The U.S. Food and Drug Administration continues efforts to increase the supply of infant formula production in the U.S.
As part of the efforts, imported infant formula that’s been reviewed by the FDA is showing up on store shelves and on the websites of formula companies and major retailers.
Because these products are new to the U.S. market, and therefore new to you, you may have questions about them. It is important to talk with your child’s health care provider for advice and the appropriate formulas to substitute as you consider your options.
Safely Increasing the Supply of Infant Formula
To increase the supply of infant formula in the U.S., the FDA set up a process so that companies that don’t normally sell their infant formula in the U.S. can request to do so on a temporary basis.
Under the process, the FDA reviews much of the same information it does under normal circumstances to help ensure infant formula is safe and nutritious. The review includes:
- The infant formula’s nutritional composition and ingredients.
- Microbiological and nutrient testing for the finished product.
- Facility inspection history.
- Manufacturing procedures and controls.
- Quality control procedures.
The FDA also will ensure any new infant formula products have labeling information about allergens and directions for preparation and use of the formula.
Identifying New Infant Formula Products Reviewed by the FDA
The process applies to companies outside the U.S. and to some companies in the U.S. as well. For example, a U.S. company that makes infant formula solely for export could request to sell its product here.
The FDA developed a webpage listing the infant formula distributed in the U.S. under the process, known as enforcement discretion.
The webpage covers regular infant formula and specialty formulas for infants with special medical needs. Information is being updated regularly.
There’s a variety of imported products on the list, including organic formula and formula made from goat’s milk.
Safely Preparing Imported Formula
Because some of the formula being distributed comes from other countries, the labels and directions may have terms you are not used to seeing, such as metric measurements.
To help you safely prepare imported infant formula, the FDA created a tip sheet. It shows conversion measurements from milliliters to fluid ounces and temperatures from Celsius to Fahrenheit (◦C to ◦F).
Avoiding Counterfeit Infant Formula Products and Other Safety Tips
The FDA monitors online marketplaces for fraudulent products. When products that are harmful or violative are found, the FDA works with major online retailers to remove those products from sale on online sites. Additionally, since many of these fraudulent products originate overseas, the FDA targets and examines these products at ports of entry. The FDA also monitors and follows up on information that comes from outside the agency, such as consumer complaints about potential counterfeit and fraudulent products.
Do Not Use Homemade Infant Formula or Dilute Formula
The FDA advises against using homemade infant formula. Homemade infant formula recipes have not been evaluated by the FDA and may not have the nutrients vital to an infant’s growth.
Also, don’t try to make your formula last longer by adding more water to it (diluting). Diluting formula can decrease the nutrient levels in the formula and cause serious health problems.
FDA and HHS Information Resources
The FDA and our government partners have created information resources to help you make decisions for feeding your baby.
The FDA webpage Infant Formula Information and Ongoing FDA Efforts to Increase Supply is a portal to FDA information, including the latest infant formula news from the FDA and to Resources for Parents and Caregivers on Imported Infant Formula.
And the U.S. Department of Health and Human Service webpage Information for Families During the Formula Shortage has a wide range of information in multiple languages. It includes advice from physicians and experts on trying new formulas and safe substitution.