If you are formula feeding your baby right now, odds are you are constantly searching for the newest formula update. There have been changes to processes, new formulas available, and a lot of finger pointing.
Chances are that if you are formula feeding, you also don’t have the time to research all the new updates as they come. It feels like there are new updates every few days!
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Backstory and Updates
In short, there are a lot of regulations around infant formula (which is good!). This means that it can be very difficult for new companies to enter the scene. We’ve had 2 in the past couple of years, but for the most part, there are only a handful of factories that can make formula in the US. This means when one shuts down, it’s a big deal.
In February, Abbott (which makes Similac products) voluntarily recalled several formulas and closed one of their manufacturing sites. Because the demand for formula is pretty stable, the other formula producing facilities were not able to ramp up production to make up for one site being closed. They were already dealing with supply chain issues.
As of February 28, WIC waivers have expired, meaning that parents are once again limited to purchasing specific formulas. Some states are allowing parents to purchase different sized cans of formula (which previously was not permitted). Many stores are still not stocking appropriate inventory of formulas leaving families that rely on WIC with little support.
On March 8, the FDA sent a letter to formula companies asking them to notify the FDA if they have any batches that test positive for cronobacter, even if the product was not shipped out. It appears that the FDA is asking formula makers to take responsibility for maintaining safe facilities as the FDA does not seem to have the authority to enforce any new rules at this time.
On March 17, there was a recall of Gerber Good Start SoothePro powdered infant formula. Per their statement “Importantly, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall.” If you are looking for a similar formula during this recall, check out this article for options.
As of June 4, Abbott is restarting infant formula production. The focus will be on Elecare and specialty formulas. They expect the formulas to be available to consumers around June 20. This is great news, but we’re not out of the woods quite yet. As of June 15, Abbott closed the plant in Michigan again due to severe thunderstorms and heavy rains causing wind, hail, power outages, and flood damage. Abbott has stated that they will conduct comprehensive testing with an independent third party and the FDA prior to restarting production again. They expect another delay of a few weeks.
Although there hasn’t been an official statement from Similac as of yet, the Michigan plant reopened July 1. The focus continues to be on Elecare, a hypoallergenic formula. Abbott did not officially release a statement until August 26th.
As of July 6, the FDA is developing a plan to keep the international formulas on our shelves indefinitely. More information on that should be coming out in the fall. There was mention that there needs to be a plan to streamline approval for domestic companies, but no further details on how that would be accomplished. In general, more competition should lead to lower prices and better quality all around.
On August 25th, the White House announced that they have sourced several shipments of Gerber Good Start Gentle formulas from Mexico to Texas.
On August 26th, Abbott released a statement stating that they restarted the Similac production in Michigan. They estimate that it will take around 6 weeks for product to hit shelves. They have quality systems in place that can detect cronobacter. If detected, they will suspend production and work with the FDA before restarting. This has happened already, showing the quality systems in place work.
On September 16, the White House announced that they were shipping in Alfamino Infant and Alfamino Jr. from Switzerland. It will be distributed to hospitals and home care providers, since these formulas are designed for kids who can’t tolerate standard formulas.
The FDA released an evaluation of their response to the crisis. It outlined issues and recommendations for improvements in the long run. One key missing recommendation (to me and many other feeding experts) was labeling Cronobacter as a nationally reportable disease which could alert officials of formula issues much sooner. I’ve outlined the report below.
On 9/30 the FDA announced a pathway to support international formulas staying in the US long term. This should help diversify the market and hopefully prevent future shocks to the system in cases of emergency. Currently the guidance extends their allowance until January 6, 2023 or later. Per the statement, if the companies send a letter stating their intent to pursue regulatory requirements, “the FDA does not intend to object to the continued marketing of covered infant formulas in the US through October 2025.” Companies will be expected to meet FDA regulations during this time.
Kendamil, Aptamil, and AussieBubs have released statements stating that they have sent in their letter of intent to pursue regulatory requirements.
Per an FDA call, the current guidance is in effect through October 18, 2025. There is a 5 phase plan with the goal of diversifying the US infant formula market which should help prevent a shortage in the future. The goal currently is for infants started on a formula to be able to continue to use the formula for as long as they need to. More information on the 5 phases of the plan will be released.
The FDA is still accepting applications for enforcement discretion. If there are international formulas who do NOT submit a letter, they can still continue importing product until December 2022. The product can remain on the shelves until it sells out or expires.
On October 14, Abbott issued a voluntary recall on several ready to feed 2 ounce formulas including: Similac Pro-Total Comfort, Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac NeoSure, Similac Sterilized Water, and Pedialyte Electrolyte Solution. The recall does not include any powdered formula or any liquid formula in other sizes. It will mostly affect hospitals and other medical facilities.
On October 21, the FDA held a webinar titled Infant Formula Discretion Transition Guidance Overview. Recordings are available. The webinar reviewed the guidelines provided on September 30.
The basic timeline for companies is that they must submit their letter of intent by December 5 (some have already done). They must submit their plan for meeting the new infant formula requirements by February 28th, 2023. By June 16, 2023, they must submit a plan to show that their formula promotes adequate growth in babies and data showing that the protein is of sufficient biological quality. They must provide the data showing adequate growth in 2024. They will submit the final formula in 2024 or 2025 depending on their timelines.
There are two broad groups: exempt and non-exempt formulas. Exempt formulas are designed for babies with inborn errors of metabolism, low birth weight, or other special medical or dietary problems. Within this group, they may or may not require a clinical study, so their due dates will depend on that. The non-exempt formulas are designed for term babies. Within this group, companies can either comply with GMS requirements or apply for exemptions or provide an alternative study design. Their due dates will be different based on the route they take.
|Phase||Action Item||Due Date|
|1||Letter of Intent||12/5/2022|
|2||Plan for Meeting Formula Requirements||2/28/2023|
|3||Data Showing Sufficient Biological Quality of Protein and Plan for Data Showing Normal Growth||Exempt: 8/1/2023|
|4||Data Demonstrating Normal Growth||Exempt: 1/5/2024 if clinical study is not required or 6/6/2025 if clinical study is required|
Non-Exempt: 1/5/2024 if using a narrative explanation on exemption from the GMS requirement or 9/6/2024 if providing a draft report of compliance or alternative study designs
|5||New Infant Formula Submission||Exempt: 2/16/2024 if clinical study is not required or 7/18/2025 if clinical study is required|
Non-Exempt: 2/16/2024 if exempt from GMS requirements or 10/18/2024 if submission complies with GMS requirements or used an alternative study design
On November 14, the FDA released a statement stating that Nutricia UCD Anamix Infant Formula would be imported. This is a metabolic formula for infants with urea cycle disorders.
On November 15, the FDA released an outline of their strategy to help prevent Cronobacter illnesses associated with infant formula. It includes things such as considering specialty staff to conduct infant formula inspections and providing additional training to staff. Improving communication to consumers about safe formula preparation and storage (check out my e-book if you want to learn more). Most importantly, there’s discussion of elevating Cronobacter infection among infants as a nationally notifiably disease. This would help alert the FDA and other regulatory agencies of outbreaks in real time, versus trying to put the puzzle pieces together after the fact.
To add to the confusion, on November 17, Amazon mistakenly sent an email stating there was another recall of Abbott products. Abbott put out a statement stating that there has been no further recalls at this time.
In other formula news, Perrigo, the maker of generic infant formula, announced that they were purchasing one of Nestle’s infant formula manufacturing facilities as well as the rights to the Good Start infant formula brand in the US and Canada. According to their statement, they will integrate the facility in 2023 and have additional capacity in 2024.
FDA commissioner Dr. Rober Califf asked for a review of the Human Foods Program in July by the Reagan-Udall Foundation, which is an independent group of experts. The review was released on December 6. The review was over the entire department, not just about infant formula, however the infant formula crisis spurred it into action. Overall, the report felt that the Human Food Program was taking a back seat to the drugs and medical device branches.
On December 11, ByHeart issued a voluntary recall on 5 batches of their Whole Nutrition Infant Formula due to concern of potential cross contamination with Cronobacter. Per their statement, no distributed product has tested positive for the bacteria and they have not received any complaints that would indicate illness. The will be covering the cost of 2 cans of alternate formula and providing 2 cans of free formula on the next order for affected families. If you aren’t sure which alternate formula to use, check out the chart in this article. ByHeart uses partially hydrolyzed proteins, so consider a formula from that line.
On 12/15, Abbott announced their plan for a new $500 million formula facility in Ohio. It will be used for specialty and metabolic formulas. Plans are to start building in 2023 with completion planned for 2026 and production starting in 2027.
On 12/19, the USDA announced their plan to extend WIC waivers for formula. Currently, families are able to buy formulas not under their state’s contract through these waivers. The waivers were set to expire at the end of the month, but the USDA announced that they plan to extend them until February 28, 2023. After that, the expectation is that parents will need to buy formulas that are under contract with WIC (which formula this is varies by state). There will be a transition period through April 30, 2023 where families will be able to buy formulas made by the state’s contract manufacturer but may have a bit more flexibility than previously, where can sizes and exact formulas were required. An exception is for specialty formula which will continue to have waivers until June 30, 2023.
Earlier this year, Congress suspended tariffs on infant formula due to the formula shortage. That suspension is set to expire at the end of the month. Some are wondering if these tariffs will exacerbate the ongoing shortage. This will likely cause higher prices for imported formulas which are currently cheaper than many name brand comparable options.
Human Foods Program Independent Expert Panel Final Report
According to the report, the FDA oversees the safety of 78% of the US human food supply. Their role includes developing and overseeing the enforcement of food safety regulations, detecting and responding to outbreaks of foodborne illness, collaborating with other federal agencies conducting food safety activities, coordinating and supporting food safety activities, conducting and supporting food safety research, and developing and disseminating food safety information.
The implementation of the Food Safety and Modernization Act was meant to move food safety towards prevention rather than reaction, but according to the report, this shift has yet to be realized. The pandemic exposed supply chain challenges, specifically the flow of products. “That crisis demonstrated what can happen when a significant, food-safety related production problem occurs in a food industry sector in which few competitors have the capacity to meet consumer needs.” The report agrees that change is necessary.
“An approach that is primarily focused on identifying and reacting to acute outbreaks of foodborne illness and death is unacceptable.” The report states that resources must be provided to make sure that the FDA has the best technology, staff, and infrastructure.
The report also notes that there is not one clearly identified person to lead the Human Foods Program which has led to overlapping roles and competing priorities which has resulted in what is perceived as “turmoil.”
The recommendations include (not all are listed):
- establishing an organizational structure with a clear leader
- making sure that there are clear roles and responsibilities within the program and that the culture is equipped to survive leadership transitions
- increasing prominence of the Human Foods Program
- importance of nutrition should be elevated
- a new Foods Advisory Committee should be established
- FDA should work to improve its staffing both in number and training
- the FDA will need additional funding to aid with these recommendations
- FDA should invest in modernizing its technological systems
- gain authority to request records from food manufacturers in advance or in lieu of an inspection to help speed things up
- seek authority to be notified when food categories, such as infant formulas, are likely to experience shortages or when supply chain disruptions are anticipated
- better structure the approach to the generally recognized as safe designation
- use the mandatory recall authority more frequently, recognizing that a process should be in place to assure accommodations are made for life sustaining products that are the only source of nutrition for certain populations (like infant formula)
On January 3, it was released that Perrigo Pharma (the company responsible for generic formula) filed a breach of contract lawsuit against Mead Johnson (the makers of Enfamil). The full complaint is not available, however Perrigo accuses Mead Johnson of “refusing to pack and sell” the generic formula despite an ongoing shortage. There is very limited information available on this lawsuit at this time. Perrigo did acquire another manufacturing facility in November, however they stated it would not be ready for production until 2024.
On January 5, ByHeart released a statement stating that they were planning on acquiring their own packaging facility. In December, they issued a recall and had stated that the issue came from the packaging facility, not their manufacturing facility. This purchase will give them “full ownership and oversight” of their end to end manufacturing process. The bad news is that it will delay their release of formula “for the next few months.”
On January 9th, the FDA released the list of formulas planning on staying in the US for the long term. The good news is that most formulas are. The formulas no longer being imported are Aptamil Gold+, Similac Advance 2-Fl, and US formulas that have been manufactured in other countries during the shortage such as Total Comfort, Neosure, and Neocate. I have an article on imported formulas which includes a side by side comparison.
On January 18th, Abbott sent a letter out stating that they are now shipping some metabolic formulas. They released a time table with expected shipping dates for other metabolic formulas as well.
On January 20, it was reported that Abbott is under criminal investigation over the baby formula crisis. They have been accused of a cover up following the contamination and recall. Abbott is stating that they are fully complying with the investigation.
On February 15, it was reported that Similac maker Abbott is under federal criminal investigation for its role in the formula shortage. The penalties may be up to $500,000 for corporations and up to a year of prison time for individuals.
On February 19, Mead Johnson recalled two batches of Prosobee 12.9 oz Simply Plant Based Infant formula. Per their statement, there was a possibility of cross contamination with Cronobacter sakazakii. All the products tested negative for the bacteria. To check to see if your can was affected, look at the bottom of the can. “Recalled product batches are ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a Use By Date of 1 Mar 2024.”
WIC formula waivers are set to expire on 2/28. These waivers allowed parents to purchase formula outside of their state’s WIC contract. Once these expire, parents will need to purchase only the formula contracted with their state. They will no longer be able to cover or subsidize imported formula.
FDA Evaluation of Infant Formula Response
In September, the FDA released an evaluation of their response to the infant formula crisis. It walked through the timeline of events and findings and recommendations. Overall, many people were underwhelmed by what the report found (or didn’t find). Much of what they reported were things that people in the field had noted months prior.
FDA Needs Modern Data Systems
The FDA reported that the technology they use is outdated and they recommend improving their processes so that people can be properly notified of public health threats. They noted inadequate processes related to whistleblower complaints resulting to delays in response. Their response was that they needed to clarify terms and offer training to staff that these incidents should be escalated. Lastly, they noted that some samples were delayed in transit by a third party and they recommended that they evaluate their procedures to see if improvements can be made.
FDA Needs to Optimize its Emergency Response Capabilities
The FDA noted a lack of training and operating procedures in case of emergencies, especially with food safety product-related emergencies. Their recommendation was training and increase trained staff for response, especially during multiple simultaneous public health emergencies. They noted that COVID 19 cases delayed in person response to complaints. Their recommendation was to gain authority to remotely access records or other information as needed. Given that this was a public health emergency, I feel that they should have procedures in place to enter facilities with known COVID 19 cases, as physicians and other medical staff had been doing since the beginning of the pandemic.
FDA Needs to Strengthen its Foods Workforce
The FDA noted that investigators conducting investigations of infant formula manufacturing facilities receive limited infant formula-specific training. They recommended a specialized training program. They noted that there has been a decrease in funding hindering their ability to keep pace with “the growing workload, increased complexity of supply chains, and scientific and technological changes in food manufacturing.” Lastly they noted that because infant formula is the sole source of nutrition for a population it presents unique challenges to public health compared to other food compliance actions. They are recommended to review procedures for critical food products to come up with a decision matrix to consider activities to minimize product availability concerns.
FDA Oversight Needs to Focus on Industry Accountability
The infant formula industry relies on dated technology and record keeping practices that was causing delays throughout the process. The FDA recommends to lay out plan for the infant formula industry to improve practices for the future. They noted that conditions at the facility were not consistent with a strong food safety culture and that the FDA does not have the authority, expertise, or resources to manage supply chain issues and shortages of critical food products.
FDA Needs to Work with Engaged Stakeholders to Close Scientific Gaps and Build a More Robust Regulatory Program
The FDA noted that Cronobacter is not a nationally reportable disease which can slow response time, however they did not recommend making it one. They instead recommended to learn more about it. They also noted that consumer education on the safe handling and preparation of infant formula is limited. I agree with this which is why I created my Formula Feeding Guide. The breastfeeding support we provide is great, but it often leaves out any education on formula.
Formula Options For Now
If you’re able to find your usual formula, great! Keep using it! Check out this guide to find out some of the basics of infant formula. For most babies, the most important thing to compare between formulas will be the protein. If your baby tolerates intact protein (standard formula), you’ll have many more options. If your baby is using partially broken down proteins, you’ll want to find a formula that’s similar.
If you’re unable to find your baby’s usual formula, check out the formula equivalent chart here to find a formula that may be similar to the one that your baby is used to.
it is incredibly rare for infants to be lactose intolerant. Lactose is the primary carbohydrate in breast milk. There are medical conditions, like galactosemia, where a baby cannot tolerate lactose, but if your baby is not tolerating their formula it’s *probably* not lactose causing the problem.
Companies can market a lower lactose formula as an option because many adults are lactose intolerant and intuitively it makes sense to us. They generally also change the protein in these formulas, so babies do tolerate them better.
The AAP stated that it is ok to use toddler formula for a short amount of time if unable to find infant formula. This is a tricky recommendation, because not all toddler formulas are the same. There are actually a few that meet all the requirements of infant formula, so I would recommend starting with those first. Talk to your pediatrician before starting any toddler formula.
- Baby’s Only Gentle Dairy Toddler Formula, Baby’s Only Premium Toddler Formula, Baby’s Only Sensitive Toddler Formula, and Baby’s Only Pea Protein Toddler Formula
- Kabrita Goat Milk-Based Toddler Formula
- Serenity Kids A2 Whole Milk Toddler Formula – this formula is lower in iron, so may be more appropriate for babies over 6 months who can also eat high iron foods
We now have some international formulas available. Some of these companies have released official statements that they plan on applying to stay in the US long term. There are a lot of great options available.
Hopefully this crisis will lead to some systemic changes. It would be great if these toddler formulas could be marketed and regulated as infant formulas. It would also be nice if we could safely import international formulas without a crisis.
If you’re looking for more basic information on formula feeding, check out my Formula Feeding Guide. It covers the basics from choosing a formula, bottle, water to how to feed and how much to feed.
Krystyn Parks is a Registered Dietitian and Lactation Consultant who specializes in feeding children. She has a Master’s Degree in Nutritional Science from California State University Long Beach. She is an International Board Certified Lactation Consultant and has been registered with the Commission on Dietetic Registration since 2013.