The Rising Concern of Skin Safety: FDA's Regulation on Skincare in the United States

By Anushka Singha Roy, Great Valley High School, Malvern, Pennsylvania, USA

In the United States, the Food and Drug Administration (FDA) was established on June 30, 1906, with the goal of safeguarding the health of Americans by verifying the quality of the food, medicine, and cosmetics that are distributed for public use (U.S. Food and Drug Administration, 2018). The Food, Drug, and Cosmetic Act (FD&C Act) brought cosmetics under FDA regulation in 1938 so products can be tested for safety before they are made available to the public (Isaacs-Thomas, 2019). Each year, a multitude of new cosmetics are put on shelves, claiming to elevate the condition of our skin, so it may come as a surprise that these products are largely unregulated. The use of cosmetics such as face wash, moisturizer, sunscreen, and more have become a part of many people’s daily routines. However, the regulations that assure us of the safety of these products have not been changed since 1938. Due to FDA involvement in the regulation of cosmetics being so limited, many consumers are exposed to skincare with negative effects.

Cosmetics cannot claim to alter an organ’s function or structure according to the FDA’s definition of a drug, but they can claim to change the appearance of a certain issue (U.S. Food and Drug Administration, 2022). For instance, a product cannot claim that it can completely eliminate wrinkles, only that it will reduce their appearance. Due to this loophole, many skincare products do not need to be tested for safety or efficacy before being sold. This allows companies to add potentially dangerous chemicals that may be ineffective and possibly harmful in the long term. Additionally, the FDA is not required to assess the safety of cosmetics’ ingredients unless they contain color additives that are not present in most hair dyes (Isaacs-Thomas, 2019). According to Susan Mayne, the director of FDA’s Center for Food Safety and Applied Nutrition “We don’t know whether cosmetic ingredients have gone through adequate, if any, safety testing” (Isaacs-Thomas, 2019). Furthermore, the FDA can only take action on a product after it has been sold and then proven as harmful. Even after recognizing the problem with a product, the FDA is not permitted by the FD&C Act to impose the recall of a cosmetic (U.S. Food and Drug Administration, 2002). If a company decides to recall a product, it is voluntary. If the company is not willing to recall a harmful product, the FDA can notify the public of health risks that come with its usage or request the company to recall the product. However, they do not have the power to order the recall of the cosmetic (U.S. Food and Drug Administration, 2002).

This laissez-faire approach to regulating cosmetics in America stands in stark contrast to cosmetic regulation in Europe. The European Union has banned the use of over 1,300 chemicals in cosmetics that are linked to cancer and birth defects (European Union Law 2022). However, the FDA has only prohibited 11 of these chemicals (Isaacs-Thomas, 2019). The most recently FDA banned chemical in 2020 was Trichloroethane because it has been found to be linked to cancer and increased risk of non-Hodgkin lymphoma, even though its risks have been known since 1977 (National Cancer Institute, 2022). Meanwhile, the European Union banned 23 chemicals on March 1, 2022, and released the ‘Restrictions Roadmap’ on April 25, 2022 for enacting the largest ever chemical ban that could result in up to 12,000 toxic chemicals being banned (Neslon, 2022).

Furthermore, the FDA’s lack of involvement in the regulation of cosmetics also affects the quality and effectiveness of sunscreen, which is crucial for preventing skin cancer. Skin cancer is the most prevalent cancer in America, and approximately 9,500 people in the U.S. are diagnosed with it daily (American Academy of Dermatology, 2022). The rates of skin cancer are increasing at a rapid pace with an estimation that 1 in 5 Americans will get skin cancer in their lifetime (American Academy of Dermatology, 2022). Currently there are 17 approved UV filters in America and the last time a UV filter was approved was 1999 even though safer filters have been found since then and are used in different countries (DSM, 2022). There are 29 approved UV filters in Europe and China, and 33 approved filters in Australia, giving Americans a smaller selection of sun protection to choose from (Pirotta, 2022). Eight sunscreen ingredients, some of which date back to 2003, are still pending FDA approval (United States Government Accountability Office, 2017). Due to how little the FDA is involved in this process, the possibility of innovation for new UV filters that are safer and more effective for consumers is very limited.

Over 80 countries have stricter cosmetic regulations and safety standards than America, meaning that over 100 countries have even more lenient cosmetic regulations, posing a huge risk to the health of people’s skin globally (Inouye, 2021). Our skin care is not as safe as it should be, so until we have stronger cosmetic safety rules, we must be more mindful of the products we buy and use for our skin.

References

"FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed." gao.gov, Nov. 2017, www.gao.gov/assets/gao-18-61.pdf. Accessed 7 Jan. 2023. 

Inouye, Brandin. "On protecting consumers from toxics in cosmetics, U.S. lags at least 80 countries." ewg.org, 10 Aug. 2021, www.ewg.org/news-insights/news/2021/08/protecting-consumers-toxics-cosmetics-us-lags-least-80-countries   Accessed 7 Jan. 2023. 

Isaacs-Thomas, Isabella. "Why your cosmetics don't have to be tested for safety." pbs.org, 16 Dec. 2019, www.pbs.org/newshour/health/why-your-cosmetics-dont-have-to-be-tested-for-safety . Accessed 7 Jan. 2023. 

"Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)." fda.gov, 25 Feb. 2022, www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic.   Accessed 7 Jan. 2023. 

Neslon, Arthur. "European Union Plans 'Largest Ever Ban' on Toxic Chemicals." Motherjones.com, 26 Apr. 2022, www.motherjones.com/politics/2022/04/eu-europe-ban-dangerous-toxic-chemicals-restrictions-roadmap/. Accessed 7 Jan. 2023. 

Pirotta, Giulio. "An overview of sunscreen regulations in the world." researchgate.net, July 2015, www.researchgate.net/publication/283515177_An_overview_of_sunscreen_regulations_in_the_world.   Accessed 7 Jan. 2023. 

"Skin Cancer." aad.org, 22 Apr. 2022, www.aad.org/media/stats-skin-cancer. Accessed 7 Jan. 2023. 

"Trichloroethylene (TCE)." cancer.gov, 8 Dec. 2022, www.cancer.gov/about-cancer/causes-prevention/risk/substances/trichloroethylene Accessed 7 Jan. 2023.

European Union Law. eur-lex.europa.eu, 17 Dec. 2022, eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:02009R1223-20150416 . Accessed 7 Jan. 2023. 

"US regulation of sunscreen products." dsm.com, 17 Oct. 2022, www.dsm.com/personal-care/en_US/sun-smart-community/shining-a-light-on-regulation/blog-4-uv-filters-us-regulation-bemt.html . Accessed 7 Jan. 2023. 

"When and why was FDA formed?" fda.gov, 28 Mar. 2018, www.fda.gov/about-fda/fda-basics/when-and-why-was-fda-formed . Accessed 7 Jan. 2023.