Helping families find formula…and Abbott responds

Photo: American Academy of Pediatrics

Yesterday, the US Dept. of Health and Human Services posted information for parents who are searching for formula for their babies under a year old:

Fact Sheet: Helping Families Find Formula During the Infant Formula Shortage

To address infant formula shortages in the wake of Abbott Nutrition’s voluntary recall of certain powdered infant formulas, the Biden-Harris Administration is working to ensure that infant formula is safe and available for families across the country. Yesterday, President Biden spoke with retailers and manufacturers, including Walmart, Target, Reckitt, and Gerber, to discuss ways to get more formula quickly and safely onto store shelves. He also announced a series of actions, including cutting red tape on the types of formula parents can buy, calling on the Federal Trade Commission and state attorneys general to crack down on price gouging and unfair market practices, and increasing the supply of formula through increased imports.

Thanks to these efforts, manufacturers have ramped up production 30-50 percent, bringing total production today above pre-recall levels with a different mix of products and sizes now available in the market. Still, it’s clear that too many families continue to encounter challenges obtaining infant formula—especially families of about 5,000 infants as well as some older children and adults with rare metabolic diseases that depend on specialty formulas.

If you are unable to readily find formula, please consult the following resources that may be able to assist:

Manufacturer Hotlines

• Gerber’s MyGerber Baby Expert : reach a certified nutrition or lactation consultant by phone, text, Facebook Messenger, web chat, or video call, who can help you identify a similar formula that may be more readily available
• Abbott’s Consumer Hotline: call 1-800-986-8540
• Abbott’s urgent product request line : ask your OBGYN or your infant’s pediatrician to submit an urgent product request by downloading and completing the form – PDF
• Reckitt’s Customer Service line: call 1-800 BABY-123 (222-9123)

Community Resources

• United Way’s 2-1-1 : dial 2–1-1 to be connected to a community resource specialist affiliated with United Way who may be able to help you identify food pantries and other charitable sources of local infant formula and baby food.
• Feeding America : call your local food bank to ask whether they have infant formula and other supplies in stock.
• Human Milk Banking Association of North America (HMBANA): certain HMBANA-accredited milk banks are distributing donated breast milk to mothers in need; please note that some may require a prescription from a medical professional. Find an HMBANA-accredited milk bank .

WIC-Eligible Families

• Contact your local WIC office to identify or obtain additional sources of infant formula nearby.

General Guidance

• Call your OBGYN or pediatrician to see if they have in-office samples or can suggest a similar formula that may be more readily available in stores and is nutritionally similar to your infant’s typical formula.
• You should not water down formula, try to make formula at home, or use toddler formula to feed infants. Don’t discard formula unless it is expired or is part of the recall. Check your formula’s lot code to see whether or not it was affected by the recall.
• You can find more guidance from the American Academy of Pediatrics .

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From the American Academy of Pediatrics

What if baby formula is out of stock everywhere?

The U.S. Food & Drug Administration announced it is taking steps to help improve supply of infant and specialty formula products. However, if you’re struggling to find baby formula during the shortage, here are some tips that can help.

Keep in mind, this advice is strictly for URGENT situations. If you have any concerns about your baby’s nutrition, please talk with your pediatrician.

• Check smaller stores and drug stores, which may not be out of supply when the bigger stores are.
  
• If you can afford it, buy formula online until store shortages ease. Purchase from well-recognized distributors and pharmacies rather than individually sold or auction sites. Do not import formula from overseas, since imported formula is not FDA-reviewed.
  
• For most babies, it is OK to switch to any available formula, including store brands, unless your baby is on a specific extensively hydrolyzed or amino acid-based formula such as Elecare (no store brand exists). Ask your pediatrician about recommended specialty formula alternatives available for your baby.
  
• Check social media groups. There are groups dedicated to infant feeding and formula, and members may have ideas for where to find formula. Make sure to check any advice with your pediatrician.

Is it OK to put more water in baby formula?

No. While it may be tempting towater down formula to stretch it out, it is not safe to do that. Always follow label instructions or those given to you by your pediatrician. Watering down formula is dangerous. It can cause nutritional imbalances in your baby and lead to serious health problems. Always mix formula as directed by the manufacturer.

Can I make my own baby formula?

The AAP strongly advises against homemade formula.Although recipes for homemade formulas circulating on the internet may seem healthy or less expensive, they are not safe and do not meet your baby’s nutritional needs. Infant deaths have been reported from use of some homemade formulas.

Can toddler formula substitute for regular formula?

Toddler formulas are not recommended for infants. However, if you absolutely have no other choice, toddler formula is safe for a few days for babies who are close to a year of age.

Is cow’s milk a safe alternative to baby formula?

This may be an option if your child is older than 6 months of age and is usually on regular formula (not a specialty product for allergies or other special health needs). In a pinch, you could feed them whole cow’s milk for a brief period of time until the shortage is better. This is not ideal and should not become routine, but is a better option than diluting formula or making homemade formula. Although we don’t have a specific amount of cow milk that infants 6-12 months should drink in this situation, follow the limits of no more than 24 ounces a day for children over a year of age. See “Recommended Drinks for Children Age 5 and Younger.”

The most important concern with giving an infant over 6 months of age cow’s milk is making sure they get enough iron to prevent anemia. Be sure to include plenty of iron-containing solid foods in their diet while you are using whole cow’s milk. You may also talk with your pediatrician about giving your baby an iron supplement.

Can I use plant-based milk instead of baby formula if needed?
Milk alternatives are not recommended for babies under a year of age or infants with certain medical conditions requiring specialized formulas. Soy milk may be an option to give babies who are close to a year of age for a few days in an emergency, but always buy the kind that is fortified with protein and calcium. Make sure to change back to formula as soon as some is available. Be especially careful to avoid almond milk or other plant milks as these are often low in protein and minerals.

What is the shelf life of baby formula?
Check the “use by” date on infant formula, which is required by FDA regulations to be on each container. Until that declared date, the formula will contain no less than the amount of each nutrient on the product label and will otherwise be of acceptable quality.

Remember
Don’t hesitate to talk with your pediatrician if you have any concerns you have about your baby’s health and nutrition. If your child has special health needs, be sure to check with their doctor about medically appropriate and safe feeding alternatives.

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ABBOTT responds strong statement about shutting of their baby formula process by the US Government:

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.

April 15, 2022

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.

This is a developing story…