Importing Baby Formula Into the U.S.: FDA Rules, CBP Requirements, & Commercial Challenges

Legally importing baby formula, or infant formula, into the U.S. requires businesses to ensure the manufacturer and product meet applicable FDA (Food and Drug Administration) registration, notification, safety, and labeling requirements, along with U.S. Department of Agriculture (USDA) regulations where applicable. 

Note: The terms ‘baby formula’ and ‘infant formula’ are often used interchangeably. For the purposes of this article, both terms refer to formulas designed for the needs of children from birth to 12 months of age. 

Is There a Recall on Infant Formula In the U.S.?

Yes. As of June 12, 2026, powdered infant formula from Nara Organics is subject to an FDA-recommended recall due to three suspected cases of botulism poisoning in infants who had all consumed the product.

How to Legally Import Baby Formula Into the USA

The first step to legally import baby formula is to make sure that all 30 FDA-mandated nutrients are included in the product. This is also the time to verify whether the manufacturing facility meets FDA requirements. 

Only facilities registered with the FDA may produce food that can be legally imported into the U.S. for commercial purposes.

FDA-registered facilities are expected to provide:

• Exact brands and products to be shipped to the U.S. 
• Shipping method
• Frequency and quantity of shipments
• Importer of Record Registration
• List of domestic distributors (if possible)

When importing any food product, the importer must file prior notice of the shipment with the FDA as well. 

Why Is Infant Formula One of the Most Regulated Food Imports In the U.S.?

Imported baby formula often contains milk or dairy products regulated by the USDA, whose responsibilities include preventing the proliferation of foot-and-mouth disease (FMD) among livestock in the U.S.

FMD isn’t transmissible to humans; however, if contaminated baby formula were introduced into the environment, the potential for the disease to spread would increase. This is one of the most noteworthy reasons infant formula can face strict oversight and compliance requirements. 

What Are the Biggest Barriers to Importing Infant Formula Commercially?

In addition to strict regulations, tariff rate quotas (TRQs), restrictions on import volume and the potential for labeling mismatches are among the barriers importers find most difficult to overcome when importing infant formula.

• Import Volume Restrictions: For 2026, infant formula is limited to an aggregate import volume of 100,000 kilograms on affected HTS codes.

• Meeting Federal Regulations: Per Title 21 of the Code of Federal Regulations (CFR), infant formula marketed in the U.S. must:
  • Contain a calcium-to-phosphorus ratio between 1.1 and 2.0
  • Contain a maximum of 4.5 grams of protein per 100 kilocalories
  • Meet adjusted minimum protein levels based on quality compared to casein
  • Only contain vitamin K in approved forms
• Labeling Mismatches: Infant formulas with labels that don’t accurately reflect nutrient values, iron levels, preparation instructions, or required warnings can trigger FDA holds.

These difficulties arise from a combination of protectionist trade policies and regulations that are meant to ensure that baby formula is free of harmful additives and toxins. Even with those policies in place, several countries export infant formula to the U.S. in significant volumes.

Which Countries Currently Export Infant Formula to the U.S.?

According to 2024 data from OEC World, the five countries that supply the most infant formula to the U.S. by value are Ireland, the United Kingdom, Mexico, Spain, and Germany. The precise values of each country’s infant formula exports to the U.S. can be viewed in the following table.

Top Five Suppliers of Infant Formula to the U.S. in 2024

Among the countries listed, Ireland is notable for its abundant and high-quality dairy goods (a key ingredient in many infant formulas), and Mexico currently benefits from reduced or removed duties as a result of the United States-Mexico-Canada Agreement (USMCA). 

Which Imported Formulas Have FDA Approval?

While the FDA does not approve infant formula for sale in the U.S., manufacturers must ensure their formula complies with the administration’s requirements regarding food safety, nutrition information, labeling requirements, and pre-market reviews for new formulations.

To meet those requirements, the formula must meet FDA nutrient requirements and applicable safety, testing, and labeling standards, be tested for the pathogens Salmonella and Cronobacter, be free of adulterants, and use water that passes Environmental Protection Agency (EPA) safety standards. 

The FDA maintains a list of all infant formulas available in the U.S. market on their website. 

When Should Importers Work With a Customs Broker for Infant Formula?

Importers should consult or partner with a Licensed Customs Broker to import baby formula when they need to confirm an HTS code, determine the FDA compliance of a supplier and/or their commodities, are unsure whether their imported formula is labeled correctly, or need assistance with filling out and submitting general importing documents like the entry summary.

If you have questions about importing baby formula for commercial purposes, call us at (855) 912-0406 or fill out a contact form online today. 

Sources:

NARA ORGANICS RECALLS ALL LOTS OF NARA INFANT FORMULA BECAUSE OF POSSIBLE HEALTH RISK, U.S. Food & Drug Administration

Infant Formula Homepage, U.S. Food & Drug Administration

Requirements for importing baby formula, U.S. Customs and Border Protection

Infant foods of cereals, flour, starch or milk, retail, The Observatory of Economic Complexity

Triple boost for Irish powder exports amidst US infant formula shortage, Teodora Lyubomirova, Dairy Reporter

Infant Formulas Marketed in the U.S., U.S. Food & Drug Administration