This article from the attorney perspective is accompanied by an article from the medical perspective on lead exposures. See "Lead Exposure in Children" for Medical and Scientific Solutions’ (“MSS”) brief primer on lead exposure in infants and children for background information on exposures – “Lead Exposure in Children.”. MSS is a team of lawyers, MDs, PhDs, nurses, researchers and technical specialists that help attorneys analyze and understand medical issues in litigation.

On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report entitled, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, released by the Chairman of the Subcommittee on Economic and Consumer Policy of the House Committee on Oversight and Reform. The Food and Drug Administration (FDA) said it was monitoring the situation.

Almost two years after the release of the Staff Report, the FDA issued draft guidance for action levels for lead in food for infants and children on January 24, 2023. This proposed draft guidance is the second step in the FDA’s Closer to Zero plan which was announced in April of 2021. The first step in the Closer to Zero plan was guidance on lead levels in juice issued by the FDA in April 2022. Additional planned actions include guidance levels for arsenic, cadmium and mercury in foods for babies and young children.

The comment period for the proposed guidance on lead in infant and children food is open until March 27, 2023. Specifically, the FDA has proposed action levels of: 

  • 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.

If the proposed action levels are adopted, then those are the levels at which the FDA could consider, pursuant to 21 CFR § 342, a product for infants and children to be adulterated and subject to enforcement actions. This could also affect the baby food litigation.

Plaintiffs have filed numerous lawsuits across the country against baby food manufacturers based on multiple theories. Defendants have moved to dismiss these complaints. One of the defendant’s arguments has been to use the primary jurisdiction doctrine to argue that the FDA should determine the appropriate levels of heavy metals in baby foods. The court in In Re: Gerber Products Company Heavy Metals Baby Food Litigation, No. 1:21-cv-269 (E.D. VA Oct. 17, 2022) was receptive to this argument. The court noted the FDA’s Closer to Zero efforts, the FDA’s expertise, and Congressional intent in giving FDA food labeling authority, in its opinion granting the defendant’s motion to dismiss. The court also noted that the court deciding what level is appropriate for heavy metals to be used on warning labels for baby food “will likely result in a patchwork of decisions that vary by location, court, manufacturer, and product, resulting in different labeling standards for substantially similar baby food products produced by different manufacturers”. We raised the issue on conflicting standards on March 4, 2021 – “Until the FDA sets national standards, manufacturers need to consider whether to set their own standards, how to scientifically defend any standards they may set, and how and when to test their products.”

Another successful argument from manufacturers in their motions to dismiss is to point out that plaintiffs failed to provide standards for the amounts of heavy metal allowed in baby food or failed to use analogous standards. The court in Kimca v. Sprouts Foods, Inc., No. 21-12977, 2022 WL 1213488 (D.N.J. Apr. 25, 2022) found that attempting to use the standards for heavy metals in bottled water, drinking water, and juice are not applicable to baby foods. The court in In Re Plum Baby Food Litigation, No. 1:21-cv-02417 (D.N.J. Oct. 31, 2022) agreed with the rationale of the court in Kimca.

The order from the court in In Re Plum Baby Food Litigation, No. 1:21-cv-02417 (D.N.J. Oct. 31, 2022), granting defendant’s motion to dismiss, held that plaintiffs did not provide any specific standards from the FDA or from the manufacturers. Further, plaintiffs needed not only to show the standards but also establish that there is a cause and effect between violating the standards and causing the injuries alleged (“Without a causal link to demonstrate that the levels heavy metals allegedly present in the Kimca baby food products were dangerous, the Kimca plaintiffs could not establish a future risk-as-injury as required for Article III standing, which is the same missing link in the instant case.”) (emphasis added). The court in In Re Plum Baby Food Litigation distinguished the deficiencies with the Kimca plaintiffs’ pleadings with the pleading by the plaintiffs in Kochar v. Walmart, Inc., 2022 U.S. Dist. LEXIS 74788 (N.D. Cal. Jan. 12, 2022). The important differences are that the Kochar plaintiffs alleged the specific heavy metal levels were above what occurs naturally, provided FDA testing of foods infants regularly eat for comparison, and provided manufacturers’ own testing results of the baby food in question. This approach helped the plaintiffs in Kochar defeat the motion to dismiss. 

If the new FDA standards for lead are approved, plaintiffs will be able to cite these FDA standards to help defeat motions to dismiss. Plaintiffs can compare the FDA standards to manufacturers’ internal testing data when available. But this may still not be enough. The court in In Re Plum Baby Food Litigation also noted that plaintiffs will need to be able to establish the causal link to the injuries. The scientific data FDA used to set the ppb for lead will be scrutinized to determine if there is evidence to establish that the levels of heavy metals in baby food caused injuries. Further, plaintiffs are going to have to prove that the lead from the baby food was the cause of the injuries versus potential other sources of lead that the infant and/or child ingested. The court in In Re Plum Baby Food Litigation concluded its order on defendants’ motion to dismiss with:

The Court recognizes that Plaintiffs have reason to be concerned, even alarmed, by the allegations raised in the House Subcommittee’s reports, as any parent would be in their desire to protect their children from harmful substances. However, the facts as alleged in this matter do not establish an injury-in-fact direct and concrete enough to bring these claims in court whose power is limited by design by Article III [of] the Constitution. In the absence of sufficient allegations of concrete and present harm and a plausible measure by which to assess it, ‘[o]nce [a] product [is] consumed, . . . there [can be] no economic injury for Plaintiffs to complain of, and the fear of future injury is legally insufficient to confer standing.’ James v. Johnson & Johnson Consumer Companies, Inc., 10-03049, 2011 WL 198026 at *2 (D.N.J. Jan. 20, 2011.

Maybe the FDA’s Closer to Zero standings will give courts reasons to deny motions to dismiss, but plaintiffs will have more to do. We will continue to monitor the final lead standards in infant and children’s food and the impact on the litigation.