In the Food and Drug Administration's first steps toward expanding its oversight over commercial baby food, the agency on Tuesday proposed new guidance for manufacturers on acceptable lead levels.
The FDA proposal covers processed baby and toddler foods in jars, pouches, tubs and boxes. The draft guidance would limit lead to a maximum of 10 parts per billion (ppb) for commercially produced fruits, vegetables, mixtures (both grain- and meat-based), yogurts, puddings and single-ingredient meats. The guidance is more lenient for single-ingredient root vegetable foods and for dry cereals, deeming 20 ppb acceptable.
One ppb is the equivalent of one drop in 500 barrels of water or 1 cent out of $10 million.
These levels would not be mandatory for food manufacturers, but they would allow the FDA to take enforcement action against companies exceeding the new limits.
With the proposed "action levels," the FDA aims to reduce exposures to lead from food while ensuring baby foods are still widely available and affordable. The action is part of Closer to Zero, the FDA's science-based plan to reduce exposure to lead, arsenic, cadmium and mercury to the lowest possible levels in foods eaten by babies and young children.
The multiyear plan was announced in 2021, a month after a congressional probe found high levels of heavy metals in baby food.
- How do heavy metals get in baby food?
Heavy metals such as arsenic, lead, cadmium and mercury can leach into fruits and vegetables from soil or water contaminated by pesticides, fertilizers and other sources. These contaminants may be the result of human activities and also occur naturally as elements in the Earth's crust. Levels in the air, water and soil used to grow crops, process foods and raise animals can vary depending on geographical differences and proximity to pollution. The amount of heavy metals in foods depends on the amount in the environment and how much the plant or animal absorbs. For instance, rice tends to readily absorb arsenic from soil, and root vegetables grown underground, such as sweet potatoes, can absorb more heavy metals.
They can also be introduced to baby foods as additives and mineral or vitamin mixes. The congressional report in 2021 found many of the products made by the country's largest commercial baby food manufacturers contain significant levels of toxic heavy metals.
- Can lead and other heavy metals hurt my child?
While pediatricians and nonprofits such as Healthy Babies Bright Futures say levels in individual baby foods do not pose a significant risk, protracted exposure over time can cause lasting neurodevelopmental disabilities in children.
Research shows exposure to even small amounts of heavy metals at an early age may increase the risk of several health problems, especially lower IQ and behavior problems, and has been linked to autism and attention-deficit/hyperactivity disorder.
- How much lead is safe?
Although the agency has set maximum allowable levels of metals such as lead in bottled water, it has not regulated levels of metals in baby and toddler foods until now, with the exception of arsenic in rice cereal, which the FDA set at 100 ppb in August 2020.
Lead is ranked as No. 2, behind arsenic, among naturally occurring substances that pose a significant risk to human health, according to the Department of Health and Human Services' Agency for Toxic Substances and Disease Registry.
- What are 'action levels' and how much will this new guidance decrease risk?
The FDA uses action levels to reduce chemical contaminants in foods when a certain level of a contaminant is unavoidable. The agency sets the level at which a food may be regarded as adulterated; if a product breaches that level, the FDA can take steps to remove it from the market or ask a company to voluntarily recall a product.
"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 to 27 percent reduction in exposure to lead from these foods," FDA Commissioner Robert M. Califf wrote in a statement Tuesday.
Many of the major baby food brands named in the congressional report came together in 2019 to form the Baby Food Council, aimed at reducing heavy metals in baby foods.
- When will this proposal take effect?
It will be finalized after a period for public comment, but there is no specific compliance date, according to the agency.
Final guidance levels don't have to be in place for the agency to take action if it deems contaminant levels to be unsafe. Industry experts say the mere prospect of FDA action can cause manufacturers to reformulate and more rigorously test products before selling them.
- How can parents minimize risk?
The draft guidance is not intended to shape consumers' food choices, according to Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition. "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," she said in a statement.
Many nutrition experts call it "eating the rainbow," suggesting that a single baby food with high levels of a heavy metal such as lead poses less of a threat to a baby who eats a broad array of foods. Some child nutrition experts also caution parents not to eschew commercial baby food entirely to make food from fruits and vegetables at home, because groceries' produce may still contain high levels of heavy metals. It's also hard to estimate calories and determine whether a baby has had sufficient nutrients in foods made at home.