide that would stimulate fibroblasts in the skin to produce key components of the extra-cellular matrix such as collagen and hyaluronic acid. The marketer explained that as we age, the skin gets thinner and during this process the sinusoidal dermo-epidermal interface layer between the dermis and the epidermis gets flatter allowing nutrients to flow from the dermis to the epidermis which can significantly affect the quality of the epidermis.

According to 1-800 Pharmacy, in-vitro testing demonstrated that palmitoyl pentapeptide-3 stimulated collagen IV synthesis by 100-327% and hyaluronic acid synthesis by 267%. Moreover, in vivo testing showed palmitoyl pentapeptide-3 to stimulate collagen synthesis by 30-117%. 

The results on the effect of palmitoyl pentapeptide-3 testing listed below show that palmitoyl pentapeptide-3 had a dramatic effect on reducing the quantity and depth of wrinkles and also improved surface smoothness:

 

Mean wrinkle depth                --     Reduced 17%

Surface area - deep wrinkles           --     Reduced 68%

Surface area - moderate wrinkles   --     Reduced 51%

Mean density of wrinkled area      --     Reduced 47%

Skin roughness                     --     Reduced 16%

Main wrinkle volume                --     Reduced 24%

According to the marketer he studies behind palmitoyl pentapeptide-3 give a clear description of the mechanism for how this is accomplished and also indicate that palmitoyl pentapeptide-3 is stimulating natural biological processes to reverse the aging process of the skin. In addition, palmitoyl pentapeptide-3 is very well tolerated by the skin.

The marketer then referred ERSP to the results of testing for acetyl hexypeptide-3. It was explained that acetyl hexapeptide-3 is used in formulas as a wrinkle preventative as well as a wrinkle reducer as an alternative to injections. 

Next, the marketer maintained that, as a wrinkle reducer, studies have shown that acetyl hexapeptide-3 at a 10% concentration was able to significantly decrease the depth of wrinkles after 30 days of treatment and it asserted that that acetyl hexapeptide-3 (i.e., Argireline) performs this activity in two distinct ways: 

The first way is by causing a reduction in facial muscle contraction, which is believed to help prevent the long-term formation of lines and wrinkles. The second way that acetyl hexapeptide-3 acts as a wrinkle preventative is by reducing the release of catecholamines (the overproduction of which is known to induce the formation of wrinkles and fine lines in the skin), specifically adrenaline and noradrenaline. 

The marketer explained to ERSP that the anti-wrinkle effect of acetyl hexapeptide-3 solution was ascertained in two different in vitro tests directly related to the formation of wrinkles in the epidermis as well as a separate in vivo test performed on healthy human volunteers.

 

For example, in one independent study of the effect of Argireline solution on the elasticity of the skin around the eyes was also referred to by the marketer and measured changes in the depth of skin wrinkling. The results showed the improvement in facial smoothness at 15 and 30 days post-Argireline treatment, compared with the results obtained without the incorporation of Argireline solution into the test cream. The researchers concluded that Argireline solution reduced the depth of wrinkles up to 17% after 15 days and 27% following 30 days of treatment.

With respect to the third ingredient, the marketer explained that palmitoyl tetrapeptide-3 is a synthetic peptide that is a fragment of immunoglobulin G that has been combined with palmitic acid to make it more lipophillic and thus enhance its affinity towards human skin. 

The marketer informed ERSP that it was relying on an in-vitro study of keratinocyte cultures and two clinical studies (using 17 and 15 blinded participants) as support for its claims of increased firmness and elasticity. According to the marketers, the researchers ascertained the following information: 

1.) Palmitoyl tetrapeptide-3 induces a marked reduction in the secretion of the cytokine IL6. This reduction is progressive and depends on the concentration of the peptide: baseline secretion may be inhibited by up to 40%. 

2.) Palmitoyl tetrapeptide-3 reduced levels of IL6 after cells were exposed to UV radiation by up to 86% even though IL6 had been increased by about 20 fold by the UV. 

Lastly, the marketer submitted materials with respect to biopeptide-CL which it explained, is a synthetic protein that is a fragment of collagen combined with palmitic acid to make it more lipophillic, to improve its stability and to enhance its affinity towards human skin. As with palmitoyl pentapeptide-3, the marketer stated, one could look at biopeptide-CL as a man-made precursor to collagen. 

The marketer referred to in-vitro testing results which showed increased collagen production by the fibroblasts by as much as 350% and increased hyaluronic acid production by the fibroblasts by as much as 146%. Moreover, the marketer called ERSP’s attention to test data that was accumulated using image analysis of volunteers who used crèmes containing a 3% concentration of biopeptide-CL for 28 days. The results were as follows:

Surface roughness -- Reduced 17%

Mean depth of wrinkles -- Reduced 23%

Depth of main wrinkle -- Reduced 39%

Skin thickness -- Increased 4%

The marketer noted that increase in skin thickness was considered especially notable and contrasts with the 6% reduction of the skin thickness that occurs after 10 years of aging. The marketer asserted that the study concluded that Biopeptide-CL is a potent active cosmetic ingredient without the adverse effects (including irritation, dehydration or long-term toxicity and instability) characteristic of retinoids. 

II. Comparative Claims

The marketer maintained that it has never made any specific assertion regarding comparative products but simply poses a comparison with the leading brand as a question for consumers (“Better than the Leader?”) to make a determination for themselves after reviewing the information contained on the website.  It noted that a consumer question is posed in a way that is similar to the method used by other competitive advertisements on the internet and provided a popular marketing phrase (“Better than Botox?”) as an example. The marketer maintained the representation is based strictly on side-by-side comparison of ingredients which is clearly ascertainable to consumers.

It also argued that the (“Bye Bye Botox”) claim will not be interpreted by consumers as a comparative performance claim with the popular surgical procedure and that any references to a “Botox-like effect” are simply innocuous statements which communicate that, like Botox procedures, OHT Peptide-3 helps to reduce wrinkles. The marketer also informed ERSP that in all future advertising it will use modifying language (i.e., “helps reduce”) to alleviate any impression that the product will categorically perform  beyond the expectations of consumers.

ANALYSIS

       Performance Claims Regarding Product Technology

 

ERSP did not object to the dissemination of general technological information regarding OHT Peptide-3 that was provided by 1-800 Pharmacy on its website. For example, the claim that OHT Peptide-3 is “targeted multi-layered therapy,”, is presented in a small box within one of several, 1-800 Pharmacy products and, while arguably not a core claim in the advertising, ERSP determined the statement to be a general characterization of the combined effect of the product’s three patented peptides. The challenger did not offer any rebuttal evidence indicating that these peptides do not perform in this manner and, accordingly, ERSP did feel it necessary to recommend discontinuance or modification of this claim.

 

Conversely, ERSP concluded that the claims stating “OHT Peptide-3 contains three patented peptides that target both upper and lower layers of the skin, reducing wrinkles and repairing stretch marks” and “… contains the exact, clinically tested dosage of each ingredient.  This potency ensures that OHT Peptide-3 delivers efficacious results” did warrant modification. In the absence of specific testing on the advertised product demonstrating actual “reduction of wrinkles” and/or “repair of stretch-marks” ERSP was not persuaded by the categorical representations of product performance and recommended that 1-800 Pharmacy use the appropriate modifiers to indicate that the product ingredients, in fact “help reduce the appearance” of wrinkles and stretch-marks. This conclusion is also entirely consistent with determinations reached in previous ERSP cases in which ingredient information was provided to show some efficaciousness with respect to reducing the appearance of wrinkles. Moreover, ERSP determined that use of the term “repair” was not entirely appropriate to describe the effect of the product usage and it is suggested that the marketer use different (i.e., more subjective) language to describe the results that consumers may expect when applying the product on stretch-marks.

 

II.        Establishment Claims

 

As ERSP has noted in previous cases, “clinically proven” claims send a very strong message to consumers, and support for such statements is carefully scrutinized.  In fact, many regulatory authorities often require two well conducted tests to support  “clinically proven” claims.  Although the test summaries submitted by 1-800 Pharmacy may provide adequate support for the potential of the general performance of the four ingredients listed in the online advertisement, ERSP was concerned about the reliability of these test summaries as providing the necessary support for a clinically based claim.

 

When making an unqualified claim that an ingredient has been “clinically proven” to perform in a particular way, ERSP determined that it would be reasonable for consumers to interpret the claim as meaning  that the ingredient were tested at the same level or concentration as they are contained in the product. However, that was not the case in subject matter. For example, the clinical summary provided on palmitoyl tetrapeptide 3 (i.e., rigin) indicates that a 3% concentration was tested. Conversely, the ingredient information indicates that the amount of palmitoyl tetrapeptide 3 contained in OHT Peptide-3  is “between 3% and 5%.” Similarly, the amount of palmitoyl oligopeptide (i.e., dermaxyl) in the product is less than 1% and the summary of in vivo tests show that the subjects applied a 2% dermaxyl solution, and, likewise, the marketer’s testing used a 10% application acetyl hexapeptide-3 (i.e., argireline) although the ingredient information indicates that the amount of this ingredient in the product is “between 5%-10%.” Moreover, no information was provided to verify the amount of biopeptide-cl contained in OHT Peptide-3 corresponds with amount of the ingredient tested.

 

ERSP certainly recognizes that the summaries made available by 1-800 Pharmacy on its website regarding the testing of these ingredients provide a better understanding of the efficaciousness of the product to consumers. However, for purposes of this self-regulatory review, the claim that OHT Peptide-3  “… contains the exact, clinically tested dosage of each ingredient” is clearly not accurately communicated, and ERSP also recommends that the marketer modify its characterization of the ingredients as being “clinically proven” to more accurately indicate that past testing of the ingredients in this product have been shown to have a reducing effect on the appearance of wrinkles and stretch-marks. Furthermore, by making such a modification and also  providing the amount of the ingredients contained in OHT Peptide-3. ERSP agreed that consumers can clearly decipher the applicability of the test summaries to the actual product.

 

III       Comparative Claims

 

ERSP determined that the claim “Experience OHT Peptide-3’s Safe, Botox-like Effects” was presented in such a context (i.e. “Learn about …”) that did not rise to the level of an express comparison and which would be interpreted by  consumers as meaning that OHT Peptide-3 is “better than” or “as good as” Botox injections and is simply a reference to safely reducing the appearance the of wrinkles and/or stretchmarks.

 

ERSP determined that the claim “Better than the leader?” in an unqualified context was not inappropriate because it simply raises the question to consumers and lets them make the independent choice based upon the side-by-side ingredient  information provided below the requested comparison and it simply could not be concluded that marketer was making a  categorical assertion that it is “better than the leading competitor”. However, the claim immediately following the main claim stating that “OHT Peptide-3 surpasses the leader with the next generation ingredients” is a definitive representation communicating the advertised product’s superiority (i.e., “We’re better than the leader”) in a context that would require comparative testing data which was not submitted during the inquiry. Conversely, ERSP recommended that the marketer modify the claim by using a term different than “surpasses” (i.e., “challenges the leader” or “is unique from the leader” or couch it subjectively – “We think that OHT Peptide-3 surpasses the leader…”). It was concluded that such a change, in combination with an amended description of the effectiveness of the individual ingredients in OHT Peptide-3 (see ERSP’s discussion of Establishment Claims above) would more accurately communicate the comparative assertion intended by 1-800 Pharmacy.

 

CONCLUSION

ERSP did not object to the dissemination of general technological information regarding OHT Peptide-3 that was provided by 1-800 Pharmacy on its website but conversely concluded that the claims stating “OHT Peptide-3 contains three patented peptides that target both upper and lower layers of the skin, reducing wrinkles and repairing stretch marks” and “… contains the exact, clinically tested dosage of each ingredient.  This potency ensures that OHT Peptide-3 delivers efficacious results” did warrant modification.  ERSP also determined that it would be reasonable for consumers to interpret the claim as meaning that the ingredients were tested at the same level or concentration as they are contained in the product  which was not the cased based on the marketer’s referenced studies. Lastly, ERSP determined that the claim “Experience OHT Peptide-3’s Safe, Botox-like Effects” was presented in such a context (i.e. “Learn about …”) that did not rise to the level of an express comparison, however, ERSP recommended that the marketer modify the claim stating that “OHT Peptide-3 surpasses the leader with the next generation ingredients.”

MARKETER’S STATEMENT

“1-800-Pharmacy accepts ERSP’s analysis and has modified, and will continue to modify, the language of its site, packaging, and/or advertising as suggested.”

 

Copyright 2005. Council of Better Business Bureaus, Inc.