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.
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The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.
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.
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 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. ■