Hindustan Unilever Limited - Novology Acne Reduction Regimen (Acne Reduction Cleanser and Serum)

Recommendation: Upheld | Medium: Suo Motu - NAMS (TAMS)

The CCC-R Decision The CCC-R panel viewed the Facebook advertisement and considered the advertiser’s submissions for Review. The CCC-R panel observed that the advertiser has relied on the clinical studies and the consumer study conducted for support of the claim made. The CCC-R panel discussed that the product’s ability to reduce acne is attributed to the presence of the ingredients - Thymol and Terpineol contained in the product. These ingredients show a substantial log reduction in antimicrobial efficacy against C. acnes in in-vitro condition. The antimicrobial effectiveness of Thymol and Terpineol demonstrates log decrease of C. acnes in a leave-on formulation. The CCC-R panel further discussed that the clinical study for Acne Reduction Serum was evaluated for acne removing effect of facial essence and skin physiological state. The results indicate that the acne decreased significantly from week 1 (day 7) compared to the baseline. The clinical study on Acne Cleanser was done to demonstrate the anti-acne benefit of cleanser cell and regime cell (cleanser plus moisturizer) containing Thymol and Terpineol on acne following 4 weeks of application and 7 days of regression (no application of test products). The product tested showed improvement in inflammatory, non-inflammatory, and total acne lesion counts during the course of the study. The findings show the change from baseline of acne where a significant difference is seen at day 7. The CCC-R panel noted that in the clinical investigation, the inclusion criteria was that the subjects were suffering from mild to moderate global acne. According to their clinical research the product starts reducing acne from day 7. However, while the advertiser has been able to show that the Serum and Cleanser reduces acne from day 7, there were a few concerns expressed by the CCC-R panel. The advertisement does not make it clear that the product works for mild to moderate acne. From a consumer standpoint, they would not be able to determine if their acne is mild, moderate, or severe, and would believe that any type of acne can be treated by using the aforementioned product, which would reduce acne from day 7. Based on this assessment, the CCC- R panel concluded that the claim, “Serum & Cleanser: Reduces acne from day 7”, is misleading by ambiguity. The said claim in the advertisement contravened Chapter I, Clause 1.4 of the ASCI Code. The earlier decision of complaint being Upheld stands on Review. Re-examination Post receiving the CCC recommendation, the advertiser had a telecon with the ASCI Secretariat to discuss their submissions for the claim, “Acne Reduction Cleanser: Prevents moisture from stripping”. During the telecon, they referred to a clinical hydration study which was submitted with their earlier response. Further for the claim, “Acne Reduction Cleanser: Prevents moisture from stripping”, the advertiser in their written response stated that, “The Hydration Clinical having Report ........ has been shared vide email ...... and is performed on Novology’s Acne Reduction Cleanser having code AAC 01 given on page 16 of the report. There is no discrepancy between the product on which the clinical is conducted vs the FDA licenced formulation. The Hydration Clinical is carried out on the Low cost Glycinate Cleanser formulation which includes all the surfactants and not on only Glycinate which demonstrates that the Cleanser does not cause dryness and is non stripping”. The CCC viewed the Facebook advertisement and considered the advertiser’s submissions for Re-examination of the CCC recommendation. The CCC observed that the advertiser has submitted a clinical study from a third party laboratory in support of the claim. They have also provided product approval licence along with product composition details for Novology Acne Reduction Cleanser. The CCC discussed that the clinical hydration study was conducted to evaluate the efficacy of test products in maintaining skin hydration in Female participants. The test products involved in the study were cleansers, sunscreens, skin cream, body lotion, sunscreen gel, and sunscreen gel lotion. The advertiser has confirmed that the product listed in the study as `Acne Reduction Cleanser with code AAC 01’ is their product - Novology's Acne Reduction Cleanser. The CCC further took note of the advertiser’s response that there is no discrepancy between the product on which the clinical is conducted and the FDA licenced formulation. The CCC further discussed that the corneometer readings indicate that the tested product (AAC 01) shows significant improvement in skin hydration as compared to the baseline and untreated groups. The hydration increases quickly upon cleansing and remains significant for up to 24 hours when compared to the baseline. The product also significantly reduces trans epidermal water loss as assessed by Tewameter. Based on the hydration testing results, it can be concluded that the promoted product - 'Novology Acne Reduction Cleanser' can maintain hydration and does not induce skin dryness. The CCC concluded that the claim, “Acne Reduction Cleanser: Prevents moisture from stripping”, was substantiated. The said claim is not in contravention of Chapter I of the ASCI Code. This complaint is Not Upheld on Re-examination. CCC Recommendation The CCC discussed that the advertiser has used the term regimen, which, according to the clinical study report, refers to using a cleanser followed by gel. The CCC then deliberated that the product used in the clinical study differs from the one represented in the FDA-licensed formulation. The list of ingredients present in Ponds clear balance anti-acne essence which represents the serum formulation and is used in the clinical study is different from the list of ingredients mentioned in FDA Lic of Novology Acne Reduction. The ingredients - Witch hazel extract, centella asiatica extract, disodium glycyrrhizate, cannabis sativa seed oil, etc are enlisted in the anti-acne essence but are not present in the serum formulation. This discrepancy in the list of ingredients for both the formulations may affect the efficacy of the products, hence the claims cannot be validated. The CCC further discussed that the clinical study has assessed the inflammatory, non-inflammatory, and total acne lesions that contribute to acne-related disorders. According to this study, these lesions have decreased from baseline but are not totally eradicated. The term "good bye to acne" suggests that all acne-related issues are completely resolved, which is not the case. The CCC then deliberated that the advertiser has provided a clinical trial document evaluating the cleanser's anti-acne effect. According to the questionnaire replies, less than 50% of individuals agree to the questions at week one, i.e. after 7 days; however the other data indicates that the acne lesions improve from day 7. The CCC further discussed that according to the clinical study, the cleanser reduces acne from day 7. However, the study does not reveal the cleanser's actual composition. Without this data, it is impossible to determine whether the study was conducted on the final formulation. Similarly, the serum product descriptions list only three ingredients rather than the final formulation. The addition of ingredients such as skin conditioning agents and humectants may affect the safety and efficacy of the final formulation. Thus, while the active ingredients demonstrate a reduction in acne from day 7, the claim that the final formulation reduces acne from day 7 cannot be supported. The CCC then discussed that the advertiser has submitted the final formulation data. It is not clear that the annexure named Product code A which contains Thymol and Terpineol both in the range of 0.045 to 0.055 is provided for which type of formulation. The Product code B is a placebo formulation. The LCG product cleanser formulation list provided does not match with the one provided earlier by the advertiser. The ingredients like PEG 150 distearate, sodium hydroxide etc are missing in the LCG product cleanser formulation list used in the clinical study. The acne cleanser's formula includes sodium lauroamphoacetate, decyl glucoside, lauroamidopropyl betaine, and PEG-150 distearate as surfactants. The letter submitted refers to sodium cocyl glycinate as a surfactant, when the annexure describes it as a skin conditioning agent. The literature on surfactants supports the claim that certain surfactants are less irritant than soap. The literature support on Surfactant vs Glycinate Cleanser provides evidence in the form of a clinical study conducted in-house rather than by a third party that glycinate is a mild conditioning surfactant. The hydration clinical trial demonstrates that low-cost glycinate is a mild surfactant that improves hydration and reduces dryness. However, neither of these documents provide evidence that the other surfactants are mild or do not cause dryness. According to the Hydration study data provided by the advertiser, the cleanser can maintain hydration and does not cause skin dryness; however, the claim cannot be substantiated due to a discrepancy in the list of ingredients present in the formulation used in the clinical study and the FDA licensed formulation. Based on this assessment, the CCC concluded that the claim, “Regimen: Say goodbye to acne with our travel-friendly Acne Reduction Regimen!”, was inadequately substantiated. The claim is misleading by exaggeration, and is likely to lead to widespread disappointment in the minds of consumers. The source for the claim is not indicated in the advertisement. The said claim in the advertisement contravened Chapter I, Clauses 1.1, 1.2, 1.4 and 1.5 of the ASCI Code. This complaint was UPHELD.