The Biden Administration Pressured Countries to Weaken Baby Formula Health Rules

The Biden administration has quietly pushed more than a half-dozen countries to weaken, delay or rethink baby formula regulations aimed at protecting the public’s health — sometimes after manufacturers complained, a ProPublica investigation has found.

In the European Union, the U.S. opposed an effort to reduce lead levels in baby formula. In Taiwan, it sought to alter labeling that highlighted the health benefits of breastfeeding. And in Colombia, it questioned an attempt to limit microbiological contaminants — the very problem that shut down a manufacturing plant in Michigan in 2022, leading to a widespread formula shortage.

“Infant formula companies want to sell more infant formula,” said Marion Nestle, professor emerita of nutrition, food studies and public health at New York University. “The idea that governments are aiding and abetting them in their commercial enterprise over the public health interest is really shocking to me.”

The interference, documented in trade letters sent during President Joe Biden’s first two years, represents the latest chapter in the federal government’s long-running support for the multibillion-dollar formula industry, even as the Biden administration has publicly promised a different approach.

As ProPublica reported earlier this year, the U.S. has long used its diplomatic and political muscle to advance the interests of companies like Abbott, which makes Similac, and Mead Johnson, maker of Enfamil, while thwarting the efforts of developing countries to safeguard the health of their youngest children.

Through public records, academic research and other sources, ProPublica found evidence of such meddling in 21 countries, plus Hong Kong, Taiwan and the European Union, over decades. In multiple instances, countries either tabled or changed proposed formula regulations after the U.S. lodged objections.

The stakes for global health are high. Experts say industry advertising — the target of many foreign regulations — often misleads parents about the benefits of formula products and that promotions such as free samples, discounts and giveaways can result in mothers abandoning breastfeeding too soon. Studies show that can lead to more life-threatening infections for babies and a higher risk for long-term conditions like diabetes and obesity.

In January, the Biden administration told ProPublica that it overhauled how the U.S. approaches trade, respecting foreign governments’ efforts to pass regulations rather than immediately deeming such rules trade barriers. The Office of the United States Trade Representative, which advises the president on trade, said that it’s committed “to making sure our trade policy works for people — not blindly advancing the will of corporations.”

But the documents, obtained from the agency’s own files through a records request, suggest those corporations still have outsized clout when it comes to baby formula regulation.

In early 2021, for example, formula company representatives set up a conference call with USTR staff to oppose legislation in Kenya, which was seeking to restrict formula advertising. Industry consultants shared a 10-page position paper from a trade group criticizing the Kenyan measure.

U.S. officials then raised similar issues in their correspondence with Kenyan officials. “Can Kenya explain the need for this provision?” they asked about one advertising-related measure, according to agency records. The U.S. asked whether Kenyan officials had sought input from stakeholders like food makers and retailers. Officials also suggested a host of changes to the proposed law, including recommending that Kenya replace a warning about potential contamination during the manufacturing process with a warning that focused only on “the health hazards of inappropriate preparation, storage and use.”

Kenyan officials pushed back, dismissing that suggestion and several others. Kenya needed to pass regulation, they said, because the formula industry “was not voluntarily adhering” to international guidance. Less than half of Africa’s infants under 6 months old were exclusively breastfed, Kenyan officials wrote, and the country was seeking to raise its rate to 75%.

The USTR’s office declined ProPublica’s request for an interview about that letter and eight others sent under Biden. A spokesperson also declined to answer written questions. The White House did not respond to requests for comment.

The pro-industry letters are the result of a policymaking process in which manufacturers are encouraged to weigh in. In fact, the U.S. Department of Agriculture runs a tracking system that “notifies industry and other users when potentially adverse foreign regulations” come up at the World Trade Organization, an international forum for settling trade disputes. Companies can then “provide input into official U.S. government comments.”

Multiple agencies, including the USTR, consider that feedback as they hammer out the official U.S. position, which experts say carries weight because of the country’s economic and diplomatic power. Federal officials then transmit comments — often accompanied by questions — in a letter to the foreign country proposing the regulation. (The USDA did not respond to questions about the process or the Biden-era formula letters.)

Historically, the U.S. often lodged objections to new formula rules in public at the WTO. Research shows that before 2020, the U.S. questioned proposed formula regulations in WTO forums more than 30 times — far more often than any other country, even those where foreign formula makers are based.

The Biden administration, however, has relied almost entirely on the trade letters, keeping its critiques of formula regulation largely out of public view, according to ProPublica’s analysis of WTO meeting minutes and other documents. In fact, the nine missives were so under the radar that they surprised even public health experts who follow such developments.

“Oh my goodness,” said Jennifer Pomeranz, a New York University professor and expert in public health law and food policy. “I did not know it was this extensive.”

The letters carry an implicit threat, often asking for the scientific rationale behind countries’ proposals. If the U.S. feels a nation’s regulations are not justified, it can initiate a legal fight over trade agreements.

In one letter from May 2021, the U.S. pushed back against the European Union’s efforts to reduce the amount of lead — a neurotoxin dangerous to children — in formula. The change was based on a risk assessment by a European food safety agency, European officials said, adding, “This measure is considered necessary to ensure a high level of human health protection.”

The U.S. wasn’t convinced. “We suggest the EU wait,” U.S. officials said. They cited the ongoing efforts of an international food standards body, which was considering lead limits for a range of foods. (The U.S. Food and Drug Administration, which has no lead limits for formula, told ProPublica it “has been evaluating to what extent if any, infant formula contributes to dietary lead exposure among the very young.”)

The U.S. also questioned the science behind proposed limits on cadmium, a probable carcinogen, in formula. The U.S. has no such limits.

The EU passed both measures anyway.

Other recipients, however, have acceded to the U.S.’s requests.

Taiwan, for example, changed a proposed formula labeling law after the U.S. objected to language that said, “Breastfed babies are the healthiest babies.” Taiwanese officials switched to wording the U.S. suggested in a 2022 letter: “Breast milk is the best food for your baby.”

The change, while subtle, makes a difference, said Nestle, who is not related to the formula company of the same name. “These statements may seem identical, but the formula industry wants formula to be viewed as equivalent to or better than breastfeeding,” she said. “‘Healthiest’ can seem stronger, and that’s all it takes for formula companies to fight it.”

The Infant Nutrition Council of America, an industry trade group, said its members support breastfeeding but “believe that parents should have access to accurate, balanced information on all appropriate infant feeding options.” Formula makers also meet regulatory and “nutritional science” requirements in countries where they sell products, the group’s statement said.

Abbott and Mead Johnson did not respond to requests for comment.

To be sure, formula remains crucial when babies do not have access to breast milk. But the WTO has long promoted breastfeeding because of its well-documented benefits for babies’ health and cognitive growth. Multiple studies have found fewer infant deaths among breastfed children. Breastfeeding mothers lower their own risk of certain cancers, too.

David Clark, former legal specialist with UNICEF and an international public health law consultant, said interventions like those of the U.S. can have a “chilling effect” on countries’ efforts to regulate formula marketing and protect breastfeeding. “It’s like the bully in the playground,” he said. “The U.S. is a big, powerful country.”

In 2021, the U.S. sent Colombia questions as it was considering a limit on microbiological contaminants. The country has yet to adopt the measure, said Rubén Ernesto Orjuela Agudelo, an infant nutrition expert at the National University of Colombia. He said such a provision is needed.

In 2023, the U.S. sent a letter to Mozambique, challenging a proposal that sought to limit the information formula makers can provide to “higher level healthcare professionals” — a key target of industry lobbying. Trade officials took issue with the country’s description of formulas as “ultra-processed products with high sodium content” that contribute to long-term health problems.

The status of the measure is unclear. The country’s embassy did not answer questions from ProPublica.

Lori Wallach, director of the Rethink Trade program from the the American Economic Liberties Project, said that Biden’s trade representative, Katherine Tai, has made a significant effort to reduce corporate influence at USTR. But Wallach said it’s possible some career trade officials are still “marching along to the corporate drums that have been setting their path for the last decades.”