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  • By Dana Casadei

Cosmetics contamination: Little FDA oversight

Melissa Cooper Sargent would start every workshop on cosmetics at the Ecology Center with one question, "True or false, the FDA must approve all cosmetics before they go on the market?" It's a slightly leading question but it would get people's attention and to Sargent's point, quickly. "We make a lot of assumptions that we’re in this country and the products on the shelves must meet certain criteria, but it’s false," said Sargent, environmental health advocate, Ecology Center. If you're surprised by that fact, you aren't alone. The Food and Drug Administration (FDA) actually has very little oversight when it comes to the cosmetics industry. Out of the hundreds of pages that make up the Federal Food, Drug, and Cosmetic Act – the law that governs the FDA's oversight of cosmetics – only about one-and-a-half pages are dedicated to cosmetics laws, which haven't been meaningfully updated since 1938, when it was first enacted. The list of things the FDA can't do is much longer than what it can. Currently, there are only a few laws on the books regarding the cosmetic industry. To put it simply, cosmetics must not be "adulterated" or "misbranded," and must be safe for consumers when used in an expected way. They need to be made in a clean environment and also need to be properly labeled. The only ingredient that needs FDA approval before going on the market is color additives. There are some major loopholes when it comes to the law about labeling, though. Take, for instance, some of the actual words on the label, things like BHA (butylated hydroxyanisole), coal tar dyes, parabens, sulfates, phthalates, oxybenzone, propylene glycol, and petrolatum. They might literally be on the label – but their definitions aren't. "There are general categories of chemicals that have come to the forefront as concerning," said Dr. Nicole Acevedo, PhD, founder & CEO, Elavo Mundi Solutions, LLC, a company focused on consulting with personal care and cosmetic brands to create solutions for cleaner and more sustainable product development. Dr. Acevedo also worked as the principal scientist for BeautyCounter, a skin-care and beauty company dedicated to safer, smarter products. A few of those concerning chemicals include all of those listed above, found in many cosmetics, for very legitimate reasons. Petrolatum is often used as a barrier to lock moisture in the skin in products like moisturizers and hair care. It's been around for centuries but can become a health hazard if it hasn't been refined, one of a variety of concerns to using the chemical. "The risk there, from a makeup perspective, is you’re exposing yourself to petrolatum when you really don’t need to, you really shouldn’t be. That could add up to a lifetime exposure that might add to some sort of health problems," said Nicholas Schroeck, associate dean of experiential education, associate professor of Law Director, Environmental Law Clinic, University of Detroit Mercy School of Law. Phthalates are also common, found in nail polish, hairspray, deodorant, and perfume. These have been known to cause endocrine disruption, headaches, and respiratory problems. A common chemical found in hair dye, lead acetate, can impact the development and function of the brain. According to Acevedo, lead acetate is classified as a Prop 65 carcinogen, which is strictly prohibited for use in cosmetics in the European Union and Canada but can still found in certain at-home hair color restorer formulations sold in the U.S. More commonly found in hair dye is P-Phenylenediamine (PPD), which may be carcinogenic. There are parabens, a preservative in skin-care products. While it hasn't been considered fatal, the longer chains of parabens – propyl, butylparaben, isopropyl, and isopropyl parabens – may inflict disruption to the endocrine system, which then would cause reproductive and developmental disorders. Acevedo, who has an expertise in endocrine-disrupting research, said that endocrine-disruptors have been shown to interfere with the normal functions of the hormone pathways in your body. "The tricky thing with endocrine active chemicals is that they can act like hormones...their mode of action may not be as clear cut as for carcinogens, but there is growing scientific evidence that they can have long-term adverse effects on human health," she said. Harmful chemicals can be listed on a label as something else too, such as formaldehyde. Consumers will see formaldehyde-releasing preservatives, which she said have the job of breaking down to release formaldehyde, and is a known human carcinogen. Acevedo said if it doesn't say formaldehyde, consumers should look for DMDM hydantoin, diazolidinyl urea and imidazolidinyl urea, Quaternium-15. Another ingredient that's commonly seen on labels but gets around some pretty big loopholes is fragrance. "If you want to reduce your overall chemical exposure starting with things that are fragrant-free is a good place to start," said Melanie Benesh, Environmental Working Group's legislative attorney. That's because there is little to no transparency. "You have elements under this veil of secrecy," Acevedo said. On a label, it may be listed simply as "fragrance" – and that's the issue. Fragrance isn't just one thing – it could be hundreds or thousands of different chemicals, some of which could be harmful or not oroperly tested for safety. Even if manufacturers wanted to disclose everything in their product to the FDA and consumers, they might not be able to due to the fragrance supplier, who legally doesn't have to give anyone a list of what's in their fragrance blend. "It’s 2020. We can’t keep on going with this whole, 'oh, you don’t need to know what’s in that, don’t worry your pretty little head.' No, we need greater transparency in fragrance," said Mia Davis, director of environmental and social responsibility at Credo Beauty, the largest clean beauty retailer with nine brick and mortar stores and their website, Davis was also the first official hired at BeautyCounter, and served as their head of environment, health and safety. Everyone's hands are tied though, as there is no federal law in regards to companies being required to list any of the chemicals in the fragrance mix. Another area the FDA has no legal responsibility over has to do with ordering recalls of cosmetics, which they are not authorized to do. Recalls of cosmetics are voluntary and undertaken by the manufacturers or distributors. Take for instance, what happened with teen retailers Claire's and Justice. In a statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, published last March 2019, they were able to confirm findings from 2017 of asbestos contamination in multiple cosmetic companies by the companies. But they couldn't put out a recall on the products – they could only put out an update on independent testing results and a safety alert warning about the products that had been tested positive for asbestos that were still on the market. "The FDA requested that Claire's recall the products because they should not be used by consumers. Claire's has refused to comply with the FDA's request, and the agency does not have the authority to mandate a recall," the statement said. A more recent example would be from late January 2020, when the Environmental Working Group released findings about IQ Toys' Princess Girl’s All-in-One Makeup Palette, where they found four million asbestos fiber structures in every gram of the talc-containing eyeshadow powders. "The main concern with asbestos is the fibers are very small and they get lodged in our lungs and we don’t expel’s carcinogenic so it can lead to lung cancer and the most common form associated with asbestos is mesothelioma," Schroeck said. "So, the concern with makeup, which potentially has asbestos as far as the talcum powder, is that people might actually breathe that in and those small fibers could lead to, in a worst-case scenario, cancer." "The issue with makeup is when we’re mining for talc to make talcum powder, it’s not regulated, it’s not tested appropriately, you could potentially get asbestos in through the mix," he noted. Nneka Leiba, vice president of EWG’s healthy living science program, said that the product was taken down from Amazon, eBay, and the IQ Toys' website after their alert was put out January 16, 2020. According to Schroeck, if someone was to come forward and show people had been exposed to a harmful product and sickened by it, they could potentially get tens of thousands of potential class members, depending on the company and its distribution, and it would be the "perfect set of facts for a class action lawsuit." Take for example Wen, a hair care company that had cleansing conditioners that users said allegedly made their hair fall out. The company settled a class-action suit for $26 million. Johnson and Johnson has also had to deal with legal ramifications because of their products, including wide-ranging law suits over baby powder which includes talc, where they had multi-million dollar settlements to those who said they got ovarian cancer from using their baby powder for years. "I do think things are shifting, and I think it’s largely due to the fact that bad things have happened," said Mozhgon Rajaee, PhD, MPH, assistant professor, Public Health Department of Public and Environmental Wellness, School of Health Sciences at Oakland University. At the state level there are multiple bills being pushed to clean up toxins in makeup. In Michigan, Rep. Laurie Pohutsky (D-Livonia) introduced House Bill 5406 in late January. The bill would amend 1978 PA 368, Public Health Code, by adding part 55b, to deal with toxic chemicals in cosmetics. The bill states "a person shall not sell, offer for sale, manufacture, or transfer to any person an adulterated cosmetic in this state." Adulterated cosmetics in this bill refers to those which contain 10 different ingredients that would not be allowed in cosmetics, including asbestos, lead, and mercury and related compounds. In California, there are two bills to look out for. If any of the 13 toxic chemicals – all of which are already banned in the European Union – listed in the Toxic-Free Cosmetics Act, A.B. 495, were found in products, said product would be considered adulterated and not allowed to be sold in California. California Toxic Fragrance and Flavor Chemicals Right to Know Act of 2019 (SB 574) would require cosmetics companies to report toxic fragrance or flavor ingredients to the California Safe Cosmetics Program. On the federal level, there also is a lot of movement to try to rein in the cosmetic industry. On February 4, 2020, the FDA held a public meeting on testing methods for asbestos in talc and other cosmetic products containing talc. At the hearing, they heard from government and testing experts, industry representative, and consumer advocates. It was the first FDA hearing on asbestos testing in talc since 1971. Currently, there are five bills that have been introduced, one that has to do with asbestos, specifically in cosmetics products for children. Introduced last March by Michigan Rep. Debbie Dingell (D-Dearborn), H.R. 1816 – also called the Children's Product Warning Label Act of 2019 – would "amend the Federal Food, Drug, and Cosmetic Act to require that children’s cosmetics containing talc include an appropriate warning unless the cosmetics are demonstrated to be asbestos-free, and for other purposes." "The studies that have been done have found asbestos in children’s cosmetics, and I think that’s where we have to target it the fastest because children are the most vulnerable," said Dingell. "Even small levels of asbestos exposure...can cause lung cancer, mesothelioma." The congresswoman is optimistic that they can get this done in the calendar year. "I think if we get it through the Senate, the President will sign it," Dingell said, who noted she hasn't had any resistance from those she's spoken with. Many of the cosmetic bills circulating are being considered bipartisan issues, with sponsorship coming from both sides of the aisle. Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S726) last March. The bill would give the FDA the power to ensure that the chemicals used in cosmetics and other everyday personal care products are safe. H.R. 5279 – the Cosmetic Safety Enhancement Act of 2019 – was introduced by Rep. Frank Pallone, Jr. (D-NJ) and would "amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes." Two bills, H.R. 4296 and H.R. 5017, do multiple things none of the others do. Rep. Janice Schakowsky (D-IL) introduced the former, the Safe Cosmetics and Personal Care Products Act of 2019. Janet Nudelman, director of program and policy, Breast Cancer Prevention Partners, director, Campaign for Safe Cosmetics, said they are considering Rep. Schakowsky's bill to be "the gold standard of federal cosmetic safety legislation." According to Nudelman, H.R. 4296 is the only piece of federal cosmetic safety legislation that calls for full fragrance ingredient disclosure and transparency along the entire supply chain. It's also the only bill that addresses the overexposure of women of color to toxic chemicals in the harmful products marketed to them. Then there's H.R. 5017 from Rep. Sean Maloney (D-NY). The bill is intended to address the misuse and abuse of marketing claims purporting to be “natural.” It would create a federal definition of the term "natural" to mean the product has at least 70 percent of its ingredients coming from natural substances and the other 30 percent have to be naturally derived, with definitions of both those given. It also doesn’t allow for the processing of the natural ingredients that produce toxic chemicals. "The word ‘natural’ on a product doesn’t mean anything because there is no legal definition of natural," Nudelman said. "Consumers want to be able to trust that natural means something." Much like how consumers want to believe when a product is defined as “clean” that it actually means something. "Just because a product says that they’re clean doesn’t actually mean that they are," Leiba, of EWG’s healthy living science program, said. Acevedo, of Elavo Mundi Solutions, even went so far as to say that the "free from" or "free of" terminology may be unintentionally doing more harm to clean beauty than good. "It almost gives a false sense of security as 'okay, this product is being marketed as safe and clean. It’s non-toxic, it’s free of these chemicals, it’s great.' But then you look at the label," said Acevedo, who mentioned once you look at the label there could be a list of chemicals of concern on it. Plus, not all natural products are good for you. Cosmetic chemist Ginger King said that poison ivy is the classic example of a natural product that's still harmful. In the same vein, not all chemicals are bad. "Someone makes a noise about something bad, and consumers start to check ingredient listings," King said. "I’m very clear to say a chemical in and of itself is not necessarily harmful. There are a lot of times that word gets thrown around to mean synthetic or bad," Acevedo said. "Water is technically a chemical." Credo Beauty's Davis agrees. "I'm always careful to make the point that this is just one’s not like I think, ‘God, if you use x, y or z product it’s going to give you cancer,'" Davis said. "We’re very careful not to be anti-chemical. We’re just trying to take a very rational, logical, and precautionary approach here." Unlike the United States, the European Union tends to be more cautious and take that precautionary approach when it comes to their cosmetic standards. The EU has been working and looking closely at toxicity in chemicals for nearly two decades, and has banned over 1,300 different chemicals compared to the U.S., which has banned only around 30. Why is that though? Why hasn't the U.S. banned more chemicals? Well, there are a few reasons. "The cosmetic industry has aggressively fought and advocated for maintaining the status quo," said Patrick Celestine, federal relations counsel, American Association for Justice. "These companies and their surrogates have no real interest in being regulated in a meaningful way." The lobbyists from groups like Johnson and Johnson and their trade association, the Personal Care Products Council, which many multi-national companies are a part of, have been known to give pushback on regulations at both the state and federal levels. There's also the Fragrance Creators Association, which Nudelman said lobby at the federal level against having fragrance disclosure. "This is a problem that they argue very passionately on behalf of, but it’s a problem that they also created," she said. "They argue that if the chemicals in an individual fragrance formulation were to be disclosed that it would crush their industry. That by disclosing the ingredients of Chanel No. 5 perfume that anyone could go in to a laboratory and could create a replica." Another issue is cost. Sargent, environmental health advocate with Ecology Center, said if things were to change, companies would have to think more about the ingredients they were using in products. Harmful chemicals, like phthalates, are cheaper. With higher quality ingredients they would have to invest more money. While better ingredients could cost more, it could potentially also save companies money in the long run. Davis brought up "real cost accounting," the cost to your consumers' health and litigation risks, like the millions Wen and Johnson and Johnson have had to spend in litigation and to settle cases. The cost for consumers would also lower. Acevedo made the point that when more companies are going along the clean beauty philosophy that the cost of goods would drop so everyone would be working off a lower cost of material. In regard to just replacing the harmful products with new ones, that's where things get a little tricker. "It’s about the expectation of how your product is going to look and function," Acevedo said. "It might be a little different but there are some choices you can make to make sure those aren’t in there." Acevedo said that when you look at it from an ingredient category perspective, you can find replacements, like with the preservative, paraben. Makeup needs easy ingredients so it doesn't grow things like mold or bacteria, but there are other preservatives that don't have the same health concerns. Take sunscreens. Acevedo said that different chemical ultraviolet filters, like oxybenzone and octinoxate, have similar modes of action and can carry similar risks to human health and the environment that include interference with normal hormone function, toxicity to aquatic species, and persistence in the environment. It's safer to use mineral-based sunscreens to avoid these risks. She does think we'll reach a point where all the harmful chemicals will be replaced in makeup. Clean beauty it still a young industry and has already made a lot of strides. "You have formulators in these manufacturing labs for the products. They’re formulating chemists, they’re working with what they know functionally works and everyone has been telling them for years to use it and now, all of a sudden they’re like, these are problematic ingredients," she said. "So, they’re having to reinvent the wheel," Acevedo continued. "It’s a bit uncomfortable in the short term but as the movement continues to grow – and I sincerely believe we’re not going back on this – you’re just going to find that raw material suppliers are going to be more innovative and take a lot more care and attention in how they create these materials to make sure they don’t have these hazards. And formulators are learning to work with new materials better." Until then, there are a lot of educational tools out there for consumers. The EWG has their Skin Deep guide to cosmetics, which rates over 70,000 personal care products, and its EWG Verified program. Credo Beauty has their Clean Standard, which Davis said is a 26-page operating document that brands have to comply with, sign, and get trained on. BeautyCounter has The Never List, full of more than 1,800 questionable or harmful chemicals that they never use as ingredients in their products. The Campaign for Safer Cosmetics website also has a wealth of information. With programs like those, the consumer is becoming more educated and therefore not content with products that don't stand up to their new standard of clean beauty. "Once you, for lack of a better term, pull the wool from over somebody’s eyes, they can’t unsee that phthalates are associated with endocrine disruption or that formaldehyde is a well-known carcinogen," Leiba, of EWG’s healthy living science program, said.

What started as a niche market – where products could lean more towards the expensive side – has now grown into a much bigger industry and more large companies are starting to join the fight against toxic chemicals. EWG's Verified program now has popular, mainstream brands like Herbal Essences, which has over 200 products with the verified mark. In January, the EWG made a big announcement that Revlon became the first global brand with an EWG verification to mass retailers with Revlon's PhotoReady Prime Plus Perfecting + Smoothing Primer. Leiba said that more and more companies have reached out about becoming EWG Verified. They've also seen a lot of companies who didn't meet the standard go back and work to reformulate their product. "Companies are looking for a third-party verification to prove they meet higher ingredient and manufacturing standards, and at the moment, the verified mark is being held to a high standard in that regard so more companies are reaching out to us," she said. Other movement is happening in the big-box store category, such as beauty retailer Sephora, which now has their Safer Chemicals Policy. Target has more and more clean beauty options gracing the shelves, and CVS announced in 2017 that they would be removing parabens, phthalates, and other ingredients from their store brand CVS Health, Beauty 360, Essence of Beauty, and Blade product lines by the end of last year. So there have been changes happening quietly and not-so-quietly in the cosmetic industry – but where does clean beauty go from here? "So, what are the most important next steps?" Nudelman said. "There’s three ways I would answer that question." One would be for consumers to become smarter shoppers. This leads to her second point, how companies need to step up to the plate, be better corporate citizens, and make the kind of voluntary changes that consumers are demanding, to sell safer products, provide more and better ingredient disclosures and have transparency. Lastly, it has to do with the government. "At the end of the day, we also need and deserve a government that protects us," Nudelman said. "We need the U.S. Congress to enact more health protective federal cosmetic safety policy reform. We need more strong. FDA oversight in regulation to the cosmetics industry, but in order for that to happen we need a better and stronger federal law in place to guide them." Acevedo has more specific goals. She wants to reach a point where there are more refined standards and to get materials benchmarked to be working off those standards. She knows it's a lofty goal to create a standard template to have all companies working from, but she's extremely hopeful of making it happen. "There’s always going to be ways brands can differentiate from each other, but it shouldn’t have to be because one is safer than the other," Dr. Acevedo said.­

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