Scientists Jason Schrum and Kerry Benenato solved crucial challenges in mRNA vaccine development.
Derrick Rossi, a scientist at MIT, and Noubar Afeyan, a Cambridge-based investor, launched Moderna in September 2010. Their idea was to create mRNA molecules capable of delivering instructions to the body's cells, directing them to make proteins to heal ailments and cure disease. Need a statin, immunosuppressive, or other drug or vaccine? Just use mRNA to send a message to the body's cells to produce it. Rossi and Afeyan were convinced injecting mRNA into the body could turn it into its own laboratory, generating specific medications or vaccines as needed.
At the time, the notion that one might be able to teach the body to make proteins bordered on heresy. Everyone knew mRNA was unstable and set off the body's immune system on its way into cells. But in the late 2000's, two scientists at the University of Pennsylvania, Katalin Karikó and Drew Weissman, had figured out how to modify mRNA's chemical building blocks so the molecule could escape the notice of the immune system and enter the cell. Rossi and Afeyan couldn't convince the University of Pennsylvania to license Karikó and Weissman's patent, however, stymying Moderna's early ambitions. At the same time, the Penn scientists' technique seemed more applicable to an academic lab than a biotech company that needed to produce drugs or shots consistently and in bulk. Rossi and Afeyan's new company needed their own solution to help mRNA evade the body's defenses.
Some of Moderna's founders doubted Schrum could find success and they worried if their venture was doomed from the start.
The Scientist Who Modified mRNA: Jason Schrum
In 2010, Afeyan's firm subleased laboratory space in the basement of another Cambridge biotech company to begin scientific work. Afeyan chose a young scientist on his staff, Jason Schrum, to be Moderna's first employee, charging him with getting mRNA into cells without relying on Karikó and Weissman's solutions.
Schrum seemed well suited for the task. Months earlier, he had received a PhD in biological chemistry at Harvard University, where he had focused on nucleotide chemistry. Schrum even had the look of someone who might do big things. The baby-faced twenty-eight-year-old favored a relaxed, start-up look: khakis, button-downs, and Converse All-Stars.
Schrum felt immediate strain, however. He hadn't told anyone, but he was dealing with intense pain in his hands and joints, a condition that later would be diagnosed as degenerative arthritis. Soon Schrum couldn't bend two fingers on his left hand, making lab work difficult. He joined a drug trial, but the medicine proved useless. Schrum tried corticosteroid injections and anti-inflammatory drugs, but his left hand ached, restricting his experiments.
"It just wasn't useful," Schrum says, referring to his tender hand.*
He persisted, nonetheless. Each day in the fall of 2010, Schrum walked through double air-locked doors into a sterile "clean room" before entering a basement laboratory, in the bowels of an office in Cambridge's Kendall Square neighborhood, where he worked deep into the night. Schrum searched for potential modifications of mRNA nucleosides, hoping they might enable the molecule to produce proteins. Like all such rooms, there were no windows, so Schrum had to check a clock to know if it was day or night. A colleague came to visit once in a while, but most of the time, Schrum was alone.
Some of Moderna's founders doubted Schrum could find success and they worried if their venture was doomed from the start. An established MIT scientist turned down a job with the start-up to join pharmaceutical giant Novartis, dubious of Moderna's approach. Colleagues wondered if mRNA could produce proteins, at least on a consistent basis.
As Schrum began testing the modifications in January 2011, he made an unexpected discovery. Karikó and Weissman saw that by turned one of the building blocks for mRNA, a ribonucleoside called uridine, into a slightly different form called pseudouridine, the cell's immune system ignored the mRNA and the molecule avoided an immune response. After a series of experiments in the basement lab, Schrum discovered that a variant of pseudouridine called N1- methyl-pseudouridine did an even better job reducing the cell's innate immune response. Schrum's nucleoside switch enabled even higher protein production than Karikó and Weissman had generated, and Schrum's mRNAs lasted longer than either unmodified molecules or the modified mRNA the Penn academics had used, startling the young researcher. Working alone in a dreary basement and through intense pain, he had actually improved on the Penn professors' work.
Years later, Karikó and Weissman who would win acclaim. In September 2021, the scientists were awarded the Lasker-DeBakey Clinical Medical Research Award. Some predict they eventually will win a Nobel prize. But it would be Schrum's innovation that would form the backbone of both Moderna and Pfizer-BioNTech's Covid-19 vaccine, not the chemical modifications that Karikó and Weissman developed. For Schrum, necessity had truly been the mother of invention.
The Scientist Who Solved Delivery: Kerry Benenato
For several years, Moderna would make slow progress developing drugs to treat various diseases. Eventually, the company decided that mRNA was likely better suited for vaccines. By 2017, Moderna and the National Institutes of Health were discussing working together to develop mRNA–based vaccines, a partnership that buoyed Moderna's executives. There remained a huge obstacle in Moderna's way, however. It was up to Kerry Benenato to find a solution.
Benenato received an early hint of the hurdle in front of her three years earlier, when the organic chemist was first hired. When a colleague gave her a company tour, she was introduced to Moderna's chief scientific officer, Joseph Bolen, who seemed unusually excited to meet her.
"Oh, great!" Bolen said with a smile. "She's the one who's gonna solve delivery."
Bolen gave a hearty laugh and walked away, but Benenato detected seriousness in his quip.
Solve delivery?
It was a lot to expect from a 37-year-old scientist already dealing with insecurities and self-doubt. Benenato was an accomplished researcher who most recently had worked at AstraZeneca after completing post-doctoral studies at Harvard University. Despite her impressive credentials, Benenato battled a lack of confidence that sometimes got in her way. Performance reviews from past employers had been positive, but they usually produced similar critiques: Be more vocal. Do a better job advocating for your ideas. Give us more, Kerry.
Benenato was petite and soft-spoken. She sometimes stuttered or relied on "ums" and "ahs" when she became nervous, especially in front of groups, part of why she sometimes didn't feel comfortable speaking up.
"I'm an introvert," she says. "Self-confidence is something that's always been an issue."
To Benenato, Moderna's vaccine approach seemed promising—the team was packaging mRNAs in microscopic fatty-acid compounds called lipid nanoparticles, or LNPs, that protected the molecules on their way into cells. Moderna's shots should have been producing ample and long-lasting proteins. But the company's scientists were alarmed—they were injecting shots deep into the muscle of mice, but their immune systems were mounting spirited responses to the foreign components of the LNPs, which had been developed by a Canadian company.
This toxicity was a huge issue: A vaccine or drug that caused sharp pain and awful fevers wasn't going to prove very popular. The Moderna team was in a bind: Its mRNA had to be wrapped in the fatty nanoparticles to have a chance at producing plentiful proteins, but the body wasn't tolerating the microscopic encasements, especially upon repeated dosing.
The company's scientists had done everything they could to try to make the molecule's swathing material disappear soon after entering the cells, in order to avoid the unfortunate side effects, such as chills and headaches, but they weren't making headway. Frustration mounted. Somehow, the researchers had to find a way to get the encasements—made of little balls of fat, cholesterol, and other substances—to deliver their payload mRNA and then quickly vanish, like a parent dropping a teenager off at a party, to avoid setting off the immune system in unpleasant ways, even as the RNA and the proteins the molecule created stuck around.
Benenato wasn't entirely shocked by the challenges Moderna was facing. One of the reasons she had joined the upstart company was to help develop its delivery technology. She just didn't realize how pressing the issue was, or how stymied the researchers had become. Benenato also didn't know that Moderna board members were among those most discouraged by the delivery issue. In meetings, some of them pointed out that pharmaceutical giants like Roche Holding and Novartis had worked on similar issues and hadn't managed to develop lipid nanoparticles that were both effective and well tolerated by the body. Why would Moderna have any more luck?
Stephen Hoge insisted the company could yet find a solution.
"There's no way the only innovations in LNP are going to come from some academics and a small Canadian company," insisted Hoge, who had convinced the executives that hiring Benenato might help deliver an answer.
Benenato realized that while Moderna might have been a hot Boston-area start- up, it wasn't set up to do the chemistry necessary to solve their LNP problem. Much of its equipment was old or secondhand, and it was the kind used to tinker with mRNAs, not lipids.
"It was scary," she says.
When Benenato saw the company had a nuclear magnetic resonance spectrometer, which allows chemists to see the molecular structure of material, she let out a sigh of relief. Then Benenato inspected the machine and realized it was a jalopy. The hulking, aging instrument had been decommissioned and left behind by a previous tenant, too old and banged up to bring with them.
Benenato began experimenting with different chemical changes for Moderna's LNPs, but without a working spectrometer she and her colleagues had to have samples ready by noon each day, so they could be picked up by an outside company that would perform the necessary analysis. After a few weeks, her superiors received an enormous bill for the outsourced work and decided to pay to get the old spectrometer running again.
After months of futility, Benenato became impatient. An overachiever who could be hard on herself, she was eager to impress her new bosses. Benenato felt pressure outside the office, as well. She was married with a preschool-age daughter and an eighteen-month-old son. In her last job, Benenato's commute had been a twenty-minute trip to Astra-Zeneca's office in Waltham, outside Boston; now she was traveling an hour to Moderna's Cambridge offices. She became anxious—how was she going to devote the long hours she realized were necessary to solve their LNP quandary while providing her children proper care? Joining Moderna was beginning to feel like a possible mistake.
She turned to her husband and father for help. They reminded her of the hard work she had devoted to establishing her career and said it would be a shame if she couldn't take on the new challenge. Benenato's husband said he was happy to stay home with the kids, alleviating some of her concerns.
Back in the office, she got to work. She wanted to make lipids that were easier for the body to chop into smaller pieces, so they could be eliminated by the body's enzymes. Until then, Moderna, like most others, relied on all kinds of complicated chemicals to hold its LNP packaging together. They weren't natural, though, so the body was having a hard time breaking them down, causing the toxicity.
Benenato began experimenting with simpler chemicals. She inserted "ester bonds"—compounds referred to in chemical circles as "handles" because the body easily grabs them and breaks them apart. Ester bonds had two things going for them: They were strong enough to help ensure the LNP remained stable, acting much like a drop of oil in water, but they also gave the body's enzymes something to target and break down as soon as the LNP entered the cell, a way to quickly rid the body of the potentially toxic LNP components. Benenato thought the inclusion of these chemicals might speed the elimination of the LNP delivery material.
This idea, Benenato realized, was nothing more than traditional, medicinal chemistry. Most people didn't use ester bonds because they were pretty unsophisticated. But, hey, the tricky stuff wasn't working, so Benenato thought she'd see if the simple stuff worked.
Benenato also wanted to try to replace a group of unnatural chemicals in the LNP that was contributing to the spirited and unwelcome response from the immune system. Benenato set out to build a new and improved chemical combination. She began with ethanolamine, a colorless, natural chemical, an obvious start for any chemist hoping to build a more complex chemical combination. No one relied on ethanolamine on its own.
Benenato was curious, though. What would happen if she used just these two simple modifications to the LNP: ethanolamine with the ester bonds? Right away, Benenato noticed her new, super-simple compound helped mRNA create some protein in animals. It wasn't much, but it was a surprising and positive sign. Benenato spent over a year refining her solution, testing more than one hundred variations, all using ethanolamine and ester bonds, showing improvements with each new version of LNP. After finishing her 102nd version of the lipid molecule, which she named SM102, Benenato was confident enough in her work to show it to Hoge and others.
They immediately got excited. The team kept tweaking the composition of the lipid encasement. In 2017, they wrapped it around mRNA molecules and injected the new combination in mice and then monkeys. They saw plentiful, potent proteins were being produced and the lipids were quickly being eliminated, just as Benenato and her colleagues had hoped. Moderna had its special sauce.
That year, Benenato was asked to deliver a presentation to Stephane Bancel, Moderna's chief executive, Afeyan, and Moderna's executive committee to explain why it made sense to use the new, simpler LNP formulation for all its mRNA vaccines. She still needed approval from the executives to make the change. Ahead of the meeting, she was apprehensive, as some of her earlier anxieties returned. But an unusual calm came over her as she began speaking to the group. Benenato explained how experimenting with basic, overlooked chemicals had led to her discovery.
She said she had merely stumbled onto the company's solution, though her bosses understood the efforts that had been necessary for the breakthrough. The board complimented her work and agreed with the idea of switching to the new LNP. Benenato beamed with pride.
"As a scientist, serendipity has been my best friend," she told the executives.
Over the next few years, Benenato and her colleagues would improve on their methods and develop even more tolerable and potent LNP encasement for mRNA molecules. Their work enabled Moderna to include higher doses of vaccine in its shots. In early 2020, Moderna developed Covid-19 shots that included 100 micrograms of vaccine, compared with 30 micrograms in the Pfizer-BioNTech vaccine. That difference appears to help the Moderna vaccine generate higher titers and provide more protection.
"You set out in a career in drug discovery to want to make a difference," Benenato says. "Seeing it come to reality has been surreal and emotional."
Editor's Note: This essay is excerpted from A SHOT TO SAVE THE WORLD: The Inside Story of the Life-or-Death Race for a COVID-19 Vaccine by Gregory Zuckerman, now on sale from Portfolio/Penguin.
*Jason Schrum's arthritis is now in complete remission, thanks to Humira (adalimumab), a TNF-alpha blocker.
Overabundance of dissolved carbon dioxide poses a threat to marine life. A new system detects elevated levels of the greenhouse gases and mitigates them on the spot.
To date, though, methods for measuring CO2 in water at scale have been either intensely expensive, requiring fancy sensors that pump CO2 through membranes; or prohibitively complicated, involving a series of lab-based analyses. And that’s led to a bottleneck in efforts to remove carbon as well.
But recently, Boudinot cracked part of the code for measurement and mitigation, at least on a small scale. While the rest of the industry sorts out larger intricacies like getting ocean carbon markets up and running and driving carbon removal at billion-ton scale in centralized infrastructure, his decentralized method could have important, more immediate implications.
Specifically, for shellfish hatcheries, which grow seafood for human consumption and for coastal restoration projects. Some of these incubators for oysters and clams and scallops are already feeling the negative effects of excess carbon in water, and Vycarb’s tech could improve outcomes for the larval- and juvenile-stage mollusks they’re raising. “We’re learning from these folks about what their needs are, so that we’re developing our system as a solution that’s relevant,” Boudinot says.
Ocean acidification can wreak havoc on developing shellfish, inhibiting their shells from growing and leading to mass die-offs.
Ocean waters naturally absorb CO2 gas from the atmosphere. When CO2 accumulates faster than nature can dissipate it, it reacts with H2O molecules, forming carbonic acid, H2CO3, which makes the water column more acidic. On the West Coast, acidification occurs when deep, carbon dioxide-rich waters upwell onto the coast. This can wreak havoc on developing shellfish, inhibiting their shells from growing and leading to mass die-offs; this happened, disastrously, at Pacific Northwest oyster hatcheries in 2007.
This type of acidification will eventually come for the East Coast, too, says Ryan Wallace, assistant professor and graduate director of environmental studies and sciences at Long Island’s Adelphi University, who studies acidification. But at the moment, East Coast acidification has other sources: agricultural runoff, usually in the form of nitrogen, and human and animal waste entering coastal areas. These excess nutrient loads cause algae to grow, which isn’t a problem in and of itself, Wallace says; but when algae die, they’re consumed by bacteria, whose respiration in turn bumps up CO2 levels in water.
“Unfortunately, this is occurring at the bottom [of the water column], where shellfish organisms live and grow,” Wallace says. Acidification on the East Coast is minutely localized, occurring closest to where nutrients are being released, as well as seasonally; at least one local shellfish farm, on Fishers Island in the Long Island Sound, has contended with its effects.
The second Vycarb pilot, ready to be installed at the East Hampton shellfish hatchery.
Courtesy of Vycarb
Besides CO2, ocean water contains two other forms of dissolved carbon — carbonate (CO3-) and bicarbonate (HCO3) — at all times, at differing levels. At low pH (acidic), CO2 prevails; at medium pH, HCO3 is the dominant form; at higher pH, CO3 dominates. Boudinot’s invention is the first real-time measurement for all three, he says. From the dock at the Navy Yard, his pilot system uses carefully calibrated but low-cost sensors to gauge the water’s pH and its corresponding levels of CO2. When it detects elevated levels of the greenhouse gas, the system mitigates it on the spot. It does this by adding a bicarbonate powder that’s a byproduct of agricultural limestone mining in nearby Pennsylvania. Because the bicarbonate powder is alkaline, it increases the water pH and reduces the acidity. “We drive a chemical reaction to increase the pH to convert greenhouse gas- and acid-causing CO2 into bicarbonate, which is HCO3,” Boudinot says. “And HCO3 is what shellfish and fish and lots of marine life prefers over CO2.”
This de-acidifying “buffering” is something shellfish operations already do to water, usually by adding soda ash (NaHCO3), which is also alkaline. Some hatcheries add soda ash constantly, just in case; some wait till acidification causes significant problems. Generally, for an overly busy shellfish farmer to detect acidification takes time and effort. “We’re out there daily, taking a look at the pH and figuring out how much we need to dose it,” explains John “Barley” Dunne, director of the East Hampton Shellfish Hatchery on Long Island. “If this is an automatic system…that would be much less labor intensive — one less thing to monitor when we have so many other things we need to monitor.”
Across the Sound at the hatchery he runs, Dunne annually produces 30 million hard clams, 6 million oysters, and “if we’re lucky, some years we get a million bay scallops,” he says. These mollusks are destined for restoration projects around the town of East Hampton, where they’ll create habitat, filter water, and protect the coastline from sea level rise and storm surge. So far, Dunne’s hatchery has largely escaped the ill effects of acidification, although his bay scallops are having a finicky year and he’s checking to see if acidification might be part of the problem. But “I think it's important to have these solutions ready-at-hand for when the time comes,” he says. That’s why he’s hosting a second, 70-liter Vycarb pilot starting this summer on a dock adjacent to his East Hampton operation; it will amp up to a 50,000 liter-system in a few months.
If it can buffer water over a large area, absolutely this will benefit natural spawns. -- John “Barley” Dunne.
Boudinot hopes this new pilot will act as a proof of concept for hatcheries up and down the East Coast. The area from Maine to Nova Scotia is experiencing the worst of Atlantic acidification, due in part to increased Arctic meltwater combining with Gulf of St. Lawrence freshwater; that decreases saturation of calcium carbonate, making the water more acidic. Boudinot says his system should work to adjust low pH regardless of the cause or locale. The East Hampton system will eventually test and buffer-as-necessary the water that Dunne pumps from the Sound into 100-gallon land-based tanks where larvae grow for two weeks before being transferred to an in-Sound nursery to plump up.
Dunne says this could have positive effects — not only on his hatchery but on wild shellfish populations, too, reducing at least one stressor their larvae experience (others include increasing water temperatures and decreased oxygen levels). “If it can buffer water over a large area, absolutely this will [benefit] natural spawns,” he says.
No one believes the Vycarb model — even if it proves capable of functioning at much greater scale — is the sole solution to acidification in the ocean. Wallace says new water treatment plants in New York City, which reduce nitrogen released into coastal waters, are an important part of the equation. And “certainly, some green infrastructure would help,” says Boudinot, like restoring coastal and tidal wetlands to help filter nutrient runoff.
In the meantime, Boudinot continues to collect data in advance of amping up his own operations. Still unknown is the effect of releasing huge amounts of alkalinity into the ocean. Boudinot says a pH of 9 or higher can be too harsh for marine life, plus it can also trigger a release of CO2 from the water back into the atmosphere. For a third pilot, on Governor’s Island in New York Harbor, Vycarb will install yet another system from which Boudinot’s team will frequently sample to analyze some of those and other impacts. “Let's really make sure that we know what the results are,” he says. “Let's have data to show, because in this carbon world, things behave very differently out in the real world versus on paper.”
Many children use makeup and body products such as glitter, face paint and lip gloss. Scientists are pointing to the harmful chemicals in some of these products, and advocates are looking to outlaw them.
In 2013, Toxic-Free Future launched Mind the Store to challenge the nation’s largest retailers in adopting comprehensive policies that eliminate toxic chemicals in their personal care products and packaging, and develop safer alternatives.
Now, more efforts are underway to expose and mitigate the harm in cosmetics, hair care and other products that children apply on their faces, heads, nails and other body parts. Advocates hope to raise awareness among parents while prompting manufacturers and salon professionals to adopt safer alternatives.
A recent study by researchers at Columbia University Mailman School of Public Health and Earthjustice, a San Francisco-based nonprofit public interest environmental law organization, revealed that most children in the United States use makeup and body products that may contain carcinogens and other toxic chemicals. In January, the results were published in the International Journal of Environmental Research and Public Health. Based on more than 200 surveys, 70 percent of parents in the study reported that their children 12 or younger have used makeup and body products marketed to youth — for instance, glitter, face paint and lip gloss.
Childhood exposure to harmful makeup and body product ingredients can also be considered an environmental justice issue, as communities of color may be more likely to use these products.
“We are concerned about exposure to chemicals that may be found in cosmetics and body products, including those that are marketed toward children,” said the study’s senior author, Julie Herbstman, a professor and director of the Columbia Center for Children's Environmental Health. The goal of the survey was to try to understand how much kids are using cosmetic and body products and when, how and why they are using them.
“There is widespread use of children’s cosmetic and body products, and kids are using them principally to play,” Herbstman said. “That’s really quite different than how adults use cosmetic and body products.” Even with products that are specifically designed for children, “there’s no regulation that ensures that these products are safe for kids.” Also, she said, some children are using adult products — and they may do so in inadvisable ways, such as ingesting lipstick or applying it to other areas of the face.
Earlier research demonstrated that beauty and personal care products manufactured for children and adults frequently contain toxic chemicals, such as lead, asbestos, PFAS, phthalates and formaldehyde. Heavy metals and other toxic chemicals in children’s makeup and body products are particularly harmful to infants and youth, who are growing rapidly and whose bodies are less efficient at metabolizing these chemicals. Whether these chemicals are added intentionally or are present as contaminants, they have been associated with cancer, neurodevelopmental harm, and other serious and irreversible health effects, the Columbia University and Earthjustice researchers noted.
“Even when concentrations of individual chemicals are low in products, the potential for interactive effects from multiple toxicants is important to take into consideration,” the authors wrote in the journal article. “Allergic reactions, such as contact dermatitis, are some of the most frequently cited negative health outcomes associated with the use of cosmetics.”
Children’s small body side, rapid growth rate and immature immune systems are biologically more prone to the effects of toxicants than adults.
Adobe Stock
In addition to children’s rapid growth rate, the study also reported that their small body size, developing tissues and organs, and immature immune systems are biologically more prone to the effects of toxicants than adults. Meanwhile, the study noted, “childhood exposure to harmful makeup and body product ingredients can also be considered an environmental justice issue, as communities of color may be more likely to use these products.”
Although adults are the typical users of cosmetics, similar items are heavily marketed to youth with attention-grabbing features such as bright colors, animals and cartoon characters, according to the study. Beyond conventional makeup such as eyeshadow and lipstick, children may apply face paint, body glitter, nail polish, hair gel and fragrances. They also may frequent social media platforms on which these products are increasingly being promoted.
Products for both children and adults are currently regulated by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act of 1938. Also, the Fair Packaging and Labeling Act of 1967 directs the Federal Trade Commission and the FDA “to issue regulations requiring that all ‘consumer commodities’ be labeled to disclose net contents, identity of commodity, and name and place of business of the product's manufacturer, packer, or distributor.” As the Columbia University and Earthjustice authors pointed out, though, “current safety regulations have been widely criticized as inadequate.”
The Personal Care Products Council in Washington, D.C., “fundamentally disagrees with the premise that companies put toxic chemicals in products produced for children,” industry spokeswoman Lisa Powers said in an email. Founded in 1894, the national trade association represents 600 member companies that manufacture, distribute and supply most personal care products marketed in the United States.
No category of consumer products is subject to less government oversight than cosmetics and other personal care products. -- Environmental Working Group.
“Science and safety are the cornerstones of our industry,” Powers stated. For more than a decade, she wrote, “the [Council] and our member companies worked diligently with a bipartisan group of congressional leaders and a diverse group of stakeholders to enhance the effectiveness of the FDA regulatory authority and to provide the safety reassurances that consumers expect and deserve.”
Powers added that the “industry employs and consults thousands of scientific and medical experts” who study the impacts of cosmetics and personal care products and the ingredients used in them. The Council also maintains a comprehensive database where consumers can look up science and safety information on the thousands of ingredients in sunscreens, toothpaste, shampoo, moisturizer, makeup, fragrances and other products.
However, the Environmental Working Group, which empowers consumers with breakthrough research to make informed choices about healthy living, believes the regulations are still not robust enough. “No category of consumer products is subject to less government oversight than cosmetics and other personal care products,” states the organization’s website. “Although many of the chemicals and contaminants in cosmetics and personal care products likely pose little risk, exposure to some has been linked to serious health problems, including cancer.”
The group, which operates the Skin Deep Database noted that “since 2009, 595 cosmetics manufacturers have reported using 88 chemicals, in more than 73,000 products, that have been linked to cancer, birth defects or reproductive harm.”
But change, for both adults and kids, is on the horizon. The Modernization of Cosmetics Regulation Act of 2022 significantly expanded the FDA’s authority to regulate cosmetics. In May 2023, Washington state adopted a law regulating cosmetics and personal care products. The Toxic-Free Cosmetics Act (HB 1047) bans chemicals in beauty and personal care products, such as PFAS, lead, mercury, phthalates and formaldehyde-releasing agents. These bans take effect in 2025, except for formaldehyde releasers, which have a phased-in approach starting in 2026.
Industry and advocates view this as a positive development. Powers, the spokesperson, praised “the long-awaited” Modernization Cosmetics Regulation Act of 2022, which she said, “advances product safety and innovation.” Jen Lee, chief impact officer at Beautycoutner, a company that sells personal care products, also welcomes the change. “We were proud to support the Washington Toxic-Free Cosmetics Act (HB 1047) by mobilizing our community of Brand Advocates who reside in Washington State,” Lee said. “Together, they made their voices heard by sending over 1,000 emails to their state legislators urging them to support and pass the bill.”
Laurie Valeriano, executive director of Toxic-Free Future, praised the upcoming Washington state law as “a huge win for public health and the environment that will have impacts that ripple across the nation.” She added that “companies won’t make special products for Washington state.” Instead, “they will reformulate and make products safer for everyone” — adults and children.
You shouldn’t have to be a toxicologist to shop for shampoo. -- Washington State Rep. Sharlett Mena
The new legislation will require Washington state agencies to assess the hazards of chemicals used in products that can impact vulnerable populations, while providing support for small businesses and independent cosmetologists to transition to safer products.
The Toxic-Free Future team lauds the Cosmetics Act, signed in May 2023.
Courtesy Toxic-Free Future
“When we go to a store, we assume the products on the shelf are safe, but this isn’t always true,” said Washington State Rep. Sharlett Mena, a Democrat serving in the 29th Legislative District (Tacoma), who sponsored the law. “I introduced this bill (HB 1047) because currently, the burden is on the consumer to navigate labels and find safe alternatives. You shouldn’t have to be a toxicologist to shop for shampoo.”
The new law aims to protect people of all ages, but especially youth. “Children are more susceptible to the impacts of toxic chemicals because their bodies are still developing,” Mena said. “Lead, for example, is significantly more hazardous to children than adults. Also, since children, unlike adults, tend to put things in their mouths all the time, they are more exposed to harmful chemicals in personal care and other products.”
Cosmetologists and hair professionals are taking notice. “Safety should be the practitioner’s number one concern” in using products on small children, said Anwar Saleem, a hair stylist, instructor and former salon owner in Washington, D.C., who is chairman of the D.C. Board of Barbering and Cosmetology and president of the National Interstate Council of State Boards of Cosmetology. “There are so many products on the market that it can be confusing.”
Hair products designed and labeled for children's use often have milder formulations, but “every child is unique, and what works for one may not work for another,” Saleem said. He recommends doing a patch test, in which the stylist or cosmetologist dabs the product on a small, inconspicuous area of the scalp or skin and waits anywhere from an hour to a day to check for irritation before continuing to serve the client. “Performing a patch test, observing children's reactions to a product and adequately adjusting are essential.”
Saleem seeks products that are free from harsh chemicals such as sulfates, phthalates and parabens, noting that these ingredients can be irritating and drying to the hair and scalp. If a child has sensitive skin or allergies, Saleem opts for hypoallergenic products.
We also need to ensure that less toxic alternatives are available and accessible to all consumers. It’s often under-resourced, low-income populations who suffer the burden of environmental exposures and do not have access or cannot afford these safer alternatives. -- Lesliam Quirós-Alcalá.
Lesliam Quirós-Alcalá, an assistant professor in the department of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said current regulatory loopholes on product labeling still allow manufacturers to advertise their cosmetics and personal care products as “gentle” and “natural.” However, she said, those terms may be misleading as they don’t necessarily mean the contents are less toxic or harmful to consumers.
“We also need to ensure that less toxic alternatives are available and accessible to all consumers,” Quirós-Alcalá said, “as often alternatives considered to be less toxic come with a hefty price tag.” As a result, “it’s often under-resourced, low-income populations who suffer the burden of environmental exposures and do not have access or cannot afford these safer alternatives.”
To advocate for safer alternatives, Quirós-Alcalá suggests that parents turn to consumer groups involved in publicizing the harms of personal care products. The Campaign for Safe Cosmetics is a program of Breast Cancer Prevention Partners, a national science-based advocacy organization aiming to prevent the disease by eliminating related environmental exposures. Other resources that inform users about unsafe ingredients include the mobile apps Clearya and Think Dirty.
“Children are not little adults, so it’s important to increase parent and consumer awareness to minimize their exposures to toxic chemicals in everyday products,” Quirós-Alcalá said. “Becoming smarter, more knowledgeable consumers is the first step to protecting your family from potentially harmful and toxic ingredients in consumer products.”