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FDA is increasing import flexibility for certain infant formula products to increase availability while protecting the health of infants.

The agency is encouraging suppliers worldwide to take advantage.

As part of a number of significant actions the FDA has undertaken to increase supply, the agency had already implemented a streamlined process to facilitate the importation of infant formula at U.S. ports of entry so that formula coming from abroad can be dispersed quickly throughout the country.

The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D. “Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely. We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”


Useful Links & Resources

  • FDA Encourages Importation of Safe Infant Formula

  • Helping Families Find Formula During Shortage

  • Updates on Activities to Mitigate Formula Supply Challenges

  • Guidance: Infant Formula Enforcement Discretion Policy


FDA: Notice to FSVP Importers & Filers (Example)


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