FDA Draft Guidance for Lead In Baby Food

On January 24, 2023 FDA released draft guidance for Action Levels for Lead in Food Intended for Babies and Young Children. There are a few important details for IFPA member to note from this draft guidance: 

• This draft guidance defines action levels for processed foods “purported to be specifically for babies and young children less than two years old.” 
• Fruit and vegetable products, both mixed and single ingredient, are included in the draft action levels, but they do not apply to raw agricultural commodities or homemade foods.
• Single-ingredient root vegetable products are singled out as having higher lead levels than other vegetables, based on FDA sampling data from 2008-2021, thus they have their own action level defined.
• FDA recommends that baby food manufacturers consider increased testing of ingredients or finished products that are historically known to contain elevated lead levels
• FDA will host a webinar to provide an overview of the draft guidance and answer stakeholder questions; IFPA’s food safety team will share details on that webinar as soon as they are available.

As a reminder, although action levels are established through guidance documents (which represent FDA’s current thinking on a topic and do not establish legally enforceable responsibilities), FDA may (and does) use these action levels to define a level of contamination at which a food may be regarded as adulterated according to the FD&C Act.

To learn more about FDA’s draft guidance on Action Levels for Lead in Food Intended for Babies and Young Children and to download the guidance yourself, you can visit FDA’s webpage. You can also read more about FDA’s Closer to Zero Action Plan for Baby Foods here.

Dr. Emily Griep Moyer will be leading comments on behalf of IFPA. If you would like to be involved in the process of drafting comments or if you have any related questions, you can reach out to Emily at any time.