WASHINGTON aEUR
Wednesday's announcement by the Food and Drug Administration was made by the Food and Drug Administration. It announced plans to assist overseas producers who have shipped supplies to the United States under emergency approval. This will allow them to secure long-term authorization for marketing their formula in the United States.
This agency will allow producers to temporarily sell in the U.S. and meet current regulatory requirements. They can then stay on the marketplace, giving consumers more options and increasing supply resilience against future and present shortages.
The FDA will host meetings and offer producers a single point-of-contact to help them navigate the regulatory system. This will make the application process easier.
In a statement, the FDA commissioner Dr. Robert Califf and Susan Mayne (director of the Center for Food Safety and Applied Nutrition) stated that "the need to diversify and reinforce the U.S. Infant Formula supply is more urgent than ever." "The recent closure of a major infant formulation plant was caused by unanticipated natural weather events and has demonstrated how fragile the supply chain is."
After the February closure of a Michigan baby formula plant by Abbott, the country's largest manufacturer, the U.S. tried to increase supply. After the company had committed to further sanitizing the facility and safety protocols, the plant was reopened on June 4. However, it was closed again mid-June due to severe weather that caused the plant to be damaged.
According to the company, it will take time to assess damage and clean up after heavy rains and severe thunderstorms that swept through Michigan in June 13.
The FDA relaxed federal import regulations in May to allow baby formula to ship to the United States. President Joe Biden also authorized the use the Defense Production Act. This federal support allows formula to be imported from overseas and brought into the United States.
According to the White House, 43 million 8-ounce equivalents of infant formula will be imported into the United States by Sunday. The equivalent of 400 million 8 ounce bottles has been cleared by FDA for import into the U.S.
Califf and Mayne stated that infant formula is an essential food product and is the only source of nutrition for many babies in America. They also required that companies and manufacturing facilities meet strict FDA standards to ensure that the formula was safe and nutritious. These standards are essential to protect our children, and they will not be sacrificed because of long-term supply concerns.
Although the FDA's temporary enforcement discretion policy is due to expire in November of this year, the administration has stated that it will continue to enforce it if necessary to maintain domestic supply.
White House spokesperson Kevin Munoz stated that FDA's announcement today will make the infant formula supply market less susceptible to future supply shocks. It will also provide families with the assurance of consistent access to safe formulas.
