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FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

For Immediate Release:

Today, the U.S. Food and Drug Administration announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U.S. 

“Parents and caregivers should have confidence that our collective work with federal partners, manufacturers and retailers means more infant formula that is safe and nutritious, including product coming in from other countries, is on shelves nationwide. The information and resources the agency is providing should help parents and caregivers find and understand how to use these safe, nutritious infant formula products that are comparable to those they’ve traditionally seen on store shelves,” said FDA Commissioner Robert M. Califf, M.D. “Importantly, a combination of increased domestic production and infant formula being imported is steadily improving what parents and caregivers are seeing on the shelves. We will continue our around-the-clock efforts to make sure that parents and caregivers have access to safe and nutritious infant formula where and when they need it.”

Flexibilities Have Resulted in More Than 520 Million Bottles Worth of Infant Formula Coming to the U.S.

As of July 8, FDA has helped facilitate the import of 524.1 million 8oz bottles (23.2 million cans) of safe and nutritious infant formula from other countries.

Increased flexibilities regarding infant formula products announced by the FDA on May 16 have resulted in the infant formula products from nine countries, with a total estimated quantity of 23 million cans, or 35 million pounds or more than 520 million full-size, 8-ounce bottles, headed to the U.S.  

These flexibilities have been successful in helping to bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis to address the formula shortage. Additionally, the FDA recently announced that it is developing a new framework for continued, long-term and expanded access to infant formula options for U.S. parents and caregivers beyond the current temporary flexibilities.

These products have already started to hit the U.S. market and more will appear in stores over the coming weeks and months. The FDA is creating “Names to Know” graphics featuring the label pictures and details about imported formulas to help parents and caregivers recognize these products as they hit store shelves. An accompanying infographic featuring the amounts of imported formula is also available.

New Resources for Parents, Caregivers on Using Safe and Nutritious Imported Infant Formula

The FDA is helping facilitate the import of safe and nutritious infant formula from other countries. FDA's review includes looking at the ingredients, nutrient testing, manufacturing safety, allergen labeling, and directions for preparation.

The FDA has created resources, including infographics and a Consumer Update for parents and caregivers to learn more about the factors the agency considered in determining whether to exercise flexibilities for these products and how they should be used. Additionally, the agency has created a series of short consumer videos of consumers’ most frequently asked questions.

Consumers should have confidence that the infant formula that is being imported to the U.S. through FDA flexibilities involved a thorough review of the information provided by the companies, including details about the product’s nutritional adequacy and safety, microbiological testing results, labeling information, and importantly, details about the manufacturing facility’s food safety production practices and inspection history.

Additionally, because formula that is available in the U.S. under FDA flexibilities is primarily coming from other countries, the labels and directions may have terms not normally used in the U.S., such as metric measurements. To help safely prepare imported infant formula, consumers are encouraged to use the FDA’s conversion chart to convert milliliters to fluid ounces and common conversions from Celsius (°C) to Fahrenheit (°F).

As a general practice, and especially for babies with certain medical conditions, it is important for parents and caregivers to talk with a baby’s health care provider for recommendations on changing feeding practices and formulas to substitute as options are considered because the provider will know the baby and his or her health history.

Tips on Where to Find Products and Comparable Formulas

Although the supply of infant formula is steadily increasing, there are tips available for consumers for finding safe substitutes in the interim, including trying a new brand of formula (see list of comparable formulas) and talking to a pediatrician or health care provider about submitting an urgent request for specialized formula

Many of the imported products are, or will be soon, available through regular places consumers would shop for infant formula, like major retailers, grocery stores and their online counterparts, as well as through company-specific websites. However, consumers are urged to be vigilant when buying formula that’s made outside of the U.S. from online marketplaces, as it has the potential to be counterfeit
 

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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