{"id":6339,"date":"2025-02-13T17:09:28","date_gmt":"2025-02-13T17:09:28","guid":{"rendered":"https:\/\/blogs.luc.edu\/compliance\/?p=6339"},"modified":"2025-02-13T17:09:28","modified_gmt":"2025-02-13T17:09:28","slug":"glass-skin-meets-red-tape-how-korean-beauty-navigates-fda-rules","status":"publish","type":"post","link":"https:\/\/blogs.luc.edu\/compliance\/?p=6339","title":{"rendered":"Glass Skin Meets Red Tape: How Korean Beauty Navigates FDA Rules"},"content":{"rendered":"

Madison Obata<\/em><\/p>\n

Associate Editor<\/em><\/p>\n

Loyola University Chicago School of Law, JD 2026<\/em><\/p>\n

Among the trends of self-care lies skincare. As self-care has increased in popularity over the last few years, skincare has become increasingly trendy. In 2022, there was a boost in skincare sales<\/a> with products such as anti-aging products and moisturizers. In the skincare industry, there are known and established brands<\/a>, but what has recently emerged through popularity on social media and TikTok is Korean beauty (\u201cK-beauty\u201d) products. K-beauty products help consumers achieve \u201cglass skin<\/a>,\u201d which is clear, poreless, and shiny skin that looks like glass by using specific K-beauty products. In the states, sunscreen is a staple K-beauty product that has emerged.<\/p>\n

Why are K-beauty sunscreens better than American brands?<\/strong><\/p>\n

Korean sunscreen has exceeded the sales<\/a> of United States (US) brands because of its elegant packaging and protection against ultraviolet (UV) rays, specifically UVA rays.<\/p>\n

UVA rays make up 95%<\/a> of the UV radiation that reaches the earth. UVA rays contribute to wrinkles and premature aging of the skin<\/a>. K-beauty brands, such as Beauty of Joseon and Round Lab, offer sunscreens with better protection against UVA rays over American competitors, at a low price, and without the fear of acne breakouts<\/a>.<\/p>\n

Consumers prefer K-beauty sunscreens because, along with the skincare benefits, there is a better texture when wearing makeup under the sunscreen. Consumers can also avoid a white cast<\/a>, which is what can cause skin discoloration after putting on sunscreen.<\/p>\n

Furthermore, K-beauty brands have access to more ingredients<\/a> for their products. In the US, sunscreens are considered a drug and approval is up to the US Food and Drug Administration (FDA)<\/a>, which requires a formal drug approval process. In South Korea, the process to approve<\/a> sunscreen formulas is much faster compared to the US, because sunscreen is considered \u201cfunctional cosmetics<\/a>.\u201d<\/p>\n

A main ingredient that surpasses ingredients in US sunscreens, such as zinc oxide and titanium dioxide<\/a>, is Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (\u201cbemotrizinol\u201d)<\/a>. Bemotrizinol is not approved<\/a> in the US, because it needs to be tested on animals<\/a> because it is classified as a drug and not a cosmetic.<\/p>\n

FDA approval of bemotrizinol<\/strong><\/p>\n

Companies have been seeking approval from the FDA for bemotrizinol<\/a> for the past 20 years. Bemotrizinol is available in countries such as Europe and Asia and it is very \u201cphotostable<\/a>,\u201d which means it does not easily deteriorate under UV rays.<\/p>\n

The urge for FDA approval has even made its way to congress with politicians Rep. Alexandria Oscasio-Cortez and Sen. Mike Lee<\/a> agreeing that the US is behind when it comes to regulations and FDA approval. This push for FDA approval comes with the motivation that skin cancer is the most common cancer<\/a> and can be prevented by using sunscreen. More recently, K-beauty brands, like Beauty of Joseon, have announced limitations with shipping<\/a> its sunscreens due to the lack of FDA approval. However, it is possible bemotrizinol could get FDA approval by the end of 2025<\/a>.<\/p>\n

Current FDA sunscreen approval process<\/strong><\/p>\n

Since sunscreen is categorized as a drug, sunscreen needs to go to through the same approval process as over-the-counter (OTC) drugs<\/a>. The process starts with a New Drug Application (NDA) process. If an ingredient outside of the US has been marketed for at least five consecutive years<\/a>, a manufacturer can submit a request to the FDA. If the FDA accepts the request, the process moves on to testing for safety and efficiency<\/a>.<\/p>\n

This period of testing can take years to be approved. The testing includes review of clinical data, scientific studies, and other reports<\/a> that prove that the ingredient is appropriate for UVA protection. During this period, the FDA also looks at the long-term health effects and if there are any potential risks. Then, the ingredient is tested on people<\/a> for safety and efficiency.<\/p>\n

The period of testing takes up the most time in the process. The last time the FDA approved a new sunscreen ingredient was in 1999<\/a>.<\/p>\n

After the testing period, there is FDA review process<\/a>, which includes proposed labeling, patent information, and compliance information. When the review process concludes, the FDA will decide if it is approved for the US.<\/p>\n

Consequences of a slow FDA approval process<\/strong><\/p>\n

Since brands like Beauty of Joseon cannot import products into the US because of FDA import restrictions<\/a>, consumers will turn to alternatives or try to find ways to get their hands on the products they know and love. One danger can involve consumers buying counterfeit products<\/a> as a result.<\/p>\n

Buying counterfeit sunscreen poses a deadlier danger to personal health compared to buying a counterfeit purse. As mentioned earlier, sunscreen is a main way to protect skin from the sun and is a way to prevent skin cancer. If the sunscreen is counterfeit, that means consumers are likely not getting enough protection from UV rays or possibly not getting any protection at all.<\/p>\n

The issue with not approving bemotrizinol, a potentially lifesaving ingredient for sunscreen, shows that the FDA approval process is too slow. Just with sunscreen alone, it has taken the FDA almost 40 years<\/a> to consider approving new sunscreen ingredients, like bemotrizinol.<\/p>\n

Even with the Sunscreen Innovation Act in 2014<\/a>, a bill that has a goal to speed up the approval process specifically for sunscreen, it still takes decades for approval. When the FDA receives a submission to approve a new drug, it takes about six to ten months<\/a> for priority applications.<\/p>\n

Unlike the application, the testing and studies portion does not have a timeline or even an estimated timeline. The timeline depends on the drug and the complexity<\/a>.<\/p>\n

There needs to be changes to the FDA\u2019s approval process. A more efficient approval process would most likely result in greater access to effective sunscreens and other preventative medications. An improved approval process means there a potential for reducing the risk of dangerous counterfeit alternatives.<\/p>\n","protected":false},"excerpt":{"rendered":"

Among the trends of self-care lies skincare. As self-care has increased in popularity over the last few years, skincare has become increasingly trendy. In 2022, there was a boost in skincare sales with products such as anti-aging products and moisturizers. In the skincare industry, there are known and established brands, but what has recently emerged through popularity on social media and TikTok is Korean beauty (\u201cK-beauty\u201d) products. K-beauty products help consumers achieve \u201cglass skin,\u201d which is clear, poreless, and shiny skin that looks like glass by using specific K-beauty products. In the states, sunscreen is a staple K-beauty product that has emerged.<\/p>\n","protected":false},"author":155,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24,27],"tags":[659,810,2298,2297,1843,1913],"class_list":["post-6339","post","type-post","status-publish","format-standard","hentry","category-fda","category-food-and-drug-law","tag-drug-approval","tag-fda","tag-food-and-drug-law","tag-korean-skin","tag-skincare","tag-sunscreen"],"_links":{"self":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/6339","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/users\/155"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=6339"}],"version-history":[{"count":1,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/6339\/revisions"}],"predecessor-version":[{"id":6340,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/6339\/revisions\/6340"}],"wp:attachment":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=6339"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=6339"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=6339"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}