FDA issues final guidance for lead action levels in baby food

US and international authorities all agree that there is no safe level of lead exposure for children. Yet, before today, there were no finalized federal limits on lead in children's foods and industry was left to self-regulate. The recent lead poisoning outbreak from applesauce pouches, combined with earlier Congressional investigations showing the baby food industry's failure to limit contamination through self-regulation, emphasize the urgent need for FDA to set and enforce limits on lead and other toxic heavy metals in foods consumed by infants and young children.

As such, FDA's actions today are a step forward and will help protect children. However, the agency took too long to act and ignored important public input that could have strengthened these standards. When FDA issued its draft action levels two years ago, CSPI urged the agency to revise its approach to better ground its lead limits in public health protection, rather than setting levels that most of industry could meet. The levels finalized today are unchanged from those proposed two years ago, and FDA seemingly did not revise its approach, leading us to question whether FDA has done enough to maximize protections for children.

Importantly, the action levels finalized today are not binding limits but rather are non-binding recommendations to industry. We hope that even voluntary levels will motivate industry to change its practices to protect kids.

We hope that FDA, with Congress's help, will act more quickly and decisively as it continues its work on the Closer to Zero program. CSPI further encourages states to step in, following the lead of California and Maryland, which have both passed laws requiring manufacturers to test baby food products for heavy metals and disclose the results. These laws help to fill the gaps in federal laws and regulations that have allowed heavy metal-contaminated products on store shelves for too long.