FDA Effects on Sunscreens: Research paper made in WRT 102 at SBU

             The Food and Drug Administration’s (FDA) outdated sunscreen regulation exposes Americans to outdated protection despite the fact that skin cancer, the most common cancer in the nation, affects millions of people annually. The FDA is a regulatory agency within the U.S. Department of Health and Human Services. Like its name, it is tasked with regulating all food, drugs, and cosmetics in the US in order to protect public health. Lately, the FDA has been under heavy criticism on nationwide screens. The face of this campaign against the FDA is Mr. Robert F. Kennedy Jr., the present U.S. Secretary of Health and Human Services. He had gone on national television repeatedly criticizing the FDA for permitting products on US shelves that have been hurting Americans for the past couple of years. Now that he has become the man in charge of this department, it has become ever more important to look at the FDA’s decisions. The FDA’s outdated classification of sunscreen as a drug that has been driven by bureaucratic inertia and corporate lobbying has hurt American citizens. This has stagnated innovation and delayed access to safer and more effective UV filters approved globally. By reclassifying sunscreen as a cosmetic, along with moving towards a more global standard, it would allow American consumers access to advanced sun protection technologies already proven successful, and a way for reform.

The FDA has directly failed US citizens, specifically in the sunscreen market, where it is obvious that countries across the world use sunscreens far more advanced than those here. Sunscreen is extremely important in our day-to-day life. Sunscreen acts as a barrier between our skin and the UV rays coming from our sun that give us radiation. As time has gone on, the sun's rays have increased in strength, making sunscreen that much more indispensable. Haley Westman, a graduate of the University of Seattle Law, states, “Skin cancer is the most common type of cancer in the United States, and about 90% of skin cancer cases are associated with sun exposure.” As explained before, due to the ozone layer decreasing, the sun’s rays have been able to reach Earth’s surface more. As soon as we step outside into the sun, these waves of radiation directly touch us. As a result, the amount of radiation we receive increases daily. This is happening to everyone, from the people taking their kids or pets on a walk to the athletes who train outside consistently. Exposure to this radiation can and will cause cancer, which is why having effective and top-of-the-line sunscreen is so important. According to the Environmental Working Group (EWG), a non-profit organization focused on people’s health, they “warn that 75% of U.S. sunscreens would fail EU efficacy standards…Americans have fewer choices than Europeans in their sunscreen options and, on average, U.S. products, especially non-mineral sunscreens, have notably poorer protection from harmful ultraviolet A, or UVA, rays”. This highlights the evident failures of the FDA when viewed on the global level. When compared to Europe, there is an obvious discrepancy in our access to sunscreens that can protect against the harmful rays of the sun. For example, Tinosorb S, Tinosorb M,  Mexoryl SX, and Mexoryl XL are just some sunscreen filters available in the EU and not the US. The decision by the FDA to allow sunscreens with less protection to be sold and used by Americans when there are newer, better sunscreens showcases their obsolescence. Furthermore, “The United States has not approved a new ultraviolet (UV) filter since 1999. Studies have also found that only thirty-five percent of U.S. sunscreens are strong enough to pass EU standards”(Release). As such, the repercussions of an outdated agency are on full display when viewed on the global stage. Hence, it is crystal clear that the EU is living light years ahead of the US. Especially, when we see how long it's been since a new sunscreen filter has been approved, while the EU continually evolves. Due to the lack of advancement on the FDA’s part, Americans are forced into a position where they are more likely to get skin cancer than Europeans.

    The FDA falls short when compared to other countries since it categorizes Sunscreen as a “drug”, compared to the European Union (EU), where it is under cosmetics. Or in other words, they create strict regulations that set up new sunscreen filters to fail. From the New York Times, many dermatologists argue that “the U.S. is stuck in the Stone Age of sunscreen technology” (Garcia). Dermatologists are medical doctors who specialize in our skin. Hearing this from them gives insight into how behind the FDA is regarding sunscreen. Using the analogy of the US and the FDA being in the Stone Age challenges the FDA's inability to adapt to modern society.“The EU regulates sunscreens as cosmetics, which allows more flexibility in which active ingredients sunscreen manufacturers can use to protect against UVA rays. The EU has 34 UV filters approved for use in sunscreens, compared to 16 in the US… Americans are being shortchanged with inadequate sunscreens, especially compared to European ones”(EWG). Something that can be seen in the FDA’s use of categorizing Sunscreen as a “drug” is the blatant ineffectiveness when compared to Europe. They quantified how Americans have access to sunscreens with deficient sunscreens due to strict regulations that are stifling advancement in sunscreens and, therefore, the agency itself. Looking directly at the EU, we can assess how much they flourish in terms of better and more efficient sunscreens. On the flip side, in Carolyn Zaccaro’s “Stop Being Shady” article From Boston College Law Review Journal, she adds that “the FDA has taken a risk-averse approach to sunscreens, and in particular, approvals of new sunscreen active ingredients, as they have consistently denied approvals for new ingredients due to insufficient safety data” (Zaccaro). In the FDA’s eyes, this stagnation is caused not because of outdatedness but instead for safety. They categorize sunscreen as a “drug” as such, however due to this it means sunscreen needs to go through clinical trials as a requirement for approval, which allows for little advancement. Meanwhile, the EU has “looser” regulations that allow for prosperous innovation and advancement. Keeping in mind that the EU’s looser regulations still protect its citizens. By making the US treat sunscreens as drugs, the FDA has created a stagnant and lagging agency that ignores proven international methods that work. This stagnation denies its US citizens from potentially life-saving advancements that are already available elsewhere.

    With corporate lobbying and politicization, the FDA’s ability to focus on public health has come to a halt. While the FDA has failed in policymaking, as seen in naming sunscreen as a “drug”, something can be said about the way it runs as a whole. Daniel G. Aaron, in the article “The Fall of FDA Review” in the Yale Journal of Health Policy, Law, and Ethics, states, “longstanding efforts to undermine FDA governance by corporations and financial power writ large. Corporate deregulatory efforts have operated through courts, Congress, the President, and the agency’s leadership itself” (Aaron). Aaron elaborates on how corruption within the US government itself has a part to play in how ineffective the FDA has become. However, more importantly, it is failing Americans specifically with sunscreen. He explains that foreign powers and lobbyists are to blame for this. Lobbying, in simple terms, is the act of an outside power influencing government decisions. In this case, they have lobbied against the advancement of new sunscreen filters so that they can hold the market in their arms, instead of being forced to compete with other companies that can innovate filters. Coming together, this explains how the FDA is ineffective in its job due to deregulation efforts from the government that have lobbyists whose only goal is for corporations to succeed. Therefore, it causes harm to us, the consumers. Mason Marks from the Duke Law Journal adds, “the agency has become overly political and too accommodating to industry while lowering its standards.” Marks helps further explain Aaron's point that the beauty industry plays a part in how the FDA runs, which causes the FDA to not be efficient. He highlights that the FDA has aligned itself too much with the rest of the government, not allowing it to run properly. The bottom line is that outside forces in Congress, which consist of lobbyists, allow for policies in the FDA to run inefficiently in order to preserve their complete chokehold on our US market, especially seen in the Sunscreen market here.

         Pharmaceutical lobbyists in Congress are key members of the ineffectiveness of the FDA. An example can be seen in Wang’s “History, Status, and Politicization of the FDA”, who notes how pharmaceutical lobbyists pressure the FDA to maintain the harsh drug classification to protect market monopolies (Wang et al.).  The lobbyists have allowed for market monopolization by forcing the FDA through government pressures that make the FDA follow suit. By controlling the government and therefore the FDA, it has allowed it to become ineffective. This has, in turn, allowed present policies and policymaking to be ineffective or at a standstill. On the other hand, According to Robert K. Kennedy Jr., “FDA’s war on public health is about to end…if you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags” (“A Look at RFK Jr.’s Take on FDA.”). Robert K. Kennedy Jr.'s perspective on this is that the FDA is just corrupt and that it needs to be rebuilt. He calls the FDA a “corrupt system.” This, however, is not true at all; the FDA has built-in policies that make it fail, as seen in the sunscreen categorization. In addition, the corruption that he speaks of stems from outside forces, such as lobbyists, that make the FDA stagnant. In the case of sunscreen, these lobbyists do not want more sunscreen filters to come out as it would lessen the hold of the filters they can and cannot produce, therefore making their monopolies weaker in the US market. These outside influences from the industry cause harm to the FDA’s ineffectiveness. Instead of Kennedy Jr.’s idea that it needs to be ripped apart, it is true to say that it needs to be reformed to remove outside influences that allow bad policies to flourish.

    Sunscreen is crucial for everyday life; However, it has been negatively impacted due to the FDA. This has been highlighted in the categorization of sunscreen as a “drug”, which has limited advancements for better sunscreens. Compared to the EU, American citizens have been dealt a bad hand. This can be explained due to the FDA’s outdated systems that come from third parties, which make us live behind the global standard. These forces can be traced back to the lobbyists in the government who deny the FDA’s advancement and innovation. The industry that the lobbyists speak for wants the FDA to remain ineffective to allow them to continue their monopolies in our society. The FDA is perpetuating a cycle of bureaucratic stagnation and corporate success. Furthermore, as the EU has proven, innovation and safety are not mutually exclusive; therefore, the FDA does not need to keep its outdated regulations. It is time for the FDA to abandon its antiquated framework and embrace reform. The FDA’s failure to modernize sunscreen goes further than just bureaucratic inertia, it is a public health crisis. Every day, Americans are forced to face a higher chance of skin cancer due to the outdated filters, while safer, more effective options sit on shelves in Europe and beyond. This disparity is utterly indefensible. We cannot allow these corporate lobbyists and antiquated policies to dictate our health outcomes. It’s time to demand change. Therefore, call up your representatives and demand that this issue be seen and taken into account.

Work-Citied Page

Aaron, Daniel G. “The Fall of FDA Review.” SSRN, University of Utah, 18 Apr. 2023,   papers.ssrn.com/sol3/papers.cfm?abstract_id=4413047. 

“A Look at RFK Jr.’s Take on FDA.” Brownstein Hyatt Farber Schreck, 15 Nov. 2024, www.bhfs.com/insights/alerts-articles/2024/a-look-at-rfk-jr-s-take-on-fda. 

EWG (Environmental Working Group). “Does Europe have better sunscreens?”, 2024, https://www.ewg.org/sunscreen/report/executive-summary/

Garcia, E, Sandra. “Why Can’t the U.S. Get Better Sunscreen?” The New York Times, 12 Aug. 2023, www.nytimes.com/2023/08/12/style/sunscreen-fda-regulation-aoc.html

Marks, Mason. “Automating FDA Regulation.” SSRN, Duke Law Journal Vol. 71, 15 Dec. 2021, papers.ssrn.com/sol3/Delivery.cfm?abstractid=3980973. 

“Release: Gottheimer Introduces ‘Sunscreen Safety Plan’ to Ensure Americans Access to Effective Sunscreen.” Home, gottheimer.house.gov/posts/release-gottheimer-introduces-sunscreen-safety-plan-to-ensure-americans-access-to-effective-sunscreen. Accessed 30 April 2025. 

Wang, Will, et al. “History, Status, and Politicization of the FDA.” Research in Social and  Administrative Pharmacy, Elsevier, 26 June 2021, www.sciencedirect.com/science/article/pii/S1551741121002114. 

Westman, Haley. “A Hot Topic: Is the FDA’s Approach to Sunscreen Regulation Failing Consumers?” Seattle University School of Law Digital Commons, Seattle UL Rev. 46, 201, 2022, 2022, digitalcommons.law.seattleu.edu/sulr/vol46/iss1/8/.

Zaccaro, Carolyn R. “Stop Being Shady: How Current Sunscreen Regulatory Processes and Standards Burn Consumer Protection.” EBSCOhost, Boston College Law Review, 2025, Vol 66, Issue 1, p211, 1 Jan. 2025, openurl.ebsco.com/contentitem/doi:10.70167%2Fsmpt3323?sid=ebsco%3Aplink%3Acrawler&id=ebsco%3Adoi%3A10.70167%2Fsmpt3323.