Over-the-counter (OTC) skin lightening products, also known as “skin whitening” or “skin bleaching” products, have been in the news lately, and not for good reasons.

In March of 2022, the US Food and Drug Administration (FDA) issued warning letters to 12 companies for selling illegal OTC skin lightening products with hydroquinone as an active drug ingredient.¹ When used incorrectly, products containing dangerous levels of hydroquinone, mercury, and corticosteroids can cause harmful side effects, including skin rashes, facial swelling, and discoloration of the skin (ochronosis) that can become permanent when the products are used for extended periods of time.^1-3 The FDA warning follows recent announcements by the World Health Organization about specific substances used for skin lightening and increased regulation of OTC skin lightening products by both the European Medicines Agency and the FDA, as well as other health organizations across the globe.^2-4 There is now a large amount of evidence about the potentially harmful health consequences from the unregulated use of specific ingredients that are commonly marketed for use in OTC skin lightening products.³

Dermatologists are paying attention

While clinically proven skin lightening agents are sometimes medically necessary for treating dermatologic conditions such as melasma, postinflammatory hyperpigmentation, and other dyschromias, the unregulated and unsupervised use of OTC skin lightening products is a major concern for dermatologists.^5,6  Patients with these skin conditions can be treated with clinically tested, safe, and effective formulations of hydroquinone, retinoids, corticosteroids, glycolic acid, and antioxidants under the supervision of their dermatologist or healthcare provider.^5,6 For instance, a triple-combination therapy containing a safe coformulation of hydroquinone (4%), a retinoid (tretinoin 0.05%), and a corticosteroid (fluocinolone 0.01%) is the only FDA-approved prescription skin lightener for the treatment of moderate to severe melasma.^1,5 As consumer demand for OTC skin whitening products has increased, dermatologists are spending more time questioning what drives people to risk trying these OTC products.⁶ Many dermatology practitioners view unregulated skin lightening products as a global public health issue with direct implications for patients, especially women and patients with darker skin tones.⁷

Despite the many regulations and health warnings, social media commentary and advertising by influencers continue to perpetuate extensive public interest in OTC skin lightening products, causing a boom in the global market.⁸ A recent report by the American Academy of Dermatology (AAD) estimated that the global market for skin lighteners was $8.6 billion in 2020, with projections of $12.3 billion by 2027.⁷

What is driving the phenomenon of OTC skin lighteners?

In a recent interview with the AAD, Dr. Seemal Desai, a board-certified dermatologist at the University of Texas Southwestern Medical Center, said that deeply rooted historical and cultural beliefs that promote skin bleaching affect many patients in the United States, and “poisonous information” in product marketing and social media relies on the assumption that lighter skin equals more beautiful skin.⁷

Dr. Nina Jablonski, a physical anthropologist and author of the book Living Color: The Biological and Social Meaning of Skin Color, says that skin lightening extends beyond being a fad to a “commercial extension of the now-worldwide extension of colorism.”⁹ Dr. Jablonski argues that the historically and culturally rooted beliefs that lighter skin equates to higher social status, success, and happiness have been used to drive the market and sales for skin lightening products worldwide.⁹ In the United States, commercial development of skin lightening products began in the post-Reconstruction/segregation era when dark skin was depicted as undesirable, and messages of “bright and glowing complexions” drove these product sales.⁹

Figure. A skin bleaching cream advertisement from the 1930s. The taglines read "have lighter looking skin"/"have the skin men love"/"know the joy of a lighter appearing complexion." (Public domain image source: Collection of the Smithsonian National Museum of African American History and Culture https://nmaahc.si.edu/object/nmaahc_2011.166.21)

It is important to understand this history because it underpins the high psychological motivation for people from different backgrounds to pursue skin lighteners and points to why patients may use risky treatments without consulting their healthcare provider.  

Skin lighteners use ingredients meant to suppress the natural production of melanin.⁹ Most skin bleaching agents, including mercury and hydroquinone, work by inhibiting tyrosine, an enzyme that regulates the production of melanin in the melanocyte cells of the epidermal layer.⁹ Corticosteroid agents, including clobetasol and betamethasone, lighten skin by inhibiting cyclic adenosine monophosphate (cAMP) production.^9,10  These agents are found in the bulk of the OTC skin lightening products reported to violate the global health standards in place to protect consumers.^3,6

OTC cosmetics that contain prohibited substances and violate regulations may be masquerading as genuine medications, and in some cases they may not include ingredient lists at all.¹¹ Dermatologists should be aware that their patients might be using products that evade government surveillance or can otherwise be a danger to themselves.³

Healthcare providers can help address the unsupervised use of skin lightening products by understanding the side effects of potentially risky OTC skin lighteners and by having constructive dialogue with patients and other health professionals. Skin disorders that cause hyperpigmentation and hypopigmentation place a burden on patients and require safe and effective treatments.³       

Table. The most common OTC skin lightening agents (topicals), hypothetical mechanism of action (MOA), adverse effects, and reported violations 2005–2018 (European Union only).^3,6,9,10 The exact mechanism of all ingredients is unknown.

References:

1. FDA works to protect consumers from potentially harmful OTC skin lightening products. US Food and Drug Administration. Published April 19, 2022. Updated May 10, 2022. Accessed August 2, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-works-protect-consumers-potentially-harmful-otc-skin-lightening-products

2. World Health Organization. Mercury in Skin Lightening Products. World Health Organization, 2019. Accessed August 2, 2022. https://apps.who.int/iris/rest/bitstreams/1262414/retrieve

3. Michalek IM, Liu B, Benn EKT, Caetano Dos Santos FL. Skin lightening products' violations in Europe: an analysis of the rapid alert system for dangerous non-food products 2005–2018. Regul Toxicol Pharmacol. 2019;106:50-54. doi:10.1016/j.yrtph.2019.04.020

4. European Commission Scientific Committee on Consumer Safety. Directorate-General for Health and Food Safety. Opinion on Deoxyarbutin Tetrahydropyranyloxy Phenol. European Commission; 2015. Accessed August 2, 2022. https://data.europa.eu/doi/10.2875/293523

5. Elbuluk N, Grimes P, Chien A, et al. The pathogenesis and management of acne-induced post-inflammatory hyperpigmentation. Am J Clin Dermatol. 2021;22(6):829-836. doi:10.1007/s40257-021-00633-4

6. Pollock S, Taylor S, Oyerinde O, et al. The dark side of skin lightening: an international collaboration and review of a public health issue affecting dermatology. Int J Womens Dermatol. 2021;7(2):158-164. doi:10.1016/j.ijwd.2020.09.006

7. Board-certified dermatologist warns consumers about the dangers of skin bleaching to achieve a lighter complexion. American Academy of Dermatology. Published April 23, 2021. Accessed August 1, 2022. https://www.aad.org/news/dangers-skin-bleaching-to-achieve-lighter-complexion

8. Iftekhar N, Zhitny VP. Overview of skin bleaching history and origins. Dermatology. 2021;237(2):306-308. doi:10.1159/000509727

9. Jablonski NG. Living Color: The Biological and Social Meaning of Skin Color. 1st ed. University of California Press; 2012. Accessed August 3, 2022. http://www.jstor.org/stable/10.1525/j.ctt1pn64b

10. Solano F, Briganti S, Picardo M, Ghanem G. Hypopigmenting agents: an updated review on biological, chemical and clinical aspects. Pigment Cell Res. 2006;19(6):550-571. doi:10.1111/j.1600-0749.2006.00334.x

11. Maneli MH, Wiesner L, Tinguely C, et al. Combinations of potent topical steroids, mercury and hydroquinone are common in internationally manufactured skin-lightening products: a spectroscopic study. Clin Exp Dermatol. 2016;41(2):196-201. doi:10.1111/ced.12720