Amazon’s Policy on Selling Infant Formula in the United States

On this page, you will find:

• What is infant formula?
• Amazon’s policy on selling infant formula
• How do I request approval to sell infant formula?
• Documents you are required to submit if approved to sell infant formula
• How to submit required documents
• How to request product removal from Amazon fulfillment centers
• Consequences for policy violations and reporting a violation
• Frequently asked questions

What is infant formula?

Infant formula is for infants from birth to one year, which also includes follow-on infant formula intended to progressively diversify the diet of infants from six months to one year.

What is Amazon’s policy on selling infant formula?

Amazon’s policies require that all sellers of infant formula provide documents that demonstrate the product is safe and approved by the United States Food and Drug Administration (FDA).

See: Infant Formula Guidance Documents & Regulatory Information.

How do I request approval to sell infant formula?

Resellers must submit an invoice and an image of the product and/or its packaging. Manufacturers must submit an image of the product and/or its packaging.

What information/documents do I have to submit in order to be compliant?

To sell infant formula, you must submit the following two documents:

1. Required document one
   • A Good Manufacturing Practices (GMP) certificate from an Accredited certifying body or a Global Food Safety Initiative (GFSI) based certificate
2. Required document two - a premarket notification
   • 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

How do I submit the required information/documents?

Complete the following steps to start the application process:

1. In Seller Central, select Inventory, and then click Add a Product.
2. Search for the ASIN you want to sell.
3. In the search results, click the Listing limitations apply link next to the ASIN.
4. Click Request Approval to start the application process.

How do I request 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:

• Amazon Services Business Solutions Agreement
• Remove inventory overview
• Fix stranded inventory

What are the consequences for policy violations?

Violations of Amazon's policies for listing infant formula may result in, but may not be limited to, the following actions:

• Cancellation of the listing
• Suspension of listing privileges

These potential consequences are in addition to, and in no way limited to, the consequences allowed by any agreement between Amazon and the seller. Amazon reserves the right to make judgments at its sole discretion about whether or not a listing is appropriate.

Amazon encourages sellers to report listings that may violate our policies or any applicable law by contacting Selling Partner Support. Select Report a violation and be sure to include all relevant information so that we can conduct a thorough investigation.

Frequently asked questions

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

Approved sellers will receive an email notification with this information.