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FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability
May 16, 2022
Dear International Colleague,
Today, the U.S. Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.
“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.”
The U.S. normally produces 98% of the infant formula it consumes, with the primary source of imports coming from trading partners in Mexico, Ireland and the Netherlands. However, given the production and distribution issues that have led to reduced supplies of infant formula in some parts of the country, the FDA has outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. It also may provide flexibilities to those who manufacturer infant formula products domestically for export and may be able to increase further domestically produced product for the U.S. market.
Companies seeking to take advantage of these flexibilities should submit information for the FDA to quickly evaluate whether the product can be used safely and whether it provides adequate nutrition. For example, labeling, information on nutritional adequacy and safety testing, and information about facility inspection history. The agency intends to prioritize submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest. The FDA is already in discussions with some manufacturers and suppliers regarding additional supply.
As part of a number of significant actions the FDA has undertaken since February 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. This work has already resulted in more infant formula coming into the U.S. Imports of infant formula year-to-date are up more than 300% from last year. The FDA has and will continue to actively work with the U.S. Department of Agriculture, U.K., and European authorities to expedite entry for products made abroad.
All of this around-the-clock work has already begun to improve supply and availability with most manufacturers, now producing at normal or expanded capacity. The FDA expects that the measures and steps it is taking with infant formula manufacturers and others will mean more and more supply is on the way or on store shelves moving forward.
Data from Information Resources Inc. (IRI) indicate that in-stock rates in retail stores are improving and the FDA’s actions are expected to continue to increase product availability. While some data suppliers have reported lower in-stock rates, the most complete data sets available from IRI are showing nearly 80% in-stock rates at the week ending May 8. The agency’s best current assessment is that with all of the current actions, including today’s announcement, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility to safely resume production in the near-term, the supply of infant formula will continue to improve over the next couple of months. In the meantime, the agency is encouraged to see that as of early May the amount of infant formula sold in the U.S. continues to rise.
It is important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula products that would not pose significant health risks to consumers. The agency continues to advise against making infant formulas at home. Caregivers are encouraged to work with their child’s health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services has also released a fact sheet with information to help families find infant formula.
The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.
The FDA is holding a media briefing to discuss its plans to exercise flexibilities regarding the importation of certain infant formula products from abroad. The 7 p.m. EDT press conference is accessible on www.youtube.com/watch?v=uFg9mpDDuzknd and can be rewatched there.
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