Ana Santos Rutschman, SJD, LLM

Professor of Law; Faculty Director, Health Innovation Lab Villanova University

  • Villanova PA

Professor Rutschman, SJD, LLM researches topics in health law, biotech, innovation policy, patent law, and law and technology.

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3 min

Cosmetic or Drug? The FDA's Classification of Sunscreen Limits Which Products Hit US Shelves

As stifling rays of sunshine beat down across the United States, it’s the time of year citizens flock to the store to load up on sun protection. It’s also the time of year consumers and media raise the annual question of why Europe is able to market sunscreen that contains more potentially effective ingredients, but the U.S. isn’t. The answer is not related to sunscreen or its ingredients, but rather how the country’s regulatory body – The Food and Drug Administration (FDA) – legally operates. “In order for the FDA to legally regulate products, those products are given classifying labels,” said Ana Santos Rutschman, a professor of law at Villanova University who studies health law. “A toothbrush, for instance, is labeled a medical device. That’s because it has to fit in one of the sources of authority of the FDA and the FDA, per the law, regulates drugs or medical devices.” Here is where it gets tricky. The FDA does not have to approve cosmetics, aside from certain color additives, before those products go to market. In the European Union’s European Medicines Agency (EMA), sunscreen is labeled as a cosmetic. Many other countries also classify it as such. In the U.S., however, sunscreen is labeled a drug because it has a therapeutic effect, and thus falls under the authority of the FDA. To make the classification system even more convoluted, some items are labeled as both a cosmetic and drug by the FDA. Shampoo, for instance, is inherently cosmetic. “But if it’s anti-dandruff shampoo, then it’s also a pharmaceutical,” said Santos Rutschman. “It’s super common for this to happen with a lot of products that you and I would not think are classified as drugs. It’s very natural under the regulatory regime that we have, but then it is very hard to bring anything to market – harder than other countries.” Case in point, sunscreen used in the EU that contains ingredients which may be more effective against certain types of ultraviolet rays cannot simply just come to market in the U.S. “If sunscreen fits the definition of a drug, then it must meet drug requirements,” said Santos Rutschman. “If you want a new drug to enter the U.S., you have to show efficacy and safety. But in order to do that, there must be clinical trials, and if those trials happened elsewhere, they would not conform to our domestic protocols. “Even if another country performed their own clinical trials, the odds the FDA would utilize the data are not incredibly high. If you think another country recognizes something we should, based on their data, then immediately this is going to raise questions of why we are deferring to a foreign regulator.” The FDA could go through the process of approving ingredients in question – and has indicated it will do so – but it’s a complicated process, and there is “also a matter of risk,” according to Santos Rutschman. “The FDA has always been less risk averse than its counterparts in Europe. I understand the market concerns, but this seems about right from a regulatory perspective… We aren’t talking about a specific drug that people need and cannot access. Sunscreen is available for the average American to purchase.” Barring an overhaul to the regulatory system in the U.S. to include an agency for cosmetics – an idea some argue has merit, but Santos Rutschman described as “not feasible” with the available funding – the only way Europe’s sunscreen would be available for Americans to purchase is if the FDA moved forward in regulating the ingredients. And that will continue to take time. “The FDA has never moved quickly on anything,” said Santos Rutschman. “It just can't.”

Ana Santos Rutschman, SJD, LLM

Areas of Expertise

Drug Prices
Intellectual Property/Patent
Innovation Policy
Health/Bio 3D Printing
Health AI
Vaccines
Pharmaceuticals
Biotech
Health Tech

Biography

Ana Santos Rutschman is Professor of Law and Faculty Director of the Health Innovation Lab at Villanova University Charles Widger School of Law, where she teaches and researches topics related to health law, intellectual property, innovation in the life sciences, and law and technology. She is a nationally and internationally recognized expert on vaccine law and policy, the regulation of emerging health technologies, and access to medicines.

Professor Rutschman’s work has been recognized by numerous institutions, including the American Society of Law Medicine & Ethics, which named her a Health Law Scholar in 2018 and Bio Intellectual Property Scholar in 2017. In 2018, she was also named a Wiet Life Sciences Law Scholar by the Beazley Institute for Health Law and Policy at Loyola University Chicago. In 2022, the Boston Congress of Public Health selected her as one of the inaugural recipients of a 40 Under 40 Public Health Catalyst Award for her work on vaccine law and policy.

Professor Rutschman’s book, Vaccines as Technology: Innovation, Barriers and the Public Health, was published in 2022 by Cambridge University Press. Her legal scholarship has appeared or is forthcoming in UCLA Law Review, Emory Law Journal, Indiana Law Journal, UC Davis Law Review, Arizona Law Review, Yale Law Journal Forum, Harvard Public Health Review and Vanderbilt Journal of Transnational Law, among several others. Her peer-reviewed work has appeared in Nature Biotechnology, Vaccine, Emerging Infectious Diseases and American Journal of Infection Control, among others. Her commentary pieces have been published by Health Affairs Blog, Bill of Health, Saint Louis Post-Dispatch, the Huffington Post and The Conversation, and republished in Scientific American, Newsweek Japan and numerous U.S. newspapers.

Before joining Villanova Law in 2022, Professor Rutschman taught in the health law program at Saint Louis University School of Law (2018-2022) and served as the inaugural Jaharis Fellow in Health Law and Intellectual Property at DePaul University College of Law in Chicago (2016-2018). Professor Rutschman has also consulted for the World Health Organization in (2022 and 2015-2016) on matters related to the development of drugs and vaccines against COVID-19, Zika and Ebola.

Select Media Appearances

23andMe Wants to Sell its Most Valuable Asset. Will your Private DNA Data be Safe?

MarketWatch  online

2025-03-27

“There is nothing specific in bankruptcy law that automatically protects the data of 23andMe’s consumers in this situation,” Ana Santos Rutschman, law professor and faculty director of the Health Innovation Lab at Villanova University, told MarketWatch via email. “The Bankruptcy Code only says that companies cannot sell identifiable personal information unless the sale is enabled by that company’s privacy policy.”

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Could RFK Jr. Really Take Away ADHD Medication?

Rolling Stone  online

2025-02-23

Banning or restricting access to any medication currently used in the treatment of ADHD would have to involve the Food and Drug Administration (FDA), which falls under and follows the policies of the Kennedy-led Department of Health and Human Services, Rutschman says. “These ADHD drugs have been approved by the FDA — which by law has to make a determination that a drug is safe and effective before a company can sell it,” she says. “Also by law, the FDA can withdraw approval or restrict distribution if new evidence suggests that an approved drug is not safe or effective.” So, banning or restricting access to these drugs would require some sort of FDA-initiated decision based on data raising concerns about a specific ADHD drug.

According to Rutschman, the MAHA Commission report itself wouldn’t be a sufficient source of this data; rather, it would need to come from several studies reflecting the current “scientific consensus” demonstrating that a specific ADHD drug was causing issues, or was not effective.

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Trump's Pick for FDA to Test 'Due Diligence' of Agency's Science

Bloomberg Law  online

2024-11-25

Makary could take “positive steps” in regulating and eliminating “harmful components that are still allowed in food, supplements, food containers and packaging,” according to Ana Santos Rutschman, professor at the Charles Widger School of Law at Villanova University.

“Among all the nominations so far in the public health space, this is the candidate with the strongest credentials,” Rutschman said. “And I think that there is, at least for now and in theory, room for some positive developments at the FDA.”

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Research Grants

Innovation, Business & Law Center Prize (with Ruqaiijah Yearby)

University of Iowa

2020

Beaumont Research Award

Saint Louis University

2020

Spark Microgrant Award (with Timothy Wiemken)

Saint Louis University

2020

Select Academic Articles

Increasing Equity in the Transnational Allocation of Vaccines Against Emerging Pathogens: A Multi-Modal Approach

Journal of Law, Medicine & Ethics

2023

This article proposes the adoption of a multi-modal system for allocating vaccine doses during large transnational outbreaks of infectious diseases. The chosen allocative criteria (public health need; country-income level; qualification through funding; and, subsidiarily, a modified lottery system) are adapted from a current embodiment of allocative multi-modality outside the context of public health: the New York City Marathon.

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Vaccine Contracts in the Context of Pandemics and Epidemics

New York University Journal of International Law and Politics (JILP)

2022

This symposium essay explores the architecture of vaccine contracts, as well as the allocation of resulting vaccines in preparation for, and in response to, pandemics and large-scale epidemics. Drawing on contracts predominantly related to COVID-19 vaccines collected through publicly available databases, the work begins by providing an overview between the relationships between the parties entering into these agreements; the bargaining processes adopted and their timeline relative to market demand for vaccines; and the substantive obligations imposed by these contracts.

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Contractual solutions to overcome drug scarcity during pandemics and epidemics

Nature Biotechnology

2022

Licensing provisions that obligate recipients of government funding to share relevant technology and know-how for scarce drugs during pandemics and epidemics can reduce shortages and overcome obstacles that intellectual property rights present.

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