Deadlines for Baby Food Metal Policy Vanish as Lawmakers Object

The US Food and Drug Administration has quietly removed deadlines for setting guidelines on heavy metals in baby food from its website, sparking more concerns from lawmakers who have long faulted the agency’s slow response to the issue.

“The lack of urgency combined with the lack of further information … starts to look like resistance,” said Rep. Raja Krishnamoorthi (D-Ill.), who led the House Oversight and Reform Subcommittee on Economic and Consumer Policy when it investigated data from baby food manufacturers in 2021.

In January, the FDA published proposed action levels for lead in some foods consumed by babies and young children, including fruits, vegetables, yogurts, and single-ingredient meats. The announcement came just weeks after Bloomberg Law published findings from a months-long investigation that found lead, arsenic, and/or cadmium in almost all the baby food products it tested.

At the same time the FDA released this draft guidance, it also updated its Closer to Zero website by eliminating the timelines for further action. The agency started Closer to Zero in April 2021 to establish guidelines for toxic metals in foods consumed by babies and young children, following pressure from Congress and interest groups.

An FDA spokesperson confirmed to Bloomberg Law that the website changes were made at the same time the agency released the lead draft guidance. But the spokesperson added that the “changes are non-substantive and did not impact the FDA’s goals and therefore did not necessitate a public announcement.”

“Identifying action levels is a complex process both scientifically and procedurally, but as we committed to at the launch of the Closer to Zero initiative, we are working toward proposing guidance on action levels for these four environmental contaminants and finalizing guidance within 1-2 years of proposing,” the spokesperson said in an email.

Still, critics say the change, along with the FDA’s delayed response to lawmakers’ request for additional information on its progress, doesn’t bode well for public trust in the agency’s ability to limit exposure to toxic metals, which are known to slow childhood development and trigger other serious health problems.

“The lack of explanation as to why they’re doing this, it raises all kinds of questions,” said David Acheson, who previously served as associate commissioner for foods and chief medical officer at the FDA’s food center.

“For an administration that prides itself on transparency, it’s like, why are you making these changes, which are pretty important, and not telling us why?”

Quiet Changes

When FDA launched Closer to Zero in 2021, it divided its goals into three phases for proposing and finalizing guidance: April 2021-April 2022, April 2022-2024, and April 2024-beyond.

The FDA no longer has these phases on its website. Instead, the agency lists completed and planned actions for each of the four heavy metals targeted under Closer to Zero: lead, arsenic, cadmium, and mercury.

The previous timeline said FDA planned to finalize action levels for lead in categories of foods consumed by babies and young children by April 2024. The existing website doesn’t list a goal date for finalizing these or other action levels.

The FDA referred to Closer to Zero as a “living” plan, and that the goal dates “are estimates based on the current state of evolving science, the agency’s analysis of relevant data, and the regulatory process for developing and issuing guidance to industry.”

“As more information is garnered, the FDA will update its website with these dates,” the spokesperson said.

The FDA initially planned to issue the draft action levels in lead by April 2022, but didn’t send proposed levels to the White House’s Office of Management and Budget until that month. OMB didn’t complete its review of the draft guidance until January of this year.

Despite the lack of transparency, the FDA’s approach of taking into account both concentration of metals in foods and their degree of consumption among babies and young children before settling on recommendationsis “inherently is a good one,” Acheson said.

While it’s normal for a federal government program to have delays, providing goal deadlines for the public is “a means for the agency to be held accountable,” said Tom Neltner, the Environmental Defense Fund’s senior director for safer chemicals.

Finalizing guidelines also “matters when it comes time to ensuring compliance,” Neltner said.

“If it’s not final, the inspectors are not looking for it in the same way, the whole system is not designed to go after the companies that are not taking it as seriously,” he added.

In January, Sen. Tammy Duckworth (D-Ill.) led colleagues in a letter to FDA Commissioner Robert M. Califf asking what steps the FDA plans to take “in the interim to address the high levels of toxic heavy metals found in the baby foods tested in the recent Bloomberg Law report and other similar reports?”

The lawmakers gave the FDA a deadline of Feb. 20, 2023 to respond. Duckworth said in a March 15 interview that the agency hadn’t sent a formal response. Members of Duckworth’s staff did hold a briefing with FDA staff, who were optimistic there would be no further delays in the Closer to Zero timeline, according to Duckworth’s office.

“It is unacceptable that there are still high levels of toxic heavy metals in our nation’s baby food—parents and children deserve better,” Duckworth said.

In February, Sen. Rick Scott (R-Fla.) sent his own letter to Califf criticizing the FDA’s lack of action. “The guidance the FDA proposes does not go far enough,” he wrote.

Krishnamoorthi said that without a clear explanation from the FDA, his constituents would view the website changes as “foot-dragging.”

“Let’s just say that the FDA will have some explaining to do,” he said.

‘Complete Disarray’

Even with the Closer to Zero plan, the FDA’s enforcement on the issue is limited. The agency is proposing action levels—essentially guidelines—rather than binding regulations that require the agency to act.

But that may change. The Biden administration’s fiscal 2024 budget request to Congress included a legislative proposal to amend the Federal Food, Drug, and Cosmetic Act to “establish binding contamination limits in foods, including those consumed by infants and young children, via an administrative order process.”

The proposal would include limits on arsenic, lead, cadmium, and mercury, among other contaminants, according to an agency spokesperson.

Most people “believe that the FDA has all of the authority it needs to be able to keep the food supply safe. And so what the FDA is asking for is actually what most people believe is already there, and that should be there,” said Charlotte Brody, national director of Healthy Babies Bright Futures. The organization focuses on promoting awareness of children’s exposure to toxic substances.

But the proposal also comes at a time when the FDA’s human foods program is undergoing sweeping organizational changes. In January, the agency launched a proposed vision for a unified foods program under a new deputy commissioner.

Just one week before the announcement, Frank Yiannas announced his resignation as deputy commissioner of the agency’s Office of Food Policy and Response. In his resignation letter, he cited concerns about inheriting a decentralized structure of the foods program that he argued significantly impaired the FDA’s ability to operate as an integrated team and protect the public.

“They are in a state of complete disarray,” said Acheson, citing his own interactions with agency staff over the past couple months. He currently runs his own food safety consulting firm.