Child Health
FDA Outlines Immediate National Strategy to Further Increase the Resiliency of the U.S. Infant Formula Market
Last Updated on March 29, 2023 by Daily News Staff
The U.S. Food and Drug Administration released a national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable populations continue to have access to safe, nutritious infant formula and to increase resiliency of the U.S. infant formula market and supply.
“Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible,” said FDA Commissioner Robert M. Califf, M.D. “Now, with this strategy, we are looking at how to advance long-term stability in this market and mitigate future shortages, while ensuring formula is safe”
The Food and Drug Omnibus Reform Act of 2022 (FDORA) directed the FDA, in consultation with other federal government partners, to develop this immediate strategy to increase the resiliency of the U.S. infant formula market. Key elements of the immediate strategy released today include:
- Ensuring industry is aware of requirements to develop and implement redundancy risk management plans. These plans are intended to help industry identify risks to the supply chains of infant formula and medical foods and to develop mitigation plans against potential disruptions that could impact production.
- Continuing to enhance inspections of infant formula manufacturers, including by expanding and improving infant formula training for investigators.
- Expediting review of premarket submissions for new infant formula products to mitigate or prevent shortages.
- Continuing to monitor the infant formula supply and developing a forecasting model to enable FDA to prepare for and mitigate future supply disruptions.
- Engaging with U.S. government partners who play a role in mitigating other factors that may influence the infant formula supply, such as tariffs and market concentration, to sustain the safe, continuous production of infant formula.
- Engaging with the U.S. Department of Agriculture to support efforts to build resiliency within its Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
- Continuing to advance the agency’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula.
- Improving the agency’s consumer education materials relating to infant formula on FDA.gov.
- Enhancing and leveraging the FDA’s partnerships with health care providers and professionals, particularly infant care professionals, to further expand the agency’s consumer education program.
These actions are well underway. FDORA also called on the FDA to trace the events that led up to and followed the voluntary recall of infant formula in February 2022 by Abbott Nutrition, the temporary pause in production at the facility in Sturgis, Michigan, and the numerous factors that contributed to the fragility of this particular supply chain.
“The events that led up to and ultimately resulted in the voluntary recall of certain infant formula products in February 2022 shocked the infant formula supply in the U.S., creating an unparalleled challenge for parents and caregivers,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “Since then, the agency has had ongoing and extensive engagement with the infant formula industry to identify and implement opportunities to strengthen preventive control practices. The immediate strategy released today will play an important role in increasing the resiliency of the infant formula market as the agency continues its critical work to improve industry’s processes and programs for the protection of those who rely on infant formula while incentivizing additional infant formula manufacturers to enter the market.”
The strategy also describes initial actions the FDA took to address the infant formula shortage and details the agency’s plans for improving the safety and resiliency of the infant formula supply, while noting considerations beyond the purview of the FDA.
The agency remains committed to improving the infant formula supply and ensuring that consumers have the utmost confidence that infant formula available in the U.S. is safe and nutritious.
This initial strategy represents a first step toward issuing — with input from the National Academies of Science, Engineering and Medicine (NASEM)— a long-term national strategy, also called for in FDORA, to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain and preventing contamination. That long-term strategy will follow the plan released today and outline methods to incentivize entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend necessary authorities to gain insight into the supply chain and risks for shortages. The long-term strategy is due to Congress one year after enactment, or 90 days after the NASEM issues its report. The FDA anticipates issuing this strategy publicly in early 2024.
Related Information
- Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
- Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, Constituent Update
- FDA’s Infant Formula Response Activities – Fact Sheet
Source: FDA
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Food and Beverage
A Lesson in Kindness, Inclusion and How Kids Eat Differently
Kids Eat Differently: The school year brings new classmates, routines and opportunities for children to learn about people whose experiences may be different from their own. They could include friends who use a wheelchair, carry an inhaler or even receive nutrition through a feeding tube.
A Lesson in Kindness, Inclusion and How Kids Eat Differently
(Feature Impact) The school year brings new classmates, routines and opportunities for children to learn about people whose experiences may be different from their own. They could include friends who use a wheelchair, carry an inhaler or even receive nutrition through a feeding tube.
Watch this video to learn more
For families who rely on tube feeding, it is an essential part of daily life but is often understood only by those who experience it. That limited awareness can leave children who are tube fed and their families feeling isolated or unseen, according to Gerard Minor, a pediatric gastroenterology and hepatology specialist.
Parents can use everyday questions as opportunities to help children understand there are many ways people receive nourishment. Teachers, classmates, caregivers and communities can also help make tube feeding part of the everyday conversation around childhood rather than something that separates children from it.
“Helping children understand those differences early can encourage curiosity, kindness and inclusion,” Minor said.
To help bring greater awareness, understanding and representation to children and families who experience tube feeding every day, Compleat, a leader in tube feeding formulas, launched “What Is Better Than How,” featuring “Sesame Street’s” Elmo and his signature warmth and curiosity. The original song celebrates the many ways people eat. Some people eat with a fork, some use a spoon and some use a tube, reinforcing a simple message: What matters is not how you eat. What matters is that you are nourished, loved and included.
To hear the song, create a personalized version and learn more about the campaign, visit Compleat.com/WhatIsBetterThanHow.
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Child Health
Changing the Landscape of Childhood Cancer Survivorship
Childhood Cancer: hile “cancer” is a term no family wants to hear, especially when it comes to their children, there is reason for hope. Today, 85% of children diagnosed with cancer survive at least five years. Survival is only part of the journey, however.
Changing the Landscape of Childhood Cancer Survivorship
(Feature Impact) While “cancer” is a term no family wants to hear, especially when it comes to their children, there is reason for hope. Today, 85% of children diagnosed with cancer survive at least five years, according to the National Cancer Institute, up from 75% three decades ago.
Watch this video to learn more
“This progress is driven in large part by dedicated research,” Hyundai Hope on Wheels Board Member Kevin Reilly said. “Over the last 28 years, Hyundai Hope on Wheels has committed over $300 million in pediatric cancer research and program grants, awarding more than 1,600 grants to 210 medical institutions nationwide, impacting thousands of young lives each year.”
Survival is only part of the journey, however. Nearly half (46%) of U.S. adults believe a child ringing the hospital bell after cancer treatment means the child is cancer-free and their medical journey is largely over, according to a survey conducted by Atomik Research on behalf of Hyundai Hope on Wheels. For the children and families living through a diagnosis, the reality is far more complex.
“The reality is that healing continues long after treatment, which is why sustained investment in survivorship care is a priority for us,” said John Guastaferro, executive director of Hyundai Hope on Wheels.
Isabella Franco-Capps, 11, understands that journey firsthand. Diagnosed with B-cell acute lymphoblastic leukemia at age 5, her journey took two years before she could say she’s “a cancer survivor.”
“I was diagnosed with b-cell acute lymphoblastic leukemia,” she said. “This began my two-year-long journey of scans, pokes, chemotherapy and hospital stays. And now I’m a cancer survivor.”
Fellow Hyundai Hope on Wheels National Youth Ambassador, Jackson Trihn, 12, is using his voice to call for continued research and to bring hope to others.
“The role … is being able to share my story,” he said. “Not just to spread awareness but to spread hope to kids that need it. And awareness is so important because people don’t understand how hard pediatric cancer can be.”
Continued progress can help ensure more children ring the bell and receive the care and support they need long after they’ve had the opportunity to do so. To learn more about these efforts and how you can help, visit HyundaiHopeOnWheels.org.
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💪 Your health journey starts here! Explore the latest health news, fitness tips, wellness trends, and healthy living advice. Share your thoughts in the comments and subscribe to the STM Daily News newsletter to stay informed and inspired every day.
Women's Health
From Pregnancy to Parenthood: How Medicaid Supports Women Across the Maternal Health Journey
When women are planning, expanding or raising families, access to healthcare is a vital source of physical and mental support. For millions of women and families across the U.S., Medicaid provides that support, enabling parents and children to access the reproductive, maternal and pediatric healthcare they need to thrive.
(Feature Impact) When women are planning, expanding or raising families, access to healthcare is a vital source of physical and mental support. For millions of women and families across the U.S., Medicaid provides that support, enabling parents and children to access the reproductive, maternal and pediatric healthcare they need to thrive. It’s there for anyone who needs it, from working adults to families navigating unemployment or disability.
To learn about how Medicaid supports growing families through every stage of the parenthood journey, consider this information from the maternal health experts at Community Catalyst.
Making Family Planning Possible
When people are able to plan and prepare to welcome children into the world, it can remove a lot of stress, uncertainty and complication from their journeys. Medicaid family-planning coverage may include reproductive health counseling, pre-pregnancy screenings, many forms of FDA-approved contraception and other preventive services. Comprehensive access to birth control allows women and couples to make their own decisions about pregnancy timing or spacing between siblings.
Supporting Healthy Pregnancies
Pregnancy is no small endeavor, and a woman with a healthcare team at her side is better prepared to face whatever challenges may arise. Pregnancy often requires frequent appointments for ultrasounds, laboratory testing and monitoring – all of which are made possible and affordable through Medicaid. Since 1 in 4 Medicaid recipients are women ages 15-49, this care can make a difference during their childbearing years.
Covering Labor and Delivery Costs
Labor and birth can be unpredictable, but being able to afford them shouldn’t be. Without Medicaid, which finances approximately 41% of U.S. births, based on data from the National Center for Health Statistics, the cost of hospitalization and delivery could be financially devastating to young families. Coverage for labor, delivery and NICU care, if needed, gives parents the ability to focus on their new babies instead of overwhelming medical bills.
Providing Postpartum Care
The need for maternal healthcare doesn’t end when mother and child are discharged from the hospital. Physical recovery takes time, especially if there were any complications during the pregnancy or delivery. Beyond that, postpartum women may need mental health support, treatment for chronic conditions, contraception renewals and other health services that Medicaid can provide. Currently, 49 states plus Washington, D.C. have extended postpartum Medicaid coverage to 12 months, which helps new mothers get continuous care without worrying about insurance lapses.
Caring for Growing Kids
Nearly half of all Medicaid recipients in the U.S. are children ages 0-18 – and sometimes kids qualify for Medicaid even when their parents don’t. The program can help new parents stay up to date with well-child visits for infants, immunizations and ongoing preventive care throughout childhood.
To learn more about access to essential services at every stage of life, visit communitycatalyst.org/maternalhealth.
Filling Gaps in Pregnancy and Postpartum Care: Kayla and Tru’s Story
When Kayla found out she was pregnant at 24 years old, she had no idea how she was going to afford all the costs that were coming. Despite having part-time employment and primary insurance through her mother, she faced gaps in coverage for pregnancy care.
Qualifying for Medicaid changed everything. Not only did it cover Kayla’s prenatal visits, labs, ultrasounds and delivery, but once her son Tru was born, both mother and baby required an extended hospital stay. Medicaid made it possible for Tru to get the care he needed in the NICU while Kayla recovered from birth complications.
Afterward, the program continued to cover Kayla and Tru for follow-up appointments and well-child visits. She’s grateful it was there during her time of need and has one simple message to share: If you qualify for Medicaid, apply.
“You never know what’s going to happen,” she said. “I didn’t expect to be in the hospital as long. I didn’t expect for him to be where he was. But it was definitely needed and helpful.”
Photo courtesy of Shutterstock (mother leaning over hospital bassinet)
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