FDA Announces Increased Flexibilities Regarding Importation of Infant Formula

by t_king

infant formula

In an effort to further increase the availability of infant formula across the United States, while still protecting the health of infants, the U.S. Food and Drug Administration announced a new guideline on May 16th that outlines increased flexibilities regarding the importation of certain infant formula products. Manufacturers of infant formula worldwide are encouraged to take advantage of these flexibilities to help ensure that all infants have access to the nutrition they need.

The FDA recently stated “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,” stated 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.”

The new guideline provides increased flexibility in a number of areas, including:

  • Allowing manufacturers to distribute their products in the United States without first establishing a business presence here
  • Temporarily waiving certain labeling requirements
  • Providing guidance on how to submit required data to the FDA electronically

The agency is hopeful that these flexibilities will help increase the availability of infant formula products in the United States, and that manufacturers will answer the call to help meet the needs of infants across the country. For more information on the new guideline, please visit the FDA website.

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