Background

The Food and Drug Administration has increased its flexibilities regarding the importation of certain infant formula products and is encouraging manufacturers worldwide to take advantage of these flexibilities. This action comes in response to a shortage of infant formula in the U.S. following a recall of some products and a related temporary shutdown of a major U.S. manufacturing facility.

According to an FDA press release, the U.S. normally produces 98 percent of the infant formula it consumes, with the rest supplied by imports primarily from 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 U.S., the FDA has outlined a process by which it would not object to (1) imports of certain infant formula products intended for a foreign market or (2) distribution in the U.S. of products manufactured in the U.S. for export to foreign countries. The FDA also may provide flexibilities to those who manufacture infant formula products domestically for export and may be able to further increase 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 provides adequate nutrition; e.g., labeling, information on nutritional adequacy and safety testing, and information about facility inspection history. The FDA says it intends to prioritize submissions for products that can demonstrate 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 new flexibilities follow other steps the FDA has taken to allow for increased formula imports, including (1) expediting the necessary certificates to allow for flexibility in the movement of already-permitted products from abroad into the U.S., (2) offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records, and (3) exercising enforcement discretion on minor labeling issues for both imported and domestic products.

For more information on this or other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

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