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In brief

On January 24, 2023, the US Food and Drug Administration (FDA) issued draft guidance on action levels for lead in certain categories of processed foods intended for babies and children under two years of age. These action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the the Federal Food, Drug & Cosmetic Act (FFDCA). FDA will consider these action levels when determining whether to bring an enforcement action so they are of particular interest to our clients.

  • FDA’s proposed action levels for lead in processed food intended for babies and young children are:
    1. 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
    2. 20 ppb for root vegetables (single ingredient)
    3. 20 ppb for dry infant cereals
  • The draft guidance does not apply to raw agricultural commodities, homemade foods, infant formula, or any beverages, including toddler drinks.

In more detail

The current draft guidance represents FDA’s most recent step in implementing its Closer to Zero action plan.1 Following a staff report issued by Congress on February 4, 2021, which summarized the results of investigations relating to heavy metals in baby foods, FDA initiated the Closer to Zero action plan to help reduce as much as possible exposure to toxic elements, including lead, from foods eaten by babies and young children. Under the plan, FDA will propose action levels for arsenic, lead, cadmium, and mercury in foods commonly eaten by babies and young children.

Because lead may be present in environments where crops are grown, various foods may unavoidably contain lead. To evaluate the potential for adverse effects of dietary lead, FDA developed interim reference levels (IRL) for dietary lead of 2.2 μg/day for children.  In developing the action levels, FDA ensured that dietary exposure from the identified foods does not cause consumers to exceed 2.2 µg/day.

FDA also took the achievability (manufacturers’ ability to achieve the action levels for lead) into consideration in establishing the action levels.  Based on FDA’s estimate, the percentage of samples in each food category that fell at or below the proposed action levels are: 96% for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats, at 10 ppb; 88% for root vegetables, at 20 ppb; and 90% for dry infant cereals, at 20 ppb. 

Key takeaways

  • FDA will consider action levels when determining whether to bring enforcement actions relating to food products intended for babies and young children.
  • FDA has consulted with the United States Department of Agriculture Food Safety Inspection Service, which supports the FDA action levels for single-ingredient meats and mixtures that include meats as an ingredient intended for babies or young children.
  • There have been a number of class action lawsuits filed around the country relating  to heavy metals in foods. The action levels have the potential to significantly impact ongoing or future litigation.
  • FDA is accepting comments for the draft guidance until March 27, 2023.  

Thank you to Alexa Blackmon for her contributions to the article. For further information and to discuss what this development might mean for you, please reach out to the Baker McKenzie contacts provided above.

1 Also as part of the Closer to Zero action plan, in April 2022, FDA announced another draft guidance on action levels for lead in juice.


Mark Goodman is a partner in the Firm's San Francisco office who serves as co-Chair of the firm’s North America Commercial Litigation group and is part of the North America Trial Team. Mark has led complex multidistrict litigation, handled class actions and tried cases in state and federal courts across the US for both domestic and international clients. Mark regularly presents on product liability, risk mitigation and cross-border disputes. Listed in Who's Who in American Law and a Fellow of the American Bar Association, Mark has been regularly recognized as a Northern California Super Lawyer, a member of the Legal 500 and as a member of the International Who's Who of Professionals.


Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and currently heads our US Food and Drug Law Practice. A former research biochemist, Xin brings a deep understanding of the complex scientific issues that relate to the US FDA's legal and regulatory requirements, enabling him to help clients with all phases of product development, manufacturing, and marketing. As the science and technology continues to evolve, Xin supports our clients to constantly innovate and push the boundaries of what's possible in the world of life science. Xin is a frequent speaker and writer on US FDA legal developments related to emerging technology, and he has been selected to serve on the 2023 Law360 Life Sciences Editorial Advisory Board.


Genevieve M. Razick is an associate in the Litigation and Government Enforcement Practice Group in the Washington, DC office. Genevieve practices in the area of US Food and Drug Administration and healthcare regulatory and compliance law.

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