Overview

Amazon enforces strict compliance requirements for sellers listing infant formula products on its marketplace. These rules are designed to ensure that all infant formula sold through Amazon meets federal safety standards set by the U.S. Food and Drug Administration (FDA). Sellers who fail to meet these requirements risk having their listings removed and facing additional enforcement actions.

Key Points / What Sellers Need to Know

• Infant formula is heavily regulated — All products must comply with applicable federal laws, Amazon's own policies, and FDA manufacturing standards before they can be listed.
• Two product types are covered — The policy applies to both standard infant formula (birth to 12 months) and follow-on formula (typically 6 to 12 months), but does not cover general baby food.
• FDA registration is mandatory — All manufacturers, including those based outside the United States, must be registered with the FDA.
• Third-party audit certification required — Sellers must provide GFSI-accredited audit certifications covering Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Points (HACCP) for every manufacturing facility.
• Document authenticity is enforced — All test reports, certificates, and compliance documents submitted to Amazon must be original and unmodified.
• Amazon can request additional proof at any time — Even after initial approval, Amazon reserves the right to ask for further documentation to verify product safety.

Products Covered Under This Policy

Amazon's infant formula policy covers two distinct product categories. Standard infant formula is defined as a breast-milk substitute that is specially manufactured to meet the complete nutritional needs of infants from birth through 12 months of age. These products may be derived from cow's milk, goat's milk, or other animal milks, as well as blends of multiple sources. Follow-on formula, sometimes referred to as follow-up or toddler milk, is intended for infants typically between 6 and 12 months old and serves as a liquid component of a complementary diet. It is important to note that general baby food products fall outside the scope of this policy and are governed by separate Amazon guidelines.