In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to “reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods.” However, multiple coalitions of state AGs have been vocal in advocating for more stringent and urgent measures. Over the last four years, these coalitions have urged the FDA to take decisive action to ensure the safety of baby food products, particularly as it relates to the presence of toxic metals. In January 2025, the FDA issued final guidance setting action levels for lead in processed foods intended for babies and young children under the age of two.

The Push for Stricter Guidelines

In February 2021, New York AG Letitia James expressed deep concerns about allegedly high levels of toxic metals, including arsenic, lead, cadmium, and mercury in baby foods being sold by some of the nation’s largest manufacturers. In her letter to the acting FDA commissioner, she claimed that, without additional oversight, baby food manufacturers “have been able to set their own internal standards for levels of toxic metals.” She called on the FDA to set standards for all baby foods and require manufacturers to test their finished products for toxic metals.

A few months later, in October 2021, James led a coalition of 23 AGs in a petition to the FDA requesting the agency to “issue interim proposed action levels for four toxic heavy metals in all relevant categories of infant and toddler food.” The petition argued that many of the timelines the FDA proposed in their “Closer to Zero” plan were too far off, and the magnitude of the safety risk these heavy metals pose necessitated interim action levels. Specifically, this petition called on the FDA to (i) propose science-based limits for inorganic arsenic, lead, cadmium, and mercury; (ii) lower the existing FDA action level for inorganic arsenic in infant rice cereal; and (iii) instruct baby food manufacturers to test finished products for toxic heavy metals.

We saw continued state AG advocacy after the FDA denied the 2021 petition in June 2022 when a coalition of 22 AGs issued a letter to the FDA commissioner, FDA deputy commissioner, and U.S. Department of Agriculture (USDA) secretary. This letter urged these agencies to take immediate and robust action to address “children’s exposure to neurotoxic heavy metals” by accelerating the timelines of the “Closer to Zero” plans.

In February 2024, a coalition of 20 AGs once again called on the FDA to take urgent action, alleging that “some manufacturers and distributors of baby foods in the U.S. currently lack a clear understanding of the proper way to apply preventive controls.” This request referenced a widespread recall of certain cinnamon applesauce pouches, which had lead levels more than 200 times the action levels the FDA had proposed in their draft guidance. This letter reinforced the AGs’ arguments for immediate action on toxic heavy metals in baby food.

The FDA’s New Guidance on Lead Action Levels

On January 6, the FDA took an initial step in addressing some of the concerns raised in these AG efforts by releasing their final guidance, establishing action levels for lead in processed food intended for babies and young children.

Under 21 CFR 109.6(d), the FDA may establish action levels, which set the level of a substance at which the FDA may treat the food as “adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” These are not legally enforceable guidelines, but rather reflect the FDA’s recommendations for those in the industry.

The FDA considered the practical implications of these action levels, such as the need for a limited number of action levels to ensure simplicity, the goal of reducing exposure to lead, and data demonstrating the varied levels of lead concentrations in different types of processed foods intended for babies and young children. As such, the FDA set the following action levels:

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats;
• 20 ppb for single-ingredient root vegetables; and
• 20 ppb for dry infant cereals.

The action levels are separated into these categories due to differences in food properties, the levels of lead found in these products, and achievability. For example, root vegetables can absorb lead more readily from the soil than other crops while fruits, other vegetables, mixtures, yogurts, custards/puddings, and single ingredients of meats tend to have lower levels of lead compared to single-ingredient root vegetables and dry infant cereals.

These guidelines do not apply to raw agricultural commodities, homemade foods, snack foods (including grain-based or freeze-dried snacks), infant formula, or any beverage (including toddler drinks).

The FDA reiterates that these are nonbinding recommendations, intended to encourage manufacturers to maintain levels of lead in these processed foods below the action levels to reduce risks associated with dietary lead exposures for young children and babies.

Conclusion

The FDA’s “Closer to Zero” initiative lays out a timeline for evaluating the data and establishing action levels for arsenic, cadmium, and mercury in foods intended for babies and young children as well as action levels for lead in juices. Currently, the FDA is targeting finalized action levels for lead in juices in 2025, with the goal of the other contaminants’ action levels to follow the completion of reviewing data and the issuance of draft guidance.

The FDA’s issuance of final guidance on action levels for lead in processed foods intended for babies and young children marks a significant step forward in addressing the concerns raised by state AGs. While these guidelines are not legally enforceable, they represent a regulatory effort to reduce the risks associated with dietary lead exposure in young children.

Troutman Pepper Locke State Attorneys General Team

	Ashley Taylor – Co-leader and Firm Vice Chair Ashley is co-leader of the firm’s nationally ranked State Attorneys General practice, vice chair of the firm, and a partner in its Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group. He helps his clients navigate the complexities involved with multistate attorneys general investigations and enforcement actions, federal agency actions, and accompanying litigation.
	Clay Friedman – Co-leader Clay co-leads the firm’s State Attorneys General practice and is nationally ranked by Chambers USA for AG Government Relations and in Best Lawyers for Advertising Law. He has dedicated his entire career to state attorney general and federal work, serving for nearly a decade in a senior role and more than 25+ years in private practice. Clay focuses his practice on helping industry-leading companies mitigate the risks associated with state and federal regulatory investigations and associated litigation.
	Chris Carlson Chris advises clients on regulatory, civil, and criminal investigations and litigation. With a background as an assistant attorney general, he provides practical guidance to clients with matters involving state attorneys general and federal regulatory agencies.
	Lauren Fincher Lauren has vast experience handling state attorneys general investigations, navigating complex regulatory compliance matters, and providing strategic counsel in enforcement actions across various industries. She helps clients manage high-stakes regulatory matters and guides them through complex legal landscapes.
	Stephen Piepgrass Stephen leads the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group, representing clients in single and multistate enforcement actions, including inquiries and investigations, as well as litigation involving state attorneys general and other state and federal governmental enforcement bodies. He has significant experience handling actions with federal agencies, including the CFPB and FTC, as well as single plaintiff and class action litigation for clients in highly regulated sectors such as financial services, health care, pharmaceutical, and education.
	Michael Yaghi Mike handles high-profile state attorneys general, FTC, and CFPB investigations by advising clients through these complex government inquiries. He assists clients through the entire life cycle of investigations, from regulatory enforcement through formal litigation.
	Samuel E. “Gene” Fishel Gene is a former regulator with two decades of experience who has overseen state privacy and cybersecurity regulation enforcement, led national, multistate attorneys general privacy investigations, and prosecuted computer crimes at the state and federal levels. He has served at the forefront of state attorney general and federal enforcement, and utilizes this experience to proficiently represent client interests.
	Jay Myers Jay assists clients in heavily regulated industries, including health care, energy, insurance, emerging industries, and data privacy. He provides both regulatory legal advice and government relations strategies. Jay’s past and current clients include Fortune 10 companies, startups, nonprofits, industry associations, and advocacy groups. Recognizing that state government matters are often complex and multifaceted, he utilizes regulatory guidance, government advocacy, or both in tandem to deliver tailored solutions for each client’s unique needs.
	Chuck Slemp Chuck advises clients on a wide range of complex issues that frequently involve government actions, including investigations, inquiries, regulatory matters, and litigation. With a distinguished background in the law and public service, he served as chief deputy attorney general of Virginia before joining the firm. In addition to overseeing the Department of Law and Division of Debt Collection, Chuck managed a team of attorneys who handle complex litigation and investigations. He also directed the attorney general’s legislative affairs and represented the attorney general in various capacities.
	Jessica Birdsong Jessica is an associate in the firm’s Regulatory Investigations, Strategy + Enforcement Practice Group. She received her J.D. from the University of Richmond School of Law, magna cum laude, where she served as associate articles editor of the Journal of Law & Technology.
	Blake R. Christopher Blake collaborates with clients on matters related to government contracting, investigations, and disputes. His senior-level government experience generates valuable insights and strategies for clients across a variety of industries.
	Nick Gouverneur Nick is an associate in the firm’s Regulatory Investigations, Strategy + Enforcement Practice Group. He received his J.D. from the University of Illinois College of Law, where he served as a member of the Journal of Law, Technology & Policy.
	Troy Homesley Troy is an accomplished litigator who has represented and defended clients across a wide range of complex, high-stakes disputes at both the trial and appellate levels. He has represented technology companies, business executives, law firms, investment funds, high-ranking federal officials, international non-profits, and asylum seekers. Troy draws on his broad litigation experience to advise clients before litigation arises, while claims are pending or threatened, and leading up to and through trial and appeals.
	Natalia Jacobo Natalia is an associate in the firm’s Regulatory Investigations, Strategy and Enforcement (RISE) practice, based on the West Coast. She routinely counsels clients on a variety of state and federal regulatory matters, with a particular emphasis on consumer protection and data privacy matters.
	Namrata Kang Namrata (Nam) is an associate in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group, based in the Washington, D.C. office. She routinely advises clients on a wide variety of state and federal regulatory matters, with a particular emphasis on state consumer protection laws relating to consumer financial services and marketing and advertising. Nam’s experience transcends multiple industries, including financial services, telecommunications, media, and sports betting.
	Michael Lafleur Michael is an associate in the firm’s Regulatory Investigations, Strategy, and Enforcement Practice Group. Based out of the firm’s Boston office, Mike has deep experience in litigation, investigations, and other regulatory matters involving state-level regulators and state attorneys general.
	Lane Page Lane specializes in federal and state regulatory investigations and complex civil litigation. He focuses on representing financial institutions and other businesses, with a particular emphasis on consumer protection and fair lending issues.
	Dascher Pasco Dascher is an attorney within the Regulatory Investigations, Strategy, and Enforcement practice, based in the Richmond office. She joined our firm after working in personal injury and medical malpractice for a Virginia trial law firm. Dascher brings varied legal experience to the firm with strong litigation and regulatory strategy capabilities.
	Kyara Rivera Rivera Kyara is an associate in the firm’s Regulatory Investigations, Strategy + Enforcement Practice Group. She received her J.D. from the University of Richmond School of Law, cum laude, where she served as publications and online editor of the Public Interest Law Review.
	Trey Smith Trey focuses his practice on representing and advising regulated utilities before state public utility commissions. He routinely helps clients obtain certificates of public convenience and necessity for transmission infrastructure. In this role, Trey works with his clients’ subject-matter experts to manage administrative proceedings, including by preparing initial filings; responding to discovery requests; drafting rebuttal testimony; and litigating any disputed issues.
	Daniel Waltz Dan helps clients navigate all aspects highly regulated relationships between industry participants and federal, state and local governments. Whether engaging with regulators, negotiating transactions or representing clients in the courtroom, he delivers solutions that help his clients achieve their strategic goals.
	Cole White Cole is a member of the firm’s Regulatory Investigations, Strategy and Enforcement (RISE) group. He has a decade of experience working in the attorney general community, having joined the firm from the Wyoming Office of the Attorney General, where he was assistant attorney general.
	Stephanie Kozol Stephanie is Troutman Pepper Locke’s senior government relations manager in the state attorneys general department.