FDA issues letter to baby and toddler food manufacturers on chemical hazards

On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. [1] 

In the letter, the FDA reminds the industry of their existing responsibility to consider risks from chemical hazards, including heavy metals (e.g., lead and arsenic), when conducting a hazard analysis for products for babies and young children. Notably, the FDA letter follows a Staff Report released on 4 February 2021 by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that raises questions on what more can be done to reduce heavy metal levels in baby food. 2

In addition to the ongoing surveillance sampling assignment targeting these products, the FDA is also finalizing a comprehensive plan to further reduce levels of toxic elements in foods for babies and young children. 3

In the near term, the FDA is committed to:

  • Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
  • Engaging in focused compliance and enforcement activities, including inspections.
  • Providing guidance to industry on how to meet their obligations under current regulations.

Next steps   

We will continue to monitor the legal and regulatory developments related to chemical hazards in baby and toddler food. If you have any questions in the meantime, please do not hesitate to contact us.


Authored by Joseph Levitt, Maile Hermida, Xin Tao and Sam Dietle


[1]  21 CFR Part 117.   
[2] Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury, Staff Report, Subcommittee on Economic and Consumer Policy, U.S. House of Representatives,  4 Feb. 2021.
[3] FDA Constituent Update, FDA Letter to Industry on Chemical Hazards, including Toxic Elements, in Food and Update on FDA Efforts to Increase the Safety of Foods for Babies and Young Children, 5 Mar. 2021.  
Joseph Levitt
Senior Counsel
Washington, D.C.
Maile Gradison Hermida
Washington, D.C.
Xin Tao
Senior Associate
Washington, D.C.
Samantha Dietle
Senior Associate
Washington, D.C.


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