The U.S. Food and Drug Administration has published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure the U.S. continues diversifying its infant formula market and make families less susceptible to shocks in the infant formula market.
Specifically, the FDA is continuing, under certain conditions, to exercise enforcement discretion relating to the importation and sale in domestic commerce of certain infant formula products as part of its effort to provide stable, longer-term access to safe and nutritious infant formula across the country. The FDA is communicating directly with, and has made available to manufacturers, the steps to take to continue marketing certain formulas under enforcement discretion while they work to meet all U.S. regulatory requirements. In July 2022, the agency committed to developing a new framework for continued and expanded access to infant formula products for U.S. parents and caregivers.
“We’ve made important progress toward improving the infant formula supply in the U.S. and paving the way for a more robust and diverse marketplace for the future. However, the FDA can’t do it alone. We’ll need to work with all stakeholders to evaluate what other steps could be taken to encourage a more diverse and resilient infant formula marketplace,” said FDA Commissioner Robert M. Califf, M.D. “Manufacturers from around the world have demonstrated their commitment to helping bolster U.S. supply and, in turn, we are committed to continuing these flexibilities for their products to safely remain on the market while ensuring they meet our standards.”
In May 2022, the FDA announced increased flexibilities for the importation of infant formula products to address the temporary supply shortage. The FDA has issued 16 enforcement discretion letters to eight companies across nine countries, which has helped to ease the shortage, replenish store shelves and diversify the supply of infant formula in the U.S. As of September 2022, this work has resulted in the import, or planned import, of safe and nutritious infant formula, which the companies estimate to be about 403 million 8-ounce bottles (18.9 million cans). Enforcement discretion for these products was set to expire Nov. 14, 2022; however, under certain conditions outlined in the guidance, the new guidance extends that date to Jan. 6, 2023, or longer.
Manufacturers currently marketing their products in the U.S. under enforcement discretion should send a letter to the FDA by Dec. 5, 2022, outlining their intent to pursue completion of all regulatory requirements. Upon receipt, the agency intends to evaluate the request to determine whether to extend the period of enforcement discretion and issue a new letter of enforcement discretion by Jan. 6, 2023. For manufacturers that receive a new letter of enforcement discretion, the FDA does not intend to object to the continued marketing of covered infant formulas in the U.S. through October 2025 while the manufacturers take steps to achieve compliance with all requirements that apply to their products. Some manufacturers may have most of the information needed to meet all U.S. requirements, and therefore, could achieve compliance fairly quickly, while others may need the full timeframe being provided.
“The FDA remains committed to strengthening the U.S. infant formula market, ensuring one of the nation’s most vulnerable populations have access to safe, nutritious products,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “In addition, we understand that the continued availability of infant formulas brought in through enforcement discretion is important for infants who started on a specific formula during the shortage and now are accustomed to that formula as an essential source of nutrition.”
All companies — including those who received enforcement discretion — seeking to market their products long term in the U.S. must ultimately comply with all regulatory requirements, including those related to safety, nutrient adequacy, labeling and packaging. The FDA continues to review submissions from infant formula manufacturers that are received through the established regulatory pathway. Among the requirements for infant formulas, the FDA specifies minimum amounts for 30 nutrients that must be included. For 10 of these nutrients, there are maximum amounts as well. In addition, any ingredient used in infant formula must be safe and suitable for such use. The FDA also has specific requirements for labeling infant formulas. Such requirements include directions for preparation and use, a pictogram showing the major steps for preparing infant formula, use by date, and instructions indicating whether water should be added. The requirements for imported or domestically produced infant formula are the same. Infant formulas also must meet the quality factor requirements in our regulations, namely, sufficient biological quality of protein and the support of normal physical growth of infants. Typically, these quality factors are demonstrated through specific types of studies detailed in the FDA’s regulations. Facilities that manufacture infant formula are also subject to inspection.
