The Applications and challenges of Probiotics/ Postbiotics in Cosmetic and personal care products

Shengquan Huang, Hailing Wang, Xiaolan Wang

Renhe Global (Shanghai) Big Health Research Institute Co., LTD. Guangfu West Road No. 2666, Putuo District, Shanghai 200333, P.R. China

*Corresponding author

*Shengquan Huang, Renhe Global (Shanghai) Big Health Research Institute Co., LTD. Guangfu West Road
No. 2666, Putuo District, Shanghai 200333, P.R. China

Abstract

Probiotics, defined as “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host,” are becoming increasingly popular and marketable. However, too many products labeled as probiotics fail to comply with the defining characteristics. In recent years, the cosmetic industry has increased the number of products classified as probiotics. While there are several potential applications for probiotics in personal care products, e.g., oral, skin, and personal care, proper regulation of the labeling and marketing standards is still required to guarantee that consumers are indeed purchasing a probiotic product. Postbiotics were defined as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the target host.” Actually, most of the cosmetic industry’s probiotic products belong to inactivated probiotics or postbiotics products. This review explores the current market, regulatory aspects, and potential applications of probiotics in the personal care industry.

Keywords: Probiotics; postbiotics; cosmetics; lysates; microbiome

Introduction

According to the U.S. Food and Drug Administration (FDA), a cosmetic is defined as “a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” This definition applies to products for skin, hair, and oral care. It is important to note that this description does not include any health claims. Using beneficial microbes to manipulate the microbiome in a given niche in favor of health has grown substantially in the field of products. Nowadays, the market for postbiotics products has maintained robust growth momentum worldwide. Postbiotics, defined as extracts of non-viable probiotics and comprising cell membrane components such as surface proteins, lipopolysaccharides, teichoic acids, etc., can be single metabolites or complex mixtures [1].

The market for probiotics/postbiotics in cosmetic applications is projected to snowball in the next ten years. This article will explore current research on probiotics/postbiotics for potential cosmetic and personal care applications and how “probiotic cosmetics” are currently being marketed.

Cosmetics for skin

The increase in products termed probiotic on the market does not necessarily equate with a reason to celebrate the successful translation of science to commerce and consumers. Too many products fail to comply with the characteristics of probiotics. Many false claims and rampant misuse of the term have resulted in mainstream consumer channels providing incorrect information to consumers. Probiotics are not inside us, not in fermented food, and not necessarily better if there are more species or a higher viable count. Formulations are being concocted not based on research evidence but on marketing and what might appeal to consumers. For example, products are being composed supposedly to improve oral health using strains not documented to compete with urogenital pathogens, improve immunity or do anything that can restore homeostasis to that region of the body. In other words, there are no data to support their selection. Yet, the internet, the use of words to reach the first page of search engines, and the use of pseudo-experts for promotion provide a means for these products to be highly rated and appear to be the best clinically documented for preventing or curing pathogen infections in the skin or vagina. The net result is misleading and confusing to consumers, making personal care professionals leery of the whole field of probiotics. To counter this, we need to re-state essential facts. For a product to be considered probiotic, it must comply with three core characteristics: 1. The strain(s) must be characterized, including genetically and phenotypically, and a rationale given based on documented experiments published in peer-reviewed papers for their inclusion in the intended use. 2. The product must contain sufficient efficacy at the time of use that is equivalent to when the product was shown in clinical studies to confer a benefit to the desired target site. 3. The delivery method, dosage, and duration of use should be based on scientific evidence in humans if humans are the intended recipient. It makes it difficult for potential users if the product label does not state strain designations because tracking the research performed on the contents becomes impossible. Dosages are rarely stated on labels, and some products only contain filtered extracts, ferments, or lysed bacteria, meaning that no live microorganisms are present. Thus, the product is not probiotic, and the term should not have been used.

The cosmetic industry has quickly entered this space by focusing its efforts on skincare. There are several areas of opportunity and great value in this concept. To date, hundreds of products are already being commercialized with a claim to contain probiotic or postbiotics cosmetics in China. Figure 1 shows a word cloud with the top 30 terms used in their statements. Most are for skin care, while some are for deodorants and hair care. The most common claims are geared towards “balancing” the skin microbiome, improving the skin barrier, and enhancing the skin’s overall appearance. The type of probiotic products targeted for skincare usually involves cream, serum, mask, gel, exfoliant, cleanser, foundation, soap bar, balm, or primer deodorant. And the ingredients of these products mainly include Lactococcus ferment lysate, Lactobacillus ferment, Bifida ferment lysate, Streptococcus thermophiles ferment, Bacillus coagulans, Saccharomyces ferment filterate, Lactococcus ferment extract, Leuconostoc ferment filtrate, etc.

These claims by themselves require critiquing. There is no single healthy skin microbiome, so what would it take to “balance” the one that a given individual possesses? Furthermore, the skin has many layers, with microbes detected in the dermis, adipose, follicle, and epidermis [2]. A product claiming to “balance” the microbiome should have studies indicating in many subjects, preferably thousands, how a given probiotic product changes the various layers of microbiota in such a way as to restore and maintain it to what is deemed healthy for each individual. Since it seems highly unlikely that such studies have been performed for most products, claims of balancing the skin microbiome should not be made. It is vital because consumers like the sound of products that do that, especially since terms like “microbiome” and “balance” are widely used.

Enhancement of the skin’s overall appearance can be subjective for consumers, but it also has some scientific principles. Factors such as contrast reduction, visible aging marks or spots, skin color, melanin, and hemoglobin can be measured [3]. Assessments provide the means to give tangible results that can then offer substance to claims of improvements. The ability of specific probiotic strains to improve epithelial and epidermal barrier function has been reported. The latter is so critical in the function of the skin and a well-used target for making claims that appeal to consumers. If strains being used as cosmetics do indeed improve barrier function, experiments can be performed to verify this. Indeed, researchers from a well-renowned cosmetic company have shown that a lysate from the probiotic Bifidobacterium longum Reuter strain could decrease vasodilation, edema, mast cell degranulation, and TNF-alpha release, and using trans-epidermal water loss to assess barrier function, showed improvement with application of the lysate containing product [4]. Some products state that they include a filtrate of either ferments or lysates. In the case of filtrates, bacterial cells (alive or not) are removed along with potentially some other large-weight molecules (e.g., peptides). Some bioactive compounds and bacterial cell compnents might be removed during these processes. Therefore, filtrates are excluded from the definition of postbiotics and cannot be deemed probiotics.

Lysates are cells whose outer membrane has been broken down due to chemical or physical processes [5]. These preparations have been used in medical practice as immunomodulators for fifty years. They can contain bacterial components that up-regulate the immune response of the host cells; they are particularly effective in managing skin issues [6]. Although there is value in using these types of preparations, further studies are still required on a strain-dependent basis before drawing conclusions and making claims. The cell composition, elasticity, and activation of macrophages differ between bacterial strains, even within the same species [7]. In one study, lactobacilli lysates altered their ability to increase the re-epithelialization of keratinocytes [8], again emphasizing the need to check strain properties before making claims. Notably, little has been reported on the chemical composition of the lysates used in cosmetics. This should require cell wall and analysis, including the use of liquid chromatography–tandem mass spectrometry (LC-MS/MS)-based metabolomics [9] or newer methods such as surface-enhanced Raman spectroscopy (SERS) [10]. In doing so, it will soon be highly apparent that metabolite types and quantities differ between strains; therefore, their application to human tissues would also differ. This again illustrates the need to perform tests in humans with whole microbial cells, lysates, or filtrates to show what activity is being promoted by applying any given product, ideally to know which component of the lysate is responsible.

Figure 1: The top 30 words used in the claims of probiotic products. Word cloud generated using a compilation of the shares of at least 50 products claiming to contain probiotics.

Numerous studies provide evidence of the benefits of specific postbiotics for skin health [11-13]. Meanwhile, anti-ageing mechanisms suggest strains can help regulate pH, reduce oxidative stress, protect from photoaging, and improve skin barrier function [14]. However, the cosmetic industry needs to be consistent and transparent in its labelling practices and direct efforts to generate more scientific evidence before making claims.

Topical delivery and formulation of probiotics

Not all applications for skincare for males or females require a local application. Orally administered probiotics have been demonstrated to affect the intestinal microbiome leading to a potential improvement in skin conditions such as atopic dermatitis, acne, and/or rosacea [15-18]. Early studies suggested that probiotic may be required during gestation and early life to reduce the incidence and adversity of atopic dermatitis [19], implying immune modulation and improving the maturing gut barrier function [20].

Freeze-drying of probiotic strains is common place. However, depending on the drying protectant used, final viability can vary. The most used protectants are skim milk, serum, trehalose, glycerol, betaine, adonitol, sucrose, glucose, lactose, and polyethylene glycol; these may not be compatible with the intended use of the product or the physicochemical characteristics of the formula [21]. When using this method, the strains should not be exposed to water; otherwise, they will prematurely rehydrate [22]. It is challenging for the cosmetic industry to create topical formulas that retain probiotic bacterial viability from production to the value chain and the consumer. Moisture would allow the dried organisms to hydrate and multiply or die, so oil-based formulations are needed. The question becomes how easily the organisms can emerge from the oil once placed on the skin and thence become metabolically active sufficient to deliver the probiotic effects required. In addition, many creams are not produced in sterile conditions; therefore, preservatives are often added with bactericidal and/or bacteriostatic effects. These potentially can affect the probiotic strain viability and inadvertently alter the recipient’s microbiota.

Regulation of probiotics is primarily concerned with safety. There is no specific requirement for commercializing probiotics, and products are regulated according to their final use, whether as a drug, medical device, food, dietary supplement, or cosmetic. The descriptiveness and level of documentation required to claim a cosmetic probiotic are substantially less than for one making drug claims in China and elsewhere. However, to maximize profit, some companies make disease or illness-alleviation statements associated with their cosmetic products, when this should be reserved for drugs or clinically proven supplements.

Due to safety concerns, cosmetic products are expected to have a low content of microorganisms. It is not a viable option for them to contain live bacteria, meaning that there cannot be a cosmetic that is a true probiotic. However, they can still have components sourced from probiotic strains that could be beneficial. These can constitute bacterial lysates, ferments, and filtrates, sometimes referred to as postbiotics, defined as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the target host. [23].” This definition does not include purified metabolites or components without cells, which should be listed following their chemical nomenclature. Filtrates without cell components are not considered postbiotics. However, depending on their composition, bacterial lysates and ferments might fit into this category.

However, as shown in Figure 2, from the ingredients in the labels of at least the 50 cosmetic products we analyzed, none of them stated the strain designation of the microorganism included, and the only minority of the listed ingredients had the name of the species used. Those products listing probiotic use included it on their labels as “probiotic ferment lysate,” documented as an inactivated suspension of probiotics in an aqueous medium, which, as previously described, can improve barrier function as well as decrease skin sensitivity. Nonetheless, products containing this ingredient cannot be marketed as probiotics due to the absence of live bacteria.

With proper regulations in place, and potentially labelled as over-the-counter (OTC) drugs instead of cosmetics, there is value in using probiotics as topical treatments. Their antibacterial and immunomodulatory properties make them promising candidates to target skin ailments such as acne, psoriasis, and atopic dermatitis, and aid in wound healing [16, 18, 24-27]. Nonetheless, further human research and randomized clinical trials are still required to validate these potential uses.

Figure 2: Debrief of the ingredients listed in 50 cosmetic products. Panel A shows the frequency in which each microbial component was included. Panel B shows the frequency in which each type of preparation was used in the products analyzed.

Probiotics for Female Intimate Care

A abundance of lactobacilli mostly populates a healthy vaginal environment. Various triggers, from the use of douches and antibiotics to multiple sexual partners and influx of pathogens into the area, disrupt the homeostasis giving rise to bacterial vaginosis, urinary tract infections, candidiasis, and other conditions. This provided a rationale to supplement the urogenital tract with lactobacilli to restore a healthy state. Therefore, the vaginal administration of probiotic strains of Lactobacillus through suppositories or vaginal ovules has been explored [16]. A range of strains have been tested, including Limosilactobacillus (formerly Lactobacillus) Reuteri RC-14 and Lactobacillus crispatus CTV05 to reduce the recurrence of urinary tract infection (UTI) [28, 29], Lacticaseibacillus rhamnosus IMC 501 in combination with Lactobacillus paracasei IMC 502 to maintain vaginal homeostasis [30] and L. rhamnosus Lcr35 for B.V. and vulvovaginal candidiasis [31, 32].

Given the significant negative impact of antimicrobial therapy on the urogenital microbiota and failure to restore homeostasis, probiotic strains have been used in combination to help with recovery. These include Lactobacillus gasseri EN-153471 (EB01) for the management of B.V. [33] and L. rhamnosus GR-1 plus L. reuteri RC-14 in combination with antibiotics or antifungals [34]. Additional strains have become available in the American market with minimal clinical and scientific documentation [35]. The supplements are believed to function through an ascension from the rectal skin to the vagina, where they reduce pathogen ascension and inhibit and displace pathogens while also conferring antimicrobial defenses through the production of bioactive compounds such as lactic acid, hydrogen peroxide, and bacteriocins. Therefore, these are essentially cosmetic in action on the skin. Still, they are promoted through a higher level of regulation where some functional, structural, or even disease risk reduction claims can be made. The application of strains directly into the vagina using suppositories applied vaginally is approved in China. Other products are being delivered through coating tampons and pomades, but further evidence is required to confirm they are probiotics and benefit the host.

An emerging area is for probiotic strains to reduce urogenital malodor that significantly impacts the quality of life of women, especially in combination with bacterial vaginosis [36]. Many non-probiotic products such as vaginal douches, vinegar rinses, and fragrances claim to help reduce malodor. However, their efficacy is dubious, and they can increase the risk of infection, including sexual acquisition, by disrupting of the beneficial microbes [37, 38]. An advantage of an effective probiotic is its ability to grow and produce metabolites that degrade or neutralize malodorous compounds [39, 40]. Depending on the nature of such a product, it may have to be registered as an OTC drug and not as a cosmetic or personal care product. The development of topical gel containing probiotic lactobacilli is already underway, with promising results for treating vulvo-vaginal candidiasis [41].

It could be argued that applications in the urogenital tract do not strictly fall within the definition of a cosmetic intended to restore or improve a person’s appearance. Likewise, applications for reducing halitosis [42-44] may also not fit, depending on how‘appearance’ is defined and interpreted. Reducing acne symptoms with lactobacilli in a topical cream would work as a cosmetic [45].

Conclusion:

The recognition that certain types of microbes provide health benefits to the host and that the human body and planet are filled with microbes has brought new opportunities to managing personal and ecosystem health. Companies in all business spheres, including cosmetics, have used this knowledge to develop new products and increase profits. Terms such as probiotics, prebiotics, postbiotics, and microbiome were unheard of in cosmetic products twenty years ago. Their use would be encouraging if it coincided with solid scientific research supporting claims and uncovering the mechanisms of action of the strains and material being promoted. However, this is rarely the case. While chemistry is a mainstay of the cosmetic field, it has not been sufficiently well applied to identify the molecules responsible for the benefits provided by microbial products. Given microbiome field’s expansion, microbiology and chemistry expertise will be needed to ensure high-quality cosmetics adhering to definitions (of a probiotic, prebiotic, etc.) can reach consumers.

There is no question that the modulation of microbes can lead to novel ways to improve appearance and well-being. This will provide regulatory challenges as it brings cosmetic products into the health realm. While advocating the need for regulatory agencies to upgrade their often-antiquated systems and categories, we must insist on product safety, clinical verification, and proof of using high standards for handling, storing and applying products containing microbes and their metabolites or cell walls. Unproven claims help no-one, whereas reasonable scientific investigation can bring products of great merit to human health and well-being.

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