The U.S. Food and Drug Administration Tuesday announced draft guidance for the industry on “action levels” for lead in processed foods that are intended for babies and children under two years old, for the purpose of reducing potential health effects in this vulnerable population from dietary exposure to lead.

According to the FDA, the proposed “action levels” would result in significant reductions in exposure to lead from food while ensuring the availability of nutritious foods. The guidance is part of Closer to Zero, which sets forth the FDA’s science-based approach to continually reducing exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible in foods eaten by babies and young children. 

Consumer Reports (CR) called the FDA’s proposed limits on lead in processed food for babies and young children an encouraging first step, but said stricter limits are needed to protect this vulnerable population. CR is calling on the FDA to strengthen the proposed limits as it finalizes the standard in the coming months. 

“We’re encouraged that the FDA has proposed these new standards, but clearly more needs to be done to limit exposure to toxic lead and protect babies and young children,” said Brian Ronholm, director of food policy for Consumers Reports. “The FDA should set strict limits on so-called baby junk food – grain-based snacks such as puffs, rusks, and wafers – since those foods typically contain the highest levels of lead.” 

FDA Commissioner Dr. Robert M. Califf, MD, said the agency has worked for more than 30 years to reduce exposure to lead and other contaminants from food. The commissioner says FDA’s work has resulted in a dramatic decline since the mid-1980s in lead exposure from foods.

““For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27 percent reduction in exposure to lead from these foods, ” Califf added.

Foods covered by the draft guidance, Action Levels for Lead in Food Intended for Babies and Young Children, are those processed foods, such as food packaged in jars, pouches, tubs, and boxes and intended for babies and young children less than two years old. The draft guidance contains the following action levels: 

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), and yogurts. custards/puddings and single-ingredient meats. 
• 20 ppb for root vegetables (single ingredient).
• 20 ppb for dry cereals.

Consumer Reports, which has long been involved in the issues, said the FDA did not propose limits for grain-based snacks. Under the FDA’s draft guidance announced Tuesday, CR said the agency is proposing the following action levels for lead in processed foods for babies and small children: 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures, yogurts, custards/puddings and single-ingredient meats); 20 ppb for root vegetables (single ingredient); and 20 ppb for dry cereals. 

“It appears that the proposed standards were set based more on current industry feasibility to achieve the limits and not solely on levels that would best protect public health,” said Ronholm.  “The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure. We look forward to working with the FDA to build on this proposal and gradually lower and eventually eliminate toxic heavy metals in baby food.” 

In 2018, Consumer Reports analyzed 50 nationally distributed packaged foods made for babies and toddlers, checking for lead and other heavy metals considered to be the most harmful to human health. about two-thirds of the products — 34 — contained concerning levels of lead, cadmium and/or inorganic arsenic; 15 of them would pose a risk to a child who ate one serving or less per day. CR found that snacks and products containing rice and/or sweet potatoes were particularly likely to have high levels of heavy metals.

Exposure to even small amounts of heavy metals, including lead, at an early age may increase the risk of several health problems, especially lower IQ and behavior problems, and have been linked to autism and attention deficit hyperactivity disorder. A 2018 study in the journal Lancet Public Health suggests that even low levels of lead from food and other sources contribute to 400,000 deaths each year, more than half of them from cardiovascular disease.

The FDA considers these action levels to be achievable when measures are taken to minimize the presence of lead and expects that the industry will strive for continual reduction of this contaminant. Baby foods have differing action levels, to account for variances in consumption levels of different food products and due to some foods taking up higher amounts of lead from the environment. Action levels are one regulatory tool the FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable, for example, because of environmental factors. To identify the action levels for categories of foods, the agency considered, among other factors, the level of lead that could be in food without dietary exposure exceeding the FDA’s Interim Reference Level, a measure of the contribution of lead in food to blood lead levels.

Just as fruits, vegetables, and grain crops readily absorb vital nutrients from the environment, these foods also take up contaminants, like lead, that can be harmful to health. The presence of a contaminant, however, does not mean the food is unsafe to eat. The FDA evaluates the level of the contaminant in the food and exposure based on consumption to determine if the food is a potential health risk. Although it is not possible to remove these elements entirely from the food supply, we expect that the recommended action levels will cause manufacturers to implement agricultural and processing measures to lower lead levels in their food products below the proposed action levels, thus reducing the potentially harmful effects associated with dietary lead exposures.

Although not binding, the FDA would consider these action levels, in addition to other factors, when considering whether to bring an enforcement action in a particular case.

“The action levels in today’s draft guidance are not intended to direct consumers in making food choices. To support child growth and development, we recommend parents and caregivers feed children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy, and protein foods,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “This approach helps your children get important nutrients and may reduce potentially harmful effects from exposure to contaminants from foods that take up contaminants from the environment.”

As part of our approach, as laid out in 2021 when the FDA released Closer to Zero, the agency is committed to assessing if action levels should be lowered even further, based on evolving science on health impacts and mitigation techniques, and input from industry on achievability. We expect the draft action levels announced today, along with the draft action levels for lead in juice announced in 2022, will result in even lower levels of lead in the U.S. food supply.

Moving forward, the agency will continue to gather data and collaborate with federal partners to establish the scientific basis for establishing Interim Reference Levels for arsenic, cadmium and mercury.

Additionally, the FDA is considering the more than 1,100 comments it received in November 2021 during the “Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages for Babies and Young Children” public meeting to inform its strategy moving forward for future planned action on contaminants and fostering engagement, education, and sharing of public data and information.

The FDA will host a webinar to provide an overview of the draft guidance and answer stakeholder questions. More details on the webinar will be announced shortly.