Abbott will have produced 8.7 million pounds of infant formula in June for the U.S., or the equivalent of 168.2 million 6 oz. We are initially manufacturing EleCare and anticipate beginning to release EleCare products in the coming weeks. The FDA on Monday also confirmed it will allow the sale of foreign formula in the U.S. Abbott will be importing 1.1 million pounds of powder infant formula to the U.S. from our manufacturing facility in Granada, Spain, beginning this month through this summer, after receiving enforcement discretion from the U.S. Food and Drug Administration (FDA). 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. This will likely delay production and distribution of new product for a few weeks. Consulting with industry experts to implement the latest technological advancements in food manufacturing processes, including a 3D augmented reality system, which will provide a clearer visualization of product as it moves through the facility, enhancing Abbotts ability to make informed decisions (including remotely) during the manufacturing process, Increasing our finished product testing, which already meets or exceeds regulatory requirements, Implementing auto sampling technology throughout the manufacturing line to further enhance the speed with which any potential manufacturing issues are identified, Enhancing the environmental monitoring program by increasing the sampling of non-product contact areas by two to three times, Enhancing electronic records to provide immediate real-time information for each batch, Increasing production of Similac formulas at our other FDA-registered facilities, Bringing Similac Advance into the U.S. from an FDA-registered manufacturing site in Europe, including daily shipments by air of product, Prioritizing some production of other Abbott liquid products to Similac and Alimentum to make more ready-to-feed liquid formula available, Working with USDA and state agencies to provide authorization for parents who get formula from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) with other Similac products at no cost, including for other manufacturers' products, Contacting other manufacturers to provide information regarding supply constraints for specialty formulas so they can address the demand, Engaging with healthcare providers to identify potential alternative formulas, whenever we can, Investing in additional manufacturing of specialty products for infants who can't tolerate standard formula products. "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. The shortage has moved Congress and the Biden administration to take emergency actions to alleviate it. Stores will start carrying or may already have these options. Washington, D.C. 20201 We look forward to working with the FDA to quickly and safely re-open the facility," said chairman and CEO Robert B. Ford. The company appreciates the support of the Administration and FDA for making it possible to ship product from manufacturing locations outside the U.S. They may require different amounts of powder or water than formulas made in the U.S. Because a lot of people are looking for formula, you may experience long wait times. AAP also said premature formula can be safely given to full-term babies for several weeks if no other option is available. We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall. 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. The February voluntary recall involved four complaints of Cronobacter sakazakii a common environmental bacteria in infants who consumed infant formulas produced in this plant. Note: Children younger than 6 months old should only drink breast milk or infant formula. 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. 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. The website that you have requested also may not be optimized for your screen size. This law puts U.S. formula manufacturers first in line to receive the resources they need to increase formula production. In particular weve been focusing on production in our Cootehill, Ireland, facility to servestate Special Supplemental Nutrition Program for Women, Infants and Children (WIC)consumers. 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. This will offer relief to retailers and allow companies to manage inventories to meet demand. 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. We are continuing to make progress to fully restart production at our plant in Sturgis, Mich., and resumed production on July 1. These torrential storms produced significant rainfall in a short period of time overwhelming the citys stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant. Talk to your pediatrician or other health care provider if you're considering using toddler drinks. The White House The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022. apologized Saturday in a new op-ed for his company's role, Biden on Wednesday invoked the Defense Production Act, Former Obama White House aide Seth Andrew sentenced to year in prison for charter school theft scheme, House passes bill to boost U.S. chip production and China competition, sending it to Biden, Former Trump White House chief of staff Mick Mulvaney to meet with Jan. 6 committee, Senate passes bill to boost U.S. chip production and China competition, sending to House, President Biden tests negative for Covid and will end strict quarantine, Merrick Garland does not rule out prosecuting Trump over Jan. 6. 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. Some states are already doing this. Call your pediatrician or other health care provider if you have questions. 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. To date, production has ramped up 30-50%. The facts about what was learned about the cases of Cronobacter have not been widely communicated. 'A DESPERATE SITUATION FOR MANY FAMILIES': How the baby formula shortage is costing parents, SAFE SUBSTITUTES: Here's what you can feed your baby and what you shouldn't, Califf said that while an adequatesupply of formula needed to feed every baby is finally in place at this point, "it's not necessarily in the right place. From the time we restart the site, it will take six to eight weeks before product is available on shelves. 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. "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. 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. All Rights Reserved. If you need help buying formula, youre not alone. I have high expectations of this company, and we fell short of them," Ford wrote. For families who are using both breast milk and formula, consider shifting more of your babys diet to breast milk. Talk with your pediatrcian or other health care provider if you are having difficulty breastfeeding or finding infant formula. parmesan fries rosemary oven baked going need re ourbestbites 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. This could mean you need to increase your breast milk supply. Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. Never purchase human milk on the internet. 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. We'll be in touch with the latest information on how President Biden and his administration are working for the American people, as well as ways you can get involved and help our country build back better. 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. Don't try to make formula at home. Abbott is committed to upholding the highest standards for manufacturing of all nutrition products. 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. Since the recall,one of our priorities has been to mitigate the supply issues. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores. Organizations in your community and formula companies may be able to help you find formula or safe substitutes. 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. Adding more water means your baby does not get enough of the nutrients they need and can lead to serious health problems, like seizures. The Food and Drug Administration (FDA) has allowed these formula companies to market certain products in the United States, and may allow more infant formula products that meet its criteria to be sold in the U.S. Slowly increase the amount of the new formula over time. "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. 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. "We will not take risks when it comes to the health of children," he wrote. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of. 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. You have JavaScript disabled. Four infants who drank formula from the Michigan plant were hospitalized with bacterial infections. Please enable JavaScript to use this feature. Logistical details and product availability are being finalized and will be updated as soon as the information is available. Toll Free Call Center: 1-877-696-6775, Information for Families During the Formula Shortage.