Updated June 24, 2022
Background

U.S. Food and Drug Administration’s (FDA) issued an advisory that directs consumers to not consume implicated baby formula products produced in the Abbott Nutrition’s Sturgis, MI facility. Abbott Nutrition has also issued a voluntary recall.

Related Links
When will FDA be making a public statement that the Sturgis facility has resumed production to assure consumers that product meets FDA regulations? (NEW 6/10/2022)

A communication plan is in development

How should retailers and consumers identify product from Sturgis after reopening?  We strongly suggest that new UPC codes be used for product and product clearly identified as being new.  (The lot codes provided by Abbott for the recall were insufficient for retailers to identify impacted product and we cannot use lot code digits to identify new product.) (NEW 6/10/2022)

FDA will consider this request

Our members have many outstanding questions related to the enforcement discretion announced on May 16.  Is there a contact person for questions? (NEW 6/10/2022) 

All questions should be sent to infant_formula_flexibility@fda.hhs.gov 

What is the best way for retailers to make it known that they are interested in obtaining formula brought in under this program?  Many retailers are interested in selling formula and many are smaller companies without national distribution. (NEW 6/10/2022)

Formula is brought in through the FDA enforcement discretion, but the government is not taking possession of the product and is relying on normal distribution channels. 

For retailers or manufacturers with the opportunity to provide or procure imported formula, is there a point of contact to help them ensure that product is brought in under this program and legal for distribution and sale?  We understand there are letters issued but are hearing that companies have certificates.  Can you share examples of documentation so that retailers and distributors know what to look for and how to evaluate product? (NEW 6/10/2022)

All approved companies are listed on the FDA website and that remains the sole list of approved vendors – https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies

We are hearing states need WIC waivers for imported product to be eligible for sale to WIC customers.   We strongly encourage FDA to work with FNS to facilitate communication and simplify the process to make product available for WIC participants
We have also heard from one of our members trying to bring formula in from overseas that there are tariffs left over from the previous Administration that are driving up the price.  Can those tariffs be waived in this situation? (NEW 6/10/2022)

FDA is working with other government agencies to reduce regulatory burden and they are aware of tariffs

White House Infant Formula Dashboard (*NEW* 6/6/22)

The Biden-Harris administration has created a web page that includes data points on national infant formula sales as well as commitments the White House has received from manufacturers on importing formula into the United States. The page also outlines actions the administration has taken to date to address the shortage of infant formula, such as invoking the Defense Production Act, launching Operation Fly Formula, and granting additional WIC waivers, among others. 

Enforcement Discretion on Certain Infant Formula Products for Import (*NEW* 6/3/22)

FDA recently issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. The guidance will be in effect until November 14, 2022. The agency has posted a list of the products receiving enforcement discretion for import into the United States, and this list will be regularly updated as additional products are added.

USDA Infant Formula Recall & Supply Landing Page

The U.S. Department of Agriculture (USDA) has created a new landing page on infant formula safety which includes a state map and drop down list of the current WIC infant formula flexibility waivers, information on specialty formulas, consumer information and more.

Abbott Recalled Product Substitution List

FMI has received various product substitutions for the recalled Similac, Elecare and Alimentum formulas from FMI supplier and retailer members. We have compiled these substitutions into a single document to assist your company in providing customers with recommendations for the recalled products. The document includes separate tabs that list substitutions for the various affected Abbott formulas, non-affected Abbott products, non-affected brands with substitution info provided to FMI, and non-affected brands more generally. Additionally, the cells that are highlighted in yellow are manufactured by Perrigo and sold as store brands. Click here to download the list.

WIC Infant Formula Recall Waivers 

The following waivers have been approved for the States listed under each waiver. States are in the process of reviewing and implementing these flexibilities and will coordinate with their vendors as necessary. Click here.

What product is affected by this voluntary recall?

The FDA is advising consumers not to use Similac, Alimentum or EleCare powdered infant formulas if:

  • the first two digits of the code are 22 through 37 and
  • the code on the container contains K8, SH, or Z2, and
  • the expiration date is 4-1-2022 (APR 2022) or later.
Recall does not include any metabolic deficiency nutrition formulas.

No Abbott liquid formulas or other Abbott nutrition powders and brands are impacted.

What are the affected UPC Codes?

FMI has been in contact with both Abbot Nutrition and FDA and is awaiting a response as of Feb. 18. We have learned that some members – but not all – have received a recall list from Abbott.

What should I do if I purchased one of these products?

The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.

Abbott Nutrition recommends visiting similacrecall.com and typing in the code on the bottom of the package, or calling +1-800-986-8540 (U.S.) and following the instructions provided. Abbott notes that no action is needed for previously consumed product. Contact your healthcare professional if you have further questions or concerns about your child’s feeding or nutrition.

Should parents or caregivers make or feed homemade infant formula to infants?

No. FDA states that parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants.

What should we expect about the product moving forward? Will we have rolling recalls?

FDA says the recall is only affecting powdered product from the Sturgis, MI facility at this time (Feb. 18).

If I’m a WIC customer, how do I redeem a voucher?

For purposes of the WIC program, we understand that there might be a situation where a particular state relies on paper vouchers. In this situation, exemption from the limits may be necessary, and stores should provide the WIC paper voucher amounts fully. 

How will WIC substitution information be offered to the customer?

WIC state agencies will develop processes and communicate to retailers the substitution information in their states.

Would it be possible for the state WIC offices to re-issue "liquid" formula for WIC participants?

FMI is awaiting information from USDA Food and Nutrition Service and state specific guidance (Feb. 18).

How should retailers resolve WIC substitution challenges?

Please check with your state WIC office for specific instructions.

Can you give cash refunds to those who bought the infant formula using WIC?

Cash refunds are never allowed for products purchased with WIC benefits.

Will there be one website for WIC substitutions by state?

The WIC Association said it will do its best to consolidate information regarding vouchers. Once FMI has a link, it will be added to this FAQ.

What are retailers doing to ensure shoppers have enough infant formula?

Regarding supply chain concerns, FDA has asked our retailer members to consider purchase limits of five cans per customer (per child on formula), with the exception of allowing the entire quantity allowed by WIC paper vouchers in states still using paper vouchers. Our members have also been encouraged to only pull implicated products from their shelves, but many are awaiting details on recalled products.

Is there enough infant formula in the food supply?

Yes, there are multiple manufacturers of infant formula and there is product available to meet consumers’ needs. Manufacturers are working with retailers and government agencies to help ensure availability and continued access to infant formula.

Social Media Posts for Members

Please feel free to utilize and customize these posts appropriately. 

In light of Abbott Nutrition’s recall of certain baby formulas, we are removing these products from our shelves to protect the health and safety of our customers while also ensuring alternatives are available. More information on the recall is available here: https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022

.@US_FDA is advising consumers not to use certain Abbott Nutrition baby formula following an investigation into bacterial contamination. We understand this can be frustrating for our customers and ask for patience as we remove these products from our shelves and offer available alternatives.

Due to the recall of certain Abbott Nutrition baby formula and subsequent removal of these products from our shelves, we are asking customers to limit their purchase of other formulas to five cans per customer to ensure enough product for every family that needs it.

In light of @US_FDA’s warning to consumers not to use certain Abbott Nutrition baby formula, please remember FDA states that parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. | MORE: https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-parents-and-caregivers-not-make-or-feed-homemade-infant-formula-infants

We understand our paper voucher WIC customers in need of infant formula may have concerns given the recall of certain Abbott Nutrition baby formula. Rest assured, we are still accepting WIC paper vouchers and providing these customers with product amounts in full quantities.