FDA issues voluntary guidelines for toxic lead levels in baby foods amid calls for mandatory measures

The Food and Drug Administration (FDA) has set maximum levels for lead in baby food such as fruits, vegetables, yogurts and cereals in an effort to reduce infant exposure to harmful contaminants.

Its guidance for food manufacturers is not mandatory and covers packaged processed foods for babies or young children less than two years old. Foods in jars, pouches, tubs or boxes, ready-to-eat food such as purees, and semi-prepared foods like dry infant cereals are covered as part of its advice. 

Jane Houlihan, research director for advocacy group Healthy Babies Bright Futures, tells Food Ingredients First the guidelines represent a “baby step.” 

“The new limits for lead in baby food are insufficient to drive meaningful change. Nearly all commercial baby foods already comply, and foods that account for the majority of children’s exposure fall outside the scope of FDA’s action.”

“FDA’s narrow focus on commercial baby food misses the broader issue of lead exposure. Most of children’s dietary lead exposures—about three-fourths in total—come from other foods, including infant formula and homemade or store-bought foods purchased outside the baby food aisle.” 

“FDA needs to set lead limits in these foods to make significant headway in reducing children’s lead exposures.”

The recommended levels by the FDA for processed foods are 10 parts per billion for fruits, vegetables, yogurts, puddings and single-ingredient meats and 20 parts per billion for dry infant cereals and single-ingredient root vegetables. The guidance does not cover infant formula, beverages, or snack foods like puffs and teething biscuits. 

Infant exposxre to lead has been linked to health issues such as developmental and neurological problems. Lead and other toxic heavy metals have been found at dangerously high levels in some commercial baby foods sold in the US. 

A 2019 study by the not-for-profit organization Healthy Baby Bright Futures found that 95% of baby foods tested were contaminated with heavy toxic metals like arsenic, lead, cadmium and mercury. This sparked a national debate about the need for urgent FDA action and whether homemade baby food was a safer alternative. 

Closer to Zero initiative 

The FDA’s announcement is part of its “Closer to Zero” initiative, which focuses on actions to reduce the levels of lead and other contaminants in food products for babies and young children as much as possible.

“It is not possible to remove lead entirely from the environment or the food supply. 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. It is important to note, however, that the FDA does not need an action level or guidance to take action with respect to a food product that is in violation of the law,” says the agency in a statement.

Contaminants such as lead can occur naturally as environmental pollutants in air, water and soil. They may enter the food supply when plants and animals take them up, similarly to how they take up nutrients, with children and babies particularly vulnerable if exposed.

Last month, leading US baby food manufacturer Gerber said it was committed to “addressing the issue of heavy metals” in baby food. The company, along with other market leaders like Beech-Nut, has been subject to lawsuits by families who say their children were harmed by their products.

“We strongly support the FDA Closer to Zero Action Plan and welcome the opportunity to work collaboratively with the FDA and other stakeholders to advance this important effort to continue to reduce the levels of heavy metals in infant and toddler foods. Strong standards are good for babies, parents and our industry,” Gerber said in a statement at the time.