Food & DrinkThe supply of infant formula

The supply of infant formula


The US Food and Drug Administration (FDA) continues its efforts to increase the supply of infant formula production in the United States.

As part of this effort, imported infant formulas that have been reviewed by the FDA are hitting store shelves and on the websites of formula companies and major retailers.

Since these products are new to the US market and therefore new to you, you may have questions about them. It is important to talk with your child’s healthcare provider for advice on appropriate formulas to substitute as you consider her options.

Increase the supply of infant formula safely

To increase the supply of infant formula in the US, the FDA established a process for companies that do not normally sell their infant formula in the US to apply to do so on a temporary basis.

Under the process, the FDA reviews much of the same information as under normal circumstances to help ensure that infant formula is safe and nutritious. The review includes:

  • The nutritional composition and ingredients of infant formula.
  • Microbiological and nutrient tests of the final product.
  • Facility inspection history.
  • Manufacturing procedures and controls.
  • Quality control procedures.

The FDA will also ensure that all new infant formula products have label information about allergens and instructions for preparing and using the formula.

How to identify new FDA-reviewed infant formula products

The process applies to companies outside of the US and also to some companies in the US For example, a US company that manufactures infant formula solely for export may apply to sell its product here.

The FDA created a web page listing infant formulas that can be distributed in the US under the streamlined process, known as “enforcement discretion.”

The website lists regular infant formulas and specialized ones for babies with special medical needs. The information is updated regularly.

There are a variety of imported products on the list, including organic formula and a goat’s milk formula.

Safe imported formula preparation

Since some of the formulas being distributed come from other countries, the labels and instructions may contain terms you are not used to seeing, such as metric measurements.

To help you safely prepare imported infant formulas, the FDA has created a tip sheet. It shows conversion measurements from milliliters to fluid ounces and temperatures from Celsius to Fahrenheit (◦C to ◦F).

Thumbnail and link to Tips for Preparing Imported Infant Formula Spanish language pdf.

Tips for preparing imported infant formula (PDF)

How to avoid counterfeit infant formula products and other safety tips

The FDA monitors online marketplaces for fraudulent products. When harmful or violative products are discovered, the FDA works with major online retailers to remove those products from sale on online sites. Also, since many of these fraudulent products originate abroad, they are screened by the FDA at ports of entry. The FDA also monitors and tracks information coming in from outside sources, such as consumer complaints about possible counterfeit and fraudulent products.

The FDA has information about what counterfeit formulas are and how you can avoid buying them. And the Federal Trade Commission has information to help you avoid online scammers.

Do not use homemade or diluted infant formulas

The FDA advises against the use of homemade infant formulas. Homemade infant formula recipes have not been evaluated by the FDA and may not contain nutrients vital to a growing baby.

Also, don’t try to make your formula last longer by adding more water (diluting it). Diluting the formula can affect the nutrient levels in the formula and cause serious health problems.

Informational Resources from the FDA and HHS

The FDA and our government partners have created informational resources to help you make decisions about feeding your baby.

The FDA web page Information on infant formula and the FDA’s ongoing efforts to increase supply is a portal for FDA information, including the latest news on infant formula.

And the US Department of Health and Human Services (HHS) Information for Families During Missing Formula web page has a wide range of information in multiple languages. Includes advice from doctors and experts on how to try new formulations and safe substitution.

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