A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require baby food manufacturers to test and publish heavy metal levels in their products. Litigation alleging that babies have developed autistic spectrum disorder (ASD) and / or attention deficit hyperactivity disorder (ADHD) has been continuing while the FDA finalized its guidance. In fact, last year the litigation was centralized in an MDL in the Northern District of California. Currently there are 88 cases in the MDL, and a pending motion to dismiss in which defendants have stated, among other things, that plaintiffs cannot prove a direct link between heavy metals in baby food and plaintiff’s alleged injuries. However, discovery is proceeding.

Last week the FDA set its action level for lead in baby food at the same levels proposed in the draft guidance: 

• 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;
• 20 ppb for root vegetables (single ingredient); and
• 20 ppb for dry infant cereals.

Lead is just one of the heavy metals under scrutiny from the FDA as part of its “Closer to Zero” program. The FDA is also considering cadmium, arsenic, and mercury with a target date to issue draft guidance this year for cadmium and arsenic. Mercury is found predominantly in seafood. The FDA has already issued Advice About Eating Fish for pregnant and lactating women and young children.

So – does the new FDA action level for lead impact the ongoing litigation? Doubtless both sides will cite the new action levels, but its impact remains to be seen. Basic product liability law requires plaintiffs to prove that heavy metals in the defendants’ baby foods were a substantial contributing factor to a plaintiff’s ASD or ADHD. Does the new lead action level advance that effort? 

In adopting its action level for lead, the FDA acknowledged:

Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavioral difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.

However, in setting lead levels, the FDA analyzed lead levels in various baby foods going as far back as 2014. The FDA data showed that:

All food categories had mean lead concentrations well below 10 ppb, with the exception of root vegetables, which had a mean concentration of 11.6 ppb.

Consequently, the vast majority of all baby foods for at least the past ten years have had lead concentrations below the new FDA action levels. While the FDA has not defined any level of lead exposure as “safe,” if the FDA actions levels are accepted by the courts as “safe” levels, that would seem to be a barrier to plaintiffs’ efforts to recover. Plaintiffs’ likely retort is that single exposures are not the issue, but the cumulative exposures are. Such an argument by plaintiffs leads to potential defenses. How are plaintiffs going to link the cumulative exposure in infants to particular manufacturers? Heavy metals are ubiquitous in the environment. Babies can acquire heavy metals in utero, from breast milk, from soil, from water, from air pollution, from lead paint in homes, and the list goes on. Further, plaintiffs’ experts will face Daubert (or similar challenges) as to whether heavy metal exposure in baby food is even capable of causing the injuries at issue. 

While the new FDA action levels for lead do provide guidance to manufacturers as to how to avoid FDA enforcement actions, their impact on litigation remains to be seen. How the MDL court rules on pending motions to dismiss and the results of upcoming discovery and expert motion practice will be instructive. Thus far, plaintiffs have failed at the motion to dismiss and Daubert stages. This blog will continue to follow developments.