I will not rest. The Granada facility has been producing a wide portfolio of powder products for infants and adults for more than 30 years and for distribution to more than 50 markets around the world. ", Ford wrote that Abbott believed that the voluntary recall "was the right thing to do.". Informal human milk sharing in the community also has risks. If your baby is vomiting, has gas pains, is crying or can't be calmed down during feedings, is losing weight, has diarrhea, has blood or mucus in their poop, or is straining to poop, they may not be tolerating the new formula. "We will not take risks when it comes to the health of children," he wrote. Abbottwillcontinue to pay rebates for competitive products through August 31. ", He added,"We'll need to be watching this every step of the way because as you know, we don't want to be sending product out which is dangerous for infants. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer. "And yes, we take great pride in manufacturing nutrition and formula to feed America's infants, including our most vulnerable," Ford wrote. We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. "However, the FDA's investigation did discover a bacteria in our plant that we will not tolerate. feedings. We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can. 2022 USA TODAY, a division of Gannett Satellite Information Network, LLC. How can I avoid buying such products? In all four cases, all unopened containers tested negative. Your pediatrician or other health care provider is always the best resource because they know your baby and their health history. He also wrote that consumers "can feel safe buying any Abbott product you find on the store shelves.". I want everyone to trust us to do what is right, and I know that must be earned back.". Abbott has been working with the USDAandWIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available. We have a global manufacturing and supply network were leveraging to better meet demand and increased production at an FDA-registered facility in Europe and are air freighting in Similac Advance infant formula powder. It can be tempting to buy as much formula as possible right now, but the AAP suggests buying no more than a 10-14 day supply to help improve shortages. Once it does, Abbott says it will start producing the formulas. Read more about the additional steps that President Biden is taking to address the formula shortage. Stores will start carrying or may already have these options. We know getting your baby high-quality infant formula is your priority it is ours too. Be patient, since it may take some time for your baby to get used to it. Today, President Biden spoke with retailers and manufacturers, including Wal-Mart, Target, Reckitt, and Gerber, to discuss ways we can all work together to do more to help families access infant formula. And this product will be available on retail shelves and online soon. The President, agencies across the U.S. government, retailers, and the formula industry are working around the clock to address this shortage and get formula back on shelves. These shipments will include powder Similac Total Comfort (for babies with sensitive stomachs) and Similac NeoSure (for premature and low birthweight infants after leaving the hospital), the equivalent of 686,350 cans or more than 16.5 million 8 fl. Homemade formula also increases the risk of contamination, which could make your baby sick or lead to infection. Families across the country remain concerned about the availability of infant formulaespecially families that depend on specialty formulas for which the Sturgis facility is a key supplier. Most types of formula may also be out of stock. "These steps we're taking won't end the struggles of families today," Ford wrote. About 43 percent of all babies in the U.S. receive help from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). oz. Ford's apology in a Washington Post op-ed noted that the shortage was sparked by the company's recall in February of formula made at Abbott Nutrition's plant in Sturgis, Michigan, after federal health officials found a potentially deadly bacteria there. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores. Abbott to Ship 1.1 Million Pounds of Powdered Infant Formula to U.S. from Spain Beginning this Month Through the Summer. The following provides current information on the findings from the investigation, our Sturgis, Mich., facility and supply. From the time we restart the site, it will take six to eight weeks before product is available on shelves. U.S. Department of Health & Human Services These products are being released to consumers in need in coordination with healthcare professionals. Our actions include: We know there are constraints in infant formula supply and were taking action to help address this. Talk to your pediatrician or other health care provider if you're considering using toddler drinks. In the meantime, we are working to increase the supply of infant formula by prioritizing infant formula production at our facilities that provide product to the U.S. market. Read the complete Washington Post op-ed here. The Biden-Harris Administration will continue to monitor the situation and identify other ways it can support the safe and rapid increase in the production and distribution of baby formula. Retailers such as CVS, Target, and Walmart have put purchase limits on formula. We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production. Abbott is committed to upholding the highest standards for manufacturing of all nutrition products. These actions will make it easier for vulnerable families to get the necessary nutritional support for their infants. We are continuing to make progress to fully restart production at our plant in Sturgis, Mich., and resumed production on July 1.
Ford said Abbott expects to restart the Sturgis plan in the first week of June, after entering into a consent degree with the federal Food and Drug Administration. Most notably, the professional assocationnow says parents can give whole cow's milkto babies who are older than six months and don't have any allergies or other special health needs, as long as they supplement it with iron-rich solid foods. In the second quarter of the year, we expect to produce nearly three times more Similac Ready-to-Feed liquid formula than we did during the same period of time last year. "Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening ourSturgisfacility so we can ease the nationwide formula shortage. They may be impacted by the shortage, too. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. We are offeringan increased number and value of coupons available for all our infant formula products, including Similac ready-to-feed, to enable customers to purchase formula, either free or deeply discounted. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. All fifty states should. Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area. Washington, D.C. 20201 This is 95% of what we produced in January, prior to the recall and does not include production from Sturgis. Next Post: Statement by Press Secretary Jen, https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/?utm_source=link. "These are the types of flexibilities that we are communicating in this guidance," Mayne said. Millions of parents rely on our formula to feed their babies. A Division of NBCUniversal. Theres nothing as important to families as the health and safety of their babies, and the formula shortage has left many people feeling anxious about how theyll feed them. We're also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can. Our Commitment to Industry-leading Quality and Safety. Toll Free Call Center: 1-877-696-6775, Information for Families During the Formula Shortage. We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we've been seeing and hearing the stress and despair of parents who are facing empty shelves. bottles of formula. The President invoked the Defense Production Act. Supply chain issues from the pandemic contributed to the current formula shortage. confirmed it will allow the sale of foreign formula in the U.S. How the baby formula shortage is costing parents, Here's what you can feed your baby and what you shouldn't, American Academy of Pediatrics put out new guidance Tuesday, becoming a financial crisis for many families, Your California Privacy Rights/Privacy Policy. Prioritizing Infant Formula Production in Columbus, Ohio. Your baby's nutritional needs are very specific, especially in the first year of life. "Some solutions will take weeks, others will take longer, but we will not rest until it is done. The formula may not be safe and may have lost some of its nutrients. If you cant find any formula and your baby is older than 6 months, talk to your pediatrician or other health care provider about using whole cows milk as a short-term option. The U.S. Department of Agriculture is working with states, tribal nations, and territories across the country to ensure that families who participate in WIC can use their benefits to purchase additional types of formula. Don't give your baby cow's milk for more than one week, or as instructed by your pediatrician or other health care provider. Talk to your pediatrician or other health care provider if you're thinking about giving your baby cow's milk. more about the additional steps that President Biden is taking to address the formula shortage. Avoid other plant-based milks, like oat or almond milk. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility. We have prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed. This law puts U.S. formula manufacturers first in line to receive the resources they need to increase formula production. Ford noted that Abbott converted production lines for its adult nutrition products at a plant in Columbus, Ohio, "to prioritize production of ready-to-feed liquid infant formula.". We've also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of. At this facility we've made significant changes to ensure we can prioritize production of Similac Ready-to-Feed liquid formula, a product that can be used directly from the bottle. On Monday evening, baby formula producer Abbott announced it had reached a deal with the Food and Drug Administration, laying out a path to reopen a factory in Sturgis, Michigan,that shut down amid recalls earlier this year, contributing to the current shortage. Please enable JavaScript to use this feature. Todays action paves the way for companies who dont normally distribute their infant formula products in the U.S. to do so efficiently and safely," Califf said in a statement. A portion of the inventory will be provided as emergency samples to areas of the country experiencing low supply for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. Actions were taking to address supply include: We know that millions of parents and caregivers around the world count on our formulas to feed their babies and children and we are doing everything possible to address this situation. Across the U.S., we're prioritizing production of infant formula products to help replenish the supply in the market. Toddler drinks, often found in the formula aisles, are not recommended for babies under a year of age. However, if you have no other choice, these products can be safe for a few days for babies who are close to one year old. "What is available has passed rigorous inspections and is ready for your babies," he wrote. Call your pediatrician or other health care provider if you have questions. To that end,the American Academy of Pediatrics put out new guidance Tuesday on feeding babies, taking a relaxed stance on cow's milk, plant milk and formula intended for premature babies and toddlers.
The February voluntary recall involved four complaints of Cronobacter sakazakii a common environmental bacteria in infants who consumed infant formulas produced in this plant. More formula is expected to be flown on U.S military planes later. This follows the FDA's removal of the Salmonella case from its investigation earlier this month. We will ramp production as quickly as we can while meeting all requirements. Columbus, Ohio, is the headquarters for Abbott's U.S. nutrition business and is home to one of our five manufacturing facilities that produce infant formula for the U.S. market. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 200 Independence Avenue, S.W. The change is intended as a stopgap to tide babies over until the shortage abates, with the Academy warning, "This is not ideal and should not become routine.". And, USDA is urging states to relax their requirements that stores keep a certain amount of formula in stock. Abbott Laboratories CEO Robert Ford apologized in a new Washington Post op-ed for his company's role in a nationwide shortage of baby formula. More information on actions that the FDA announced earlier this week to address the shortage of infant formula can be found here. He wrote that after the plant reopens, it will take between six to eight weeks before formula from the facility is available on store shelves. If this happens: If you need help figuring out which formulas you may be able to substitute: You can also consider buying formula that's made outside of the United States in U.S. stores. The FDA on Monday also confirmed it will allow the sale of foreign formula in the U.S. "We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for, All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for, Genetic sequencing on the two available samples from ill infants did not match strains of. While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. If you can't find enough formula, there may be some short-term options that can help in an urgent situation. If you are considering feeding your baby with human milk from a source other than the babys mother, talk to your pediatrician or other healthcare provider about the potential risks. Whole cow's milk is not recommended for babies under one year old. "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We know its not easy to change your babys diet. Global Business and Financial News, Stock Quotes, and Market Data and Analysis. Two infants became sick; two tragically passed away. Avoid almond milk or other plant milks. "But the past few months have distressed us as they have you, and so I want to say: We're sorry to every family we've let down since our voluntary recall exacerbated our nation's baby formula shortage. In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In the meantime,parents are being advised to contact their pediatricians to discussthe best course of action for their child, which could entail seeking samples of new formula brands or donated pasteurized breast milk. "By the end of June, we will be supplying more formula to Americans than we were in January before the recall. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. As for toddler formula,it would be safe to give to babies who are close to their first birthday as long as use does not exceed a few days. Regarding the status of our work to reopen Sturgis: The FDA concluded its inspection with a 483 letter to Abbott on March 18. To ensure Women, Infants, and Children (WIC) program participants have continued access to high-quality, safe formula, we're extending the rebates we've been offering on competitive products until September 30, 2022, in states where Abbott holds the contract when Similac is unavailable. Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration (FDA) as part of the consent decree entered into on May 16. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. "From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves," the company noted in its statement. Although the FDA's moves offer a light at the end of the tunnel, the shortage is still raging. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses. Washington, DC 20500. "We at Abbott take great pride in helping people with diabetes check their glucose, providing critical coronavirus testing and making lifesaving heart devices," Ford wrote in the op-ed. FDA has also been meeting regularly with other major formula manufacturers who are working to produce more formula to meet the demand. What are counterfeit infant formulas? You can also participate in WIC while youre pregnant. Adding more water means your baby does not get enough of the nutrients they need and can lead to serious health problems, like seizures. Weve air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland. The federal governmentincluding the Food and Drug Administration (FDA), Department of Agriculture (USDA), Department of Justice (DOJ), Department of Transportation (DOT), U.S. Trade Representative (USTR), Department of Homeland Security (DHS), Department of Commerce (DOC), and the White Househas worked diligently over the last few months to address the shortfall in infant formula production while the Sturgis plant remains offline, including working with other infant formula manufacturers to increase production, expediting the import of infant formula from abroad, and calling on both online and in store retailers to establish purchasing limits to prevent the possibility of hoarding. The group also said that soy milk may be an acceptable temporary substitute for babies around a year old but advised parents to seek out brands that are fortified with protein and calcium. These steps include: To help further increase manufacturers ability to meet demand and distribute formula, USDA is working with states to make it easier for vulnerable families to purchase the formula they need with their WIC benefits. You have JavaScript disabled. Once the plant is re-sanitized and production resumes, we will again begin EleCare production, followed by specialty and metabolic formulas. Abbott Nutrition has stated that it will focus on specialty formulas for people with metabolic and other needs first. Talk with your pediatrician or other health care provider about using human milk from a human milk bank. The apology came hours after President Joe Biden signed into law the newly passed Access to Baby Formula Act. We are dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. Abbott Laboratories CEO Robert Ford apologized Saturday in a new op-ed for his company's role in a nationwide shortage of baby formula, which this week moved Congress and the Biden administration to take emergency actions to alleviate it. Depending on which formula your baby needs, your doctor may be able to submit an urgent request for specialized formula to Abbott Nutrition, which is releasing some specialty and low-iron formulas on a case-by-case basis. We have an FDA-registered plant in Cootehill, Ireland, where we've increased the volume of Similac Advance powder formula produced for the U.S. We're air-shipping product from this facility into the U.S. daily and the product is being restocked regularly. Slowly increase the amount of the new formula over time. Content created by Assistant Secretary for Public Affairs (ASPA), U.S. Department of Health & Human Services. This will offer relief to retailers and allow companies to manage inventories to meet demand. Try slowly introducing small amounts of the new formula by mixing it with your regular formula. The agency, which says it has already streamlined the process for distributing foreign formula once it arrives at U.S. ports, said it will also permit formula manufactured here but intended for export to be sold domestically. We look forward to working with the FDA to quickly and safely re-open the facility," said chairman and CEO Robert B. Ford. Because WIC isnot yet equipped to handleonline shopping and many families can no longerfind eligible formulasin store, some are having to use Supplemental Nutrition Assistance Program benefits or pay out of pocket, which "puts stress on the rest of the household," explainsBrian Dittmeier, senior director of public policy at the National WIC Association, the nonprofit advocacy arm of WIC. And, this year, we will more than double the amount of Similac Advance powder formula we're bringing in from our manufacturing facility in Cootehill, Ireland. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies. However, you may be able to give your baby some pasteurized (not raw), unflavored, whole cow's milk if: Your baby drinks regular formula, not a specialty product for allergies or other special health needs, Your baby is able to take some solid foods such as iron fortified infant cereals. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We're taking this very seriously and are working closely with the FDA to implement corrective actions. Check out our Infant Formula Resources multilingual social media toolkit.
Ford said Abbott expects to restart the Sturgis plan in the first week of June, after entering into a consent degree with the federal Food and Drug Administration. Most notably, the professional assocationnow says parents can give whole cow's milkto babies who are older than six months and don't have any allergies or other special health needs, as long as they supplement it with iron-rich solid foods. In the second quarter of the year, we expect to produce nearly three times more Similac Ready-to-Feed liquid formula than we did during the same period of time last year. "Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening ourSturgisfacility so we can ease the nationwide formula shortage. They may be impacted by the shortage, too. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. We are offeringan increased number and value of coupons available for all our infant formula products, including Similac ready-to-feed, to enable customers to purchase formula, either free or deeply discounted. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. All fifty states should. Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area. Washington, D.C. 20201 This is 95% of what we produced in January, prior to the recall and does not include production from Sturgis. Next Post: Statement by Press Secretary Jen, https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/?utm_source=link. "These are the types of flexibilities that we are communicating in this guidance," Mayne said. Millions of parents rely on our formula to feed their babies. A Division of NBCUniversal. Theres nothing as important to families as the health and safety of their babies, and the formula shortage has left many people feeling anxious about how theyll feed them. We're also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can. Our Commitment to Industry-leading Quality and Safety. Toll Free Call Center: 1-877-696-6775, Information for Families During the Formula Shortage. We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we've been seeing and hearing the stress and despair of parents who are facing empty shelves. bottles of formula. The President invoked the Defense Production Act. Supply chain issues from the pandemic contributed to the current formula shortage. confirmed it will allow the sale of foreign formula in the U.S. How the baby formula shortage is costing parents, Here's what you can feed your baby and what you shouldn't, American Academy of Pediatrics put out new guidance Tuesday, becoming a financial crisis for many families, Your California Privacy Rights/Privacy Policy. Prioritizing Infant Formula Production in Columbus, Ohio. Your baby's nutritional needs are very specific, especially in the first year of life. "Some solutions will take weeks, others will take longer, but we will not rest until it is done. The formula may not be safe and may have lost some of its nutrients. If you cant find any formula and your baby is older than 6 months, talk to your pediatrician or other health care provider about using whole cows milk as a short-term option. The U.S. Department of Agriculture is working with states, tribal nations, and territories across the country to ensure that families who participate in WIC can use their benefits to purchase additional types of formula. Don't give your baby cow's milk for more than one week, or as instructed by your pediatrician or other health care provider. Talk to your pediatrician or other health care provider if you're thinking about giving your baby cow's milk. more about the additional steps that President Biden is taking to address the formula shortage. Avoid other plant-based milks, like oat or almond milk. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility. We have prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed. This law puts U.S. formula manufacturers first in line to receive the resources they need to increase formula production. Ford noted that Abbott converted production lines for its adult nutrition products at a plant in Columbus, Ohio, "to prioritize production of ready-to-feed liquid infant formula.". We've also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of. At this facility we've made significant changes to ensure we can prioritize production of Similac Ready-to-Feed liquid formula, a product that can be used directly from the bottle. On Monday evening, baby formula producer Abbott announced it had reached a deal with the Food and Drug Administration, laying out a path to reopen a factory in Sturgis, Michigan,that shut down amid recalls earlier this year, contributing to the current shortage. Please enable JavaScript to use this feature. Todays action paves the way for companies who dont normally distribute their infant formula products in the U.S. to do so efficiently and safely," Califf said in a statement. A portion of the inventory will be provided as emergency samples to areas of the country experiencing low supply for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. Actions were taking to address supply include: We know that millions of parents and caregivers around the world count on our formulas to feed their babies and children and we are doing everything possible to address this situation. Across the U.S., we're prioritizing production of infant formula products to help replenish the supply in the market. Toddler drinks, often found in the formula aisles, are not recommended for babies under a year of age. However, if you have no other choice, these products can be safe for a few days for babies who are close to one year old. "What is available has passed rigorous inspections and is ready for your babies," he wrote. Call your pediatrician or other health care provider if you have questions. To that end,the American Academy of Pediatrics put out new guidance Tuesday on feeding babies, taking a relaxed stance on cow's milk, plant milk and formula intended for premature babies and toddlers.
The February voluntary recall involved four complaints of Cronobacter sakazakii a common environmental bacteria in infants who consumed infant formulas produced in this plant. More formula is expected to be flown on U.S military planes later. This follows the FDA's removal of the Salmonella case from its investigation earlier this month. We will ramp production as quickly as we can while meeting all requirements. Columbus, Ohio, is the headquarters for Abbott's U.S. nutrition business and is home to one of our five manufacturing facilities that produce infant formula for the U.S. market. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 200 Independence Avenue, S.W. The change is intended as a stopgap to tide babies over until the shortage abates, with the Academy warning, "This is not ideal and should not become routine.". And, USDA is urging states to relax their requirements that stores keep a certain amount of formula in stock. Abbott Laboratories CEO Robert Ford apologized in a new Washington Post op-ed for his company's role in a nationwide shortage of baby formula. More information on actions that the FDA announced earlier this week to address the shortage of infant formula can be found here. He wrote that after the plant reopens, it will take between six to eight weeks before formula from the facility is available on store shelves. If this happens: If you need help figuring out which formulas you may be able to substitute: You can also consider buying formula that's made outside of the United States in U.S. stores. The FDA on Monday also confirmed it will allow the sale of foreign formula in the U.S. "We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for, All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for, Genetic sequencing on the two available samples from ill infants did not match strains of. While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. If you can't find enough formula, there may be some short-term options that can help in an urgent situation. If you are considering feeding your baby with human milk from a source other than the babys mother, talk to your pediatrician or other healthcare provider about the potential risks. Whole cow's milk is not recommended for babies under one year old. "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We know its not easy to change your babys diet. Global Business and Financial News, Stock Quotes, and Market Data and Analysis. Two infants became sick; two tragically passed away. Avoid almond milk or other plant milks. "But the past few months have distressed us as they have you, and so I want to say: We're sorry to every family we've let down since our voluntary recall exacerbated our nation's baby formula shortage. In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In the meantime,parents are being advised to contact their pediatricians to discussthe best course of action for their child, which could entail seeking samples of new formula brands or donated pasteurized breast milk. "By the end of June, we will be supplying more formula to Americans than we were in January before the recall. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. As for toddler formula,it would be safe to give to babies who are close to their first birthday as long as use does not exceed a few days. Regarding the status of our work to reopen Sturgis: The FDA concluded its inspection with a 483 letter to Abbott on March 18. To ensure Women, Infants, and Children (WIC) program participants have continued access to high-quality, safe formula, we're extending the rebates we've been offering on competitive products until September 30, 2022, in states where Abbott holds the contract when Similac is unavailable. Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration (FDA) as part of the consent decree entered into on May 16. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. "From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves," the company noted in its statement. Although the FDA's moves offer a light at the end of the tunnel, the shortage is still raging. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses. Washington, DC 20500. "We at Abbott take great pride in helping people with diabetes check their glucose, providing critical coronavirus testing and making lifesaving heart devices," Ford wrote in the op-ed. FDA has also been meeting regularly with other major formula manufacturers who are working to produce more formula to meet the demand. What are counterfeit infant formulas? You can also participate in WIC while youre pregnant. Adding more water means your baby does not get enough of the nutrients they need and can lead to serious health problems, like seizures. Weve air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland. The federal governmentincluding the Food and Drug Administration (FDA), Department of Agriculture (USDA), Department of Justice (DOJ), Department of Transportation (DOT), U.S. Trade Representative (USTR), Department of Homeland Security (DHS), Department of Commerce (DOC), and the White Househas worked diligently over the last few months to address the shortfall in infant formula production while the Sturgis plant remains offline, including working with other infant formula manufacturers to increase production, expediting the import of infant formula from abroad, and calling on both online and in store retailers to establish purchasing limits to prevent the possibility of hoarding. The group also said that soy milk may be an acceptable temporary substitute for babies around a year old but advised parents to seek out brands that are fortified with protein and calcium. These steps include: To help further increase manufacturers ability to meet demand and distribute formula, USDA is working with states to make it easier for vulnerable families to purchase the formula they need with their WIC benefits. You have JavaScript disabled. Once the plant is re-sanitized and production resumes, we will again begin EleCare production, followed by specialty and metabolic formulas. Abbott Nutrition has stated that it will focus on specialty formulas for people with metabolic and other needs first. Talk with your pediatrician or other health care provider about using human milk from a human milk bank. The apology came hours after President Joe Biden signed into law the newly passed Access to Baby Formula Act. We are dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. Abbott Laboratories CEO Robert Ford apologized Saturday in a new op-ed for his company's role in a nationwide shortage of baby formula, which this week moved Congress and the Biden administration to take emergency actions to alleviate it. Depending on which formula your baby needs, your doctor may be able to submit an urgent request for specialized formula to Abbott Nutrition, which is releasing some specialty and low-iron formulas on a case-by-case basis. We have an FDA-registered plant in Cootehill, Ireland, where we've increased the volume of Similac Advance powder formula produced for the U.S. We're air-shipping product from this facility into the U.S. daily and the product is being restocked regularly. Slowly increase the amount of the new formula over time. Content created by Assistant Secretary for Public Affairs (ASPA), U.S. Department of Health & Human Services. This will offer relief to retailers and allow companies to manage inventories to meet demand. Try slowly introducing small amounts of the new formula by mixing it with your regular formula. The agency, which says it has already streamlined the process for distributing foreign formula once it arrives at U.S. ports, said it will also permit formula manufactured here but intended for export to be sold domestically. We look forward to working with the FDA to quickly and safely re-open the facility," said chairman and CEO Robert B. Ford. Because WIC isnot yet equipped to handleonline shopping and many families can no longerfind eligible formulasin store, some are having to use Supplemental Nutrition Assistance Program benefits or pay out of pocket, which "puts stress on the rest of the household," explainsBrian Dittmeier, senior director of public policy at the National WIC Association, the nonprofit advocacy arm of WIC. And, this year, we will more than double the amount of Similac Advance powder formula we're bringing in from our manufacturing facility in Cootehill, Ireland. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies. However, you may be able to give your baby some pasteurized (not raw), unflavored, whole cow's milk if: Your baby drinks regular formula, not a specialty product for allergies or other special health needs, Your baby is able to take some solid foods such as iron fortified infant cereals. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We're taking this very seriously and are working closely with the FDA to implement corrective actions. Check out our Infant Formula Resources multilingual social media toolkit.