Voluntary caps on lead levels in packaged baby food outlined by FDA in final guidance published yesterday are realistically achievable and a positive step forward, according to the agency and some industry stakeholders, but others argue the limits are too little, too late.
In a final guidance published Jan. 6, FDA said it sought to balance clinical research that suggests “no safe level of lead exposure has been identified for protecting children’s health” with the reality that “lead is widely present in the environment due to both its natural occurrence and to human activities.”
It explained that while manufacturers may be able to reduce lead levels in food through best practices, such as thoroughly peeling root vegetables and ensuring their equipment does not contribute to lead in products, it also recognized that “various foods may contain small amounts of lead” because it is present in the environment where food crops are grown.
Based on this reality, FDA affirmed previously proposed levels for lead in select packaged food for children younger than 2 years, including:
- 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats;
- 20 ppb for single-ingredient root vegetables; and
- 20 ppb for dry infant cereals.
While these caps are non-binding, FDA indicated products that exceed these levels may be considered adulterated and subject to enforcement.
Levels are ‘achievable’ – but are they still too high?
Based on data analysis, including the collection and testing of 689 samples of processed food for children under 2 years, FDA determined most available products should easily fall under the suggested lead caps when companies follow best practices.
Specifically, one study suggested 90% of all processed food samples had lead levels lower than 10 ppb, while another suggested 94% fell under the cap, according to the guidance.
As such, FDA argues the caps should be ‘achievable,’ and based on previous analysis reduce exposure risk upwards of 27%.
But according to some stakeholders ‘achievable’ is too low of a bar, and in affirming these caps the agency is not doing enough to reduce the risk the lead contamination in baby food.
“FDA’s actions today are a step forward and will help protect children. However, the agency took too long to act and ignored important public input that could have strengthened these standards,” Thomas Galligan, principal scientist for additives and supplements at the Center for Science in the Public Interest, said in a statement last night.
He explained, “When FDA issued its draft action levels two years ago, CSPI urged the agency to revise its approach to better ground its lead levels in public health protection, rather than setting levels that most industry could meet.
“The levels finalized today are unchanged from those proposed two years ago, and FDA seemingly did not revise its approach, leading us to question whether FDA has done enough to maximize protections for children.”
Consumer environmental attorney Vineet Dubey, a partner at the Los Angeles’ Custodio & Dubey firm who has sued several baby food manufacturers for alleged high levels of lead in the products, agrees that the caps set by FDA are “not as low as I would like to see,” but he added they are “still a great step in protecting babies across the country.”
He added the levels set by FDA also reflect the “reality of the marketplace and the reality of contaminated soil worldwide that vegetables and cereals are grown in.”
At the same time, they give “FDA some power to oversee that baby foods are made safer.”
States could set more stringent heavy metal regulations
Unsatisfied with FDA’s voluntary caps, CSPI’s Galligan urges state legislators to “step in” and establish more stringent standards – a practice that is gaining traction in states such as California, which beginning in 2027 will ban within its boundaries the sale of products with several food additives deemed safe by FDA and prohibit in schools foods with select synthetic dyes.
California and Maryland already have passed laws requiring manufacturers to baby food for heavy metals and disclose their results. California’s AB899 – the Baby Food Safety Act – went into effect this month and requires brands to provide monthly test results accessible via on-label QR codes.
“These laws help to fill the gaps in federal laws and regulations that have allowed heavy metal-containing products on store shelves for too long,” said Galligan, who for support pointed to the recent lead poisoning outbreak from applesauce pouches.
State actions also could spur additional FDA action, suggested Dubey, who noted, “it could be the FDA is following California in regulating lead in baby food.”
This is not the first time FDA actions followed state actions – when FDA proposed in November 2023 banning brominated vegetable oil in food, it acknowledged California’s legislative efforts to ban several food ingredients, including BVO, in the state.
Likewise, FDA is reviewing Red Dye No. 3 – an effort it undertook when California banned it.
Next steps for FDA
In addition to establishing voluntary lead caps in packaged food for children under 2 years, FDA is exploring how to limit lead and other heavy metals in products commonly consumed by children through its Closer to Zero initiative launched in 2021.
In April 2022, the agency proposed draft guidance capping lead levels in juice and in June 2023 it finalized guidance capping inorganic arsenic to 10 ppb in apple juice.
FDA reiterated yesterday that it is continuing to collect data on grain-based snacks for children, such as teething products and puffs, to establish action levels for heavy metals.
With the finalization of the guidance for lead levels in packaged food for children under 2 years, the FDA could follow through on earlier suggestions that it could seek disciplinary action against manufacturers for lead and other contaminants.
