In our modern era, health and diet are common topics of discussion, often leading to conflicting information. As enthusiasts navigate this complex landscape, the need for transparency in food safety becomes increasingly pressing. This article delves into the challenges surrounding infant formula safety, heavy metal contamination, and the role of watchdog organizations in ensuring consumer protection.
Yves here. I admit I have a keen interest in diet and health. While my mother, a self-proclaimed couch potato, managed to live to 94, our understanding of what constitutes a healthy diet is fraught with contradictions. For instance, wine has oscillated between being viewed as harmful and beneficial. Furthermore, the presence of pollutants, insufficient regulations, and inconsistent claims about food safety complicate matters. Heavy metals, which have recently made headlines due to concerning levels found in infant foods and popular protein products, exemplify this issue. These metals can be toxic even at relatively low concentrations, leading to the question: what is a safe level of exposure?
This article begins with a project from MAHA that I only just learned about, called Stork Speed, which aims to tackle the crucial issue of baby formula safety. It also highlights the less savory aspects of the “health” industry—the depths of deception that I, as an experimenter with diets and supplements, am all too familiar with. Some sellers of questionable products may be well-intentioned yet misguided, while others are fully aware of their actions. This piece primarily focuses on the Clean Label Project, which has faced criticism for employing vague criteria and for its pay-to-play certification practices.
As a quick Thanksgiving tip: if you’re concerned about birdshot, note that the meat surrounding it will typically be dark gray after cooking, making it easier to avoid ingesting the pellets.
By Peter Andrey Smith, a senior contributor at Undark. His work has been featured in publications such as Science, STAT, The New York Times, and WNYC Radiolab. Originally published at Undark
In 2017, a headline from a local TV news outlet posed a troubling question: “Are dangerous chemicals lurking in your baby food?” This alarming report highlighted a study indicating that 80% of infant formulas, along with several baby food products, tested positive for arsenic, a toxic heavy metal. Other harmful metals, such as lead and cadmium, were also present in these products.
The broadcast spotlighted the work of the Clean Label Project, a nonprofit based in Broomfield, Colorado, known for its efforts to uncover contaminants in various foods and supplements. This organization is part of a network of watchdogs, nonprofits, and advocacy groups that have emerged in response to longstanding gaps in food safety oversight in the U.S. For many consumer items, including infant formula, the U.S. Food and Drug Administration (FDA) has not set definitive maximum limits for heavy metals and other contaminants.
Although the work of third-party testers like the Clean Label Project is welcomed by many parents and consumers, critics argue that these organizations often make alarming claims regarding heavy metal levels that are below recognized safety thresholds. Some skeptics believe this approach is designed to fuel lawsuits and other legal actions, and even the most reliable auditors, they argue, cannot facilitate the regulatory changes necessary for a truly safe American food supply.
“Many organizations are monitoring and saying, ‘Look at this, look at that,’” said Tracey Woodruff, director of the University of California, San Francisco’s Program on Reproductive Health and the Environment. “However, this doesn’t solve the systemic issue.” Woodruff emphasizes that we must rethink our strategies: “It’s not just about alerting the public; it requires a comprehensive restructuring aimed at preventing pollution and safe cleanup efforts to ensure a truly safe food supply.”
Earlier this year, the Trump administration announced Operation Stork Speed, a federal initiative aimed in part at enhancing infant formula safety. In a video launching Operation Stork Speed, Robert F. Kennedy Jr., the U.S. Secretary of Health and Human Services, stated, “If there’s one food that must be safe beyond any doubt, it’s infant formula.” He added, “Certain elements, like heavy metals, are known to be harmful, so we’ll increase testing frequency to ensure that no child consumes contaminated formula.”
Nonetheless, the extent to which these efforts will be pursued remains uncertain, as does the feasibility of the government taking on the sole responsibility for testing and guaranteeing the safety of not just infant formula, but the larger food supply—a prospect deemed unrealistic by some experts. Additionally, many food safety scientists remain doubtful that existing third-party monitoring will be replaced by effective government oversight anytime soon, especially given the administration’s actions that seem to undermine toxins research and safety, including job cuts, grant terminations, and regulatory rollbacks.
“That’s not going to happen in this administration,” Woodruff remarked.
Heavy metals are naturally occurring elements found in the Earth’s crust, yet toxicologists attribute most environmental contamination to industrial activities, including fossil fuel burning and pesticide application. Lead and arsenic, for instance, turn up in soil and groundwater, with crops like rice uptaking these toxic elements, subsequently showing up in various plant-based foods. The health impacts of these toxic substances can be serious; even low lead levels can harm developing brains, while arsenic and cadmium can impair neurodevelopment and affect the immune and cardiovascular systems.
The regulatory thresholds for these heavy metals often mismatch detection capabilities (the levels that can be identified through testing) and legally accepted limits (what regulators consider tolerable). Debra Kaden, principal toxicologist at RHP Risk Management, reflects on this by pointing out that the question should consider risk rather than merely hazard. “A hazard can cause disease at a certain amount,” she explained, “but risk involves individual exposure and circumstances, asking, ‘What does this mean for me?'”
On March 20, Health Secretary Robert F. Kennedy Jr. provided an explanation of the FDA’s Operation Stork Speed in a video. The initiative aims to enhance infant formula safety and other goals. Visual: HHS/YouTube
Scientific consensus suggests that no level of lead is safe. “No amount is acceptable in food or water,” said Kristin Knox, a Silent Spring Institute scientist, referring to the Environmental Protection Agency’s lead limits. “The action level is a bit higher,” she notes, but even minimal levels are harmful. Federal agencies recognize this disparity. The FDA has launched an initiative seeking to minimize childhood exposure to heavy metals labeled “Closer to Zero.” Understandably, regulatory limits not only reflect scientific data but are also influenced by resource availability and funding. “Harm and economics intertwine,” Knox noted.
In the U.S., while the FDA can impose limits and has enacted action levels for some foods—like candy needing to have lead levels below 0.1 parts per million (ppm)—there are no established limits for infant formula. Other standards exist, but there’s a lack of consistency regarding harmful substances and their limits. For example, the European Union has set a maximum level of 0.01 mg/kg for lead in liquid formula (0.02 mg/kg for powder). To illustrate, in California, Proposition 65 mandates businesses to disclose the presence of hazardous chemicals exceeding certain exposure limits; the maximum daily dose is 0.5 micrograms per product. For example, if a baby consumes 150 grams of powdered formula containing 0.02 mg/kg of lead, they would be taking in 3 micrograms of lead—six times the maximum allowed dose from Proposition 65.
Established limits allow third-party organizations to test and certify products against these standards. However, the absence of consistent standards in the U.S. and globally makes distinguishing between what’s detectable and what’s harmful particularly challenging.
Throughout the past decade, the Clean Label Project has made headlines by identifying contaminants in a variety of consumer products, from pet food to decaffeinated coffee. Allegations later arising from a lawsuit claimed that the CLP had connections to Kevin Hicks, a serial entrepreneur known for founding Healthgrades, a health provider rating platform that has faced criticism regarding its accuracy. During Hicks’ leadership at BeverageGrades—a now-defunct nutritional resource for alcoholic beverages—data suggested that popular wines contained arsenic, which led to a court case arguing that winemakers breached California labeling laws. Ultimately, the judge dismissed the lawsuit, asserting that the existing labels adhered to regulations.
In 2012, as Hicks prepared for fatherhood, he initiated testing of baby food and established a lab named Third Party Validation & Verification LLC, which operates as Ellipse Analytics. The laboratory conducted tests and, according to sources from a Reddit AMA and a 2020 legal complaint, previously voluntered its services to the Clean Label Project, which was established as a nonprofit in 2016. According to a 2023 tax document, the nonprofit sought to market health transparency in consumer product labeling and educate the public about contaminants in food. The organization launched a certification program, and its tax filings show that part of its revenue comes from certification fees. The lab’s website states that Ellipse Analytics serves as the exclusive technical administrator for the Clean Label Project.
However, skepticism remained. In 2018, a toxicologist from NSF, a nonprofit conducting voluntary certifications of dietary supplements and foods, accused the Clean Label Project of employing vague standards, claiming its report on protein powders used “sensational language” that intertwined measurable levels with safety, implying that any detectable amount was a health risk. However, in a defense, a spokesperson for NSF noted that the toxicologist who made that determination is no longer with the organization. The Clean Label Project has since pursued lawsuits against various corporations, including Kraft Heinz, Keurig Green Mountain, Amazon.com, Panera, and two infant formula manufacturers.
Furthermore, the Clean Label Project assigned a D+ rating to Pharmavite LLC, a private company in West Hills, California, for one of its prenatal vitamins, allegedly due to heavy metal content. Pharmavite subsequently filed a lawsuit against the Clean Label Project in 2020. The initial complaint labeled the Clean Label Project a pay-to-play operation—a “money-making ‘protection racket’ reminiscent of something Michael Avenatti would admire” (Avenatti was later convicted of extortion). In its response, the legal team representing the Clean Label Project and its affiliates countered that the accusations overshadowed the genuine concern for pregnant women seeking to safeguard their unborn children. Ultimately, the dispute remains unresolved, as the lawsuit was settled privately without public terms disclosed. (Hicks was unavailable for comment, and a public LinkedIn profile suggests he no longer associates with the lab or nonprofit.)
A Panoply of Products
The Clean Label Project has certified hundreds of products with its “Purity Award,” including many meant for infants and toddlers. These items have undergone thorough analysis, according to the organization’s assertions on its website. Visual: Illustration by Undark
Numerous attempts to contact Jaclyn Bowen, the executive director at the time of the lawsuit who recently resigned, as well as Molly Hamilton, the current executive director, via email, LinkedIn, and phone have been unsuccessful. When pressed for comment, Kate Stuard, a media contact presenting herself as a representative of the nonprofit, forwarded a statement attributed to a Clean Label Project spokesperson stated that “Clean Label Project does not determine legal or scientific safety; rather, that responsibility falls on regulators and public health bodies. Our mission is to provide independent, data-driven insights into consumer products to assist families and practitioners in making informed choices. By enhancing transparency regarding detectable contaminants, we aim to uplift industry standards and promote ongoing enhancement of product quality.”
Undark reached Matt Regusci, CEO at Ellipse Analytics, listed on the lab’s website, via LinkedIn, but he did not return requests for comment. Attempts to contact others associated with Ellipse were similarly unsuccessful.
In 2021, the Institute for Legal Reform, a pro-business group funded by the U.S. Chamber of Commerce, released a report identifying the rise in food and beverage litigation, naming the Clean Label Project as a particularly active participant. The nonprofit is a notable example of so-called bounty hunters, filing legal notices under Proposition 65, which resulted in over 5,000 lawsuits and an estimated $1 billion in business expenses. Recently, class-action lawsuits against the food sector have reached record heights, with some attributing this surge to RFK Jr. and the MAHA movement.
In an ongoing class-action lawsuit, plaintiffs in California allege that manufacturers knowingly sold baby food products contaminated with heavy metals such as lead, arsenic, mercury, cadmium, and aluminum, despite being aware of the associated neurodevelopmental risks. This complaint cites a 2018 study funded by the Clean Label Project, which indicated that lead was present in 37% of U.S. baby foods. Authored by Hannah Gardener, a University of Miami epidemiologist, the study also included co-authors Bowen and Sean Callan, affiliated with Ellipse. Gardener, though identifying as a non-CLP employee, did not respond to further inquiries. In the 2018 publication, the authors noted that the levels of lead and cadmium in the baby food samples studied were “very low,” with only one exceeding the FDA’s standard for candy. (This study excluded testing for arsenic, mercury, or aluminum. Additionally, around 25% of the products surpassed Proposition 65 cadmium limits, with 14% exceeding WHO cadmium intake levels.)
More recently, Gardener and the same co-authors have published an article in the peer-reviewed journal Environmental Research that examines prenatal vitamins and heavy metals. In the conflict-of-interest statement within the publication, Gardener and Callan declared that they had been retained as expert witnesses; a report provided by the Los Angeles law firm Wisner Baum, which represents thousands of plaintiffs, indicated that Gardener was compensated $600 hourly for her testimony. The report also contained Gardener’s assertion that, based on her review of scientific literature, early exposure to heavy metals could lead to autism spectrum disorder—a topic still under debate and not universally accepted as a single condition with a known cause. It’s noteworthy that RFK Jr. has reported earning nearly $2.5 million in referral fees from Wisner Baum, with the firm also employing his son, Conor.
The study’s findings ignited debate, extending beyond the courtroom. Industry trade organizations insisted that the results from the 2025 CLP-funded research were consistent with previous studies, which show that trace levels of heavy metals like lead and cadmium are prevalent in supplements and foods due to their environmental origins.
In a statement, Jeff Ventura, vice president for communications at the Council for Responsible Nutrition, declined a request for an interview but provided a prepared response: “This study reaffirms what earlier research has consistently demonstrated: minor amounts of heavy metals are typically present in both dietary supplements and foods owing to environmental sources.” He also noted that consumers should not be concerned about avoiding prenatal vitamins.
Advocates and scientists contend that RFK Jr.’s Operation Stork Speed faces significant hurdles, many stemming from actions taken by the Trump administration itself. In March, the EPA announced “the most extensive deregulatory action in U.S. history,” which led to reduced staffing and the closure of the Office of Research and Development. This office undertook comprehensive research on a variety of pollutants and toxins, including monitoring lead levels in drinking water and establishing long-term studies to understand how infant and toddler consumption patterns contribute to cumulative exposure risks.
Nan Du, a Boston Children’s Hospital physician, has participated in FDA expert panels focused on infant formula and argues for the necessity of further research to clarify uncertainties regarding low-level heavy metal exposure, the combined effects of multiple toxins, and moderate exposure levels.
However, cuts and alterations at the National Institutes of Health may jeopardize core research that could elucidate the complex relationships between environmental chemicals and health outcomes. For instance, NPR reported in June that potential federal funding reductions threaten eight members of a coalition of researchers known as Project TENDR. Ultimately, as Woodruff from UCSF, a participant in TENDR, explains, “You’ll lack awareness about exposures and their impacts on child health.”
Even with Operation Stork Speed clarifying the maximum allowable heavy metal limits in U.S. infant formula, experts are skeptical about the federal government’s capacity to conduct thorough testing across all infant formulas. Some even doubt the practicality of ensuring comprehensive testing before products reach store shelves. “In a theoretical perfect world, the FDA or any single entity might find it impractical to conduct pre-market testing for all these products,” stated Pieter Cohen, a physician at Harvard Medical School specializing in supplements.
The Department of Health and Human Services did not address Undark’s inquiries about the current testing rates among manufacturers or the proposed enhancements expected under Operation Stork Speed. A statement from HHS press secretary Emily G. Hilliard asserted that “the MAHA Strategy outlines the FDA’s commitment to modernizing nutrient standards for formula, intensifying testing for heavy metals and other contaminants, and encouraging the development of new infant formulas.” Hilliard did not provide follow-up commentary.
Looking ahead, advocates like Ken Cook, co-founder of the nonprofit Environmental Working Group, predict that the government will struggle to keep pace while the industry advocates for more lenient regulations. “That encapsulates our dilemma,” Cook remarked. “This situation is consistent across all consumer product contamination issues—the disparity between what’s legal and what’s genuinely safe.”
This ongoing conflict highlights a perpetual struggle between third-party advocates and industry, which critics assert is unlikely to diminish.
As federal financial resources for research dwindle and reliance on industry self-regulation continues, independent organizations are likely to maintain significant influence—both positively and negatively. “Money changes hands in settlements, yet the question remains: ‘Is the problematic product still on the market?'” expressed Cook from the EWG. “Tracking these issues remains nearly impossible, and settlements are usually confidential.”
“It would be far better,” he concluded, “if the government fulfilled its responsibilities.”
