Lawmakers Push Swift FDA Action on Baby Food After Probe (1)

A group of Democratic lawmakers are reigniting pressure on the FDA to limit heavy metals in baby foods, citing a recent Bloomberg Law investigation that found lead and other toxic metals in several popular products.

Sen. Tammy Duckworth (D-Ill.) led colleagues in a letter to Food and Drug Administration Commissioner Robert Califf on Friday, writing that the agency has made “little tangible progress” in its Closer to Zero action plan to lower amounts of lead and other heavy metals in baby foods. The lawmakers made several references to Bloomberg Law’s probe into the issue, which found that all but one of 33 baby food products tested by an accredited laboratory contained at least two of three heavy metals: lead, arsenic, and cadmium.

“Despite the establishment of the Closer to Zero initiative and FDA’s additional actions to regulate the presence of toxic heavy metals in baby foods, it appears that unacceptable levels of toxic heavy metals persist in these foods,” Duckworth wrote, along with Sen. Amy Klobuchar (D-Minn.), Rep. Raja Krishnamoorthi (D-Ill.), and Rep. Tony Cárdenas (D-Calif.)

“Their continued presence poses a threat to the Nation’s public health and food supply,” they added.

On Jan. 24, just weeks after Bloomberg Law published its findings, the FDA published proposed draft limits for lead in baby foods. The proposal came months after the agency’s initial deadline of April 2022. The FDA sent its proposed levels to the White House’s Office of Management and Budget that month, but OMB didn’t complete its review of the draft guidance until Jan. 18.

Read the Bloomberg Law investigation: Baby Foods With Toxic Metals Stay on US Market While FDA Dithers

The draft guidance, if finalized, would establish an action level of 10 parts per billion for lead in fruits and vegetables, and some other foods consumed by children, including grain and meat-based mixtures, yogurts, custards/puddings, and single-ingredient meats. For single-ingredient root vegetables and dry infant cereals, the FDA is proposing a lead draft action level of 20 ppb.

The lawmakers thanked the FDA for issuing the draft guidance, but added that “more must be done to ensure the safety of foods consumed by babies and young children.” They called on the agency to quickly finalize the proposed action levels, and “continue working to fulfill, if not expedite” the other phases of its Closer to Zero plan, which include drafting limits for arsenic, cadmium, and mercury in baby foods.

The elected officials also asked FDA to answer a list of questions by Feb. 20, including 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 demands come after the lawmakers and several of their colleagues requested an update on from the FDA on Closer to Zero in a June letter. They wrote at the time that the FDA’s failure to meet its April deadline to propose action levels for lead “may indicate future delays in the Closer to Zero timeline for issuing drafting action levels for arsenic, cadmium, and mercury.”

The FDA received the latest letter from lawmakers and plans to respond to them directly, an agency spokesperson said in an email.

‘New Vision’

The FDA plans to release by Tuesday an update on a “new vision” for the FDA’s Human Foods Program to build on recommendations from an outside group to improve the agency’s response to food safety issues.

In December, a report organized by the nonprofit Reagan-Udall Foundation called on the FDA to restructure the organization of the food program and appoint a strong leader to limit turmoil and internal conflicts. Califf said in a statement at the time that the “work of these independent evaluators will help to inform a new vision for the FDA,” and that the “agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023.”

Just last week, the FDA’s top food safety official, Frank Yiannas, announced plans to step down from his role, effective Feb. 24. He cited concerns about inheriting a decentralized structure of the foods program that he said significantly impaired the agency’s ability to operate as an integrated team and protect the public.