FDA Issues Action Levels for Lead in Baby Food

On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly addressing lead in baby food and is the latest step FDA has taken as part of its Closer to Zero initiative, aimed at reducing childhood dietary exposure to heavy metals and other contaminants. FDA’s latest guidance comes amid ongoing lawsuits against baby food manufacturers and could have an impact on litigation risk, regulatory enforcement, and product formulation and testing within the industry.

Action levels are one regulatory tool that FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable.[1] Action levels are not a regulatory limit, but instead reflect a “level at which [FDA] may regard the food as adulterated.”[2] In simple terms, an action level functions as an internal benchmark that FDA may use when considering whether to bring an enforcement action in a particular case.

The final guidance sets action levels at 10 parts per billion (ppb) for fruits, vegetables, mixtures (including grain- and meat-based mixtures), yogurts, custards, puddings, and single-ingredient meals; 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals.[3] The guidance does not cover infant formula, beverages, or snack foods, though FDA is continuing to collect data on grain-based snacks to determine whether an action level would be appropriate.

Impact on Product Liability Litigation

In recent years, dozens of lawsuits have been brought against baby food manufacturers for alleged harms caused by lead in their products, including cognitive impairment, lower IQ, hearing loss, visual effects, delayed speech, learning disabilities, poor attention, hyperactivity, difficulty with reading and arithmetic, and emotional and behavioral problems. In particular, baby food manufacturers Gerber Products Co., Hain Celestial Group Inc., Beech-Nut Nutrition Co., and others face consolidated lawsuits in the Northern District of California alleging that their products caused autism because of their high levels of heavy metals, including lead.

Plaintiffs have faced difficulty showing causation and harm in individual cases brought on product liability and personal injury theories. Additionally, there have been several class actions brought for breach of warranty, fraud, and negligent misrepresentations. In these cases, plaintiffs have run into problems establishing standing and subject matter jurisdiction.

In the ongoing lawsuits, both defendants and plaintiffs are likely to seek to use FDA’s guidance to their benefit. Plaintiffs may cite lead levels exceeding the action levels to show causation and harm. However, this argument is vulnerable on the basis that the new guidance does not affirmatively establish a level at which lead is harmful. Instead, the agency has focused on providing guidance to reduce childhood lead exposure, rather than defining a level of concentration that does pose a clear danger.

Defendants, on the other hand, may use the new guidelines to claim that products with lead levels below the action levels are safe. While lead levels within the guidelines could support that the product was less of a risk, it does not guarantee the safety of a product. The argument that conformity with the action levels defeats causation is vulnerable because FDA did not define safe and dangerous levels of lead.

Defendants may also claim that the new FDA guidelines preempt state common law and consumer protection claims. This argument will likely be unavailing, considering that the guidance is nonbinding and puts much of the responsibility on industry players to conform to the action levels. 

Nonbinding Guidance and Enforcement

Ultimately, FDA’s guidance does not modify the responsibility of the manufacturer to identify potential hazards and take precautionary steps to avoid heavy metal contamination in its products. Instead, the guidance document informs industry of its enforcement priorities.

Importantly, the stated action levels do not create safe harbors. Manufacturers can still face legal consequences, both from agency enforcement actions and from private litigation, even if lead levels in products are not found to exceed the stated action levels.

Additionally, Companies may be subject to state laws about heavy metals in baby foods. In California, for example, manufacturers are required to test samples of their baby food products for certain toxic elements (including lead) and publish the results.[4]

Monitoring and Updating

Manufacturers should also be aware that FDA plans to monitor lead levels via additional market surveillance and adjust action levels as appropriate. For example, FDA monitors lead levels through the Toxic Elements in Food and Foodware and Radionuclides in Food – Import and Domestic Compliance Program (the Toxic Elements Program or TEP), surveys, and the Total Diet Study (TDS). The agency selects foods for analysis that are suspected of having elevated lead levels based on historical data or other information, with a particular emphasis on foods for babies and young children. As FDA continues to monitor lead levels, the agency will consider whether to revisit the issued guidance. Additionally, the agency may add more foods or food categories in the future.

Background

FDA’s action follows years of attention on the issue of heavy metals in baby food. In 2021, the Subcommittee on Economic and Consumer Policy (“Subcommittee”), part of the Committee on Oversight and Reform of the U.S. House of Representatives, published two reports following an investigation into heavy metal contamination in baby and children’s food products. The reports contained information from product tests and internal documents of seven major manufacturers of baby food, finding lead at levels as high as 641 ppb, an amount 64 times higher than that advised under the recently issued guidance.[5]

In its report, the Subcommittee recommended that FDA issue standards on heavy metal levels. In 2021, FDA launched its Closer to Zero initiative, aimed at lowering the levels of heavy metals in the food supply to as low as possible, while acknowledging that complete elimination is not possible due to the presence of lead in our environment. In 2023, FDA released draft guidance, followed by a stakeholder comment period, after which FDA began work on the final guidance released this month.[6] 

During the comment periods, industry groups expressed support for action levels and asked FDA to consider the achievability of draft action levels, particularly for products containing root vegetables. These groups also expressed support for snack exemptions and requested clarity about the scope of guidance. Environmental, consumer, and health groups urged FDA to adopt even more stringent action levels, include additional heavy metals, and increase oversight. Both industry and consumer groups encouraged FDA and other agencies to develop consumer messaging about risk management. In the final guidance, FDA made no changes to action levels contained in the draft guidance.

The final guidance applies only to packaged food (e.g., in jars, pouches, tubs, or boxes) represented or purported to be for babies and young children less than two years old. This includes ready-to-eat foods (e.g., purees) and semi-prepared foods (e.g., dry infant cereals), but the guidance does not apply to raw agricultural commodities, homemade foods, snack foods, or beverages. This is largely consistent with the scope put forth in the draft guidance, but the snack foods exemption has been expanded to all snack foods. The previous draft guidance only exempted grain-based snacks, but the final guidance exempts the broader category of “snack foods,” including those that are “grain-based” or “freeze-dried.” FDA intends to periodically adjust action levels as the agency gathers more information across various categories of food eaten by babies and young children.

Conclusion

These new action levels are meant to encourage industry to progressively reduce heavy metal levels in food products intended for babies and young children. While the guidance may be predictive of FDA enforcement practice, it does not establish safe harbors, and manufacturers may still face regulatory action for noncompliance with good manufacturing practices. The industry should also be aware that the guidelines are subject to change as FDA continues to monitor the issue of lead in baby food.

MoFo’s Consumer Product and FDA teams are actively monitoring federal, state, and local developments concerning baby foods and regularly advise clients on compliance and risk mitigation under the evolving regulatory landscape.

[1] See 21 C.F.R. § 109.6(d).

[2] Id.

[3] FDA Issues Final Guidance for Industry on Action Levels for Lead in Processed Food Intended for Babies and Young Children | FDA

[4] Assembly Bill No. 899 (codified at Cal. Health & Safety Code § D. 104, Pt. 5, Ch. 5, art. 8.5.)

[5] Food and Drug Admin., Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry 3 (2023), https://www.fda.gov/media/164684/download.

[6] Food and Drug Administration, Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry; Draft Guidance, Regulations.gov (Jan. 24, 2023), https://www.regulations.gov/document/FDA-2022-D-0278-0002.