The U.S. Food and Drug Administration (FDA) announced guidelines to increase flexibility on the importation of baby formula to ease the strain felt by parents due to a nationwide shortage of supply.
These actions come after a nationwide shortage of baby formula was further exacerbated in the last several weeks, causing strain to families, especially among those reliant on specialty formula.
Abbott Nutrition, the largest manufacturer of infant formula in the U.S., initiated a voluntary recall of several lines of powdered formula on Feb.17 due to concerns about bacterial contamination at a Michigan facility. The recall was announced after four infants fell ill and two died.
Abbott's Sturgis, Michigan site is currently offline, but the FDA said it could reopen in the near term. The company said it would restart the plant within two weeks after the FDA confirms it has met its requirements.
“​​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 an adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D.
The U.S. normally produces 98 percent of the infant formula it consumes, with the primary source of imports coming from trading partners in Mexico, Ireland, and the Netherlands. As a response to the shortage, the FDA has outlined a process by which it would not reject the importation of certain infant formula products intended for a foreign market.
The FDA provided more flexibility to those who manufacture infant formula products domestically for export and may be able to increase further domestically produced products for the U.S. market.
Companies are encouraged to submit information to the FDA for a quick evaluation to determine whether products provide adequate nutrition.
“The agency intends to prioritize submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of product availability and/or those who can get product onto U.S. shelves the quickest,” an FDA statement read.
The agency said it is in discussions with some manufacturers and suppliers regarding additional supply. A streamlined process to facilitate the importation of infant formula was implemented shortly after the recall, resulting in a 300 percent increase in imports compared to 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,” the agency said in a statement.
A White House official said the government has offered transportation and logistics support to Abbott as well as Reckitt Benckiser, Nestle and Perrigo Co Plc (PRGO.N), and retailers such as Target Corp (TGT.N), Amazon.com Inc (AMZN.O) and Walmart Inc (WMT.N).
This week, Congress plans to address rules about the Women, Infants and Children (WIC) program, and emergency funding to increase supplies.
The public is discouraged from making infant formulas at home. Individuals can visit HHS.gov/formula for "resources and places that parents can go to obtain the formula, including contacts with companies, food banks (and) health care providers".
