By: Olivia Clausen
In recent years, South Korea has emerged as a leader in skincare, developing new and innovative cosmeceuticals, which are cosmetics with biologically active ingredients that have therapeutic benefits. Gaining a lot of international recognition in particular is Korean sunscreen, which is known to be more effective and more comfortable to wear than many US sunscreens. However, many new Korean sunscreens are not available in the United States because some of their active ingredients have not been approved by the FDA. This discrepancy between Korean and American sunscreen has caused skincare afficionados to wonder why the United States is lagging in their sunscreen innovation, especially considering that skin cancer is the most common cancer in the United States. In fact, one in five Americans will be diagnosed with skin cancer in their lifetime, and the majority of these cases are attributable to UV exposure.
The reason that Korean sunscreen has seen such drastic improvements in recent years is due to the development of new bioactive ingredients which improve sunscreen products in terms of both aesthetics and sun protection. This enhanced protection comes from chemical filters which are the component of sunscreen that protects the skin from damaging UV rays. In the United States, the FDA has not approved any new UV filters since 1999 despite many attempts by sunscreen manufacturers and politicians to do so. These recent innovations in sunscreen ingredients often do a better job at protecting against both UVA and UVB rays, while some US sunscreens fail to block UVA rays, which cause 90% of skin aging.
To remedy the lack of innovation in sunscreen in the United States, Congress passed the bipartisan Sunscreen Innovation Act in 2014, which established a new, expedited process for sunscreen approval. This Act set forth a five-year time frame to review new active ingredient requests and directed the Secretary of Health and Human Services to issue timely decisions on the effectiveness and safety of sunscreens. However, despite the positive intentions of this Act, there remain to be no new approved chemical filters since its passage ten years ago.
The slow progress in US sunscreen innovation is attributable to FDA regulations, which are lengthy in comparison to the Korean Ministry of Food and Drug Safety (MFDS) procedures for approving new chemical filters for sunscreens. First, the MFDS classifies sunscreen as a cosmetic, while the US FDA classifies sunscreen as an over-the-counter (OTC) drug, which is subject to a lengthier regulatory process (including animal testing) than a cosmetic product would be. This classification of sunscreen as a drug was promulgated by the 1938 Food, Drug, and Cosmetic Act, which defines drugs as articles “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and cosmetics as intended for “cleansing, beautifying, promoting attractiveness, or altering the appearance.”
The Korean MFDS has a category that does not exist in US regulatory frameworks, which is a functional cosmetic, regulated by the 2018 Cosmetic Act. The Cosmetic Act defines a functional cosmetic as a “product aiding in the whitening of the skin … aiding in improving wrinkles in the skin… [and] aiding in tanning skin gently or protecting skin from ultraviolet rays,” differing from the definition of a general cosmetic in its purposes. The MFDS has standards and testing methods that must be documented to approve functional cosmetics, including data on efficacy and functionality, data on SPF ratings and UV protection, and data on human testing.
To see how the Korean regulatory process differs from the regulatory process in the United States, bemotrizinol (also known as Tinosorb S) serves as a prime example of an active sunscreen ingredient approved for use across Asia and Europe but remains unavailable in the US due to lengthy FDA processes. In fact, the FDA has rejected several applications of bemotrizinol in the past because “more safety data was required to prove the absence of long-term damage from sun filters.” To gain FDA approval, OTC drugs and ingredients must be classified “generally recognized as safe and effective” (GRASE). For a new sunscreen active ingredient to be GRASE, it must undergo human, animal, and environmental testing to collect sufficient safety data prior to FDA review.
The safety tests required of bemotrizinol by the FDA has cost an estimated $18 million and over ten years to complete. These safety and testing procures all occur before FDA review, which takes an additional two to three years or more before a decision is finalized. After this, the FDA requires a 45-day public comment period, which can be no earlier than one year before a final decision. This compares to the Korean MFDS decision, which takes about 4-6 months to be concluded once clinical and efficacy data is submitted. Like the FDA, the MFDS requires a 60-day comment period and revised regulations six months after the notice announcement.
Some studies suggest that the US FDA should accept foreign market data in their sunscreen approval processes to help adopt new products deemed safe and effective in other countries and improve consumer trust of products being used internationally. Further, an act of Congress could improve the regulatory process for sunscreen and fund public health research to develop products that are both safe and effective. The lack of impact of the 2014 Sunscreen Innovation Act on new UV filters in the US shows a need for this to meet the level of sunscreen innovation occurring in South Korea and in other countries across the world.
