FDA Closer to Zero for baby food brands: policy vs a mark

Closer to Zero is the name of an FDA action plan for reducing exposure to environmental contaminants from foods commonly eaten by babies and young children. Quality and regulatory teams already brief it. This page draws a line between that policy work and a voluntary certification. It is not legal advice. It is not a claim that Heavy Metal Tested is an FDA program.

A policy plan can set research priorities, consult, and publish action levels over time. It does not, by itself, license a marketing mark. Treating Closer to Zero as a seal is how overclaims start.

What Closer to Zero is (and is not)

Closer to Zero is federal policy context for infant and young-child foods. It is an action plan, not a certification program. It is not a pack mark a brand can license from the agency. It is not a pass/fail seal. It does not replace the brand's own quality system, and it does not replace testing-and-disclosure duties a state statute may already impose.

Two facts are easy to miss in a hurried briefing:

• Policy language about reducing exposure is not the same as a licensed claim against a published private standard.
• Meeting an action-plan expectation, if and when one applies to a SKU, does not automatically mean a product meets a published certification standard. Those are different questions, scored against different documents.

This page does not name analytes. It does not publish action levels. Confirm current FDA documents with counsel. Companion state-law context sits on AB 899 for baby-food brands.

What a licensed mark adds (and does not add)

Heavy Metal Tested is an independent Paleo Foundation certification that evaluates food, supplement, and consumer products against a published standard and licenses a mark to products that meet it.

That is a voluntary certification program, not a laboratory, and not a government filing. Testing for certification is coordinated through a qualified independent ISO/IEC 17025 laboratory. The Heavy Metal Certified mark is licensed only to products that meet the published subcategory standard. Certification is valid one year, with annual retesting.

FDA does not require this certification. No government agency requires this certification. The program does not make a product approved, preferred, or endorsed by FDA. It does not satisfy, replace, or discharge federal expectations. It does not claim that a product is safe.

A brand already tracking Closer to Zero is not finished with heavy-metal questions. Parents still look for a mark. Reviewers still ask what standard sits behind a claim. Teams still need a rule for when a result supports on-pack language.

Certification can sit beside policy. It cannot sit in place of it.

See what Heavy Metal Tested certification is and certification for infant and toddler food brands.

How teams usually split the work

Regulatory owns the federal file and any applicable action-level work. Quality owns the measurement system. Brand and legal own any on-pack claim. Certification is a claim-control tool, not a shortcut through an agency plan.

That is why lot testing versus certification is a companion page. A lot result can support an internal spec or a policy file. A licensed mark is a different artifact: it says a product met a published subcategory standard under a certification program.

Language that will not survive review

• Do not print "Closer to Zero" as if it were a certified seal.
• Do not imply FDA licenses, approves, or prefers Heavy Metal Tested.
• Do not treat an action plan as a year of on-pack language.
• Do not upgrade either object into a statement that the product is safe.
• Do not use an absence claim.

The process, when a product is in scope: apply; coordinate testing through a qualified independent ISO/IEC 17025 laboratory; license the Heavy Metal Certified mark only if the product meets the published subcategory standard; recertify annually with retesting. If it does not meet the standard, the mark is not licensed.

FAQ

Does FDA require Heavy Metal Tested certification? No. Closer to Zero is a policy action plan. Certification is voluntary and does not replace federal work.

Can we put Closer to Zero on pack as a mark? Not as a substitute for a licensed certification mark, and not as if FDA issued you a seal. Confirm any policy language with counsel.

If we already follow the action plan, why consider a mark? Policy work is not a licensed claim against a published private standard. Those are different communications.

Does the mark mean we are finished with FDA expectations? No. Federal expectations remain the brand's obligation.

How should we start? A 30-minute eligibility conversation. It is not an application and not a close.

Next step

If you own quality, regulatory, or compliance for a US baby-food line, book a 30-minute eligibility conversation. Bring the SKU list. We will talk about whether a published standard and a licensed mark are in scope, not about treating an FDA action plan as a seal.