The draft guidance would act as guidelines for manufacturers to reduce children’s exposure to harmful heavy metals like lead. It comes two years after a government report that alleged “dangerously high levels” of heavy metals in baby food products.

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That report resulted in class action lawsuits against major US baby food manufacturers and calls for further regulation in the industry. The FDA responded with this new guidance, which is a part of the agency’s “closer to zero” initiative of continually reducing exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible in foods.

“The proposed action levels announced today, along with our continued work with our state and federal partners, and with industry and growers to identify mitigation strategies, will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods,” said FDA commissioner Robert M. Califf.

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods.”

Determining risk in heavy metal levels

If finalised, the maximum amount of lead in processed food intended for babies and young children would be limited to 10 parts per billion for fruits, vegetables, mixtures, yoghourts, custards, puddings, and single-ingredient meats, 20 parts per billion for root vegetables, and 20 parts per billion for dry cereals.

The FDA explained that the fruits, vegetables, and grain crops that are used to make baby food can absorb contaminants like lead from the environment. But that does not necessarily make foods unhealthy to eat, and the FDA takes more factors into consideration when evaluating whether a food is a 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 potential harmful effects associated with dietary lead exposures,” the FDA said in its press release.

The FDA is accepting public comments on the new draft guidance until 27 March, 2023.

“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,” the FDA said.

Is ‘closer to zero’ close enough?

Some say this guidance from the FDA still falls short of expectations, however, such as the Center for Science in the Public Interest (CSPI), a non-profit group that advocates for safer and healthier foods.

“CSPI is glad to see FDA making progress in its efforts to reduce lead contamination in foods consumed by young children,” Thomas Galligan, CSPI’s principal scientist on chemicals, said in an emailed statement to IngredientsNetwork.

“However, [CSPI] is disappointed by the approach taken in developing these draft action levels. FDA again is basing action levels on industry feasibility—which itself is based on current levels of lead in the market, not what level might be possible if industry made a concerted effort to limit lead contamination in baby food.”

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“Protecting public health, not industry achievability, should be the foundation of action levels for toxic heavy metals in childrens foods. CSPI will submit comments urging FDA to prioritise children over achievability,” Galligan said.

In 2022, the FDA similarly released guidance for lead levels in juice products, and CSPI criticised the FDA for “taking an inadequately protective approach to setting action levels for lead in juice in the action plan”.

“The proposed guidance does not go far enough to protect children from dangerous levels of lead exposure,” CSPI said in its comments.

“Infants and young children are especially susceptible to the neurotoxic effects of heavy metals because their brains are still developing and because they absorb lead at higher rates than adults. There is no safe level of lead exposure for children.”