baby eating food from spoon, FDA guidance

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FDA’s Guidance on Lead in Baby Food Might Just Be Too Little, Too Late

January 7, 2025

The U.S. Food and Drug Administration (FDA) released guidance that limits the levels of lead in processed baby food. The rules are part of the FDA’s Closer to Zero initiative to lower contaminants like lead in the foods children consume.

The new rules state that baby yogurts, custards, single-ingredient meats, and puddings must not contain more than 10 parts per billion of lead. Also included in the list are processed fruits and vegetables as well as mixtures of fruits, vegetables, grains, and meat. The guidelines apply to baby food in any package, including jars, pouches, boxes, or tubes, and forms, such as ready-to-eat purees and semi-prepared foods like dry cereals.

Carrots, sweet potatoes, and other root vegetables, which already contain lead from the soil, are limited to 20 parts per billion under the FDA guidance. Dry cereals must also be at or below the same threshold.

Not included in the FDA’s recommendations are infant formula, beverages, or snack foods like puffs and teething biscuits. 

This is the first time the agency has set guidelines for lead in baby food, but the rules are suggestions, and the industry is not obligated to follow them. However, the FDA, under some circumstances, may decide to act on a case-by-case basis if deemed necessary.

“Guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” the agency noted. “The use of the word should in FDA guidances means that something is suggested or recommended, but not required.”

The FDA’s Lead Advisory May Be Inadequate

Organizations and advocates dedicated to improving the health and well-being of children see the agency’s guidance as irrelevant. Some say the agency took too long to address such a crucial health issue and even disregarded public outcry for stricter standards.

“Nearly all baby foods on the market already comply with these limits, making the new standards largely ineffective,” said Jane Houlihan, Healthy Babies Bright Futures’ national director of science and health, per CNN.

While the FDA’s guidance seems to have good intentions, the agency has known about dangerous levels of lead in baby food for years but has done little to combat it. Scott Faber, an executive with the nonprofit Environmental Working Group, says lead in food causes permanent damage, especially to developing brains.

 “The FDA owes parents answers and must enforce these limits immediately to finally protect our most vulnerable population,” he said.

According to the Centers for Disease Control and Prevention (CDC), lead can be harmful at any level. When children consume or breathe in lead, which then enters the bloodstream, it can adversely affect learning and academic achievement.

The FDA, however, suggests parents feed their children “a variety of healthy foods” to minimize exposure to toxic substances. Adequate nutrition “can help to prevent lead from having harmful effects,” according to the agency.

It is crucial parents remain vigilant when it comes to their baby’s food. Earlier this year, a baby formula recall was issued by Dairy Manufacturers Inc. when it was discovered their product did not meet FDA requirements.