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On January 24, 2023, the US Food and Drug Administration (FDA) issued draft guidance on action levels for lead in certain categories of processed foods intended for babies and children under two years of age.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• The draft guidance does not apply to raw agricultural commodities, homemade foods, infant formula, or any beverages, including toddler drinks.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The current draft guidance represents FDA’s most recent step in implementing its Closer to Zero action plan.¹ Following a staff report issued by Congress on February 4, 2021, which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.