FDA Announces Thresholds for Lead in Baby Foods

Baby food is offered for sale at a grocery store in Chicago, Ill., on Feb. 13, 2024. Scott Olson/Getty Images

The U.S. Food and Drug Administration (FDA) issued guidance regarding lead levels in processed foods for babies and young children under the age of 2.

The guidance applies to “foods in jars, pouches, tubs or boxes and may include ready-to-eat foods such as purees, as well as semi-prepared foods,” said a Jan. 6 update from the agency.

For fruits, vegetables, mixtures (including those based on grains or meats), single-ingredient meats, custards/puddings, and yogurts, the lead threshold is 10 parts per billion (ppb). For single-ingredient root vegetables and dry infant cereals, the limit is 20 ppb.

While these limits are not “binding” for food manufacturers, the FDA said it plans to consider these numbers along with other information “when considering whether to bring enforcement action in a particular case.”

“It is not possible to remove lead entirely from the environment or the food supply,” it said. However, “setting action levels like those in the guidance can help lower levels of contaminants in foods when a certain level of a contaminant is unavoidable.”

So far, industry groups have not commented on the guidelines.

According to the U.S. Centers for Disease Control and Prevention (CDC), ensuring that children are not exposed to lead “is important to lifelong good health.”

“Even low levels of lead in blood have been shown to affect learning, ability to pay attention, and academic achievement,” it warned. “If caught early, there are things you can do to prevent further exposure and reduce damage to your child’s health.”

According to the FDA, the current guidance is not aimed at pushing people to opt for certain foods. It recommends against throwing away processed or packaged baby foods entirely. The key is to adhere to “good nutrition,” which helps protect the baby from harmful effects of lead exposure, the agency said.

The FDA clarified that the guidance does not cover beverages, infant formulas, and snacks like teething biscuits and puffs.

For lead presence in juices, a separate draft guidance was previously issued. As for lead in grain-based snacks, the agency is collecting additional data to determine whether to set limits.

Contaminants like lead “may enter the food supply when plants and animals take them up similarly to how they take up nutrients, making the food both a source of essential nutrients for child growth and development but also a source of exposure to contaminants,” the agency said.

“Because the very young are more vulnerable to adverse health effects associated with exposure to contaminants, we prioritized reducing exposure from foods commonly consumed by young children.”

Tackling Heavy Metal Contamination

According to the FDA, the recent limits for lead are part of the agency’s “Closer to Zero” initiative.

Specifically, the agency is looking to tackle four contaminants—lead, arsenic, mercury, and cadmium. The FDA has so far proposed arsenic and cadmium thresholds for baby foods and is evaluating limits for mercury.

Food manufacturers have a legal obligation to minimize or avoid exposure to chemicals, the FDA said.

“If the agency finds that the level of a contaminant in a food causes the food to be unsafe, we take action, which may include working with the manufacturer to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market.”

In May last year, lawmakers introduced the Baby Food Safety Act of 2024. The legislation is intended to establish a mandate that baby food products do not carry toxic heavy metals beyond a specific limit.

States are also taking action. Starting Jan. 1, manufacturers of baby foods sold in California have to post on their websites all details about the amounts of heavy metals in their items.

“This new law will help protect babies,” said Assemblyman Al Muratsuchi (D-Calif.) who authored the legislation.

“By requiring this testing and reporting in California, the biggest consumer market in the nation, baby food manufacturers across the United States will hopefully take greater action to ensure their products are free of toxic heavy metals.”