Yves here. Yours truly pleads guilty to being a diet and health, erm, enthusiast. On the one hand, a bit of fetishism yields better outcomes over time (although my mother, a self-declared couch potato, did live to be 94 and was sharp up to her last 18 months, and still not bad even then). On the other, the combo plate of lots of pollutants, limited rigor and resulting contradictory claims about what a healthy diet is (e.g., wine went from being bad to being good to being bad again), and store/restaurant foods nearly always having an uncertain provenance is a fertile breeding ground for dodgy theories and products. Heavy metals, back in the news due to worrisome stories about concentrations in infant foods and popular protein products, are an example. They are toxic at not-high concentrations. But what is a pretty safe level?
This article below starts with a MAHA project that I have to confess not to have heard of until now, Stork Speed, to address the ultimate apple-pie-and-motherhood issue, baby formula safety. But the article gets into terrain that as an exercise/diet/dietary supplement experimenter I know all too well: the depth of chicanery in the “health” industry. Some purveyors of quackery are well meaning but deluded. Others know what they are up to. The article below focuses on the Clean Label Project, which has been accused of using opaque and vague standards while also running pay-to-play certifications.
Oh, and a Thanksgiving lead-avoidance tip. The meat around birdshot will usually be dark grey even after cooked, so you should be able to avoid ingesting the pellets.
By Peter Andrey Smith, a senior contributor at Undark. His stories have also been featured in Science, STAT, The New York Times, and WNYC Radiolab. Originally published at Undark
In 2017, a headline on a local TV news website asked a distressing question: “Are dangerous chemicals lurking in your baby food?” The associated broadcast, citing “an alarming study,” reported that 80 percent of infant formulas and several other popular baby food products had tested positive for arsenic, a toxic heavy metal. Such products had also tested positive for the heavy metals lead and cadmium.
The newscast highlighted work by the Clean Label Project, a nonprofit now based in Broomfield, Colorado, that has made a name for itself detecting contaminants in a range of foods and supplements. The group is part of a network of watchdogs, nonprofits, and consumer advocacy groups that have cropped up over the years in response to a longstanding regulatory void in the American food supply: For many consumer products, including infant formula, the U.S. Food and Drug Administration has no clearly established maximums for heavy metals and many other contaminants.
While the efforts of third-party testers — including the Clean Label Project — are often welcomed by parents and other consumers, skeptics have long complained that such groups too frequently traffic in bold claims over heavy metal levels that are far below what is typically considered the threshold for harm, a tack critics say is intended to drum up lawsuits and other legal activities. And even the most reliable third-party auditors, some experts say, cannot drive the regulatory change the American food supply really needs.
“A lot of groups are doing this monitoring and they’re like, ‘Oh, look at this and this and this,’” said Tracey Woodruff, director of the University of California, San Francisco’s Program on Reproductive Health and the Environment. “But it doesn’t address the underlying structural problem.”
It’s not just a matter of alerting the public to these contaminants, Woodruff added: “It really requires a totally different way of restructuring how we approach this — to think about how do we stop polluting and do the necessary cleanup to ensure we have a truly safe food supply.”
Earlier this year, President Donald Trump’s administration signaled that it might be doing just that with Operation Stork Speed, a federal initiative intended, in part, to improve the safety of infant formula. In a video about the launch of Operation Stork Speed in March of this year, Robert F. Kennedy Jr., the U.S. Secretary of Health and Human Services and the face of the Make America Healthy Again movement, said: “If there is one food that must be safe beyond any doubt, it’s infant formula.”
“Some things we know are bad, like heavy metals,” he added, “so we’re going to increase the frequency of testing to make sure that no child drinks contaminated formula.”
Just how far he might be willing to take that agenda, however, is far from clear. So, too, is the question of whether the government could ever be solely responsible for testing and ensuring the safety of infant formula, let alone the wider food supply — something some experts say is unrealistic. And given other Trump administration moves that seem designed to undermine toxins research and safety — reduced federal staffing, terminated grants, and rolled back regulations — many food safety scientists remain skeptical that the imperfect and sometimes conflicted regime of third-party monitoring will be replaced by efficient and effective government oversight anytime soon.
“That is not going to happen,” Woodruff said, “in this administration.”
Heavy metals occur naturally in the Earth’s crust, but toxicologists trace most environmental contamination to industrial activity, such as burning fossil fuels and applying pesticides. Two heavy metals, lead and arsenic, are found in soil and groundwater; crops, such as rice, absorb trace amounts of these toxic elements, which then show up in many plant-based foods. These toxic substances can have a wide range of health effects. At very low levels, lead harms developing brains; arsenic and cadmium can also have serious consequences, affecting neurodevelopment, the immune system, and the heart.
When it comes to regulating these heavy metals, however, there is a mismatch between the thresholds for detection (what is technically possible with analytic testing) and the legal thresholds for harm (what regulators agree is acceptable). Debra Kaden, principal toxicologist at RHP Risk Management, a for-profit environmental and human health consulting firm headquartered in Chicago, reiterated the old adage about the dose making the poison. Kaden said the question should be framed as: “What does it mean in terms of the risk as opposed to the hazard?” A hazard, she said, refers to something that can cause a disease at a particular concentration. Risk, meanwhile, can vary person to person depending on exposure and other factors, she added: “Risk is more, ‘What does that mean for me?’”
On March 20, Health Secretary Robert F. Kennedy Jr. appeared in a video explaining the FDA’s Operation Stork Speed. The federal initiative aims to improve the safety of infant formula, among other goals. Visual: HHS/YouTube
The science suggests the safe limit for lead would be zero. “No amount is okay to have in your water, your food. But the drinking water action level isn’t zero,” said Kristin Knox, a scientist at the Silent Spring Institute, an independent scientific research institute, referring to the U.S. Environmental Protection Agency limits on lead. “It’s slightly higher than that. Even though any amount is bad.” Federal regulators acknowledge this discrepancy: For instance, an FDA initiative launched in 2021 that aims at reducing childhood exposure to heavy metals is called “Closer to Zero.” Regulatory limits don’t just reflect the science; they also reflect what can be realistically achieved with finite resources and funding. “It’s a combination of harm,” Knox said, “but also economics.”
In the U.S., the FDA has the regulatory authority to set limits, and has established action levels on heavy metals in some foods — candy, for instance, must be below 0.1 part per million (ppm) for lead — but not for infant formula. Other standards for infant formula exist, but there is a lack of consistency both in terms of what harmful substances are included and what the limits are. The European Union, for instance, has established limits of 0.01mg/kg for lead, or 0.01 ppm, in liquid formula (0.02 mg/kg for powder). (To put this in context, a hundredth of a part per million is a fraction of a drop of liquid in a bathtub filled to the brim.) In California, under Proposition 65, a law which requires businesses to disclose the presence of potentially hazardous chemicals over a certain exposure limit, the maximum allowable dose is 0.5 micrograms per day per product or source of exposure. To compare, if a baby consumes 150 grams of powdered formula containing 0.02 mg/kg of lead, they’ll consume 3 micrograms of lead, six times the maximum allowable dose level under Proposition 65.
With an established limit, third-party organizations can test and certify that products meet these standards. But given the lack of standards in the U.S. and the lack of consistency worldwide, the line between what’s detectable and what’s harmful remains unclear.
Over the last decade, the Clean Label Project made headlines detecting contaminants in consumer products ranging from pet food to decaf coffee. According to allegations later made public in a lawsuit, the CLP had ties with Kevin Hicks, a serial entrepreneur, who previously helped found Healthgrades, an online rating system for doctors, hospitals, and health care providers. (Several studies question Healthgrades’ ratings, including one published in 2002 in the medical journal JAMA, which noted “little information is available about their validity.”) Hicks was among those behind BeverageGrades, a now-defunct online resource for nutritional information about alcoholic drinks. During Hicks’ tenure as CEO, BeverageGrades released data suggesting that many wines, including best-selling budget brands like Cupcake and Trader Joe’s Charles Shaw, contained arsenic. These results later became the basis for a lawsuit alleging that winemakers violated California labeling laws, but a judge ultimately dismissed the case, saying the existing warnings complied with the regulations.
In 2012, according to a report published in Wired magazine, just as Hicks was about to become a father, he started testing baby food and spun out a lab: Third Party Validation & Verification LLC, which does business as Ellipse Analytics. The lab tested products and, according to a Reddit ask-me-anything with two people who worked with the CLP, as well as a 2020 legal complaint, the lab previously donated its services to the Clean Label Project, which became a nonprofit in 2016. According to a 2023 tax filing, the nonprofit focused on marketing to “promote health and transparency in consumer product labeling to educate the public regarding contaminants found in consumer food products.” The organization established a certification program, and its tax filings report that a portion of its revenue comes from certification. The lab’s website explains the relationship: “Ellipse Analytics is the exclusive technical administrator for the Clean Label Project (CLP), the non-profit consumer advocacy group that is changing the definition of food safety and defining what ‘clean label’ means.”
Others weren’t so sure. In 2018, a toxicologist at the nonprofit NSF, which conducts voluntary certification of dietary supplements and food products, accused the Clean Label Project of using opaque standards, saying in a post that now appears to have been deleted that a report of theirs on protein powders used “sensational language” that conflated “measurable” with unsafe, “implying that any detectable level of contamination presents a health risk to consumers.” But, the toxicologist wrote, “it’s not that simple.” When asked for comment, Anj Oto, regional communications manager for NSF, provided a response that she requested be attributed to a spokesperson: “The statement was made more than seven years ago as a specific response to when the CLP report on protein powders was published,” and noted that the toxicologist who made that statement is no longer employed with NSF. The Clean Label Project also filed lawsuits against companies, including Kraft Heinz, Keurig Green Mountain, Amazon.com, Inc., Panera, and two infant formula manufacturers.
But then the Clean Label Project and its affiliates gave Pharmavite LLC, a private company in West Hills, California, a D+ on one of its prenatal vitamins, allegedly because they found heavy metals in the product. Pharmavite filed a suitagainst the Clean Label Project in 2020. The original complaint made public in the case describes the Clean Label Project as a pay-to-play certification — or, as the attorneys alleged, “a money-making ‘protection racket’ that Michael Avenatti likely would have envied.” (In 2020, Avenatti, the celebrity attorney, was convicted of trying to extort millions from sportswear company Nike.)
In its response, attorneys representing the Clean Label Project and its affiliates disputed the claims, saying they obscured the real victims: pregnant women seeking to protect the health of their unborn children. But, in the end, the accusations remain unproven. The lawsuit settled out of court, and the terms have not been made public. (Hicks could not be reached for comment, but, according to a public LinkedIn profile, he no longer appears affiliated with the lab or the nonprofit.)
A Panoply of Products
The Clean Label Project has certified hundreds of products with their “Purity Award,” including many for infants and toddlers. These products have undergone comprehensive analysis by the Clean Label Project, the nonprofit states on its website. Visual: Illustration by Undark
Repeated attempts to reach Jaclyn Bowen, the executive director at the time of the suit who recently resigned from the Clean Label Project, via email and phone, and through LinkedIn, were unsuccessful. Similar attempts to reach Molly Hamilton, CLP’s current executive director, were also unsuccessful. In response to an emailed request for comment, Kate Stuard, a media contact who lists her affiliation on the nonprofit’s press releases, forwarded a statement that she said was attributable to a CLP spokesperson: “Clean Label Project does not determine what is legally or scientifically unsafe, that responsibility lies with regulators and public-health authorities. Our mission is to deliver independent, data-driven insight into what’s in consumer products so families, practitioners, and even brands can make informed decisions. By increasing transparency around detectable contaminants, we aim to elevate industry standards and support continuous improvement in product quality.”
At Ellipse Analytics, Undark reached Matt Regusci, who is listed as CEO on the lab’s website, via LinkedIn, but he did not respond to repeated requests for comment. Others affiliated with Ellipse could not be reached.
In 2021, the Institute for Legal Reform, a pro-business advocacy group funded by the U.S. Chamber of Commerce, released a report on the rise in food and beverage lawsuits, which named the Clean Label Project as one of the more active parties. The nonprofit was among the many so-called bounty hunters, filing legal notices under Prop 65, the California law, which cumulatively resulted in more than 5,000 lawsuits and an estimated $1 billion in business expenditures. More recently, class-action lawsuits against the food industry have neared record highs, and some speculate that the industry may be buoyed by RFK Jr. and the MAHA movement.
In one ongoing class action lawsuit, plaintiffs in California claim that manufacturers knowingly sold baby food products “contaminated with lead, arsenic, mercury, cadmium, and aluminum (collectively ‘Toxic Heavy Metals’)” and did so knowing these toxins “cause brain damage and neurodevelopmental harm.” The complaint cites the 2018 studyfunded by the Clean Label Project, which detected lead in 37 percent of U.S. baby foods. Hannah Gardener, a University of Miami epidemiologist, led the study. Her co-authors were Bowen, the former executive director of the nonprofit, and Sean Callan, who listed his affiliation with Ellipse. In an email, Gardener said she is not a CLP employee, but did not respond to additional questions. Neither of her co-authors could be reached for comment. In the 2018 paper, the authors wrote, “Overall, the concentrations of lead and cadmium in the baby food samples are considered very low, with only one sample exceeding 100 PPB for lead, which is the current FDA standard for candy and certain dried fruits.” (The study did not test for arsenic, mercury, or aluminum, and found that about a quarter of the products tested exceeded Prop 65 cadmium guidelines, and 14 percent exceeded WHO cadmium intake levels.)
More recently, Gardener and the same two co-authors published a paper in Environmental Research, a peer-reviewed journal, on prenatal vitamins and heavy metals. In a conflict-of-interest statement included in the paper, Gardener and Callan stated that they have been retained as expert witnesses; in a written expert report posted by the Los Angeles law firm Wisner Baum, which has thousands of plaintiffs, Gardener said she was paid $600 an hour for testimony. In that same report, she wrote that, after reviewing the scientific literature, she concluded “to a reasonable degree of scientific certainty” that early life exposure to heavy metals can cause the development of autism spectrum disorder. (That causality is still under debate, and there’s scientific consensus that autism is not a single condition or diagnosis with a single known cause.) RFK Jr. has reported almost $2.5 million in referral fees from Wisner Baum, according to financial disclosure forms; the firm also employs his son, Conor.
As is often the case, the study sparked controversy — not just in court. Trade groups representing the industry maintain the 2025 CLP-funded study’s results were not revealing, and demonstrated a consistent pattern of conflating what’s detectable versus what’s considered unsafe.
In an email, Jeff Ventura, vice president for communications at the Council for Responsible Nutrition, a member-based group, declined an interview request, but sent a prepared statement: “This study confirms what prior research has consistently shown: trace levels of heavy metals like lead and cadmium are commonly found in both dietary supplements and foods due to their presence in the environment.” The statement also said: “Consumers should not be alarmed into avoiding prenatal vitamins.”
Advocates and scientists say that when it comes to bringing clarity and rigor to all of this, RFK Jr.’s Operation Stork Speed faces headwinds created by the Trump administration itself. In March, the EPA announced “the biggest deregulatory action in U.S. history,” and later reduced staffing and announced the closure of its Office of Research and Development, which pursued a wide range of research on toxic substances and pollutants. This included limits of lead in drinking water and long-term studies that would help understand how eating patterns in infants and toddlers contribute to cumulative risks of exposure.
Nan Du, a doctor at Boston Children’s Hospital who has sat on FDA expert panels related to infant formula, argues that further research is needed to resolve uncertainty around the long-term effects of low-level exposure to heavy metals, the synergistic effects of multiple toxins, and medium-level exposure.
But cuts and other changes at the National Institutes of Health may undermine the basic research that could better understand the complex associations between chemicals in the environment and human health. For instance, NPR reported in June that at least eight members of a coalition of researchers known as Targeting Environmental Neuro-Development Risks, or Project TENDR, face potential federal funding cuts to research. The net effect, said Woodruff from UCSF and a Project TENDR participant, is: “You won’t know what’s going on. You won’t know where these exposures are. You won’t know how they impact children’s health.”
Even if Operation Stork Speed clarifies the maximum allowable limits for heavy metals in infant formula in the U.S., observers say they cannot assess the federal government’s capacity to test all infant formulas. And some suspect testing everything won’t be possible. As Pieter Cohen, a physician at Harvard Medical School who studies supplements, put it: “In an ideal world, I think that it would be impractical to test these products prior to them hitting store shelves by the FDA or, honestly, by any one entity.”
HHS did not answer questions from Undark about the current rate of testing by manufacturers nor the proposed increase under Operation Stork Speed; a statement released by HHS press secretary Emily G. Hilliard said, “As the MAHA Strategy states, the FDA will modernize nutrient requirements for formula, increase testing for heavy metals and other contaminants to help ensure access to high-quality and healthy infant formula sold in the United States, and encourage companies to develop new infant formulas.” (Hilliard did not respond to follow-up questions.)
Looking forward, advocates, such as Ken Cook, the president and co-founder of the nonprofit Environmental Working Group, expect more of the same: The government cannot keep up, and industry will continue to push for more permissive standards. “That captures the dilemma we have,” Cook said. “It’s true of contamination in consumer products across the board — that difference between what’s legal and what’s safe.”
This push and pull showcases a longstanding battle between third-party advocates and industry, one that critics say isn’t likely going away.
With fewer federal dollars available for research, and a continued reliance on industry self-regulation, independent entities are likely to continue playing a prominent role — for better or worse. “Money changes hands in a settlement and then, ‘Well, is the contaminated stuff still out there that you were so upset about?’” the EWG’s Cook said. “There’s no real way to track that. And usually, the settlements are private.
“It would be much better,” he added, “if the government did its job.”
