Case #365 (5/5/2015) LA LUMIERE, LLC illumask Anti-Acne Therapy Mask Challenger: Monitoring Product Type: Other. Disposition: Modified

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1 Case #365 (5/5/2015) LA LUMIERE, LLC illumask Anti-Acne Therapy Mask Challenger: Monitoring Product Type: Other Issues: Performance Claims Disposition: Modified BASIS OF INQUIRY Direct response advertising for illumask, marketed by La Lumiere, LLC, came to the attention of the Electronic Retailing Self-Regulation Program ( ERSP ) pursuant to its ongoing monitoring of advertising in the direct response marketplace. After review of online and broadcast advertising for illumask, ERSP identified the following claims as being representative of core messages communicated in the advertising: 1. Performance Claims Bringing the Power of Light Therapy Home Safe, effective and effortless treatment for less than a dollar a day. Acne Free Skin at the Push of a Button Get a clearer complexion and fewer breakouts with the illumask Anti-Acne Light Therapy Mask. FDA-cleared, No UV rays, no irritating chemicals, zero side effects* Safe, Pure and Powerful Light Blue light energy kills the light sensitive P. acnes bacteria on and below the skin surface while the red light boosts your natural skin cell turnover and healing process to reduce swelling, inflammation, and redness. Patented Light Array Technology Eliminates the bacteria that cause acne Heals redness and inflammation from existing breakouts Helps prevent future breakouts Gives you clearer, smoother skin Evens your skin tone and calms redness Safe for all skin tones and types including sensitive skin "Just turn up the music, put on the mask and get clear." "Get clear and stay clear." 2. Establishment Claims illumask is a simple, gentle, clinically-proven treatment for mild to moderate acne. Guaranteed results in 30 days. 93% saw results in 2 weeks and Best of all, it works. 93% of users saw real results in as little as two weeks!" Our clinical trials were conducted over 8 weeks of usage. Most people began to notice slight improvements at week 2, further improvement at week 4 and significant improvements by week Consumer/Doctor Testimonials Trusted by doctors The Acne illumask uses the same technology your dermatologist would use, but is designed for safe and easy use at home. Best of all, it is affordable, giving you an opportunity to incorporate a clinically proven acne skin care device into your daily regimen. [Dr. Z. Paul Lorenc] Anyways, this is THE only thing that helps either keep my cystic acne from sprouting up or making it go away if I have any. [Jovan] "After using the mask, all my acne's basically gone." [Brendan]

2 MARKETER S POSITION La Lumiere explained that the illumask is an acne light therapy device that uses lightemitting diode (LED) light therapy technology for the treatment of mild to moderate acne. A combination of red light (630 nm) and blue light (445 nm) is emitted from the device. Users place the lightweight mask over their face and press a button on a controlling device to begin treatment. The device automatically turns off after each treatment. According to La Lumiere, the illumask received clearance from the US Food and Drug Administration (FDA) as a 510(k) cleared medical device and is being marketed within the scope of that clearance. The marketer maintained that the illumask represents the first wearable acne medical device cleared by FDA and that it has evidence of safety and effectiveness based upon a 12-week clinical study (the illumask study ). The illumask study, which was submitted to ERSP, assessed the safety and efficacy of the illumask over an 8 week period. The product was used once per day by study subjects for 10 minutes and both the principal investigator and the subjects recorded clinical outcomes using various metrics, including the FDA Global Acne Severity Scale, lesion counts, patient self-evaluations, standardized clinical photography and documentation of adverse events. The marketer called ERSP s attention to the statistically significant improvements at week 8 across all clinical endpoints. The median number of non-inflammatory lesions showed a 73.3% decrease and the number of inflammatory lesions showed a 100% decrease. The FDA Global Acne Severity Scale showed a 50% improvement. There were also no serious adverse events reported by either test subjects or the physician investigator. Moreover, La Lumiere informed ERSP that individual attribute results were statistically significant. More specifically, at Week 2 the scores of 90% of the subjects were statistically significant and the results were 100% statistically significant at week 8. The marketer also stated that other scientific literature supports the product s mechanism of action through the use of LED lights. La Lumiere responded individually to each claim listed in ERSP s Basis of Inquiry. 1. Performance Claims Bringing the Power of Light Therapy Home La Lumiere explained that the illumask is an acne light therapy device that uses well documented LED technology. The marketer also provided ERSP with a copy of the FDA s 510(k) clearance for the illumask which was issued on August 28, 2013, noting that the product was intended for over-the-counter (OTC) home use and based on its substantial equivalence to the Omnilux Clear-U device, the FDA has determined that the illumask is an OTC 510(k)-cleared medical device. Safe, effective and effortless treatment for less than a dollar a day. According to the marketer, the safety and effectiveness of the illumask has been demonstrated by an institutional review board (IRB) approved 12-week clinical study for treatment of mild to moderate acne vulgaris. The general safety and effectiveness of light therapy for treatment of acne vulgaris has also been widely reported in the scientific literature.

3 The marketer added that its use of the term effortless refers to the fact that the illumask is operated by the ON button on the controller. At the end of the treatment period, the mask automatically turns off. The marketer asserted that the less than a dollar a day claim is based on the $29.95 retail cost of the product which is to be used once a day and has 30 treatments preloaded. Accordingly, La Lumiere stated that, on a per treatment basis, the cost is less than $1 per day. Acne Free Skin at the Push of a Button The marketer explained that the product controller contains an ON button and the product turns off automatically. It referred to the 12 week study discussed above to support the general performance characterization of the product. In addition, the marketer stated that the term acne free skin is a colloquial term used in the industry to describe the reduction in visible acne as a result of directed product use. La Lumiere emphasized that it does not in any way claim that the product cures acne. Get a clearer complexion and fewer breakouts with the illumask Anti-Acne Light Therapy Mask. As support for this claim, the marketer referred ERSP to the statistical analysis of the selfassessment scores from the clinical study. The attribute skin smoothness showed statistically significant improvement at week 8. The attribute overall skin clarity showed statistically significant improvement at weeks 4 and 8. Further, according to the marketer, the effectiveness of light therapy for the treatment of acne vulgaris has been widely reported in the scientific community and La Lumiere provided ERSP with four separate articles discussing the efficacy of blue and red LED phototherapy, at a level similar to the LED emission used by the illumask, in the treatment of mild to moderate acne. FDA-cleared, No UV rays, no irritating chemicals, zero side effects* The marketer informed ERSP that the FDA cleared the illumask to be marketed in August of 2013 and, thus, maintained that the claim FDA cleared is a truthful and accurate statement of the product s legal status. It noted that a company may not represent that the submission of a 510(k) notification or the clearance of a 510(k) is an FDA approval. Therefore, it was the position of La Lumiere that it may state in the advertising that the illumask is cleared, but not that it is approved. La Lumiere explained that the blue and red wavelengths by definition are not in the ultraviolet ( UV ) spectrum. The illumask blue light LEDs have a 445 nm wavelength and the red light LEDs have a 630 nm wavelength as confirmed by the manufacturer s specification sheets. According to the marketer, the illumask is constructed of polycarbonate and the attached glasses are the only part of the product to touch the face. Neither the LEDs nor the mask itself (which holds LEDs) comes into contact with the skin. The marketer informed ERSP that the illumask has passed all safety testing, including biocompatibility. Safe, Pure and Powerful Light The marketer stated that safety of the illumask for treatment of mild to moderate acne has been demonstrated in the illumask study. In addition, the marketer stated that the LED

4 lights have passed all photobiological testing. La Lumiere informed ERSP that the term pure simply refers to the fact that the LEDs only emit visible lights at two wavelengths: blue (445nm) and red (630nm) and that the term powerful is a monadic reference to the general effectiveness of the product as demonstrated by the illumask study. Blue light energy kills the light sensitive P. acnes bacteria on and below the skin surface while the red light boosts your natural skin cell turnover and healing process to reduce swelling, inflammation, and redness. and Eliminates the bacteria that cause acne As support, the marketer submitted an article published by the Journal of Cosmetic and Laser Therapy entitled Combination blue (415nm) and rec (633nm) LED phototherapy in the treatment of mild to severe acne vulgaris which stated that, [b]lue light therapy (415 nm) is effective at activating coproporphyrin IX, subsequently destroying P. Acnes bacteria. There is a marked correlation between the reduction in numbers of P. acnes bacteria and clinical improvement in patients with acne Since red light penetrates deeper into tissue than blue, its possible that red light actively destroys P. acnes bacteria residing in the lower regions of the sebaceous gland. Furthermore, red light has noted anti-inflammatory properties. Further, La Lumiere submitted an article ( Low Level Laser (Light) Therapy (LLLT) in Skin: Stimulating, Healing, Restoring ) which stated that [w]hen used in combination, red light and blue light have synergistic effects in treatment of acne. Propionibacterium acnes synthesizes and stores large amounts of porphyrins. Once the porphyrin is exposed to visible light (specifically blue light), it becomes chemically active Red light is proposed to exert its effects through reducing the inflammatory process. Patented Light Array Technology As support for this claim, the marketer referred ERSP to its US Patent (#8,771,328) and Foreign Patent ( ) and noted that it has several patents pending worldwide. In addition La Lumiere informed ERSP that the illumask has trademark registrations for brands, product names, logos, slogans and taglines, including illumask and A Bright Idea in Skin Care Science. Heals redness and inflammation from existing breakouts It was the marketer s position that based upon the statistical analysis of the selfassessment scores from the illumask study, the attribute appearance of redness associated with pimples demonstrated a statistically significant improvement at week 8, and the attribute pain or soreness associated with pimples demonstrated statistically significant improvement at week 8. Helps prevent future breakouts According to the marketer, the published article referred to earlier herein ( Combination blue (415nm) and red (633nm) LED phototherapy in the treatment of mild to severe acne vulgaris ) discusses the efficacy of laser technology to reduce inflammation. The marketer contended that the illumask study demonstrates that use of the product substantially decreases the number of non-inflammatory lesions by week 8, suggesting that continued illumask usage diminishes the chance of future acne breakouts. La Lumiere noted that the clinical assessment for the attribute of non-inflammatory lesions demonstrated that the median percent change from baseline was 73.3% (improvement) by week 8 and the mean percent change from baseline was 71.2% (improvement) by week 8. Further, the

5 clinical assessment for the attribute number of inflammatory lesions demonstrated that the median percent change from baseline was -100% (improvement) by week 8 and the mean percent change from baseline was 82.8% (improvement) by week 8. The marketer also maintained that the scientific literature provided to ERSP supported the conclusion that, with continued use, acne breakouts are reduced. Gives you clearer, smoother skin and Evens your skin tone and calms redness La Lumiere stated that based upon the statistical analysis of the self-assessment scores from the clinical trial, the attribute skin smoothness showed statistically significant improvement at week 8. The attribute overall skin clarity showed statistically significant improvement at weeks 4 and 8. Safe for all skin tones and types including sensitive skin The marketer stated that this claim was adequate and supported based upon the fact that the LED lights passed all photobiological safety testing. It also informed ERSP that no skin types were excluded from the study (i.e., all Fitzpatrick Classification Scale skin types were included). In addition, there were no self-reported or principal investigator-reported adverse events during the clinical study. "Just turn up the music, put on the mask and get clear" and "Get clear and stay clear." The marketer again relied upon the statistical analysis of the self-assessment scores from the clinical trial, which indicated that for the attribute skin smoothness there was a statistically significant improvement at week 8. The attribute overall skin clarity showed statistically significant improvement at weeks 4 and 8. La Lumiere also stated that use of the product, as indicated in the clinical study, demonstrated that the number of non-inflammatory and inflammatory lesions decreased substantially by week 8 which the marketer maintained demonstrated that continued use diminishes the chances of future acne breakout. The marketer re-iterated that the clinical assessment for the attribute of non-inflammatory lesions demonstrated that the median percent change from baseline was -73.3% (improvement) by week 8 and the mean percent change from baseline was -71.2% (improvement) by week 8. Further, the clinical assessment for the attribute number of inflammatory lesions demonstrated that the median percent change from baseline was -100% (improvement) by week 8 and the mean percent change (improvement) from baseline was -82.8% (improvement) by week Establishment Claims illumask is a simple, gentle, clinically-proven treatment for mild to moderate acne. Guaranteed results in 30 days. The marketer advised ERSP that the gentle claim is based upon the illumask study during which no adverse events were reported and that the safety of the LED technology has been documented in a number of scientific publications that have been submitted into the case record. La Lumiere also noted that the FDA has given La Lumiere 510(k) clearance to market the product to treat mild to moderate acne conditions. With respect to the Guaranteed results claim, the marketer explained that it offers a 30- day, no risk trial, offering a refund of the purchase price (less shipping and handling) if the

6 mask and controller are returned within 45 days of purchase. La Lumiere noted that it provides an 800 number and an address are provided for refund assistance. It was the position of La Lumiere that the claim that the illumask is clinically proven is substantiated by the illumask study. According to the study results, significant improvement was observed from baseline to week 8 in all three clinical evaluations: number of inflammatory lesions, non-inflammatory regions as well as the Overall Acne Severity assessment. Statistically significance was observed in absolute change as well as in percent change. (p>0.000 for all). Finally, the simplicity of the product is based upon the easy to use ON button on the product controller which also shuts off automatically after each treatment period. 93% saw results in 2 weeks and Best of all, it works. 93% of users saw real results in as little as two weeks!" According to the marketer, self-assessment scores were progressive between the start of the study and week 8, with statistically significant improvements in some self-reported attributes by week 2 of use. At week 2, all but one of the patients showed improvement in at least one attribute. By week 8, 93% of all users self-reported an improvement in skin appearance. The marketer informed ERSP that it has qualified the 93% saw results in 2 weeks claim to more accurately indicate that the results were perceptible in as little as two weeks. Most people began to notice slight improvements at week 2, further improvement at week 4 and significant improvements by week 8. La Lumiere stated that fourteen (14) attributes were self-assessed during the 8-week clinical trial. The mean, median and median percent change from baseline for these attributes showed a general trend toward modest improvement at week 2, with additional improvements self-reported at weeks 4 and Consumer/Doctor Testimonials Trusted by doctors The marketer explained that the inventor of the illumask is a plastic surgeon and the principal investigator for the illumask is also a plastic surgeon. Furthermore, La Lumiere has established an advisory board with top dermatologists including in the light therapy field. The Acne illumask uses the same technology your dermatologist would use, but is designed for safe and easy use at home. Best of all, it is affordable, giving you an opportunity to incorporate a clinically proven acne skin care device into your daily regimen. [Dr. Z. Paul Lorenc] The marketer s support for characterizing the illumask as clinically proven has been explained in the previous sections of the Marketer s Position. La Lumiere relied on its scientific documentation which it maintained demonstrated that light therapy, which was originally only available in a dermatologist s office has been used for decades to treat acne. Further, as part of its position, the marketer has explained that the illumask is FDA-cleared for OTC home use and costs less than $1 per day (i.e., per treatment), which can be several times less than the cost in-office acne treatments. "After using the mask, all my acne's basically gone." [Brendan]

7 The marketer maintained that the results expressed in this testimonial are representative of the scores of the illumask study. More specifically, the median percent change from baseline was 73.3% (improvement) by week 8 and the mean percent change from baseline was 71.2% (improvement) by week 8. Further, the clinical assessment for the attribute number of inflammatory lesions demonstrated that the median percent change from baseline was - 100% (improvement) by week 8 and the mean percent change (improvement) from baseline was 82.8% (improvement) by week 8. Anyways, this is THE only thing that helps either keep my cystic acne from sprouting up or making it go away if I have any. [Jovan] La Lumiere re-iterated that the illumask is FDA-cleared for mild to moderate acne and that it has never stated or represented to FDA or the public that this product was intended for the treatment of cystic acne. The marketer stated that the user review was submitted to a third party website ( over which it has no control. The review software used pulls such reviews, positive or negative, into La Lumiere s computer systems, where they may be posted automatically to the illumask websites. La Lumiere asserted that it does not endorse the representation/review and does not use it as support for any cystic acne treatment claim. ANALYSIS According to a number of sources, acne is one of the most common, chronic skin diseases, affecting approximately more than 85 percent of teenagers and adults at some point in their lives. Current therapies to treat acne are targeted toward the multiple factors that contribute to it prevalence. For example, retinoids and anti-microbials, available in topical and oral formulation, remain the primary source of conventional acne therapy, adjunctive treatments including laser therapy are on the rise, as patients and clinicians seek to circumvent antibiotic resistance, reduce adverse effects, and employ new technologies in acne care. In the past several years, ERSP has evaluated the truth and accuracy of advertising claims for several light emitting acne treatments including the Tanda Zap hand-held light emitting acne treatment, the DermaStyle red and blue light acne treatment and the Zero acne treatment device. It is pursuant to this background that ERSP reviewed adverting for illumask, the first FDAcleared, hands free, LED light therapy skincare device for at-home use in the treatment of mild to moderate acne. 1. Performance Claims When evaluating the accuracy of advertising claims, there are two fundamental principles that were articulated in the Federal Trade Commission s ( FTC ) 1983 Policy Statement Regarding Advertising Substantiation which ERSP generally adheres to: a) Objective claims for products or services represent explicitly or by implication that the advertiser has a reasonable basis supporting these claims. These representations of substantiation are material to consumers; and b) Advertisers are required to have a reasonable basis for advertising claims before they are disseminated. The core efficacy claims disseminated in the subject advertising by La Lumiere for the illumask were categorized into two groups by ERSP: claims describing the product s laser technology and claims pertaining to expected results from using the product.

8 Bringing the Power of Light Therapy Home Low-level laser therapy (LLLT) was discovered in the late 1960s, but only recently has it been widely applied in dermatology. Published studies have indicated that acne often improves after exposure to blue visible light phototherapy and studies have also reported that red light may have anti-inflammatory properties by influencing the release of cytokine proteins. The marketer referenced a number of articles and studies demonstrating that lowlevel laser therapy is a fast-growing technology that is being used to treat a multitude of conditions that require stimulation of healing including, for example, relief of pain and inflammation and various skin conditions which, according to the literature, respond particularly well to red and near-infrared wavelengths. The materials provided by the marketer indicated that LLLT has been shown to provide beneficial dermatological effects on both wrinkles and acne scars, and has also been used to reduce UV damage both as a treatment and as a prophylactic measure. More specifically, the articles submitted by La Lumiere indicate that when used in combination, red and blue light have synergistic effects in treatment of acne. In addition, the literature indicates that light phototherapy has been proposed as an alternative therapeutic modality to treat acne vulgaris and was proposed to have fewer side effects compared with other treatment options. In addition to the four week study on the illumask which assessed the safety and efficacy of the illumask on mild to moderate acne and resulted in statistically significant improvements across all clinical endpoints, La Lumiere provided ERSP with an article from the Journal of Cosmetic and Laser Therapy entitled Combination blue (415 nm) and red (633 nm) LED phototherapy in the treatment of mild to moderate acne vulgaris. As noted by the authors, the results of the study indicated that combination of blue and red light therapy is a safe and efficacious treatment for acne vulgaris. A second article ( Phototherapy with Blue (415 nm) and red (660 nm) light in the treatment of acne vulgaris ) corroborated the marketer s position that phototherapy with mixed blue-red light is an effective means of treating acne vulgaris of mild to moderate severity. Notably, the illumask emits a similarly powerful combination of red light (630 nm) and blue light (445 nm) to treat mild to moderate acne. Accordingly, ERSP determined that the marketer provided appropriate support for its claims pertaining to the product s laser technology. Patented Light Array Technology The marketer supported this claim by producing both United States patents and corresponding foreign patents that cover the illumask and its various components. Moreover, La Lumiere called ERSP s attention to worldwide trademark registrations it has obtained for brands, product names, logos, slogans and taglines. FDA-cleared, No UV rays, no irritating chemicals, zero side effects* ; Safe for all skin tones and types including sensitive skin ; Safe, Pure and Powerful Light FDA-cleared, No UV rays, no irritating chemicals, zero side effects Safe, effective and effortless treatment for less than a dollar a day. Claims regarding the safety of the illumask were supported by published articles which expressly indicated that LLLT at the nanometer level emitted by the illumask was a safe, pain-free and easy to perform treatment for mild to moderate acne.

9 The marketer provided ERSP with the (k) clearance letter for the illumask from the FDA which determined that the product was substantially equivalent to the referenced predicate device previously cleared by the agency as an OTC medical device and did not raise any new issues of safety. In addition, there were no serious adverse events reported by either patients or the physician investigator in the 12-week illumask study provided to ERSP by La Lumiere. The marketer noted that no skin types identified in the industry accepted Fitzpatrick Classification Scale were excluded from this study. ERSP also determined the terms effortless and powerful in the context of the advertising were innocuous characterizations that did not warrant further examination. And that the dollar a day treatment description was justifiably based on the retail price of the illumask ($29.95) which includes 30 preloaded, 15 minute daily treatments. In sum, ERSP concluded the La Lumiere provided a reasonable basis for its safety and FDAcleared claims. Get clear and stay clear. Just put on the mask and get clear. and Get a clearer complexion and fewer breakouts with the illumask Anti-Acne Light Therapy Mask. By way of reference, in 2005, ERSP evaluated a Get Clear. Stay Clear claim made in advertising for the Murad Acne Skin Complex. Similarly, in a 2010 inquiry, ERSP concluded that the independent testing provided by the marketer had provided a reasonable basis for its general efficacy claims and representations that MaxClarity will help users get clear. In both of those matters, ERSP determined that the marketer had substantiated the clear claims based on a showing of a significant reduction in lesion counts. While ERSP certainly recognizes that the those two challenges involved OTC topical acne drug products and not a hand-free, red light and blue light device, it was also determined that the evidentiary criteria regarding a reduction in lesions counts was relevant and applicable. In particular, the Topical Acne Drug Product for Over-The-Counter Human Use; Final Monograph (56 Fed Reg ) states that: Any acne therapy that significantly reduces the lesion count over the first 4 weeks of treatment is effective in treating existing lesions. Any treatment that continues to reduce lesion counts beyond 4 weeks is actually preventing the development of new acne. Accordingly, if an ingredient has been shown to be effective in treating acne by reducing lesion counts over 8 weeks, it will lead to clear or almost clear skin. La Lumiere provided ERSP with the illumask study which was conducted over 12-weeks using an institutional review board protocol both for treatment and clinical photography. The primary clinical efficacy endpoint for the trial was improvement in inflammatory lesion count as compared to baseline. According to study results, both the appearance and number of pimples in test subjects were significantly reduced at week 4 and week 8. As noted in the study report, patients responded positively to the protocol and virtually the entire group identified significant improvements in their acne status. Also, the intensity of the new lesions was reduced in all parameters including size, inflammation and pain. For the reasons stated above, ERSP determined that the marketer supported its Get Clear. Stay Clear messages. Blue light energy kills the light sensitive P. acnes bacteria on and below the skin surface while the red light boosts your natural skin cell turnover and healing process to reduce swelling, inflammation, and redness. ; Eliminates the bacteria that cause acne ; Heals redness and inflammation from existing breakouts Helps prevent future breakouts Gives you clearer, smoother skin and Evens your skin tone and calms redness

10 As noted above, ERSP determined that the submitted scientific literature on LLLT and the marketer s testing on the advertised product provided a reasonable basis for the message that directed use of the product will be effective in preventing the development of new acne and, thus, it has been shown that the product Helps prevent future breakouts. In addition, ERSP reviewed several articles submitted by La Lumiere regarding the general efficacy of blue light in particular (at a similar emission level provided by the illumask). More specifically, it has been reported that blue light kills the acne-causing bacteria known as Propionibacterium acnes, or P acnes, which can cause inflammation. P acnes is sensitive to blue light. The blue light eliminates the bacteria found in the oil glands in the skin. The added presence of infrared light (heat) in the device causes the oil glands to shrink in size. The result is less oil in the skin and less bacteria, leading to the resolution of acne in the treated areas. ERSP agreed with the marketer that consequently, eliminating the bacteria from the skin with help from blue light decreases the inflammation associated with red pimples (papules) seen in acne. Similarly, the marketer s materials supported its position that red light therapy has been shown to penetrate deeper into the skin and provide many therapeutic benefits including improvement in the skin s appearance and structure (as well as relief from pain). According to the materials, red light has the ability to stimulate the production of adenosine triphosphate (ATP), an important source of energy in body tissues. ATP helps to increase blood circulation, which reduces swelling and inflammation. Increased blood circulation can benefit those with high blood pressure because good circulation allows the heart to do less work. Red light activated ATP stimulates white blood cells that work to repair damaged tissues, and increases collagen production that builds elasticity in the skin. It was noted in the marketer s evidence that red light at 633nm is absorbed by the mitochondria of the cell and stimulates this ATP production for enhanced cell vitality and permeability, increased production of new collagen, and increased turnover of collagen and elastin fibers. The illumask emits 630 nm per treatment. ERSP determined that this specific information on red and blue light therapy combined with results from the illumask study in which it was reported that there was a statistically significant improvement in the attribute skin smoothness at week 8, and appearance of redness associated with pimples at week 8, provided a reasonable basis for the marketer s specific product performance claims. The attribute overall skin clarity showed statistically significant improvement at weeks 4 and Establishment Claims Establishment claims are held to a very high standard of proof because they are, in essence, a promise that there is scientific evidence that establishes the truth of an advertiser s claims. Both the National Advertising Division of the Council of Better Business Bureaus, Inc. (NAD) and ERSP have traditionally looked to whether an advertiser has produced reliable and well-controlled clinical testing on the advertised product that can be readily verified in determining whether there is a reasonable basis for a clinically proven (establishment) claim for a product. Although the FTC will often require two reliable and competent studies to support an establishment claim, the advertising self-regulatory forums do not rigidly require that a specific number of tests be conducted as support for types of claims and, rather, focus their analyses on the quality, consumer relevance and reliability of the scientific study offered in support of an advertiser s clinically proven establishment claim. In the advertising at issue, the marketer presented its establishment claims in two different contexts. The first claim ( illumask is a simple, gentle, clinically-proven treatment for mild to moderate acne. Guaranteed results in 30 days. ) was presented in a general context.

11 As noted earlier in the decision, in addition to the scientific documentation regarding LLLT and its 510(k) submission and marketing clearance from the FDA, the marketer provided a 2013 study which assessed the safety and efficacy of the illumask over an 8 week period. The product was used as directed and both the principal investigator and the subjects recorded clinical outcomes using industry accepted various metrics, including the FDA Global Acne Severity Scale, lesion counts, patient s self-evaluations, standardized clinical photography and documentation of adverse events. More specifically, statistically significant improvements from baseline to week 8 were demonstrated using primary and secondary endpoints which included investigator ratings of inflammatory and non inflammatory lesions and patient self-assessments. Additionally, patient compliance and satisfaction rates were high and safety profile was strong. ERSP determined that the collective evidence provided by La Lumiere provided a reasonable basis for its general establishment claim regarding product performance. Similarly, ERSP concluded that statements in the advertising indicating that Best of all, it works. 93% of users saw real results in as little as two weeks! and Our clinical trials were conducted over 8 weeks of usage. Most people began to notice slight improvements at week 2, further improvement at week 4 and significant improvements by week 8. were appropriately communicated. As noted earlier in the decision, La Lumiere s 2013 study was conducted pursuant protocol and utilized measuring techniques that are accepted in the industry and its results were statistically significant. More specifically, La Lumiere provided data to ERSP demonstrating that a significant majority of test participants indicated that their skin appearance had improved after using the product for two weeks. The claim is also accompanied with qualifying information indicating that the results on patient selfassessment data. Notwithstanding the above determination, ERSP also determined that the marketer s representation of Guaranteed results in 30 days, which it acknowledged was a moneyback (i.e., and not a product performance) guarantee, could be presented more accurately. More specifically, as the FTC notes in its publication entitled Advertising and Marketing on the Internet: Rules of the Road, If your ad uses phrases like "satisfaction guaranteed" or "money-back guarantee," you must be willing to give full refunds for any reason. You also must tell the consumer the terms of the offer. Moreover, the BBB Code of Advertising states that When using the term warranty or guarantee in product advertising, the advertiser must clearly and conspicuously include a statement that the complete details of the warranty can be seen prior to sale at the advertiser's location, viewed on the advertiser s website or, in the case of mail or telephone order sales, made available free on written request. and that [w]hen satisfaction guarantee or similar representations are used in advertising, any material limitations or conditions that apply to the guarantee must be clearly and conspicuously disclosed. On the illumask website, the money-back guarantee is presented three different times. On the top of the opening page of the website, the marketer expressly communicates its 30 day no risk trial and provides an immediate link to the specific terms of the money-back offer ( Try illumask for 30 days; If you re not happy, return the mask and controller within 45 days of purchase; We will refund you the purchase price (less any s&h) ) along with a customer service to call and an address to facilitate the request. ERSP determined that the marketer s money-back guarantee in this context, was adequately communicated and that the terms of the offer were disclosed.

12 However, if a consumer scrolls down the opening page of the illumask website, the marketer makes two more claims regarding the money back guarantee ( We guarantee clearer skin in as little as four weeks and guaranteed results in four weeks ) that do not include the details of warranty or link to a disclosure that provides more information. As noted above, both the BBB and the FTC indicate that online reference to a money back guarantee should be clearly and conspicuously disclosed in close proximity to the claim. Accordingly, ERSP recommended that La Lumiere should include links to the specific terms of the money-back offer anytime the money-back guarantee is communicated on the website. ERSP also noted that on the Blog tab of the illumask website, a link entitled money-back guarantee can be found at the very bottom of the page, but the link cannot be opened. ERSP also reviewed the risk-free money back guarantee as advertised in the broadcast advertising. More specifically, ERSP reviewed two short-form commercials. In one version, the marketer clearly presents its 30 day money back guarantee while the other presents the guarantee as a 90-day guarantee which would appear to be inconsistent with the specific terms of the 30 day money-back offer (more notably, that consumers must return the mask and controller within 45 days of purchase) provided on the website. Accordingly, ERSP recommended that the marketer reconcile the use of the two different money back guarantees that are communicated in the broadcast advertising and include a disclosure in the broadcast advertising that either provides the specific terms of the moneyback offer or directs consumers to the illumask website for the specific details of the money back offer. 3. Consumer/Doctor Testimonials ERSP determined that the Trusted by doctors claim was not a core claim in the illumask advertising and, in fact, the marketer is not presently disseminating the claim in this context on the illumask website. The only similar claim currently being communicated on the website is that the illumask was developed by doctors, a representation that was consistent with the marketer s product background information. With respect to the consumer testimonials featured in the illumask advertising, as noted in section 255.1(a) of the FTC Guides, consumer testimonials may not contain any representations which would be deceptive, or could not be substantiated if made directly by the advertiser and must reflect what other users of the program and/or product can generally expect to experience. Further, according to section 255.2(b) of the FTC Guides, [a]n advertisement containing an endorsement relating the experience of one or more consumers on a central or key attribute of the product or service also will likely be interpreted as representing that the endorser s experience is representative of what consumers will generally achieve with the advertised product or service in actual, albeit variable, conditions of use. Therefore, advertiser should possess and rely upon adequate substantiation for this representation. If the advertiser does not have substantiation that the endorser s experience is representative of what consumers will generally achieve, the advertisement should clearly and conspicuously disclose the generally expected performance in the depicted circumstances, and the advertiser must possess and rely on adequate substantiation for that representation. ERSP determined that that the consumer testimonial stating "After using the mask, all my acne's basically gone" was not an atypical result and consistent with the testing data in the case record. Similarly, the statement from Dr. Lorenc ( The Acne illumask uses the same technology your dermatologist would use, but is designed for safe and easy use at home. Best of all, it is affordable, giving you an opportunity to incorporate a clinically proven acne skin care device into your daily regimen ) specifically pertains to the low level light technology used by the illumask and would not be reasonably interpreted by consumers as a

13 comparative performance claim for the product versus dermatological treatments. Accordingly, ERSP determined that the marketer provided adequate support for the two week claims of product performance. As noted earlier in this decision ERSP determined that the marketer adequately supported its establishment (i.e., clinically proven ) claims for the product. Lastly, the claim that was submitted as a consumer comment to a third party website stating that the illumask is THE only thing that helps either keep my cystic acne from sprouting up or making it go away if I have any, while clearly outside the indicated use of the product (i.e., the illumask has been FDA cleared for mild to moderate acne) was an isolated statement that would not be considered a core claim in the advertising pursuant to 1.1(C) of the ERSP Policy and Procedures and is thus outside the jurisdictional purview of ERSP s review. Additionally, as noted by La Lumiere, the company has no editorial control of third party websites that solicit consumer feedback. In closing, ERSP does note that that product indication of use for mild to moderate acne is material information for consumers and while this qualification is adequately disclosed in the broadcast advertising at issue, the illumask website does not include a similar, clear and conspicuous disclosure. Accordingly, ERSP recommends that the marketer include the qualification that the product has been cleared specifically for mild to moderate acne prominently on the illumask website. CONCLUSION ERSP determined that the marketer provided appropriate support for its claims pertaining to the product s laser technology and its Get Clear. Stay Clear messages. ERSP also determined the terms effortless and powerful in the context of the advertising were innocuous characterizations that did warrant further examination. And that the dollar a day treatment description was justifiably based on the retail price of the illumask ($29.95) which includes 30 preloaded, 15 minute daily treatments. In addition, ERSP determined that La Lumiere provided a reasonable basis for its general establishment claim regarding product performance and that its quantified percentage claims were reasonably communicated. ERSP did recommend that the marketer reconcile the use of the two different money back guarantees that are communicated in the broadcast advertising and include a disclosure in the broadcast advertising that either provides the specific terms of the money-back offer or directs consumers to the illumask website for the specific details of the money back offer. Lastly, ERSP concluded that that testimonial claims used in the illumask advertising were appropriate and that the consumer reference to the product s efficacy on a third party website regarding cystic acne was not within the editorial control of the marketer and was also not a core claim in the advertising. MARKETER S STATEMENT La Lumiere appreciates ERSP's review and confirmation of the illumask claims. We will review and consider implementing the recommendations for the guarantee statements in the broadcast advertising and on the website. We will also review the prominence of the website qualification about use in individuals suffering from mild to moderate acne. La Lumiere is committed to improving people's lives by way of light therapy and making this technology affordable and accessible to consumers everywhere.

14 (#365 PCM, closed 5/5/2015) Copyright Council of Better Business Bureaus, Inc.