July 15th, 2022
Abbott extends WIC rebates
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.
We are continuing to make progress to fully restart production at our plant in Sturgis, Mich., and resumed production on July 1. We are initially manufacturing EleCare and anticipate beginning to release EleCare products in the coming weeks. We are working to restart the production of Similac as soon as we can.
June 15, 2022
Update on Abbott's Sturgis Plant and Formula Production
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. These torrential storms produced significant rainfall in a short period of time – overwhelming the city’s stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant.
As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant. 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. This will likely delay production and distribution of new product for a few weeks.
Based upon historical demand and current projections, Abbott has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available. These products are being released to consumers in need in coordination with healthcare professionals. Parents or caregivers in need should contact their healthcare professional or contact Abbott at +1-800-881-0876 for additional information.
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. feedings. This is 95% of what we produced in January, prior to the recall and does not include production from Sturgis.
Once the plant is re-sanitized and production resumes, we will again begin EleCare production, followed by specialty and metabolic formulas. In parallel, we will work to restart Similac production at the plant as soon as possible.
June 13, 2022
Abbott to Ship 1.1 Million Pounds of Powdered Infant Formula to U.S. from Spain Beginning this Month Through the Summer
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). 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. oz. bottles of formula.
The company appreciates the support of the Administration and FDA for making it possible to ship product from manufacturing locations outside the U.S.
The formula will be available for purchase through similac.com and other online retailers once it arrives. Logistical details and product availability are being finalized and will be updated as soon as the information is available.
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.
The products were manufactured in our facility in Granada, Spain, under European Union Good Manufacturing Practices and have undergone microbiological testing prior to release. 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.
June 4, 2022
Abbott Restarts Production of Specialty Formulas at its Michigan Plant
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 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 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.
We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements. We're committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years.
May 13, 2022
Abbott Provides Infant Formula Update
Since the recall, one of our priorities has been to mitigate the supply issues. In particular we’ve been focusing on production in our Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers. Abbott has been working with the USDA and WIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available. Abbott will continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.
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. Since February:
- We’ve air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.
- We have prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed.
- We are offering an 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.
- And our other manufacturing facilities are running at full capacity as we continue to prioritize production of infant formula to help replenish the supply in the market.
At the same time, we have been working to address the FDA’s 483 observations so we can restart operations at the Sturgis, Mich., facility. We immediately began implementing corrective actions and subject to FDA approval, we could restart our Sturgis, Mich., site within two weeks.
We are confident that we can continue to produce safe, high-quality infant formula at all of our facilities as we have been doing for millions of babies around the world for decades.
May 11, 2022
The following provides current information on the findings from the investigation, our Sturgis, Mich., facility and supply.
The February voluntary recall involved four complaints of Cronobacter sakazakii — a common environmental bacteria — in infants who consumed infant formulas produced in this plant. Two infants became sick; two tragically passed away.
The facts about what was learned about the cases of Cronobacter have not been widely communicated. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.
It's important to know:
- Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
- All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.
- The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Specifically:
- Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.
- In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
- Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
- The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.
Regarding the status of our work to reopen Sturgis:
The FDA concluded its inspection with a 483 letter to Abbott on March 18. This is a list of observations that point out where Abbott did not follow our processes and where we can improve our systems and protocols.
We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We've also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.
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. We deeply regret the situation and since the recall, we've been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA's request to those who need these unique formulas.
We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage. Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.
Our Efforts to Address Infant Formula Supply
Millions of parents rely on our formula to feed their babies. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.
Abbott is working closely with the U.S. Food and Drug Administration (FDA) to restart operations at the Sturgis, Mich., facility. 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. 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.
Shipping Formula From Cootehill, Ireland
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.
Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores.
Prioritizing Infant Formula Production in Columbus, Ohio
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. 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. 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. And this product will be available on retail shelves and online soon.
Across the U.S., we're prioritizing production of infant formula products to help replenish the supply in the market. 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 dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. And we're always focused on what we can do to continue to serve our customers. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility.
We know getting your baby high-quality infant formula is your priority — it is ours too.
March 22, 2022
Abbott Update On Powder Formula Recall
We are currently reviewing the FDA's observations as provided in its Form 483 from its inspection of our powder formula manufacturing in our Sturgis, Mich., facility. We're taking this very seriously and are working closely with the FDA to implement corrective actions.
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. 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. This follows the FDA's removal of the Salmonella case from its investigation earlier this month.
Our Commitment to Industry-leading Quality and Safety
Abbott is committed to upholding the highest standards for manufacturing of all nutrition products. We have already begun implementing corrective actions and enhancements at the facility, leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there. Our actions include:
- 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 Abbott’s 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
How We're Addressing Supply Issues
We know there are constraints in infant formula supply and we’re taking action to help address this. We have a global manufacturing and supply network we’re 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. Our other U.S. plants continue to supply infant formula to the market and we’re prioritizing some production from other liquid nutritional products to Similac. Actions we’re taking to address supply include:
- 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
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.