Providing clarity on “microbiome-friendly” claims

The microbiome has turned mainstream in the personal care world. Consumers are attracted to skin care products that have been formulated to leave the skin microbiome – and thus its protective functions – intact. Products with claims about the microbiome have enjoyed rapid growth over the past few years, and projected growth estimates are optimistic. However, the industry as a whole is struggling with practical questions about how the healthy microbiome can be defined, and what type of evidence is needed to support package claims.

BaseClear recently interviewed a representative panel of industry experts from a range of different companies to ask them about developing microbiome-friendly products.

What is “microbiome-friendly”?

Microbiome-friendly products are designed to maintain the normal, healthy composition and function of the microbiome. The product ensures that the diversity and structure of the microbiome is retained during use. Whilst the skin microbiome receives the most attention, there is also interest in other areas such as the oral microbiome, the vagina, eye and also cross-location products such as gut microbiome products that help the skin. Microbiome-friendly products are supposed to increase the resilience of the microbiome to external stressors so that it can maintain its barrier function at different body sites.

Our normal microbiome is a dynamic network of microorganisms that varies depending on its location on the body and many other factors. The microbiome acts as a barrier layer on the skin to prevent pathogens from taking hold. Some minor skin conditions, which range from acne to dermatitis and dandruff, are associated with specific changes in the microbiome. In particular, it’s thought that when harsh skin care products are used on the skin, the natural balance of the microbiome is affected and causes skin irritation and sensitivity. Products that have been developed with the microbiome in mind help keep the microbiome layer intact, and may even support the microorganisms living in it.

How can we measure how much a product affects the microbiome?

Science-based claims related to “microbiome-friendly” products must show that the formulation does not negatively affect the microbiome of consumers intended to use the product, and some claims need substantiation that supports a protective role of the formulation. Testing in humans, in the demographic group targeted by the product, appears to be necessary for regulators.

One-dimensional measurements such as the presence or absence of particular species, the ratio of commensals to pathogens, or overall species diversity could be used to define a healthy baseline. The functional capabilities of the microbiome and how they affect the health of the underlying skin could also be used to define whether a product is microbiome-friendly.

There are many methods available to measure the microbiome, and the results can be affected by the exact sampling site and sample extraction method used. Is it enough to use the inexpensive 16S technology, which uses specific marker genes? Or is the depth of metagenome sequencing required to allow the measurement of other kingdoms or functional profiles? The required evidence base will determine the best method.

How consumers view “microbiome-friendly”

Consumer interest in the microbiome is considered a long-term trend by the interviewees, and one that has the potential to really take off once the concept reaches the mainstream. It is considered to be an extension on the eco-friendly and minimalist beauty trends that have been ongoing in cosmetics for decades. Currently, the market for probiotic-related cosmetics is expected to grow at 12% per annum in the period 2020-2030.

The trend has been growing slowly for two reasons: first, consumers tended to view bacteria as being “bad,” so educating them that their skin is a complete ecosystem of bacteria, yeasts and other microbes has been done delicately. Second, the more vigorous beauty treatments – everything from anti-bacterial face-washes to chemical peels and pore-cleaners – are harsh and work against the microbiome, rather than with it. Skin care product manufacturers now need to stress the importance of the microbiome for healthy skin and how microbiome-friendly products can help.

Package claims: what needs to be done?

In the survey, industry experts expressed interest in developing a consistent label for microbiome-friendly products. Not only would this be helpful for consumers, the entire industry would benefit from clear guidelines about the evidence required for the label.

The industry stakeholders identified several key developments that are needed before a microbiome-friendly label can be implemented:

  • There needs to be collaboration between regulators, academia and industry to ensure that the concepts being developed are safe, practical and meet consumers’ expectations.
  • A consensus needs to be reached on the definition of what “microbiome-friendly” is.
  • Measurements that can identify a normal or healthy microbiome should be defined clearly.
  • Testing methodologies need to be standardised.
  • The burden of proof for package claims needs to be clarified.

 

Challenges in the “microbiome-friendly” world

There are several considerations that make it problematic to prove the benefits of microbiome-friendly products. The main challenge is in defining what a healthy or normal microbiome is. It’s not as simple as “good” versus “bad” bacteria. The microbiome is a network of microorganisms that contains thousands of species and there is considerable variation between individuals. A simple measurement provides clarity, but will miss the complexity of the microbiome. However, more sophisticated tests could be difficult to standardise.

Another challenge particularly for the larger industry players is that there is a lack of consistency in the claims allowed between countries. This can make it difficult to design studies that will provide evidence for products sold in different countries.

Furthermore, many skin care products on the market are already microbiome-friendly, since harsh products that affect the microbiome will also harm the skin. The skin microbiome is also quite resilient to stress because normal residents can repopulate the surface of the skin with microbes from deep in the pores. This makes it difficult to show improvements when a formulation is changed to be more microbiome-friendly, which is important as we demonstrate in the class action lawsuit presented in this article. It’s not enough for regulators to take advantage of ambiguity in the microbiome sphere and place a “microbiome-friendly” label on regular products: an additional benefit must be apparent.

 

Looking ahead to a microbiome-friendly future

The industry experts interviewed were positive about the enduring pro-microbiome trend. However, they really wanted clarity from regulators about how to move forward with formulating and marketing microbiome-friendly products. The “good bacteria” story from the gut could potentially be applied to the skin as a way to put consumers at ease. The field of skin microbiome research is currently quite dynamic, and other areas aside from the gut could lead to exciting and innovative products.

 

References

Convinced? Get in touch

Get a quoteMeet baseClearContact form