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Selling infant formula and baby food in the US

In the US, the FDA does not approve infant formulas, but a manufacturer registers and notifies the FDA at least 90 days before marketing a new formula. Formula meets nutrient, quality and manufacturing rules in 21 CFR 106 and 107. Baby food follows the food rules, with its own nutrition labelling and FDA lead action levels.

Updated · Each section links to the official source it comes from

Regulator
The FDA
New infant formula
Registration, and notice at least 90 days before marketing
Formula rules
21 CFR Parts 106 and 107
Required nutrients
30 nutrients, set by FDA regulations
Infant
A person not more than 12 months of age
Lead in baby food
Action levels of 10 or 20 ppb, by food type

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the product an infant formula, or a food for babies and young children? Read more
  2. 2For a new formula, is the manufacturer registered and the 90-day notice made? Read more
  3. 3Does the formula meet the nutrient, quality factor and manufacturing rules? Read more
  4. 4Does the label carry the formula's nutrient table, directions, pictogram and use-by date? Read more
  5. 5For baby food, does the nutrition label follow the rules for infants and children 1 to 3? Read more
  6. 6Have lead and other contaminants been checked against FDA action levels? Read more
  7. 7Is there a plan for notifying the FDA and recalling formula? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Infant formula: registration and notice

What a manufacturer tells the FDA before a new formula is sold.

  • Infant formula is a food represented for special dietary use solely as a food for infants, because it simulates human milk or is suitable as a complete or partial substitute for it. An infant is a person not more than 12 months of age.
  • The FDA does not approve infant formulas. Before a new infant formula is introduced into interstate commerce, the manufacturer registers with the FDA, naming the formula, the manufacturer and each establishment where it will be made.
  • At least 90 days before a new formula is marketed, the manufacturer submits a notice of intent with the formulation, any processing change, and assurances on quality factors and nutrient content.
  • Formula sold in the US, whether made there or imported, must meet the same US requirements, including those for safety and nutritional adequacy.

How we help: Compliant Always keeps the registration, the 90-day submission and the formulation it described with each formula, dated, so a later change can be read against them. Ask about this

Nutrients, quality factors and manufacturing

What goes into a formula and how it is made.

  • FDA regulations specify 30 nutrients that any infant formula sold in the US must contain, and ingredients must be authorised food additives or GRAS and suitable for the use.
  • A formula meets the quality factor of normal physical growth; for a formula that is not an eligible formula, this is shown by a growth monitoring study of at least 15 weeks.
  • Manufacturers follow the current good manufacturing practice and quality control rules of 21 CFR 106, including controls against microorganisms, and FDA regulations require testing for Salmonella and Cronobacter.
  • The FDA inspects infant formula facilities annually.

How we help: Compliant Always reads each batch's nutrient and pathogen test results against the specification and keeps them with the lot. Ask about this

Labelling

What a formula label and a baby food label show.

  • A formula label gives, in a table, the fluid ounces supplying 100 kilocalories and the amount of each listed nutrient per 100 kilocalories.
  • It carries 'Directions for Preparation and Use', a pictogram of the major preparation steps, a 'Use by' date chosen on the basis of tests, and 'Add Water' or 'Do Not Add Water' where it applies.
  • It also carries a warning against improper preparation and a statement such as 'Use as directed by a physician'.
  • Foods other than formula for infants through 12 months and children 1 through 3 years bear nutrition labelling; for infant foods, no percent Daily Value is declared for saturated fat, trans fat, cholesterol, sodium, fibre or sugars.

How we help: Compliant Always sets your formula or baby food label beside 21 CFR 107 and 101.9, line by line, and keeps the evidence behind the use-by date with it. Ask about this

Lead and other contaminants in baby food

The FDA's action levels for processed food for babies and young children.

  • Under the Closer to Zero initiative, the FDA sets action levels to reduce heavy metals in food for babies and young children over time.
  • For packaged food for children under two, the lead action levels are 10 ppb for fruits, most vegetables, mixtures, yogurts, custards and single-ingredient meats, and 20 ppb for single-ingredient root vegetables and dry infant cereals.
  • Action levels are levels at which the FDA may regard a food as adulterated; the FDA can act on an unsafe level without one.
  • The FDA published draft guidance on cadmium in processed food for babies and young children in October 2026, and is targeting 2027 for draft guidance on inorganic arsenic.

How we help: Compliant Always reads heavy metal results by lot against the action levels that apply to the food type, and watches the FDA for new ones. Ask about this

Notification and recall

What a formula manufacturer does when something is wrong.

  • A manufacturer promptly notifies the FDA by telephone when it knows a formula that has left its control may not provide the required nutrients or may otherwise be adulterated or misbranded, and confirms in writing.
  • When the FDA finds that an adulterated or misbranded formula presents a risk to health, the manufacturer recalls it, down to the retail level.
  • A recalling firm telephones the FDA within 24 hours of deciding to recall, sends a written report within 14 days, and status reports at least every 14 days until the recall ends.

How we help: Compliant Always ties each document to the lot it covers, so the lots in question and their records are found from the record when time is short. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Formula manufacturerRegistration, the 90-day notice, quality factors, manufacturing practice, notification and recall.Submissions, specifications and batch records kept together by formula and lot.
Baby food manufacturerFood facility registration, preventive controls, the nutrition label and contaminant control.Labels and lot test results read against the rules that apply.
ImporterMaking sure imported formula and baby food meet US requirements, with prior notice and supplier verification.Foreign suppliers' records read and dated before the goods ship.
Brand or distributorThe label and claims, where its name is on the product.Labels and claims checked, with the paperwork behind them.

Federal and state

Federal agencies set the national rules. States can add their own: California's Proposition 65, for example, can call for a warning on a product sold there.

Retailers and marketplaces often ask for more than the law does, such as test reports by lot or third party certificates.

Questions businesses ask

Does the FDA approve infant formula?
No. The FDA does not approve infant formulas, but a manufacturer must register and notify the FDA before marketing a new formula, and the FDA reviews the submission.
How long before launch is the FDA told about a new infant formula?
At least 90 days before the new formula is introduced into interstate commerce, through a new infant formula submission under 21 CFR 106.120.
How many nutrients must US infant formula contain?
FDA regulations specify 30 nutrients that must be included in any infant formula sold in the US, with amounts set in 21 CFR 107.100.
What must an infant formula label show?
A nutrient table per 100 kilocalories, directions for preparation and use, a preparation pictogram, a 'Use by' date, 'Add Water' or 'Do Not Add Water' where relevant, a preparation warning and a statement to consult a physician.
Can imported infant formula be sold in the US?
Yes, if it meets the same US requirements as formula made in the US, including those for safety and nutritional adequacy.
Which pathogens is infant formula tested for?
FDA regulations require testing infant formula for Salmonella and Cronobacter, and manufacturers keep controls to prevent contamination by microorganisms.
What are the FDA lead limits for baby food?
Action levels of 10 ppb for most processed foods for children under two, and 20 ppb for single-ingredient root vegetables and dry infant cereals, set in January 2025 guidance.
Are FDA action levels legally binding?
Guidance is not binding in itself, but an action level is a level at which the FDA may regard a food as adulterated, and the FDA may take enforcement action.
Does baby food need a nutrition label?
Yes. Foods other than formula for infants through 12 months and children 1 through 3 years bear nutrition labelling, with specific rules for which percent Daily Values appear.
What happens when infant formula is recalled?
The firm telephones the FDA within 24 hours, makes a written report within 14 days and reports at least every 14 days, recalling down to the retail level where the FDA requires.
How does Compliant Always help with selling in the US?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches federal sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

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