FDA Closer to Zero: What Baby Food Brands Need to Know

Closer to Zero is FDA's plan for reducing exposure to toxic elements in foods eaten by babies and young children. Announced in 2021, it focuses on lead, arsenic, cadmium, and mercury, and it works step by step: FDA gathers data, proposes action levels, finalizes them, and revisits them over time.

This is an overview for brand teams. Always confirm current requirements against FDA's documents and with your counsel. FDA's Closer to Zero page.

Action levels FDA has set so far

Sources: FDA lead guidance and FDA rice cereal guidance.

What action levels mean

An action level is the level at which FDA may consider a food adulterated and take enforcement action. FDA describes these levels as achievable when manufacturers control for contamination, and expects industry to keep reducing levels over time.

Two things to keep in mind:

• Action levels are enforcement tools, not safety thresholds. A product under an action level is not declared "safe," and FDA expects continued reduction.
• They are guidance, not regulations. They are not legally binding in the way a regulation is, but FDA uses them in enforcement decisions.

What is not covered yet

The January 2025 lead guidance covers packaged foods in jars, pouches, tubs, and boxes for children under 2. It does not cover:

• Infant formula
• Beverages. Lead in juice is handled separately, in draft guidance FDA issued in April 2022.
• Snack foods, including puffs and teething biscuits. FDA has said it is still collecting data on grain-based snacks.
• Homemade foods and raw produce

What is coming next

FDA's guidance agenda lists draft action levels for cadmium in processed baby foods, and for inorganic arsenic across foods for babies and young children, as expected by the end of 2026. Mercury is still at an earlier stage. Because these timelines shift, check FDA's Closer to Zero page before planning around them.

How this connects to state law

Federal action levels also trigger state requirements. Under California's AB 899, if a baby food is tested for a metal that has an FDA action level, its label must carry a QR code linking to the brand's test results. Since FDA finalized lead action levels in 2025, that applies to most purees and cereals sold in California. AB 899 explained.

Where voluntary certification fits

Closer to Zero is a federal policy program. It does not offer a seal, and FDA does not certify or endorse individual products.

Heavy Metal Tested is a separate, voluntary certification program from the Paleo Foundation. It covers eight metals (lead, arsenic, cadmium, mercury, chromium, nickel, tin, and aluminum) against a published standard. Products are tested through qualified independent ISO/IEC 17025 laboratories, and certification renews every year with retesting.

The two work side by side. Meeting FDA's expectations remains the brand's responsibility, and certification gives parents a visible signal on the package, including for categories like snacks that federal action levels do not yet cover. Certification does not satisfy federal requirements, and FDA does not require it.

FAQ

What is FDA Closer to Zero? FDA's plan to reduce babies' and young children's exposure to lead, arsenic, cadmium, and mercury from food, using action levels that tighten over time.

What are FDA's lead limits for baby food? 10 ppb for most packaged fruits, vegetables, and mixed foods for children under 2, and 20 ppb for single-ingredient carrots or sweet potatoes and dry infant cereals.

Does FDA regulate lead in baby puffs? Not yet through an action level. The 2025 lead guidance excludes snack foods, and FDA is still collecting data.

Does FDA require Heavy Metal Tested certification? No. Certification is voluntary and separate from FDA.

Can we say our product "meets Closer to Zero"? Be careful. Closer to Zero is a policy program, not a certification. Confirm any language about FDA with your counsel.

Learn more

• AB 899 for baby food brands
• Lot testing vs certification
• What Heavy Metal Tested certification is

Next step

Tracking Closer to Zero for a baby-food line? Book a 30-minute call to see where certification could fit alongside your compliance work.