FDA to set action levels for contaminants in ‘key foods,’ in wake of baby food heavy metals report

By Elaine Watson contact

- Last updated on GMT

FDA 'does not recommend throwing out packaged foods for babies and young children' (Picture: GettyImages-monkeybusinessimages)
FDA 'does not recommend throwing out packaged foods for babies and young children' (Picture: GettyImages-monkeybusinessimages)

Related tags: Baby food, baby food lawsuits, heavy metals

Under pressure to act in the wake of the recent congressional report into heavy metals in baby food, the FDA says it will issue "guidance to identify action levels for contaminants in key foods," as lawsuits against baby food brands pile up, although it has not provided a likely timetable.

Since the Congressional Subcommittee report​​​ was published on February 4, Gerber, Beech Nut Nutrition, Campbell Soup (Plum Organics), Nurture Inc (Happy Family Organics) and Hain Celestial (Earth’s Best) have all been hit with lawsuits​​ ​​alleging consumer fraud, while New York attorney general Letitia James has written​​​ to the FDA urging it to set limits for toxic metals across all baby foods.   

To date, the FDA has set maximum allowable levels in bottled water at 10 ppb inorganic arsenic, 5 ppb lead, and 5 ppb cadmium, while the EPA has capped the allowable level of mercury in drinking water at 2 ppb.

The FDA has also set limits on lead in juice​​​ ​​​[50ppb lead], and candy ​​​​[0.1ppm lead], and has set a 100ppb limit on inorganic arsenic in infant rice cereals​​.​​ and proposed a 10ppb limit on inorganic arsenic in apple juice​. There are as yet no federally mandated upper limits for lead, mercury and cadmium in baby foods, however.

FDA: 'We are looking at foods specifically manufactured for babies and toddlers'

Asked about which 'key foods' the FDA is looking at specifically as part of its action plan, a spokesperson told FoodNavigator-USA: 

"We are looking at foods specifically manufactured for babies and toddlers (i.e. baby food) and also at foods that are commonly eaten by babies and toddlers that may also be a source of exposure to toxic elements in the environment.  Our action levels for foods will be health-protective and may take into consideration a number of factors, such as the levels of toxic elements found in these foods, through FDA sampling and other data, expected exposure based on eating patterns, and the feasibility of meeting identified action levels."

In the meantime, the spokesperson added: "We are actively working on finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.  The plan is still being developed, and will include more detailed information regarding our plans. We intend for the plan to address our process for proposing and finalizing action levels for various toxic elements for many foods consumed by babies and toddlers.  We intend to finalize our guidance on inorganic arsenic in apple juice within the next few months." 

FDA to parents: Don't ditch packaged baby food

In a statement​​​ released Friday, the FDA explained that heavy metals such as lead and arsenic are in "our air, water and soil, and therefore are unavoidable in the general food supply” ​and that it “does not recommend throwing out packaged foods for babies and young children ​​[an important point as some consumers have responded to the recent headlines by assuming making their own baby food is safer].”

While baby food brands already have a responsibility under the Food Safety Modernization Act (FSMA​) to implement controls to minimize or prevent hazards such as certain contaminants - something the FDA spelled out in a letter to baby & toddler food manufacturers this week​ - the FDA says it will “soon be putting into action a plan aimed at reducing toxic elements in foods for babies and young children to levels as low as is reasonably achievable.”

As part of that plan, it will:

  • Issue guidance to identify action levels for contaminants in key foods (see comments above), with plans to revisit those levels on a regular basis and lower them if appropriate, as well as providing guidance to industry on how to meet their obligations under current regulations;
  • Finalize draft guidance​ on reducing inorganic arsenic in apple juice and publish a draft guidance that will establish action levels for lead in juices;
  • Increase inspections and, as appropriate, taking compliance and enforcement actions;
  • Boost sampling of foods for babies and young children;
  • Work with government, academia and industry to support R&D of additional safety information on toxic elements in foods for babies and young children and additional steps that industry can take to further reduce levels;
  • Hold a public workshop to discuss the science surrounding levels of exposure that result in developmental impacts, and the foods that may contribute to those exposures;

Reiterating comments made to reporters when the report first came out​​​, the FDA explained that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study​​​, the compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food​​​ and through​ targeted sampling assignments​.

For example, FDA sampling of infant rice cereal since 2011 has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products (for which the FDA has set an upper limit of 100ppb in recent guidance​​​) through selective sourcing and testing of rice and rice-derived ingredients such as rice flour, noted the agency.

“We want to reassure parents and caregivers that at the levels we have found through our testing​, children are not at an immediate health risk from exposure to toxic elements in foods. The FDA routinely monitors levels of toxic elements in food, and if we find that they pose a health risk, the FDA takes steps to remove those foods from the market.”

However, it has not said whether it agrees with the characterization of the levels of heavy metals allegedly in some of the baby foods cited in the congressional report​​​ as “highly dangerous​,​” and has not said what levels of mercury, lead, or cadmium it considers to be too high in baby food, presenting challenges for firms facing lawsuits as there is no federal 'safe harbor' level to point to that is specific to baby food (with the exception of 2020 guidance on inorganic arsenic in infant rice cereal, set at 100ppb).

Further reading:​​

Click HERE​ ​to download a report into methods food and beverage companies can use to detect and reduce heavy metal contaminants in their ingredients from PreScouter.

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