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New FDA guidelines call for the reduction—but not elimination—of lead in baby formula

The Food and Drug Administration on Tuesday released draft guidelines listing the maximum amount of lead that can be found in baby formula products and is part of the organization’s “Closer to Zero” initiative aimed at reducing children’s exposure to reduce harmful contaminants in food.

“The proposed exposure levels would result in a significant reduction in exposure to lead from food while ensuring the availability of nutritious food,” the FDA said Twitter.

Prolonged exposure to lead can result in “learning disabilities, behavioral difficulties, and decreased IQ” as well as “immunological, cardiovascular, renal and reproductive and/or developmental effects,” the FDA said in the report, while stating that lead is “widespread.” in the environment, both naturally and partly due to human activities.

“Because lead may be present in environments where food crops used to manufacture foods for babies and young children are grown, various foods may contain small amounts of lead,” the FDA said. “Potential sources of lead in food include contaminated soil where crops are grown, contaminated water, atmospheric debris from industrial activities, and old lead-containing equipment used in food processing.”

According to the American Academy of Pediatrics, there is no truly safe concentration of lead.

“Today’s announcement of stricter standards for toxic metals in baby formula is an important step forward by the FDA,” Scott Faber, senior vice president of government affairs at the nonprofit Environmental Working Group, said in a statement.

The new guidance – which is not binding on food manufacturers – outlines the following levels as acceptable in baby formula for children under the age of two:

  • 10 parts per billion or ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixes (including grain- and meat-based mixes), yogurts, puddings/puddings and single-ingredient meats;
  • 20 ppb for root vegetables (single ingredient); and
  • 20 ppb for dry infant cereal.

“The purpose of this guidance is to provide industry information on exposure action levels for lead in foods intended for babies and young children,” the FDA said in the guidance.

“…our Closer to Zero action plan outlines additional actions we will take to further reduce lead (as well as other toxic elements) in food, and we expect the industry to strive for continued reductions over time will.”

The plan does not list any new policies or mitigation plans other toxic chemicals found in baby formulasuch as cadmium, arsenic or mercury.

“The exposure action levels released today for lead, the first toxic heavy metal the agency is addressing, are insufficient to protect the next generation of babies from harmful heavy metals in their diet,” said a statement from advocacy group Healthy Babies Bright futures

The group also noted that the FDA’s new rules don’t apply to teething cookies, which their studies say account for seven of the top 10 levels of lead in the more than 1,000 food tests the organization conducts.

Grocery shopping of young mother
Grocery shopping of young mother

d3sign / Getty Images


“These proposed action limits are insufficient to bring us any closer to zero,” said Charlotte Brody, the organization’s national director.

“The exposure action levels released today by the FDA largely put a stamp on the status quo – meaning that current lead levels in baby formula are ‘close enough’. Why has the FDA’s Closer to Zero program spent years creating guidance proposals that aren’t enough to make baby formula safer?

Jane Houlihan, the group’s director of research, told CBS News, “As it stands, the FDA is choosing round numbers that it believes the industry can easily meet. But there are many actions companies can take at lower levels, from testing to selecting fields with lower soil lead levels, adjusting soil amendments and selecting crop varieties that accumulate less lead.”

“We’ve seen with infant rice flakes and apple juice (two foods with pre-existing arsenic and/or lead limits) that the industry can significantly reduce the levels of these toxic metals in their products when the FDA issues action limits,” Houlihan said.

According to an analysis commissioned by the group, children under the age of two in the US lose over 11 million IQ points from exposure to heavy metals in food.

Last year, This was the result of an HBBF study 94% of manufactured baby formula, family formula and homemade purées made from store-bought raw foods contained detectable levels of one or more heavy metals – lead, arsenic, mercury and cadmium.

Lead has also been found in 90% of manufactured baby formula, 80% of store-bought family formula, and homemade purees.




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