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FDA Outlines Immediate National Strategy to Further Increase the Resiliency of the U.S. Infant Formula Market

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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.

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Healthy Holiday Tips for Pregnant People

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(Family Features) The holidays often bring colder weather and more indoor gatherings. Respiratory viruses like flu, COVID-19 and RSV are common this time of year.

Illness from these viruses can be dangerous for pregnant people and newborns. Staying up to date on vaccines for flu, COVID-19 and RSV during pregnancy can offer protection, and now is the time to get vaccinated if you haven’t already.

“During the holidays, pregnant people can help protect their health and the health of their baby by getting updated vaccines,” said Dr. Rachel Levine, assistant secretary for health at the U.S. Department of Health and Human Services (HHS). “During the holidays, you’re more likely to be exposed to flu, COVID-19 and RSV. Vaccination not only helps build up your immune system but can give protection for your little one.”

Here are some tips from the HHS Risk Less. Do More. public education campaign for a safe and festive holiday season:

Get vaccinated against flu and COVID-19. Getting sick with flu or COVID-19 can be dangerous for people who are pregnant and young infants. During pregnancy, there is a greater risk of flu or COVID-19 infections becoming severe and leading to hospitalization. Babies are also at risk of severe flu and COVID-19, but they cannot get vaccines until they are 6 months old. By getting vaccinated during pregnancy, you pass on antibodies that help protect your baby during the first few months of life.

Get vaccinated against RSV if you’re eligible. RSV is a common cause of severe respiratory illness in infants. In fact, it is the top reason babies in the United States are hospitalized each year. You can get an RSV vaccine if you are 32-36 weeks pregnant between September and January, the months when RSV spreads the most. The RSV vaccine helps your baby build protection from severe RSV before birth. If you do not get an RSV vaccine during pregnancy, your newborn can still get protection through a preventive antibody immunization soon after birth.

Stay home or change plans when ill. If you are not feeling well, stay home to avoid spreading illness. Also, if someone you plan to see is sick or respiratory viruses are surging in your community, consider staying home. You can also wear a mask or, if weather permits, move the gathering outdoors.

If you have questions or concerns, talk to your doctor. Knowing the facts about vaccines and pregnancy can offer confidence and comfort. Visit cdc.gov/RiskLessDoMore to learn more about getting your flu, COVID-19 and RSV vaccines before the holidays. Or visit vaccines.gov to get started.

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United States Department of Health and Human Services

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.


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Take the Stress Out of Introducing Solid Foods to Baby: 6 pediatrician-recommended tips

Watching your baby learn and grow can provide some of the most rewarding moments in life, full of emotions from parents and babies alike.

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Baby

(Family Features) Watching your baby learn and grow can provide some of the most rewarding moments in life, full of emotions from parents and babies alike. Some milestones are more stressful or frustrating than others and, during these moments of newness, seeking guidance from health care professionals can go a long way.

Healthy Baby

As the 2020-2025 Dietary Guidelines for Americans recognize, the time period from 6-24 months is when babies begin building healthy eating patterns and experience eating a variety of foods, including vegetables, fruits and whole grains. This journey can be stressful for parents as they begin to navigate what and how much is right to feed their babies. As parents begin to explore this fun and messy milestone, they often question what and how much is right to feed baby and seek guidance from experts.

While every child is different and parents should always defer to their pediatrician to be sure their baby is developmentally ready for solid foods, consider these six tips and tricks based on frequently asked questions for transitioning to solids from Dr. Whitney Casares, MD, MPH, pediatric medical consultant for Gerber.

  • Make sure baby is ready: Most babies start solid foods between 4-6 months old. Watch for signs your baby is ready to start solids like good head control, sitting up with support and swallowing food instead of pushing it back out onto his or her chin. Don’t introduce solids to your baby before 4 months old. Your pediatrician can offer guidance about when the time is right for your little one.
  • Timing is everything: When you’re first introducing solids, choose a moment in the day when your baby is happy and alert. Weekends tend to be easier times to start solid foods for families than busy weekdays. The more you can be in the moment with your child during those first feeding experiences, the better for you and him or her.
  • Feed your baby the rainbow: Offer baby a diverse array of fruits, vegetables, iron-fortified whole grains and meats. Over the first six months of your baby’s feeding journey, iron-fortified cereals and purees can make feeding your baby convenient and simple. From apple and pear to zucchini, butternut squash and parsnips, Gerber’s 1st and 2nd foods lines offer a variety of purees that are just the right consistency for babies to practice tongue movements and advance their eating skills. Your baby’s first tries at swallowing solid foods may be awkward and require practice. Offering a small amount of breastmilk or formula before solids can help ensure he or she is not uncomfortably hungry.
  • Supervise baby: Babies should always be supervised and seated in a secured highchair when eating, and parents should avoid choking hazards like whole grapes, nuts or cherry tomatoes. Use a soft, rubber-tipped spoon and start by guiding the spoon to his or her mouth with both your hand and your child’s hand on the spoon.
  • Baby-led feeding: Consider baby-led feeding as a way to capitalize on the best aspects of baby-led weaning and spoon-feeding. Offer small amounts of nutritious foods in soft, easy-to-pick-up chunks appropriate for your baby’s developmental stage in addition to purees by pre-loading the spoon with your baby’s favorite puree or infant cereal for him or her to self-feed. As your baby gets older, look for baby-led friendly snacks, such as Gerber Lil’ Crunchies, that are specifically designed for babies to self-feed and fortified with key nutrients.
  • Don’t get discouraged: Just because your baby makes a “yuck” face after trying a food for the first time doesn’t mean you should give up on it. Babies often need to try solid foods several times before they grow accustomed to them. Don’t be discouraged if your first attempt with a food seems less than successful; it’s all part of the process.

For more expert tips and resources for introducing solid foods, visit Gerber.com/learning-center.
 

Photos courtesy of Getty Images

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Gerber

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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5 Tips to Keep Kids Healthy During the Holidays

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(Family Features) As the year comes to a close, the weather gets colder and indoor festivities ramp up. Keeping children and their families healthy during the holidays should be a priority for everyone.

Healthy Kids

“While gathering with friends and loved ones is an exciting and important part of the holiday season, staying healthy should still be on top of your ‘to-do’ list,” said Drs. Tress Goodwin and Joelle Simpson, KinderCare medical advisors. “Simple actions can be some of the most effective at keeping everyone healthy to ensure this season is a joyous one.”

Consider these five tips from KinderCare’s medical experts to keep in mind throughout the holidays.

  1. Wash hands regularly. One of the simplest ways to prevent germ spreading is to wash your and your children’s hands often using soap and water or an alcohol-based sanitizer. Try to remember to wash your hands after leaving public places, before eating and after any diaper change or restroom visit. If someone in your home is not feeling well, wash your hands more often.
  2. Share joy, not germs. Try to distance yourself from anyone who is sick (like those with coughs and colds) and avoid close contact with others when you or your child are sick. Encourage children to cough or sneeze into their elbows if no tissues are available. As a good at-home practice, regularly clean and disinfect commonly touched surfaces such as toys, cabinet and doorknobs, counters and tabletops.
  3. Keep meals well-balanced. Offer a healthy snack before holiday treats or make healthier versions of holiday favorites. Consider healthy snack options like fresh vegetables, fruits and dip, dried fruits, nuts or roasted sweet potatoes that can boost immunity for children and help balance out sugary treats. It’s also important to remember to eat healthy portion sizes and encourage children to listen to their bodily cues for hunger and fullness. Avoid juices or other sugary drinks and encourage children to drink plenty of water.
  4. Schedule personal time and get plenty of rest. Festivities can be merry but also overwhelming, especially for young children. Loud music, bright lights, lots of people and changes in schedules can leave them feeling overstimulated, which can lead to emotional outbursts. Make sure to leave some time in your week for simple joys, like cuddling up to read a book together or quiet play with immediate family members, so children have a chance to step out of the hustle and bustle. Remember holidays are meant to be fun, not stressful. While it may be tempting to pack every day with fun-filled activities, try to maintain children’s routines, including nap and bedtime schedules.
  5. Stay active. No matter what the weather is like, kids still need time to be physically active. Indoor play can be just as effective as time spent on the playground. Get creative with at-home winter fun with activities like dance parties, scavenger hunts and kids’ yoga. You can also visit indoor locations such as malls and museums to get those legs moving.

For more information or tips on holiday eating, indoor exercise and keeping children safe during the holidays, visit KinderCare.com.

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KinderCare

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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