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This article applies to selling in: United States

Infant formula

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 covered by 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.

Our policy for infant formula

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:

Product Regulation/Standard requirements
Infant formula

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

Required documentation

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

AND

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:

  • Is on official brand owner letterhead
  • Contains the product name
  • Contains addresses of manufacturing locations
  • Assurance that the formula meets FDA nutrition guidelines
  • Contains reference to appropriate FDA regulations
  • Signed by an authorized representative

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:

  • Alfamino Infant
  • Alfamino Junior
  • Baby's Only
  • Burt’s Bees
  • Bright Beginnings
  • Earth's Best
  • Elecare
  • Enfagrow
  • Enfamil
  • Gerber Good Start
  • GoodSense
  • Happy Baby
  • Kabrita
  • Munchkin
  • Neocate
  • Nestle
  • Nido
  • PediaSure
  • PurAmino
  • Similac
  • Love & Care
  • Mama Bear

How to submit documentation

If we contact you to submit compliance documents (Documents 1 and 2), complete the following steps:

  1. In Seller Central, select the Performance tab, and choose Account health.
  2. Under Product compliance requests in the bottom right corner of the page, click Documentation requests.
  3. Click Provide documentation or appeal next to the product.
  4. Select No to upload documents.
  5. Follow the steps in the Submit required documents section.

How do I request approval to sell infant formula?

To apply to list a product that already exists in Amazon’s catalog and requires approval, follow these steps to submit Document 3:


  1. In Seller Central, select Catalog and then click Add products.
  2. Search for the item that you want to sell.
  3. In the search results, click Show limitations next to the item.
  4. Click Apply to sell to begin the application process.

Requesting product removal from Amazon fulfillment centers

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:

Policy violations

If you do not provide the required information by the applicable deadline, we may take the following actions:

  • Remove the relevant product listings
  • Suspend your ability to add new products or listing privileges, or both
  • Withhold any payments due to you
  • Pursue legal action

We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

FAQ

How do I know that I am approved to sell infant formula?

Approved sellers will receive an email notification with this information.

How do I get approval to sell baby food?

For information on how to sell baby food on Amazon, go to theBaby food policy.

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