If you list products on our store, you must comply with all federal, state, and local laws and our policies applicable to those products and product listings, including this policy.
Infant formula is for infants from birth to one year, and includes follow-on infant formula intended to progressively diversify the diet of infants from six months to one year.
This policy does NOT apply to baby food, which is for human babies between the ages of four months and two years old.
For information on selling baby food, go to our baby food policy.
Amazon requires sellers of infant formula to submit documentation that reflects compliance with applicable regulations or standard requirements, including but not limited to the below:
21 CFR Part 106 — Infant Formula Quality Control Procedures
21 CFR Part 107 — Infant Formula
21 CFR Part 110 — Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
21 CFR Part 113 — Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventative Controls for Human Food
For each infant formula product ASIN, you must submit the following documents:
Document 1: A valid Global Food Safety Initiative (GFSI) certificate OR a valid Good Manufacturing Practices (GMP) certificate from an accredited third-party certification body for each manufacturing facility
Document 2: A Premarket notification
Submit a copy of the original notification (proprietary information about the formulation may be redacted) or a letter of guarantee from the brand owner that meets the following requirements:
Document 3: Resellers must submit an invoice and an image of the product or its packaging, or both. The invoice needs to be directly from the brand as the supplier or from an authorized reseller. A current list of approved brands is listed below, which may change at any time. Manufacturers must submit an image of the product or its packaging, or both.
Current list of approved brands:
If we contact you to submit compliance documents (Documents 1 and 2), complete the following steps:
To apply to list a product that already exists in Amazon’s catalog and requires approval, follow these steps to submit Document 3:
If you are unable or unwilling to appeal the suppression of your ASIN, you have 30 days to create a removal order from our fulfillment centers.
Refer to the following help pages:
If you do not provide the required information by the applicable deadline, we may take the following actions:
We reserve the right to take any further actions that may be necessary in our sole discretion.
Approved sellers will receive an email notification with this information.
For information on how to sell baby food on Amazon, go to the Baby food policy.