FDA Reveals Draft Guidance for Lead in Baby Foods

Jan. 25, 2023
The first step in the agency’s “Closer to Zero” strategy sets limits on lead; will arsenic, cadmium and mercury come later?

The FDA on Jan. 24 revealed a draft guidance for action levels of lead in processed foods that are intended for babies and children under two years of age. It’s the first step in the agency’s announced “Closer to Zero” strategy.

The proposed limits are:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts. custards/puddings and single-ingredient meats.
  • 20 ppb for root vegetables (single ingredient).
  • 20 ppb for dry cereals.

“The FDA considers these action levels to be achievable when measures are taken to minimize the presence of lead and expects that industry will strive for continual reduction of this contaminant,” the agency wrote in its announcement. “The baby foods have differing action levels, to account for variances in consumption levels of different food products and due to some foods taking up higher amounts of lead from the environment.”

The FDA and other agencies have long been aware of the presence of heavy metals –including lead, arsenic, cadmium and mercury – in infant foods but took no action. The situation became notorious in 2021 when reports surfaced, including one from a congressional subcommittee, showing the high levels. Legislation was introduced to set limits, and at least five processors were hit with class-action lawsuits in several states.

“A Congressional report early in 2021 was pretty outspoken,” David Acheson, a former FDA associate commissioner for foods and founder and CEO of The Acheson Group, said in his consulting firm’s year-end webinar. “It garnered a lot of a lot of attention from social and mainstream media, but not a lot happened in 2021. But it definitely gained momentum."

The FDA announced Closer to Zero in April 2021. The agency promised to evaluate the science and propose “appropriate” levels for lead, cadmium, mercury and arsenic, in consultation with manufacturers, consumers and other stakeholders. Lead apparently is the first.

“But there are some big challenges and I think that was why cleverly FDA called this Closer to Zero and not [implying] we can zero out heavy metals, because we cannot do that,” Acheson continued.

"For more than 30 years, the FDA has been working to reduce exposure to lead and other environmental contaminants from foods,” FDA Commissioner Robert Califf said in the Jan. 24 announcement. “This work has resulted in a dramatic decline in lead exposure from foods since the mid-1980s.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.

"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,” he continued.

Foods covered by the draft guidance are those processed foods, such as food packaged in jars, pouches, tubs and boxes, and intended for babies and young children less than two years old.

These draft guidances usually are followed by a comment period before becoming final. The FDA is considering the more than 1,100 comments it received in November 2021 during the "Closer to Zero Action Plan” public meeting. Also, the FDA will host a webinar to explain the draft guidance and answer stakeholder questions. More details on the webinar will be announced shortly.

About the Author

Dave Fusaro | Editor in Chief

Dave Fusaro has served as editor in chief of Food Processing magazine since 2003. Dave has 30 years experience in food & beverage industry journalism and has won several national ASBPE writing awards for his Food Processing stories. Dave has been interviewed on CNN, quoted in national newspapers and he authored a 200-page market research report on the milk industry. Formerly an award-winning newspaper reporter who specialized in business writing, he holds a BA in journalism from Marquette University. Prior to joining Food Processing, Dave was Editor-In-Chief of Dairy Foods and was Managing Editor of Prepared Foods.

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