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If you are newly suspicious about the safety of the products in your medicine cabinet, there’s a good chance you have Valisure, a tiny laboratory in New Haven, Conn., to thank. Or blame.

Tucked away in an unassuming office park, Valisure’s team of about a dozen scientists has over the past five years detected potentially cancer-causing chemicals in widely used medications, hand sanitizers, sunscreens, antiperspirant body sprays, dry shampoos, and—most recently—acne treatments. When Valisure sounds the alarm about a new scary-sounding finding, a flood of headlines, lawsuits, and product recalls often follows. The company is helping to shatter an illusion that some 80% of Americans believe: that the products they buy have been through enough safety testing to be proved not harmful.

“Most consumers assume that because it’s for sale, it must be safe,” says Teresa Murray, who directs the consumer watchdog office at the nonprofit U.S. Public Interest Research Group (PIRG). “Oftentimes, that’s very much not true.”

Despite its nearly $7 billion annual operating budget, the U.S. Food and Drug Administration (FDA) isn’t analyzing every shampoo or supplement on sale at your local drugstore. In fact, the FDA does not approve most cosmetics before they hit shelves—let alone assess how they’ll affect human health after years of regular use. This information vacuum has given rise to a network of nonprofits, consumer-protection groups, and independent scientists dedicated to informing the public about potential hazards lurking in their products.

Within this group, Valisure has been uniquely effective at grabbing attention. Its testing has led to product recalls from household-name brands, congressional testimony, and partnerships with big-name organizations like the U.S. Department of Defense and the Kaiser Permanente health system. But Valisure—the underdog that built its reputation as a crusader for public health—has made enemies too. Critics and regulators have denounced its testing methods and the legitimacy of its scientific findings, raising doubts about the very doubts the company has raised. So every time Valisure’s results make the news, Americans are left to figure out how worried they should be.

The idea for Valisure came not from a grand plan to overhaul decades-old regulatory structures, but from one friend venting to another.

In 2015, David Light, a molecular biologist, heard from his friend and former Yale University classmate Adam Clark-Joseph about a problem with his medication. Every so often, Clark-Joseph said, he got a batch that triggered side effects and sent his chronic condition into relapse. He said his doctors mostly shrugged off these incidents as unfortunate quirks of a health care system where supply chains are so complex that quality assurance is difficult. Light remembers being far more shaken than his friend’s physicians.

“It was shocking to both of us to realize the FDA’s not testing everything, and retail stores and pharmacies aren’t doing the testing,” he says. “So who’s actually testing the product, as opposed to looking at the paperwork?”

Light and Clark-Joseph—now Valisure’s president and head of analytics, respectively—co-founded Valisure in 2015 to fulfill that mission, setting up shop down the road from their alma mater. At first, Valisure quality-tested medications, then sold them through its own online pharmacy. But four years after its founding, Valisure made a name for itself in a splashier way.

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In September 2019, Valisure’s scientists used a “citizen petition,” which everyday people can use to request action from the FDA, to announce they’d found the probable carcinogen NDMA in every batch of the heartburn medication ranitidine that they tested. Then lawyers brought a slew of lawsuits against GSK and Sanofi, pharmaceutical companies that have sold the popular ranitidine drug Zantac, linking it to clients’ cancers. (Many of these cases have been settled or dismissed.) In April 2020, the FDA asked all makers to pull ranitidine from the market.

The FDA has said that the recall was based on its own testing, not Valisure’s. Though FDA tests did find elevated NDMA levels—high enough to trigger a recall—they were much lower than Valisure’s. That’s because Valisure used extreme testing practices, like exposing the drugs to heat, that may have actually produced NDMA, the FDA said in a response to Valisure’s petition.

But to the public, a recall is a recall, and Valisure had been the first one to sound the alarm. The scandal boosted Valisure’s reputation; Light still keeps Zantac-branded memorabilia in his office as evidence of his lab’s impact.

In 2021, Valisure sold off the pharmacy business to focus on product testing. Mostly—thankfully—this business is a boring one. Valisure’s clients are mainly organizations, like health care systems, that buy lots of medications and want to know what’s in them. About 90% of the time, Light says, this testing is uneventful. But now and then, often operating on their own hunches, his staff finds something concerning. Over the past few years, Valisure has found the carcinogen benzene in a variety of consumer products, including sunscreen, dry shampoo, and acne treatments, leading to major news cycles and, in some cases, product recalls.

A range of other groups work in this space. Experts from the Cosmetic Ingredient Review assess the safety of ingredients used in beauty products, with funding from the Personal Care Products Council, an industry trade group. The University of Kentucky’s health care system also performs independent analysis of medications.

But unlike Valisure, many of the other groups informing the public about products with questionable safety data—including the Ralph Nader-aligned PIRG, the Silent Spring Institute, Toxic-Free Future, and the Environmental Working Group (EWG)—are nonprofits. Sunscreen is a regular topic of concern for these groups—not necessarily because of benzene contamination, but because of chemical ingredients linked to hormone disruption and cancer—as are things like hair products (some which have also been linked to cancer) and fragrances. These groups have had made splashes too; PIRG was behind the 2018 discovery of asbestos in makeup sold at Claire’s, leading to recalls.

“The more we look [at consumer products], the worse it looks,” says Dr. Megan Schwarzman, associate director of the Center for Green Chemistry at the University of California, Berkeley. But, Schwarzman says, it’s not always easy for scientists, let alone the average consumer, to understand what to make of the potential risks raised by these groups. “There’s lead in pigments in lipstick,” Schwarzman says. “If you wear lipstick once a month, it’s probably not a big exposure”—but is wearing lipstick a few times a week enough to cause health problems over years or decades? Is the risk high enough to swear off lipstick altogether? What about other cosmetics? These questions are difficult even for scientists to answer.

It’s also near impossible to isolate which chemical exposures, if any, are responsible for health problems, because “we are exposed to [toxins] at generally very low concentrations all the time,” adds Debra Kaden, a toxicologist and principal consultant at the environmental-consulting firm Ramboll. An astounding number of the products in the average American home, for example, contain PFAS “forever” chemicals.

Given those realities, consumer-protection groups have their work cut out for them—which is an indictment of the U.S. regulatory system, says Homer Swei, who oversees consumer-safety science at EWG. “It would be great if there was no need for organizations like this,” Swei says. “Why does a third party have to do the heavy lifting for industry and government?”

The FDA regulates most things that Americans put on and in their bodies, from vaccines to tobacco products, but the scope of its oversight varies depending on the product. Pharmaceutical companies have to conduct complex clinical trials and secure FDA approval before bringing new drugs to market. Meanwhile, the agency’s regulatory structure for cosmetics stems from a law enacted in 1938—long before the average American was using up to a dozen personal-care products, potentially containing more than 100 chemicals in total, every single day.

A 2022 law expanded the FDA’s purview over cosmetics—it can now issue a mandatory recall and suspend manufacturing facilities if a serious issue arises—and some states have passed additional laws related to consumer protection. But experts say there are still huge holes in the ways many products are regulated in the U.S. Under the current structure, cosmetics companies can decide what sorts of safety and quality testing they want to do, which often isn’t adequate, Swei says. Brands don’t even have to submit the results of their testing in most cases. And, contrary to popular belief, the FDA rarely orders a recall; more commonly, it requests a voluntary one.

Read More: What to Know if Your Doctor Put You on Statins to Lower Cholesterol

The FDA is also lenient toward potentially concerning ingredients, compared with regulators in other countries. Since 2009, Europe has required cosmetics makers to submit safety data before selling a new product. In 2023 alone, regulators in the European Union moved to ban 30 chemicals from use in beauty products—more than the FDA has banned from cosmetics in its more than 100 years in existence. Many known or suspected health hazards, like formaldehyde and parabens, are still used in a variety of products sold in the U.S., such as hair treatments and lotions.

The FDA has implicitly acknowledged gaps in its approach—like in 2019, when it asked sunscreen manufacturers for more safety data. A spokesperson wrote in a statement that “the agency remains committed to using all available tools to oversee the safety and quality of FDA-regulated products.”

The question, for some, is whether Valisure should be one of those tools. Unlike nonprofit groups, Valisure is a business backed by private investors, which means its work has “got to make financial sense,” Light says. Valisure has lobbied for policies that would push companies to pursue the kind of independent testing that’s the bread and butter of its bottom line. “Any increase in the use of independent testing will benefit Valisure as a business,” Light acknowledges. But he maintains it would also be a win for public health. Personal-injury lawyers make a similar argument, saying their fees (routinely 30% to 40% of any damages awarded) serve as a market incentive to hold companies accountable.

In court filings, Unilever has also alleged that Valisure is motivated by money. Before filing a citizen petition related to benzene in dry shampoos, Unilever said, Valisure offered to test its products and keep the results confidential if Unilever paid more than $1 million, an offer the company said it declined. And GSK and other companies have questioned Valisure’s relationship with plaintiffs’ attorneys, suggesting the lab works with lawyers to produce test results that will lead to juicy lawsuits. One of the first suits related to Zantac was filed by Light’s brother-in-law, an attorney in Florida. (Light says Valisure’s proposal to Unilever was taken out of context and the lab does not have inappropriate relationships with attorneys, including his brother-in-law, although its scientists sometimes serve as experts in cases.)

The FDA has criticisms as well. In a 2022 letter, the agency alleged that Valisure was using inappropriate methods and machinery for its tests. “Third-party testing using unreliable methods produces unreliable data, and decisions based on unreliable data are not sound,” an FDA spokesperson wrote in a statement provided to TIME.

Consider Valisure’s recent finding of benzene in benzoyl peroxide acne treatments. For that testing, Valisure scientists analyzed what happened when benzoyl peroxide products were exposed to 122° temperatures for 18 days, conditions that the Personal Care Products Council argued have little real-world relevance. (Light, however, contends the test isn’t so far-fetched: “What if it sits in a warehouse in Florida for two weeks, or sits on a shelf in a store where their air conditioner broke?”)

Dr. Philip Landrigan, director of Boston College’s Program for Global Public Health and the Common Good, argues that the public has a right to know about any level of benzene contamination. “We know that it’s a carcinogen, even down to the lowest levels,” he says.

Read More: What’s the Best Kind of Sunscreen?

But Kaden, the Ramboll toxicologist, says much of the discussion about benzene doesn’t give consumers enough context. In 2022, after Valisure tests revealed benzene in sunscreens, Kaden and a colleague did their own analysis, concluding that people could be exposed to more benzene in the vehicle exhaust they’d inhale walking down a city street than by using a sunscreen contaminated with benzene at the levels Valisure found. Other researchers have also found that people who use sunscreen actually tend to have lower blood concentrations of benzene than nonusers, which suggests these products are not major threats to the general public.

Toxin exposure is never a good thing, Kaden says, but “the dose makes the poison.” Groups like Valisure, she says, don’t always make that clear enough in their messaging to the public.

Light, however, stands by his lab and its findings. In fact, he seems to enjoy the notoriety that comes with being the guy brave enough to take on the FDA and major brands. Framed articles about Valisure’s bombshell test results line the walls of his office and the lab’s lobby, and he proudly displays the mug he got from a 2023 visit to the White House, where he was invited to talk about product safety.

Light dabbled in acting as a kid, playing a few parts on Mad TV when he was young. He still has some of that flair for the dramatic, speaking in a booming voice that prompts his publicist to shut his door when he gets going to avoid disrupting the whole office. “Some people like very straightforward spreadsheets and business plans,” Light says. He prefers the spotlight. “I’m an adventurous kind of guy, I guess.”

Sometimes, perhaps, too adventurous. During the summer of 2007, while a student at Yale, Light was arrested for firing a pistol into the ceiling of his fraternity house. Authorities reportedly found that Light—who was a gun enthusiast at the time—had numerous weapons, thousands of rounds of ammunition, and chemicals consistent with bomb-making in his room. (Light says the chemicals were not intended for illegal activity and notes that charges related to them were dropped.) He served about six months of a one-year prison sentence and eventually went on to finish his degree at Yale in 2011.

“I sincerely regret the events that occurred during my college years,” Light wrote in a statement to TIME. “I take full responsibility for my actions … and since then have made a concerted effort to rebuild my life and contribute positively to society.”

How positively Valisure contributes to society is up for debate. The FDA, court system, and trade groups sometimes treat it as a nuisance, arguing its findings scare people without the science to back up the headlines. But the scientists who do similar work maintain that information is power—that even if consumers can’t pinpoint the exact moment at which exposure to benzene or NDMA or parabens becomes dangerous, they have a right to know it’s happening. “It’s up to everybody to decide for themselves the risk-benefit ratio,” Schwarzman says. “When you have the information, you get to do that.”

Under the existing regulatory structure, Americans probably wouldn’t get that information without independent labs and consumer-interest groups digging it up. Even finding details about product ingredients and news about product recalls currently requires a little effort on the part of consumers.

That may be changing. In addition to state-level efforts, U.S. lawmakers have in recent years introduced legislation that seeks to ban risky chemicals, improve transparency around supply chains and ingredient disclosures, and strengthen oversight of over-the-counter drugs. But for now, consumers are left to operate with imperfect products and limited information, says Kristin Knox, a data scientist at the Silent Spring Institute. In her own life, she’s tried to strike a balance between caution and panic, continuing to use mass-market products while also making tweaks like swapping plastic household goods for glass, choosing unscented products, and using fewer cosmetics. “That there are things you can do that actually reduce your chemical burdens is good news,” she says. “But it’d be even better if the products didn’t have bad chemicals in the first place.”

Ultimately, any independent actor, from Valisure to Silent Spring to PIRG, has only so much authority. They can break into the news cycle, which sometimes results in recalls and changes from manufacturers, but they’re not the ones making, selling, and regulating products. Systemic change is required, Knox says, for jobs like hers to become obsolete.

“Like most people, I [used to assume], ‘Oh, it’s in the grocery store, it’s been reviewed by the government, it’s safe,’” Knox says. “It would be nice to live in a place where that’s true.”

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By: Jamie Ducharme
Title: Scientists Are Finding Out Just How Toxic Your Stuff Is
Sourced From: time.com/6975046/toxic-chemicals-in-products-valisure/
Published Date: Thu, 09 May 2024 17:33:26 +0000

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