SKIN MICROBIOME


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Much of the time, these decisions determine whether a product is categorised as cosmetic or medical. This in turn has implications for product positioning as well as regulatory ramifications. Increased understanding of the skin


microbiome will continue to stimulate new health and beauty market segments. Ultimately, brands need to draw on wide ranging expertise to turn those new ideas into marketable products that have trustworthy claims and scientifically substantiated benefits. Personal care businesses that colonise this evolving territory with compelling, compliant skincare products which consumers will love are set to flourish.


References 1. Costello EK, et al. Bacterial community variation in human body habitats across space and time. Science. 2009;326:1694–1697. A comprehensive analysis of skin, gut and oral microbiota in the same individuals.


washing. These habits are unfavourable to a stable skin microbiome, as explained by Ghita Lanzendorfer-Yu in her skin microbiome article featured in Personal Care Asia Pacific.11


Developing a regulatory strategy Creating new products that enable consumers to understand, balance and protect their skin microbiome presents various challenges. Some of these relate to practical matters, such as the formulation and packaging of products containing live ingredients. Others are linked to the accurate diagnosis of skin problems or proving the effectiveness of treatment. Another area that needs to be considered at an early stage in product development is the regulatory environment. This is a complex area, especially for products


that walk the line between beauty and medical treatment. There can also be a lack of harmony in the requirements of different markets which may complicate global product strategies. Many aspects of topical products – from claims made about them to the nature and quantities of active ingredients they use – need to come under scrutiny here. Take the EU market. Manufacturers of beauty


products making microbiome claims need to pay close attention to Commission Regulation (EU) No 655/201312


which lays down common criteria


for the justification of claims used in relation to cosmetic products. In the US, the Food and Drug Administration


(FDA) sets general guideposts for the types of claims that can be made in the Federal Food Drug and Cosmetic Act (FD&C Act). It also determines whether products should be marketed as a cosmetic or a drug, which depends in part on their intended use. Some products may be considered a cosmetic and a drug, for instance if they have two intended uses. The FDA cites the example of anti-dandruff shampoo: “A shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug.”13


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could face a similar scenario, depending on how they are positioned. Technologies used in the diagnosis of


skin microbiome issues may also encounter regulatory challenges. The FDA has previously issued warning letters to the manufacturers and distributors of some personal care products explaining that while they are intended to affect a person’s appearance: “The fact that they are intended to diagnose or treat a medical condition or affect the structure or function of the body makes them medical devices under the FD&C Act.”14 The repercussions of this are significant;


unlike cosmetics, medical devices must obtain FDA clearance before they are offered for sale in the US. This can be a lengthy and costly process that requires expert navigation.


Maximising the skin microbiome opportunity Given the regulatory challenges, it is perhaps not surprising that the above-mentioned S-Biomedic plans to release its acne treatments as consumer products rather than certified medical products. CEO, Veronika Oudova, estimates that the medical route would require up to ten additional years of clinical trials.4 Decisions like this require expert input


to ascertain the likely long-term costs and benefits of opting for a particular regulatory path. The same is true of judgements related to personal care technologies and ingredients used in products for the diagnosis or treatment of conditions related to the skin microbiome.


2. Grice EA, Segre JA. The Skin Microbiome, US National Library of Medicine National Institutes of Health, 2013 https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3535073/


3. Why You Need to Start Paying Attention to Your Skin Microbiome – Especially Now, Lauren Valenti, Vogue, March 2021 https://www. vogue.com/article/how-to-maintain-skin- microbiome


4. Smith J. Skin Microbiome Biotechs Get Funding Boost, Labiotech, February 2019 https://www.labiotech.eu/more-news/skin- bacteria-acne-microbiome/


5. Paradigm Change in Skin Health: Novel Microbiome-based Cosmetics for Acne and Other Skin Conditions, Cordis, February 2020 https://cordis.europa.eu/project/id/890930


6. Eligo Bioscience inks deal with GSK potentially worth up to $224 million, January 2021 https:// eligo.bio/gsk-deal/


7. L’Oreal signs license agreement with Dutch biotech Micreos, October 2020 https://www. loreal.com/en/press-release/research-and- innovation/l-oreal-signs-license-agreement- with-dutch-biotech-micreos-world-leader-in- targeted-bacterial-bi/


8. Israeli biopharma firm BiomX raises $32 million in private funding https://www.reuters. com/article/us-pharmaceuticals-biomx- fundraising-idUSKCN1Q91Q4


9. Skin care products with bacteriophages, Bacteriophage.news https://www.bacteriophage. news/skin-care-products-with-bacteriophages/


10. https://www.sequentialskin.com/ 11. Lanzendörfer-Yu G. The skin microbiome analysed, Personal Care Asia Pacific 2019;(4)20:33-36


12. Common Regulation (EU) No 655/2013 https://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=CELEX%3A32013R0655


13. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), FDA https://www.fda.gov/cosmetics/ cosmetics-laws-regulations/it-cosmetic-drug- or-both-or-it-soap


Products that treat skin microbiota


14. Warning Letters Highlight Differences Between Cosmetics and Medical Devices, FDA, https:// www.fda.gov/cosmetics/warning-letters- related-cosmetics/warning-letters-highlight- differences-between-cosmetics-and-medical- devices


September 2021 PERSONAL CARE


PC


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