Biotics and Dermal Cosmetics: Claims & Definitions in an Unregulated Landscape

Posted on Behalf of  Amanda Buerger, Haley Divis, Tony Cappello

With global consumer awareness of biotics (pre-, post-, and pro-), various markets, including the skin care market, have capitalized on the popularity of the topic. Dermal microbial biodiversity is essential for proper healthy skin function. Observed alterations to the dermal microbiome following application of cosmetics include changes in pH, moisture, and barrier function of the skin (Wallen-Russell, 2019). As the scientific evidence suggests that cosmetic products with synthetic ingredients may damage the skin microbiome, marketing of “microbiome friendly” or “probiotic” cosmetics has emerged.

This growth of the probiotic cosmetic market has resulted in false label claims and may provide misinformation regarding the use of the term “probiotic” (Puebla-Barragan & Reid, 2021). Many labels that claim to “balance the skin microbiome, improve the skin barrier, and enhance the skin’s overall appearance”, but there is a lack of scientific evidence supporting these "health improvement” claims (Puebla-Barragan & Reid, 2021). A recent study reported that it is “highly unlikely” necessary studies have been performed in accordance with such product claims (Puebla-Barragan & Reid, 2021).

Although the United States (U.S.) Food and Drug Administration (FDA) regulates oral probiotics and similar products (Venugopalan et al., 2010), no FDA guidance exists for the microbial claims made in the cosmetic industry. However, the FDA is aware of the growing issues related to “probiotic” claims on cosmetic products, including the fact that most cosmetic products that bear the label “probiotic” actually contain postbiotics, which are waste products of live bacteria (FDA 2019). The lack of regulatory oversight in this arena is not limited to the U.S., but is increasingly recognized as a global concern.

The International Cooperation on Cosmetics Regulation (ICCR) consists of cosmetics regulatory bodies from across the globe and meets annually to discuss topics related to cosmetics. ICCR focuses on “[e]valuating the safety, quality, and regulation of cosmetic products targeting the human skin microbiome” (ICCR, 2022). Based on input from member states, ICCR developed harmonized terminology and definitions pertaining to cosmetics and biotics, which are categorized into viable ingredients, non-viable ingredients, and other terms (below). “Other” covers terminology such as “microbiome-activated,” “microbiome-friendly,” or “gentle to the microbiome”. Notably, ICCR stipulates that these are not formal definitions, rather they act to facilitate the categorization of cosmetics on the market.

  • Viable Probiotic: Viable (live or dormant) microorganisms added to a cosmetic product in order to achieve a cosmetic benefit at the application site, either directly or via an effect on existing microbiota.
  • Non-Viable Probiotic: Non-viable ingredients added to a cosmetic product with the intention of being actively used as nutrients by the microbiota of the application site in order to achieve a cosmetic benefit.
  • Non-Viable Postbiotic: Non-viable ingredients comprised of inactivated microorganisms and/or soluble factors (products or metabolic by-products) released by live or inactivated microorganisms, added to a cosmetic product in order to achieve a cosmetic benefit at the application site, either directly or via an effect on the existing microbiota.
  • Other: Not captured by the prebiotic, postbiotic and probiotic sub-groupings.

Conclusion

With growing diversity and ambiguity of label claims regarding the health benefits of cosmetic products, better scientific support is needed to verify such claims. However, the lack of U.S. and global regulations specific to cosmetics leaves room for false claims and spread of misinformation. ICCR intends to address the gaps in global regulations through voluntary participation in its annual meeting and its development of consistent terminology for the industry. Despite this progress, regulatory guidance and oversight remains lacking on the national and international scale, leaving consumers in the dark regarding the meaning of the microbial claims on their cosmetics.

Cardno ChemRisk scientists have extensive experience performing risk assessments and safety assessments of consumer products, and providing regulatory support to various industries. Our team applies multidisciplinary approaches to understand and solve complex toxicological and public health issues related to microbial contamination and microbial risk assessments. For more information on Cardno ChemRisk’s capabilities in these areas, please contact Dr. Tony Cappello.