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

Jul 9, 2024

3 min

Ana Santos Rutschman, SJD, LLM

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.”

Connect with:
Ana Santos Rutschman, SJD, LLM

Ana Santos Rutschman, SJD, LLM

Professor of Law

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

Drug PricesIntellectual Property/PatentInnovation PolicyHealth/Bio 3D PrintingHealth AI

You might also like...

Check out some other posts from Villanova University

2 min

The EPA Cracks Down on 'Forever Chemicals' in Drinking Water

For many years, toxic per- and polyfluoroalkyl substances (PFAS) have contaminated drinking water supplies across the United States. But in April, the Environmental Protection Agency (EPA) announced major steps to rein in these stubborn "forever chemicals." In a groundbreaking move, the EPA set strict new limits on six types of PFAS that are currently present in drinking water. Permitted levels of these chemicals are now close to zero, as water suppliers will be required to reduce them to the lowest level that can possibly be measured. These are the first-ever nationwide drinking water regulations for PFAS issued by the federal government. "The EPA is asking water companies to try to get PFAS levels to zero because there's no safe level. It's very difficult to test below four parts per trillion with the equipment and the testing mechanisms we have right now, so the levels will be reduced as much as they possibly can," said Dr. Laura Anderko, Co-director of the Mid-Atlantic Center for Children's Health and the Environment at Villanova University’s M. Louise Fitzpatrick College of Nursing. So what’s driving this urgency to minimize exposure to PFAS? Our children’s health is one big reason. As Dr. Anderko explains, "Children are more susceptible and vulnerable to the health impacts of PFAS because their bodies are still growing. Some of the health issues resulting from PFAS exposure are high cholesterol and a decrease in infant growth and fetal growth - so much so that there's a tendency towards low birth weight." Adults aren't spared either. PFAS has been linked to health issues including kidney cancer, liver problems and reduced antibody response from vaccines. For pregnant women, PFAS can increase the risk of high blood pressure. “These chemicals do impact pretty much every organ system of the body," Dr. Anderko said. With many different PFAS compounds used in products from fast food packaging to Band-Aids to carpeting, avoiding exposure to them can be difficult. Dr. Anderko’s advice to reduce exposure is to educate yourself on what products contain PFAS and purchase alternative options when possible. She also cautions against relying solely on bottled water, which isn't necessarily safer than tap water. "We have this idea that bottled water is safe because it's packaged, but a lot of times that water is not tested, and we know for a fact that bottled water is filled with microplastics,” she said. “You're better off not relying on bottled water unless you absolutely have to.” Per Dr. Anderko, in the United States chemicals can be inserted into some products without stringent testing for human health effects beforehand, so the EPA's new PFAS limits represent a major step toward putting human health first. While there is still a long road ahead to completely eliminate PFAS from our daily lives, these new regulations signal a welcome shift toward protecting public health in our country.

3 min

Changes to Philadelphia's Tax Structure Could Represent "Pivotal" Economic Shift

On March 14, Philadelphia mayor Cherelle Parker delivered her first budget proposal in a 75-minute address to City Council. Throughout her speech, the new mayor touched on subjects ranging from corridor cleaning and housing programs to police spending and anti-violence grants. However, one set of items was absent from her $6.29 billion plan and presentation. In a break from recent administrations, Mayor Parker abstained from calling for cuts to the city's wage or business taxes. She also refrained from speaking on adjustments to Philadelphia's tax structure, which depends more heavily than other municipalities on wage taxes and has a relatively light property tax burden. Theodore Arapis, PhD, chair of Villanova University’s Department of Public Administration and an expert on fiscal policy in local governance, believes that changes to how Philadelphia levies and handles taxes, particularly on the real estate front, should be discussed further. "[Having property taxes play a larger role] represents a pivotal shift towards creating a more resilient and efficient revenue system," said Dr. Arapis, after reviewing the mayor's plan. "The current reliance on wage taxes is subject to considerable volatility, undermining fiscal stability. In contrast, property taxes offer a more inelastic and predictable revenue stream, suggesting a strategic move towards them would be beneficial for the city." Dr. Arapis also maintains that, with Harrisburg's go-ahead, Philadelphia's real estate taxes could be structured in a way that effectively facilitates business growth, while ensuring that homeowners are not unduly burdened. "Differentiating tax rates between commercial and residential properties could strike a delicate balance—spurring economic development while maintaining equitable tax distribution," he stated. "This segmentation could stimulate business activity by creating favorable conditions for commercial enterprises, which is essential for Philadelphia's economic vitality." Additionally, Dr. Arapis contends that tweaks to the city's tax abatement policy, which is currently in the process of a gradual phaseout, could further provide for inclusive and sustainable growth. "Tax abatements have been utilized as a policy tool to stimulate property revitalization and neighborhood renewal. However, these measures often carry unintended consequences that disproportionately impact existing residents," he shared. "Specifically, such incentives can precipitate a rise in property values and, consequently, a hike in the tax burdens of non-abated properties. This dynamic can exacerbate gentrification, leading to the displacement of longstanding community members. "To address the complexities of tax abatement policies in fostering affordable [and accessible] housing, a nuanced strategy is vital. A more equitable distribution of housing affordability could be achieved by, say, mandating that at least 50% of units in new developments meet affordability criteria... [and diversifying] the approach to income targeting, perhaps through a tiered system that caters to various income levels [and indexes] these categories to local inflation and wage growth." Despite the content of her first budget proposal and address, Mayor Parker likely shares some similar perspectives on tax reform and structural adjustments. Prior to entering office, during her years as a City Council member and days on the campaign trail, the acting executive worked to lower Philadelphia's wage tax, acknowledged the untapped potential of property taxes and expressed her desire for a differentiation of property tax rates. Before pursuing these measures further, as The Philadelphia Inquirer reports, Mayor Parker is probably (1) holding off until the newly announced Tax Reform Commission shares its findings, (2) ensuring that there are no immediate, major disruptions to the city's flow of revenue, as she launches her "safer, cleaner, greener" agenda, and (3) waiting for state lawmakers to make greater progress on raising the minimum wage and restructuring the Commonwealth's tax legislation, namely the uniformity clause. The mayor did, however, make one notable tax-related recommendation in her budget plan: She proposed an increase to the school district's share of real estate tax revenue from 55% to 56%, which could boost funding for the district by $119 million over five years. "The redistribution of real estate taxes between the school district and the city is commendable as an initial measure," observed Dr. Arapis. "However, without a comprehensive reform of the real estate tax system, encompassing regular property reassessments and adjustments to mill rates, this change is likely to yield only ephemeral benefits."

4 min

Success Is Sweet: Ferrero's Crown Jewel, Nutella, Turns 60

Six decades ago, on April 20, 1964, the first jar of Nutella left Gruppo Ferrero's factory in the Italian town of Alba. In its gooey wake, the chocolate-hazelnut treat would spread across continental Europe, and then the world, like a healthy schmear on toast. Today, Nutella is the crown jewel of Ferrero's confectionary empire, propping up a business that generates roughly 17 billion euros in revenue each year. Annually, a whopping 365,000-plus tons of the stuff are sold across 160 countries, and nearly one quarter of all hazelnuts harvested are devoted to its production. Luca Cottini, PhD, is an associate professor of Italian in Villanova University's College of Liberal Arts and Sciences and an expert on modern Italian culture, history and society. He also is the author of a book on Michele Ferrero, the mastermind behind Nutella and its meteoric rise: Il fabbricante di cioccolato. To mark the iconic Italian brand's 60th anniversary, Dr. Cottini shared some thoughts on its Willy Wonka-like creator, early (accidental) origins and recipe for international success. Here's a taste: Q: According to Business Insider, a jar of Nutella is sold every 2.5 seconds—just about the time it takes to finish this sentence. How did we get so "nuts" for Nutella, anyway? Dr. Cottini: Well, much of the success of Nutella relates to its novelty, to the idea of spreadable chocolate. At one point, to think that spreading chocolate would be popular was as crazy as to predict that spreadable coffee would be a hit. The idea developed because, in the mid-to-late 1940s, Michele Ferrero's father Pietro was to combine the scarcity of cocoa in his area with hazelnuts, which was the ingredient most available in Alba. It seemed like condemnation that they should have only hazelnuts. Well, he combined them with cocoa to produce this mix—it's called "gianduja" in Italian—and he sold it. But when the Ferreros sold it in southern Italy, they had a problem: The chocolate was melting with the summer heat; and a lot of the workers in Naples, to not waste it, started to spread it on slices of bread. And it's interesting. The Ferreros have a completely non-moralistic approach to failure. You sell chocolate; it melts. This is somewhat embarrassing. But their approach was instead to see this situation as the beginning of a new idea, of a new concept. Q: Is Nutella's story unique in this respect? DC: Several Italian innovators have similar stories to the Ferreros', especially during the 1930s. [Salvatore] Ferragamo, for instance, developed the wedge shoe because there was a shortage of steel, with an embargo imposed on Italy. So, he used Sardinian cork as a replacement, and that generated the wedge shoe. [Guccio] Gucci, during a leather shortage, started using hemp and decorating the hemp with a double "G," and that became the trademark of the company. [Alfonso] Bialetti, who produced the modern coffeepot, used the only metal that was allowed during Fascism, which was aluminum, since the Partito Nazionale Fascista would not import iron or prime metals. But Bialetti took this poor, hybrid ore and made it something that could become valuable. And so, he invented the moka coffeepot in 1933, which is one of the symbols of Italian design. That’s one of the keys of the Italian model of entrepreneurship: producing objects that are not just trendy for one season, but eventually become evergreen or classic. Q: What inspired the name "Nutella?" DC: It was the product of 18 years of research. For all intents and purposes, "Nutella" first came out in 1946. It was called "SuperCrema" and, before that, "Cremalba." But in 1962, there was a law in Italy that prevented companies in the food industry from using prefixes like "super" or "extra." So, that led Ferrero—by then, under the leadership of Michele Ferrero—to figure out a new alternative to SuperCrema. At the same time, the company was expanding into Germany and France, and they needed a brand name that could be pronounced easily. So, Ferrero joined the "ella" sound from mozzarella, stella, caramella—Italian words that people could recognize—with the word "nut," like the English "nut," which gave their product an international feel. It's really a "glocal" [global and local] name. It was conceived as a very rooted enterprise with a global horizon. Q: In 1964, were Ferrero's global ambitions practical? DC: It was honestly a bit of a gamble. In 1957, the European Economic Community was established, which is the beginning of the European Union. And that same year, Michele Ferrero organized in Rome the first conference of his company, which was by then somewhat national, to plan exportation in Europe. In the Italy of the 1950s and 1960s, this was very pioneering. Michele Ferrero was actually one of the first businesspeople to export products to Germany in the 1950s, at a time when there was a lot of resentment against Italians because of everything that happened during the Second World War. So, he entered this incredibly difficult market, and still today, Ferrero and Nutella are strong. Q: What do you think accounts for Nutella's continued popularity, 60 years after its introduction? DC: Michele Ferrero thought of his products as speaking products. It's something very common to the automobile industry in Italy. This is characteristic of Ferrari and Lamborghini; they produce cars that are appealing not just because they're "super cars," but because they say something. Nutella is a food that says something. When someone puts it on the table, it compels people to jump in and share their own stories—of trying it with a friend, of having it on a hike or of taking part in "Nutella Day." Today, if you're in the market for a chocolate-hazelnut spread, you might find products that are even better than Nutella. Actually, surely better. But they will never replicate the appeal and the grasp that Nutella has. Because Nutella has that aura of storytelling and mythmaking other products simply don't have.

View all posts