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FDA sets new lead level guidelines for baby foods

baby food
Thomas Barwick/Digital Vision/Getty Images via CNN Newsource
baby food
SOURCE: Thomas Barwick/Digital Vision/Getty Images via CNN Newsource
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FDA sets new lead level guidelines for baby foods
For the first time in history, the U.S. Food and Drug Administration has established guidance for levels of lead in processed baby foods that are sold on supermarket shelves and online. The agency鈥檚 action, announced Monday, only provides guidance to industry and is not enforceable.Under the new guidelines, baby food manufacturers should have no more than 10 parts per billion of lead in baby yogurts, custards, puddings, single-ingredient meats, processed fruits and vegetables, and mixtures of fruits, vegetables, grains and meat.鈥淭his includes foods in jars, pouches, tubs or boxes and may include ready-to-eat foods such as purees, as well as semi-prepared foods such as dry infant cereals,鈥� the FDA said in a statement.However, root vegetables such as carrots and sweet potatoes 鈥� which typically contain the highest levels of lead from the soil 鈥� and dry infant cereals should contain no more than 20 parts per billion of lead, the FDA announced.鈥淭he guidance does not cover infant formula, beverages, or snack foods like puffs and teething biscuits,鈥� the federal agency said.No level of lead is safe for infants and toddlers, according to the U.S. Centers for Disease and Prevention, the World Health Organization and the American Academy of Pediatrics.Parent should not throw away existing baby foods they have purchased or stop feeding young children a variety of foods, the FDA said.鈥淓ating a variety of healthy foods can make it less likely for an individual to be exposed to the same contaminant from the same food many times and helps to provide the range of nutrients needed for health and, for children, healthy development. Having adequate nutrients stored in the body also can help to prevent lead from having harmful effects,鈥� the agency said.鈥淭o get adequate food variety, the FDA recommends that parents and caregivers feed their children many different foods from the five food groups 鈥� vegetables, fruits, grains, dairy, and protein foods 鈥� and alternate how often they provide the same food.鈥滸erber, which is owned by Nestl茅 SA and controls much of the U.S. baby food market, told CNN that it has always worked closely with FDA regulators to reduce the levels of heavy metals in infants and young children.鈥淎ll of our baby foods meet FDA limits for heavy metals, and we expect that will hold true for the new guidance,鈥� Dana Stambaugh, director of external communications for Nestl茅 U.S., said in an email. 鈥淯ltimately, our promise is to provide nutritious and safe food for babies.鈥滷DA鈥檚 actions are too little, too lateOrganizations that prioritize children鈥檚 welfare were quick to react.鈥淣early all baby foods on the market already comply with these limits, making the new standards largely ineffective,鈥� said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies鈥� exposures to neurotoxic chemicals.Healthy Babies Bright Futures published a report in 2019 that found toxic metals in 95% of baby foods randomly pulled off supermarket shelves. The report sparked a congressional investigation that discovered some baby food ingredients contain hundreds of parts per billion of dangerous metals, according to internal documents provided by major baby food manufacturers.The baby food aisle accounts for only a fraction of children and toddler鈥檚 exposure to food sources of lead, Houlihan said, pointing to an analysis that Healthy Babies Bright Futures provided the FDA during public comments.鈥淟ead in infant formula, homemade baby food ingredients and foods bought outside the baby food aisle account for about three-fourths of children鈥檚 food exposures to lead,鈥� Houlihan said in an email. 鈥淎s it stands, the new lead limits for commercial baby foods would reduce children鈥檚 total dietary lead exposure by less than 4% 鈥� a negligible improvement.鈥漌hile applauding the FDA for acting on lead, it鈥檚 too little, too late, said Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit consumer advocacy organization.鈥淔or years, the FDA鈥檚 own data has shown dangerous levels of lead in baby food, yet the agency has dragged its feet while children鈥檚 developing brains were exposed to this neurotoxin,鈥� Faber said in an email.鈥淭he harm is permanent, and the delay has put countless kids at unnecessary risk,鈥� he added. 鈥淭he FDA owes parents answers and must enforce these limits immediately to finally protect our most vulnerable population.鈥滳NN reached out to the FDA for response but did not hear back before publication.The dangers of leadAs part of the volcanic process that created much of the continents, lead and other heavy metals occur naturally in Earth鈥檚 crust. However, manufacturing plants, mining facilities and smelting processes also add heavy metals to the environment as frequent by-products.Chips from lead-based paint, which was federally banned in 1978, and automobile exhaust fumes from leaded gasoline, which wasn鈥檛 banned until 1996, have also polluted soil and water in the U.S.It鈥檚 not just children who are at risk: There is no level of lead that鈥檚 safe for humans of any age, according to the U.S. Environmental Protection Agency. Lead bioaccumulates in the body over time and is a 鈥渢oxic metal鈥� that can be harmful even at low exposure levels, the agency said.However, experts say children are especially hard-hit due to their small size and rapidly developing brains.鈥淎 dose of lead that would have little effect on an adult can have a significant effect on a child. In children, low levels of exposure have been linked to damage to the central and peripheral nervous system, learning disabilities, shorter stature, impaired hearing, and impaired formation and function of blood cells,鈥� the EPA states on its website.The WHO considers lead one of the 10 chemicals of concern in the world. An October 2023 study published in the journal Lancet found children younger than 5 years lost 765 million IQ points in 2019 due to lead exposure worldwide. In the same year, more than 5.5 million adults died from cardiovascular disease due to lead exposure.鈥淓xposure to very high levels of lead can severely damage the brain and central nervous system, causing coma, convulsions and even death. Children who survive severe lead poisoning may be left with permanent intellectual disability and behavioural disorders,鈥� the WHO said on its website.Getting 鈥楥loser to Zero鈥橳he FDA first proposed the new lead levels in 2023 as part of its Closer to Zero initiative, which the agency says strives to lower the levels of arsenic, lead, cadmium and mercury in baby foods. In 2021, the agency acted to lower limits of arsenic in infant rice cereals, a major route of exposure, according to experts.However, that action was also judged as inadequate to protect children.鈥淭he FDA should set protective targets for reducing exposure to heavy metals with a goal of having no measurable levels in children鈥檚 food,鈥� Michael Hansen, senior scientist for Consumer Reports, which has studied levels of arsenic and other toxic metals in baby food, said at the time.Juice is another major exposure route of heavy metals in children. In 2022, the FDA proposed lowering the limits of lead in juices from 50 parts per billion to 10 parts per billion in apple juice and 20 parts per billion for all other juices. However, that draft guidance has never been finalized.鈥淭he FDA is not living up to its responsibility to protect children鈥檚 health,鈥� Houlihan said. 鈥淎s a result, infants and young children will continue to bear the burden of the FDA鈥檚 lack of resolve, consuming harmful lead with every meal.鈥漈he FDA has also not taken any action on levels of other heavy metals, such as cadmium, although that may change, Houlihan said. In September, the agency released an analysis that found 鈥渕ore than half of all children ages 1 to 6 exceed a safe daily dose for cadmium in food,鈥� she said.According to that report, the main sources of exposure for children are grains, baked goods, fruits and vegetables. Processed baby foods contribute a tiny amount (0.5%) for that age group, Houlihan added.

For the first time in history, the U.S. Food and Drug Administration has established guidance for levels of lead in processed baby foods that are sold on supermarket shelves and online. The agency鈥檚 action, announced Monday, only provides guidance to industry and is not enforceable.

Under the new guidelines, baby food manufacturers should have no more than 10 parts per billion of lead in baby yogurts, custards, puddings, single-ingredient meats, processed fruits and vegetables, and mixtures of fruits, vegetables, grains and meat.

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鈥淭his includes foods in jars, pouches, tubs or boxes and may include ready-to-eat foods such as purees, as well as semi-prepared foods such as dry infant cereals,鈥� the FDA said in a statement.

However, root vegetables such as carrots and sweet potatoes 鈥� which typically contain the highest levels of lead from the soil 鈥� and dry infant cereals should contain no more than 20 parts per billion of lead, the FDA announced.

鈥淭he guidance does not cover infant formula, beverages, or snack foods like puffs and teething biscuits,鈥� the federal agency said.

No level of lead is safe for infants and toddlers, according to the , the and the .

Parent should not throw away existing baby foods they have purchased or stop feeding young children a variety of foods, the FDA said.

鈥淓ating a variety of healthy foods can make it less likely for an individual to be exposed to the same contaminant from the same food many times and helps to provide the range of nutrients needed for health and, for children, healthy development. Having adequate nutrients stored in the body also can help to prevent lead from having harmful effects,鈥� the agency said.

鈥淭o get adequate food variety, the FDA recommends that parents and caregivers feed their children many different foods from the five food groups 鈥� vegetables, fruits, grains, dairy, and protein foods 鈥� and alternate how often they provide the same food.鈥�

Gerber, which is owned by Nestl茅 SA and controls much of the U.S. baby food market, told CNN that it has always worked closely with FDA regulators to reduce the levels of heavy metals in infants and young children.

鈥淎ll of our baby foods meet FDA limits for heavy metals, and we expect that will hold true for the new guidance,鈥� Dana Stambaugh, director of external communications for Nestl茅 U.S., said in an email. 鈥淯ltimately, our promise is to provide nutritious and safe food for babies.鈥�

FDA鈥檚 actions are too little, too late

Organizations that prioritize children鈥檚 welfare were quick to react.

鈥淣early all baby foods on the market already comply with these limits, making the new standards largely ineffective,鈥� said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies鈥� exposures to neurotoxic chemicals.

Healthy Babies Bright Futures published a report in 2019 that found toxic metals in 95% of baby foods randomly pulled off supermarket shelves. The report sparked a congressional investigation that discovered some baby food ingredients contain hundreds of parts per billion of dangerous metals, according to internal documents provided by major baby food manufacturers.

The baby food aisle accounts for only a fraction of children and toddler鈥檚 exposure to food sources of lead, Houlihan said, pointing to an analysis that Healthy Babies Bright Futures provided the FDA during public comments.

鈥淟ead in infant formula, homemade baby food ingredients and foods bought outside the baby food aisle account for about three-fourths of children鈥檚 food exposures to lead,鈥� Houlihan said in an email. 鈥淎s it stands, the new lead limits for commercial baby foods would reduce children鈥檚 total dietary lead exposure by less than 4% 鈥� a negligible improvement.鈥�

While applauding the FDA for acting on lead, it鈥檚 too little, too late, said Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit consumer advocacy organization.

鈥淔or years, the FDA鈥檚 own data has shown dangerous levels of lead in baby food, yet the agency has dragged its feet while children鈥檚 developing brains were exposed to this neurotoxin,鈥� Faber said in an email.

鈥淭he harm is permanent, and the delay has put countless kids at unnecessary risk,鈥� he added. 鈥淭he FDA owes parents answers and must enforce these limits immediately to finally protect our most vulnerable population.鈥�

CNN reached out to the FDA for response but did not hear back before publication.

The dangers of lead

As part of the that created much of the continents, lead and other heavy metals occur naturally in Earth鈥檚 crust. However, manufacturing plants, mining facilities and smelting processes also add heavy metals to the environment as frequent .

Chips from lead-based paint, which was , and automobile exhaust fumes from leaded gasoline, which wasn鈥檛 , have also in the U.S.

It鈥檚 not just children who are at risk: There is no level of lead that鈥檚 safe for humans of any age, according to the . Lead bioaccumulates in the body over time and is a 鈥渢oxic metal鈥� that can be harmful even at low exposure levels, the agency said.

However, experts say children are especially hard-hit due to their small size and rapidly developing brains.

鈥淎 dose of lead that would have little effect on an adult can have a significant effect on a child. In children, low levels of exposure have been linked to damage to the central and peripheral nervous system, learning disabilities, shorter stature, impaired hearing, and impaired formation and function of blood cells,鈥� the EPA .

The WHO considers lead one of the in the world. An published in the journal Lancet found children younger than 5 years lost 765 million IQ points in 2019 due to lead exposure worldwide. In the same year, more than 5.5 million adults died from cardiovascular disease due to lead exposure.

鈥淓xposure to very high levels of lead can severely damage the brain and central nervous system, causing coma, convulsions and even death. Children who survive severe lead poisoning may be left with permanent intellectual disability and behavioural disorders,鈥� the WHO said on its website.

Getting 鈥楥loser to Zero鈥�

The FDA first proposed the as part of its , which the agency says strives to lower the levels of arsenic, lead, cadmium and mercury in baby foods. In 2021, the agency acted to lower limits of arsenic in infant rice cereals, a major route of exposure, according to experts.

However, that action was also judged as inadequate to protect children.

鈥淭he FDA should set protective targets for reducing exposure to heavy metals with a goal of having no measurable levels in children鈥檚 food,鈥� Michael Hansen, senior scientist for Consumer Reports, which has studied levels of arsenic and other toxic metals in baby food, said at the time.

Juice is another major exposure route of heavy metals in children. In 2022, the FDA proposed lowering the limits of lead in juices from 50 parts per billion to 10 parts per billion in apple juice and 20 parts per billion for all other juices. However, that draft guidance has never been finalized.

鈥淭he FDA is not living up to its responsibility to protect children鈥檚 health,鈥� Houlihan said. 鈥淎s a result, infants and young children will continue to bear the burden of the FDA鈥檚 lack of resolve, consuming harmful lead with every meal.鈥�

The FDA has also not taken any action on levels of other heavy metals, such as cadmium, although that may change, Houlihan said. In , the agency released an analysis that found 鈥渕ore than half of all children ages 1 to 6 exceed a safe daily dose for cadmium in food,鈥� she said.

According to that report, the main sources of exposure for children are grains, baked goods, fruits and vegetables. Processed baby foods contribute a tiny amount (0.5%) for that age group, Houlihan added.