This appendix describes steps the Food and Drug Administration (FDA) and U.S. Department of Agriculture’s Food and Nutrition Service (FNS) took in response to the 2022 infant formula shortage (Table C-1). Below that, Tables C-2 and C-3 depict the timelines of events that a select few state Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) agencies experienced.
TABLE C-1 Infant Formula Shortage Response Timeline
| Date | FDA | FNS |
|---|---|---|
| January 11, 2022 | FDA receives a third Cronobacter illness complaint (Case Complaint #3). The date of illness onset was December 18, 2021. Samples collected by the Texas Department of State Health Services do not test positive for Cronobacter. This is the second case with a clinical isolate sample available for comparison to environmental samples that will be taken during FDA’s inspection later this month at the Sturgis facility. | N/A |
| Date | FDA | FNS |
|---|---|---|
| January 27, 2022 | FDA contacts Abbott Nutrition to announce their intention to proceed with an inspection. Abbott Nutrition informs FDA of a continued COVID-19 outbreak among its employees. | N/A |
| January 31, 2022 | FDA proceeds with an inspection of the Sturgis plant despite the COVID-19 outbreak given the fact pattern indicating a potential issue. FDA finds significant, fundamental sanitation, building, and equipment issues and takes multiple environmental samples. | N/A |
| February 7, 2022 | Seven of FDA’s environmental swabs suggest the potential presence of Cronobacter, but require confirmatory testing. | N/A |
| February 9, 2022 | FDA leadership informed of potential positive samples, defined as “Cannot Rule Out” (unconfirmed) taken during the inspection of Abbott Nutrition’s Sturgis plant. | N/A |
| February 10, 2022 | Food Program Leadership meets, and FDA’s Coordinated Outbreak Response Network begins coordinating a response. | N/A |
| February 11, 2022 | FDA notifies USDA’s WIC program of potential action that could impact the infant formula supply. | |
| February 13, 2022 | FDA sequences six confirmed samples of Cronobacter collected from Abbott Nutrition’s Sturgis facility environment during the recent inspection. Nineteen additional samples are being sequenced. | N/A |
| February 14, 2022 | An FDA intra-agency group, including experts and leadership from OFPR and CFSAN, begins discussions of food safety, regulatory, and supply chain issues related to the response. | FDA updates USDA WIC on the investigation status. |
| Date | FDA | FNS |
|---|---|---|
| February 15, 2022 | FDA recommends Abbott Nutrition voluntarily recall product. FDA receives additional Cronobacter sample results, and Abbott Nutrition voluntarily ceases production. In response to FDA, Abbott Nutrition agrees to exclude and hold specialty metabolic products given the critical access need and Abbott Nutrition’s lack of a mitigation plan to produce these formulas at one of its other facilities. | FDA meets with USDA WIC on the investigation, potential for a recall, and supply chain issues. |
| February 16, 2022 | FDA again recommends Abbott Nutrition voluntarily recall product. FDA, as a Co-Sector Risk Management Agency of the Food and Agriculture Sector, submits a report to U.S. government (USG) partners on the potential recall and supply chain impacts given the significant market share held by Abbott Nutrition, as well as the Sturgis facility being a critical producer of specialty metabolic and amino acid formulas. FDA begins discussion with Abbott Nutrition on additional testing for these held products and a strategy to release products to those in dire need. FDA meets with the American Academy of Pediatrics to make them aware of a significant upcoming action involving infant formula that will have ramifications for supply chains. FDA shared that their communications would advise parents to consult with the child’s health care provider for advice, with additional communications forthcoming from FDA. | N/A |
| Date | FDA | FNS |
|---|---|---|
| February 17, 2022 | FDA issues a consumer advisory warning consumers to avoid certain Abbott Nutrition products as Abbott Nutrition voluntarily recalls product (FDA, 2022b,c). FDA begins regular reports and coordination with U.S. government partners on supply chains. CDC notifies FDA of a fourth case that may be related. Daily situation reports begin for FDA staff and leadership working on the response. FDA requests from IRI infant formula in-stock rates at the national level, which was not previously tracked by FDA. FDA requests that the Food Industry Association (FMI) ask retailers to limit sales to no more than five cans per shopper. FMI recommends the limit to retailers later that day. | N/A |
| February 18, 2022 | FDA receives a fourth Cronobacter case report of a death potentially associated with Abbott Nutrition product (Case Complaint #4). FDA contacts other infant formula manufacturers to discuss actions to address potential supply chain disruptions. The date of illness onset for this case was January 4, 2022. No clinical isolate is available, and product samples do not test positive for Cronobacter. FDA requests an independent expert conduct a batch review of held specialty metabolic product. | USDA provides guidance for handling returns and exchanges of recalled product and the process for requesting WIC waivers related to infant formula shortages (USDA, 2022a). |
| FNS launches the new Infant Formula Safety webpage to provide public-facing, real-time, infant formula food safety updates to the public. |
| Date | FDA | FNS |
|---|---|---|
| February 20, 2022a | N/A |
USDA FNS begins issuing waivers to allow for product exchanges, non-contract brand of formula, and larger container sizes through September 30, 2022:
|
| February 22, 2022 | FDA receives IRI datasets | N/A |
| February 24, 2022 | Russia invades Ukraine. This leads to additional uncertainty in the infant formula supply chain as Ukraine is a major exporter of sunflower oil, an ingredient used in many infant formulas. | N/A |
| Manufacturers begin to reassess their supplies and make plans in consultation with FDA about possible substitutions. | ||
| February 28, 2022 | Due to FDA’s recommendation to cover additional products associated with the fourth case complaint, Abbott Nutrition voluntarily expands its recall. Abbott recalls one lot of Similac PM 60/40 manufactured at the same facility (FDA, 2022d). FDA advises parents and caregivers not to feed their baby certain powder formulas including Similac, Alimentum, and EleCare. | N/A |
| Date | FDA | FNS |
|---|---|---|
| Late February to early March 2022 | FDA meets with retailers and other infant formula manufacturers throughout this period on actions to address infant formula supply chain and to seek supply chain information. FDA continues regular coordination with manufacturers. FDA follows up on several additional Cronobacter complaints but eventually determines them unrelated to Abbott Nutrition. Actions ultimately result in significant increases in domestic production by late April and early May. | N/A |
| March 3, 2022 | - | USDA FNS responds to a WIC state agency requesting program flexibility for vendor formula substitutions during a transaction (USDA, 2022d). |
| March 15–16, 2022 | FDA inspection team returns to Sturgis facility to obtain additional records related to complaints received. FDA receives FY 2022 additional funding to hire four additional infant formula staff. | N/A |
| March 18, 2022 | January 2022 inspection and related sampling activities conclude. Inspection is closed, and FDA issues its inspection observations (FDA Form 483). Observations from inspection and FDA’s lack of confidence in Abbott Nutrition’s food safety culture inform FDA’s decision to negotiate a consent decree with the goal of addressing these observations and safely resuming production at Sturgis as soon as possible. | N/A |
| March 21, 2022 | FDA receives Abbott Nutrition’s independent batch review of specialty metabolic product requested on February 18th. | N/A |
| April 1, 2022 | FDA transforms response activity to an Agency-wide Incident Management Group to manage the response, including the supply chain. | N/A |
| Date | FDA | FNS |
|---|---|---|
| April 20 and 28, 2022 | FDA communicated to Abbott Nutrition their decision not to object to the release of specialty metabolic product broadly after enhanced finished product testing, and not to object to release on a case-by-case basis for urgent need. | N/A |
| April 29, 2022 | FDA issues an updated advisory to ensure consumers are aware of Abbott Nutrition’s process to release metabolic formulas on a case-by-case basis, in consultation with a health care provider, to those families who have no alternative supply. | N/A |
| May 13, 2022 | N/A | USDA FNS provides a letter to state health commissioners reminding them of flexibilities available, and encouraging follow-up action as needed (e.g., seeking waiver approval if no request had been made yet) (USDA, 2022e) |
| May 16, 2022 | FDA and Abbott Nutrition sign a proposed consent decree, in which the U.S. District Court for the Western District of Michigan enters the same day. FDA issues enforcement discretion guidance to provide flexibilities to boost the supply of infant formula (FDA, 2022e). | N/A |
| May 18, 2022 | Biden administration invokes the Defense Production Act (White House, 2022a). | |
| May 19, 2022 | The Biden administration announces Operation Fly Formula in which the Department of Defense resources are used to transport additional formula supplies into the United States (White House, 2022b). | |
| May 20, 2022 | FDA issues its first enforcement discretion letter for a specialty infant formula product. FDA is evaluating additional requests for enforcement discretion. FDA is working with USG partners to arrange air transport for amino acid and hypoallergenic hydrolyzed formulas to arrive in the United States on May 22, 2022. | N/A |
| Date | FDA | FNS |
|---|---|---|
| May 21, 2022 | N/A | President Biden signs the bipartisan Access to Baby Formula Act of 2022, (HR 7791) (ABFA), which allows the waiver of various WIC requirements in cases of supply chain disruption or emergency. |
| May 22, 2022 | Biden administration announces use of the Defense Production Act to allow infant formula manufacturers to demand their suppliers prioritize infant formula production over competing orders (White House, 2022c). | |
| May 24, 2022 | N/A | USDA FNS provides a letter to state health commissioners for WIC state agencies contracting with Nestlé/ Gerber and Mead-Johnson-Reckitt encouraging them to talk with state-contracted infant formula rebate manufacturers to discuss any flexibilities that could be implemented under their current contracts, modification to that contract, or separate agreement (USDA, 2022g). |
| June 2, 2022 | N/A | USDA FNS issues waivers to allow formula imported under FDA’s enforcement discretion. These initial approvals were superseded by extensions, starting on August 19, 2022. |
| June 6, 2022 | N/A | USDA FNS implements ABFA provisions via a letter to WIC state agencies (USDA, 2022h). |
| Date | FDA | FNS |
|---|---|---|
| June 22, 2022 | N/A | USDA FNS provides a WIC Infant Formula Distribution Toolkit for state agencies and stakeholders (USDA, 2022i). It includes a list of State agencies authorizing imported formula, relevant USDA and FDA guidance, charts of the top retailers, and maps indicating the prevalence of retailers across each region. |
| August 19, 2022 | N/A | USDA FNS extends flexibilities to allow formula imported under FDA’s enforcement discretion nationwide through November 30, 2022 (USDA, 2022j). |
| August 23, 2022 | N/A | USDA FNS extends most WIC waivers through December 31, 2022, to address the nationwide infant formula shortage under authority from the ABFA, previously under Stafford Act authority (USDA, 2022k). |
| September 2022 | FDA announces plans to provide a pathway for infant formula manufacturers under enforcement discretion to remain on the market (FDA, 2022f). | N/A |
| November 8, 2022 | N/A | USDA FNS extends regulation flexibilities for WIC state agencies through January 31, 2023 (USDA, 2022l). |
| November 22, 2022 | N/A | USDA FNS publishes the WIC Eligibility Requirements to bid on State Agency Infant Formula Contracts webpage with information and current contract holders (USDA, 2022m). |
| Date | FDA | FNS |
|---|---|---|
| December 19, 2022 | N/A | USDA FNS discusses unwinding and impacts of the infant formula shortage in a letter to WIC State agencies (USDA, 2022n). |
| January 4, 2023 | N/A | OMB’s spring regulatory agenda is published, including the initial timeline for USDA FNS’s final rule implementing the provisions of the ABFA (U.S. General Services Administration, 2023). |
| January 9, 2023 | FDA provides a plan for infant formula manufacturers that imported/sold/distributed product under enforcement discretion to continue marketing their products while they work toward meeting all applicable FDA requirements (FDA, 2023). | N/A |
| February 1, 2023 | N/A | USDA FNS publishes the Unwinding of Infant Formula Flexibilities in WIC policy memo, which provided updates to the Abbott infant formula recall waiver expiration schedule published on November 8 (USDA, 2023a). |
| June 14, 2023 | N/A | USDA FNS provides information to WIC state agencies on infant formula flexibilities for Food Package III (USDA, 2023b). |
| September 8, 2023 | N/A |
|
| Date | FDA | FNS |
|---|---|---|
| September 21, 2023 | N/A | USDA FNS updated the Federal Actions to Support Access to Infant Formula webpage, which provides information on FDA’s infant formula strategies and USDA’s response actions (USDA, 2024b). |
NOTES: The FNS timeline from USDA was developed specifically for the committee’s use. ABFA = Access to Baby Formula Act; CDC = Centers for Disease Control and Prevention; CFSAN = Center for Food Safety and Applied Nutrition; FDA = Food and Drug Administration; FMI = Food Industry Association; FNS = Food and Nutrition Service; IRI = Information Resources, Inc.; MMA = maximum monthly allowance; OFPR = Office of Food Policy and Response; OMB = U.S. Office of Management and Budget; USDA = U.S. Department of Agriculture; WIC = Special Supplemental Nutrition Program for Women, Infants, and Children.
a Updated letters replaced the initial letters issued on February 20, 2022; the links above are the latest versions issued under the Stafford Act.
SOURCES: FDA, 2022a; USDA, 2024a.
| Key: |
| Communication between FDA and FNS |
| Communications between FDA/FNS and the public |
| Communication between FNS and WIC/state agencies |
| Jurisdiction of the Biden administration |
TABLE C-2 Timeline for Maine, Connecticut, North Carolina, Texas, and New York WIC Response to the 2022 Abbott Formula recall
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| October 2021 | N/A | N/A | 28th: NC engaged local WIC agencies and vendors with requests for data regarding local and regional Gerber formula availability. | N/A | |
| November 2021 | N/A | N/A |
9th: NC WIC contacted Gerber regarding the deteriorating availability of Gerber contract formula. 15th: NC WIC made Gerber RTF and concentrate formulas available to WIC participants to combat the availability of contract Gerber powder formulas. |
N/A |
| February 2022 |
17th: FDA announces formula recall, Similac, Alimentum, and EleCare (FDA, 2022c). 18th: Maine WIC notifies local agencies (LAs), WIC participants and vendors of recall with instructions on how to return formula. Maine WIC staff go to vendors to pull recalled product from the shelves. 2x weekly calls with LAs and 1x week NERO calls established. 21st: Maine WIC applies and is granted waiver flexibilities on alternative formulas to provide, formula returns, medical documentation requirements, and the maximum monthly allowance (MMA) of formula. These waivers last until September 30, 2022. WIC updated the Approved Products List (APL). WIC holds twice weekly calls with LAs. Maine WIC attends weekly calls with NERO. |
17th: Abbott voluntarily recalls Similac, Alimentum, and EleCare powdered infant formulas manufactured at Sturgis facility in response to concerns about Cronobacter and Salmonella contamination (FDA, 2022b). FDA issues advisory report recommending that consumers do not use recalled powdered infant formulas after investigating reports about Cronobacter infections linked to formula supplied by the Sturgis facility (FDA, 2022g). 18th: CT WIC provided updates to internal staff and leadership; disseminated written guidance to LAs and authorized vendors on formula recall; shared information with key partners; and distributed participant communication via e-mail, WIC Shopper App, and the One Call Now text message system. |
17th: Abbott voluntarily recalls Similac, Alimentum, and EleCare powdered infant formulas manufactured at Sturgis facility in response to concerns about Cronobacter and Salmonella contamination (FDA, 2022b). FDA issues advisory report recommending that consumers do not use recalled powdered infant formulas after investigating reports about Cronobacter infections linked to formula supplied by the Sturgis facility (FDA, 2022g). 18th: USDA provides guidance for handling returns and exchanges of recalled product and the process for requesting WIC waivers related to infant formula shortages (USDA, 2022a). FNS launches the new Infant Formula Safety webpage to provide public-facing, real-time, infant formula food safety updates to the public (USDA, 2024c). |
17th: Abbott Laboratories voluntarily recalls Similac, Alimentum, and EleCare powdered infant formulas manufactured at Sturgis facility in response to concerns about Cronobacter and Salmonella contamination (FDA, 2022b).a Around 4:30 p.m., Texas WIC contacted Abbott Laboratories, representative to discuss impacts. They also contacted USDA’s Southwest Regional Office and sent e-mail notification to LA directors of the recall. 18th: Texas WIC sent text notification to all WIC clients receiving infant formula, informing them of the recall, instructing them to not use recalled product, and referring them to similacrecall.com. |
17th: Abbott voluntarily recalls Similac, Alimentum, and EleCare powdered infant formulas manufactured at Sturgis facility in response to concerns about Cronobacter and Salmonella contamination (FDA, 2022b). FDA issues advisory report recommending that consumers do not use recalled powdered infant formulas after investigating reports about Cronobacter infections linked to formula supplied by the Sturgis facility (FDA, 2022g). 18th: USDA provided guidance to WIC state agencies for handling returns and exchanges of recalled product and the process for requesting WIC waivers related to infant formula shortages (USDA, 2022a). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
n.d.: Maine WIC issues a formula substitution graphic and texts it to all WIC participants. Maine WIC works with MaineCare on a provider notice. Maine WIC works with ITO in Maine to ensure formula for ITO WIC participants. Maine WIC direct-ships cases of formula to the LA clinics each week. Maine WIC is having trouble obtaining Nutramigen, Neosure, and Similac Sensitive. Abbott issues rebate on all infant formulas WIC is purchasing. Rebate is extended to March 31, then changed to April 30, June 30, and currently rebate on all products go until August 31, 2022. |
CT WIC convened meetings with LAs to provide updates and guidance. Attended meetings with USDA FNS NERO and NEATO state directors on formula recall. Daily meetings set with FNS NERO. 20th: CT WIC applied for and was granted approval for three waivers through FNS NERO:
|
20th: USDA FNS begins issuing waivers to allow for product exchanges, non-contract brand of formula, and larger container sizes through September 30, 2022:b Program flexibility for MMA requirements in Food Packages I and II (USDA, 2022b). Program flexibility for medical documentation requirements in Food Packages I and II (USDA, 2022c). Program flexibility for vendor formula substitutions during a transaction (USDA, 2022d). 24th: NC submitted waiver request to FNS for additional flexibility during supply chain issues and 2022 Abbott recall—granted March 1, 2022. |
21st: USDA FNS approved all waiver requests from Texas WIC, including:
|
FNS launched the new Infant Formula Safety webpage to provide public-facing, real-time, infant formula food safety updates to the public (USDA 2024c). The New York State WIC program released “Vendor Bulletin #4: Infant Formula Public Health Advisory – Recall of Similac, Alimentum, and EleCare” to WIC vendors and Informational e-mail “Infant Formula Public Health Advisory – Recall of Similac, Alimentum, and EleCare” distributed to LAs. A follow-up informational e-mail was distributed to LAs to provide guidance on vendor exchanges, clarified all products affected, informed them of a planned mobile app |
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28th: Abbott releases return formula instructions. Maine WIC issues packing materials and instructions to LA clinics. |
|
28th: Abbott recalls one lot of Similac PM 60/40 manufactured at the same facility (FDA, 2022d). FDA advises parents and caregivers not to feed their babies certain powder formulas including Similac, Alimentum, and EleCare. |
for infant formula. This includes 7 CFR § 246.10(e)(9) Table 1 footnote 7, which requires state agencies to issue containers that are all the same size of the same physical form. |
(WIC2Go) message, and notified agencies that a message about the recall was added to the Interactive Voice Response line. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
CT WIC disseminated additional information to authorized vendors and the WIC Vendor Advisory Council about recall instructions and published this information on the DPH website. (The WIC Vendor Advisory Council serves as a communication forum between WIC authorized retail stores, professional trade organizations, food distributors, WIC LAs, and the state |
22nd: Texas WIC began adding UPCs for non-contract alternative-brand products to the APL. Seventy-five products were made available by February 25, with a total of 125 products (non-exempt and exempt) added by the end of the supply crisis. |
Program flexibility for MMA requirements in Food Packages I and II (USDA, 2022b). Program flexibility for medical documentation requirements in Food Packages I and II (USDA, 2022c). Program flexibility for vendor formula substitutions during a transaction (USDA, 2022d). 22nd: The New York State WIC program requested a waiver to temporarily waive the requirement for medical documentation for Food Package III, specifically for the formulas affected by the Abbott recall which includes, Alimentum, EleCare, and EleCare Jr. The New York State WIC program conducted a statewide call with LAs to provide |
|
WIC Office. Members of this group include the Spanish American Merchants Association, the Connecticut Food Association, manufacturer representatives, and small, medium, and large chain stores). Abbott approved rebate on non-contract and competitive formulas in a variety of sizes through March 31, 2022. CT WIC began identifying and adding alternative formula products to the APL for participant purchasing. |
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information and answer questions. A broadcast message was added to the WIC2Go mobile shopping application to notify all participants issued Alimentum, EleCare, or EleCare Jr. of the recall. 24th: The New York State WIC program distributed an FAQ document that resulted from the February 22 statewide call. The New York State WIC program requested to waive exchanges of an identical authorized supplemental food item (7 CFR § 246.12(h)(3) (ii)(A)). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
21st: CT WIC distributed information to authorized vendors and the WIC Vendor Advisory Council about allowing exchanges and credit/cash refunds. 23rd: CT WIC developed and distributed the first non-contract formula substitutes list to assist participants in purchasing non-contract formulas which was shared with LAs and authorized vendors. CT WIC developed “Breastfeeding Support During an Infant Formula Recall” guidance document and distributed it to LA staff. CT WIC held call with LA staff to review substitutes and guidance. |
23rd: Texas WIC sent text messages to clients about alternative brand options based on the formula that was currently issued to their WIC card.
24th: Texas WIC posted formula recall guidance for LA staff (Texas WIC, 2022a). |
25th: The New York State WIC program requested to waive the maximum monthly allowance requirement for infant formula in Food Package III (7 CFR § 246.10(e)(9)) and of 7 CFR § 246.10(e)(9) to allow authorization and issuance of formula containers in sizes, that when added together, most closely provide the MMA. USDA FNS approved New York State’s waiver request for vendor exchanges. 26th: The New York State WIC program distributed Vendor Bulletin #5: “Formula Recall – Vendor Exchange Waiver” notifying authorized vendors of the vendor exchange waiver approval. |
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CT WIC published substitutes list on website and shared it with participants through the WIC Shopper App and One Call Now text message system. 24th: CT WIC updated the non-contract formula list with additional products and distributed it to LAs; also updated its website and distributed through communications channels for participant awareness. |
25th: Texas WIC launched FAQ section for health care providers that outlined Texas WIC’s response and how to support their WIC patients affected by the recall for both exempt and nonexempt formulas.
|
28th: Abbott recalls one lot of Similac PM 60/40 manufactured at the same facility. FDA advises parents and caregivers not to feed their baby certain powder formulas including Similac, Alimentum, and EleCare (FDA, 2022d). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
Shared with the LAs and encouraged the use of social media posts that were planned to be posted daily on the DPH Facebook and Instagram pages, as well as the National WIC Association social media toolkit that highlighted the dangers of diluting formula or making homemade infant formula. 25th: CT WIC updated the non-contract formula list with additional products and distributed to LAs; updated website and distributed through communications channels for participant awareness. CT WIC distributed Abbott guidance to authorized vendors and the WIC Vendor Advisory Council on retail product return instructions and updated non-contract formula list. |
28th: Abbott Laboratories recalls one lot of Similac PM 60/40 manufactured at the same facility (FDA, 2022d).
|
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28th: CT WIC attended the national FNS formula rebate call. FNS NERO calls changed to weekly. |
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| March 2022 |
6th: Similac PM 60/40 added to recall. No Maine WIC participants are on this formula. Information shared with MaineCare. Information sent to MaineCare (FDA, 2022d). 11th: Maine WIC offers national re-lactation call (Maine CDC WIC, 2022b). 16th: An additional recall was announced on Similac PM 60/40. No WIC participants are on this formula. 21st: WIC local agency calls drop to 1x week. Weekly NERO calls remain. |
1st: CT WIC updated the non-contract formula list. Distributed guidance to LAs about the recall of Similac PM 60/40; guidance about what to do for participants reporting sick infants; instructions from Abbott on returning recalled product; and the updated list. Updated website and shared through communications channels. 2nd: CT WIC notified LAs of updates made to non-contract formula lists and need for medical documentation for special/exempt formulas impacted. |
3rd: USDA FNS responds to a WIC state agency requesting program flexibility for vendor formula substitutions during a transaction (USDA, 2022e). |
3rd: USDA approved waiver request for:
|
1st: The New York State WIC program released Vendor Bulletin #5: “Formula Recall Addition – Similac 60/40” distributed to authorized vendors and informational email: “Formula Recall Addition – Similac PM 60/40” to local agencies. The mobile shopping application (WIC2Go) broadcast message was updated to include participants issued Similac PM 60/40 to notify them of the recall. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
9th: Abbott extended the rebate on non-contract formulas through April 30, 2022. CT WIC sent notification to LAs including an updated list of formulas available. Also advised LAs of product availability issues (Isomil). Added new list to website and shared with participants on WIC Shopper app. 11th: CT WIC distributed updated non-contracts list to authorized vendors and advised them of the extension through April 30, 2022 and of Isomil shortages. 25th: CT WIC distributed updated non-contract substitutions list to LAs, participants, and authorized vendors. |
4th: Texas WIC sent a request to USDA to consider making an exception to policy memo #2000-2 regarding “Use of Banked Human Breast Milk (BBM) in the WIC Program” to allow donor human milk, obtained from a Human Milk Banking Association of North America accredited milk bank, as a substitute for Similac PM 60/40. This was not approved.
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3rd: USDA FNS responds to a WIC state agency requesting program flexibility for vendor formula substitutions during a transaction (USDA, 2022e). USDA FNS denied the New York State WIC program’s waiver request to temporarily waive the requirement for medical documentation for Food Package III, specifically for the formulas affected by the Abbott recall which includes Alimentum, EleCare, and EleCare Jr. 9th: The New York State WIC program notified LAs of the Abbott recall and vendor exchanges waiver via LA Memo 03/22 #12: “Voluntary Recall of Certain Abbott Powder Formulas and New York State Waivers.” |
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30th: CT WIC addressed issues related to limited availability of some Nutramigen products and sent out guidance to LAs. |
14th: Texas WIC announced extension of authorization of non-contract alternative brand formulas through April 2022: Notified LA staff. 15th: Updated public and health care provider websites and WIC app and Notified WIC-approved vendors. 17th: E-mailed health care partner organizations. 29th: Sent text messages notifying WIC clients. |
24th: The New York State WIC program maintained ongoing communications with manufacturers including shipping and distribution updates and began notifying LAs and vendor management agencies of manufacturer shipments expected to area distribution centers. 30th: The New York State WIC program released WIC Watch article: “Formula Recall Reminders” distributed to LAs, included links to the National WIC Association’s Abbott Formula Recall Social Media Toolkit, Abbott website, FDA recall notices, and CDC recall website. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| April 2022 | n.d.: Direct orders to WIC clinics occur. Store surveillance daily for stocks. |
4th: CT WIC restarted food and formula reporting from LAs on a weekly basis to monitor issues. 5th: CT WIC updated the non-contract lists to include store names for all store-brand products to help participants. Lists distributed to LAs, authorized vendors, and to participants through the website/WIC Shopper app. 11th: Abbott extended rebate on non-contract formulas through May 31, 2022. Lists updated to reflect new date and add language to purchase Abbott products when available before a non-contract/competitor product. 12th-14th: CT WIC updated website with new list and shared with participants, LAs, and authorized vendors. |
N/A |
5th: Posted on HHSC social media. 6th: Texas WIC added store label and large can size options for multiple exempt formulas to its standard formulary to increase options. (These were added within the regulations for MMA for Food Package III.) 8th: Texas WIC announced extension of authorization of non-contract alternative-brand formulas through May 2022: Notified LA staff and WIC-approved vendors. 11th: Updated public and health care provider websites and WIC app. 12th and 19th: Sent text messages notifying WIC clients. |
4th: The New York State WIC program answered questions regarding the recall during the New York State WIC Association board meeting and regional WIC coordinator meetings. 5th: Informational e-mail: “Lactaid Milk and Nutramigen Updates” distributed to WIC LAs notifying them that due to the Abbott recall, Nutramigen saw a 250% spike in demand, resulting in Mead Johnson only producing the powdered form and monitoring for overshipment to any WIC-approved vendor or geographic area. 6th: The New York State WIC program begins communication with contracted soy formula manufacturer regarding issuing competitive soy products as an alternative to Similac Soy Isomil. |
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18th: Texas WIC held opening of proposals for the infant formula competitive contract invitation to bid. (The timing of this solicitation was unrelated to the recall and a result of the normal cadence of contracting, with Abbott Laboratories’ contract set to expire September 30, 2022). 20th: Texas WIC announced intent to award the infant formula milk-based contract to Reckitt/Mead Johnson and soy-based contract to Abbott Laboratories as the responsive, responsible bidders offering the lowest total monthly net price for infant formula, respectively, consistent with 7 § CFR 246.16a(c)(5). Contracts were set to begin October 1, 2024. |
7th: Vendor Bulletin #7: “Addition of Neocate Syneo Infant 14.1 oz Powder” distributed to WIC authorized vendors to announce upcoming addition of Neocate Syneo powder. 8th: New York State WIC added Neocate Syneo Infant 14.1 oz powder to the New York State WIC Formulary as an alternative product to recalled formulas. LAs were notified via LA Memo 04/22 #18: “Addition of Neocate Syneo Infant.” 22nd: New York State WIC Central Office Staff began assisting the Vendor Management Agency with overflow calls from LAs requesting assistance in locating formula for participants. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| May 2022 |
3rd: Press requests begin. 12th: White House press release is available to the public. A meeting is held with Main CDC and HHS to obtain storage containers due to product issues with packaging (White House, 2022d). There is a palm oil and a cardboard shortage. 13th: AAP report/Dr. Belisle letter is sent to all state health commissioners (USDA, 2022f). n.d.: Maine has done all flexibilities allowed, other than the mag-stripe card (MSR, also known as an eWIC card or WIC Smart Card), as the policy will allow for fluctuations in stock without the waivers. |
4th: CT WIC contacted initially by CT Childrens’ Medical Center (CCMC) to coordinate on WIC families in their care to assist with finding special/exempt formulas in short supply. 13th: CT DPH issued a statement to CT state legislators on the status of the infant formula recall/shortages and the impact to WIC, and how WIC was supporting families that needed assistance finding formula. 16th: Abbott extended rebates on non-contract, competitor products through August 31, 2022. CT WIC accepted Abbott’s offer to send cases of Similac Sensitive to help with shortages and distributed to LAs for distribution. |
13th: USDA FNS provides a letter to state health commissioners reminding them of flexibilities available, and encouraging follow-up action as needed (e.g., seeking waiver approval if no request had been made yet) (USDA, 2022f). 16th: FDA issues regulatory guidance and announces a policy of regulatory flexibility to allow streamlined importation of infant formulas into the U.S. market in response to shortages (FDA, 2022e). 18th: Biden administration invokes the Defense Production Act (White House, 2022a). Waiver approved for MMA. |
18th: Texas WIC announced extension of authorization of non-contract alternative brand formulas through August 2022 and activated communication plan. Notified WIC LA staff, updated public and health care provider websites and WIC app, and notified WIC-approved vendors. 20th: Included updates in health care partner organization newsletters. Posted on HHSC social media May 19th, 20th, 25th and the 31st. Sent text messages on May 18th and 25th notifying WIC clients of continuation of alternative brand formula options through August. |
6th: New York State WIC received confirmation from contracted soy formula manufacturer that it will continue to provide rebates on competitive Similac Soy Isomil products with a first use-by date no later than July 31, 2022. 12th: New York State released a press release: “Governor Hochul Announces Resources for New York Families Amid Infant Formula Shortages.” This press release included resources to support families impacted by the formula shortage and included a link to the New York State WIC program website and virtual assistant, tips, such as switching to another available brand, contacting health care providers for samples, calling stores |
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16th: Child Health Leadership releases report. Maine WIC orders 100 cases of Similac Sensitive. Abbott’s press release (Abbott Nutrition, 2022) and American Academy of Pediatrics’ report (AAP, 2022) is available to the public. Maine WIC sends participants a survey (Maine CDC WIC, 2022c) on the challenges of formula, for results, see Maine CDC WIC, 2022d. Maine WIC will be doing post boosts to continue to get the word out on formula substitutions allowed and contact participants who request follow-up. |
17th: CT WIC met with CCMC’s pediatric dietitians to coordinate access to special formulas for families on WIC, share information about formula shortages, and answer WIC-related questions. Attended Committee on Children and Public Health Committee Joint Informational Forum on Baby Formula Shortage to discuss the formula shortage and available resources through WIC. |
19th: Biden administration announces Operation Fly Formula in which Department of Defense resources are used to transport additional formula supplies into the United States (White House, 2022b). |
to find what formula they have in stock, and warned against homemade formulas. The press release also discussed how the Department of Health was communicating with formula manufacturers to monitor production amounts, supply, and shipments, and noted the WIC program’s coordination with manufacturers to get formula to WIC participants when they cannot find it locally. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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17th: COVID-19 Community Care Partners Meeting. n.d.: Maine WIC has requested a waiver from FNS to allow infants who have had to switch to an alternative formula to be allowed to stay on the alternative formula until the child turns 1 year to avoid further dietary disruption. To this point, this waiver has been denied verbally. |
18th: Developed joint CT-specific fact sheet for families on navigating formula recall/shortages with CT Office of Early Childhood (OEC) (CT OEC, 2022). 26th: Met with CT Hospital Association reps to provide information on WIC, formula, and how WIC was supporting participants during recall/shortages. |
20th: NC waiver approved for non-contract specific products. Initiated daily report-outs to senior leadership regarding corporate vendors and LAs reporting formula shortages in their communities. NC continues to get formula inventory updates biweekly from corporate vendors. Process streamlined to include additional detailed data: Distribution center, store-level data, orders filled/unfilled/closed/visuals; (corporate vendors make up more than 75% of retailers across the state) 21st: President Biden signs the bipartisan ABFA (HR 7791), which allows the waiver of various WIC requirements in cases of supply chain disruption or emergency. |
13th: USDA FNS provides a letter to State Health Commissioners reminding them of flexibilities available, and encouraging followup action as needed (for example, seeking waiver approval if no request had been made yet) (USDA, 2022f). The New York State WIC program distributed an informational e-mail to LAs: Governor Hochul Announces Resources for New York Families Amid Infant Formula Shortages. The New York State WIC program requested program flexibility with regard to medical documentation requirements and requested to waive 7 CFR 246.10(d)(1)(i) which requires medical documentation for the issuance of noncontract-brand infant formula. |
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22nd: Biden administration announces use of the Defense Production Act to allow infant formula manufacturers to demand that their suppliers prioritize infant formula production over competing orders (White House, 2022c). 24th: USDA FNS provides a letter to state health commissioners for WIC state agencies contracting with Nestlé/Gerber and MeadJohnson-Reckitt encouraging them to talk with state-contracted infant formula rebate manufacturers to discuss any flexibilities that could be implemented under their current contracts, modification to that contract, or separate agreement (USDA, 2022g). 31st: NC made eight additional Gerber products available to families. |
14th: The New York State WIC program received USDA FNS approval for waiver to 7 CFR § 246.10(d) (1)(i) which requires medical documentation for the issuance of non-contract-brand infant formula. 16th: FDA issues regulatory guidance and announces a policy of regulatory flexibility to allow streamlined importation of infant formulas into the U.S. market in response to shortages (FDA, 2022e). 18th: Biden administration invokes the Defense Production Act (White House, 2022a). 19th: Biden administration announces Operation Fly Formula in which DoD resources are used to transport additional formula supplies into the United States (White House, 2022b). The New York State WIC program requested program flexibility with regard to the MMA requirements to remove regulatory barriers in case needed to respond to the ongoing formula shortage. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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19th: Biden administration announces Operation Fly Formula in which DoD resources are used to transport additional formula supplies into the United States (White House, 2022b). The New York State WIC program requested program flexibility with regard to the MMA requirements to remove regulatory barriers in case needed to respond to the ongoing formula shortage. 20th: USDA FNS approved New York State’s request to waive the MMA for infant formula provided to healthy infant participants receiving Food Packages I and II only. The New York State WIC program released “Local Agency Memo #22: Temporary |
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Soy Formula Alternatives,” announcing the implementation of the medical documentation waiver for soy formula and the addition of two alternative soy formulas to the New York State WIC Formulary. 21st: President Biden signs the bipartisan ABFA (H.R. 7791), which allows the waiver of various WIC requirements in cases of supply chain disruption or emergency. 22nd: Biden administration announces use of the Defense Production Act to allow infant formula manufacturers to demand their suppliers prioritize infant formula production over competing orders (White House, 2022c). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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23rd: “Vendor Bulletin #10: Supporting Authorized New York State WIC Vendors During Formula Shortage” distributed. Vendors were advised to maintain communications with and report any stocking issues to the vendor management agency. “Vendor Bulletin #11: Temporary WIC Minimum Stock Requirement Changes for Pharmacies” and Grocers with Embedded Pharmacies distributed. Advised vendors to temporarily stock any combination of certain approved soy formulas needed to meet minimum stock requirements. The New York State WIC program met with contracted soy formula manufacturer to discuss rebate amounts on competitor soy formulas. |
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24th: USDA FNS provides a letter to state health commissioners for WIC state agencies contracting with Nestlé/ Gerber and Mead-Johnson-Reckitt encouraging them to talk with state-contracted infant formula rebate manufacturers to discuss any flexibilities that could be implemented under their current contracts, modification to that contract, or separate agreement (USDA, 2022g). Mead Johnson agreed to the addition of several infant formula products under the infant formula rebate contract in a collaborative effort to create greater flexibility for WIC families. The New York State WIC program began providing daily updates to USDA FNS on shortages/supply issues. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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Two additional soy formulas were added to the New York State WIC Formulary as temporary options under the medical documentation waiver for Food Packages I and II. A mobile shopping application (WIC2Go) broadcast message was added to notify participants of the temporary soy formula availability. 25th: The New York State WIC program made modifications to Wanda virtual assistant to include new dialogue to address the formula shortages and clarify WIC’s role, benefits, and resources. 31st: The New York State WIC program requested approval to waive WIC regulations at 7 CFR § 246.10(e)(9), Table 1, which set forth MMA requirements for is-suance of WIC infant formula per medical documentation to participants receiving Food Package III. The New York State WIC program received USDA FNS approval to waive WIC regulations at 7 CFR § 246.10(e)(9), Table 1, |
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which set forth MMA requirements for issuance of WIC infant formula per medical documentation to participants receiving Food Package III. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| June 2022 | N/A |
1st: Started weekly meetings with the Office of the Governor (OTG), CT Dept. of Social Services (DSS), OEC at OTG’s request to coordinate and gather data on impact of formula recall/shortages. Data were compiled and shared with stakeholders each week. 2nd: USDA FNS issues waivers to allow formula imported under FDA’s enforcement discretion. CT WIC opted in. 6th: Attended Formula Roundtable event convened by Rep. Joanna Hayes to discuss impact of infant formula recall/shortages. 10th: Presented at the Medical Assistance Program Oversight Council Women & Children’s Subcommittee meeting. |
2nd: USDA FNS issues waivers to allow formula imported under FDA’s enforcement discretion. These initial approvals were superseded by extensions, starting on August 19, 2022. 3rd: NC system changes complete; MMA waiver to expand can size availability implemented for families. n.d.: NC worked to finalize statewide map of all vendors that could be filtered by retailer to ensure statewide access to formula. NC mapped larger retailer distribution centers and compared them to Gerber’s data to determine issues with some communities not having formula. Determined that there was a design change that was flagged incorrectly in the |
6th: Texas WIC opted into the waivers related to authorization of imported formulas under the FDA enforcement discretion, including:
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2nd: USDA FNS issues waivers to allow formula imported under FDA’s enforcement discretion. These initial approvals were superseded by extensions, starting on August 19, 2022. New York State obtained contracted manufacturer support for implementation of the waiver. Under waivers for the MMA for Food Packages I and II and medical documentation for Food Packages I and II, New York State WIC temporarily added larger sizes and store-brand alternatives of Enfamil Infant, Enfamil AR, and Enfamil Gentlease to New York State WIC Formulary. The |
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14th: CT WIC added the first foreign formula to APL, updated non-contract substitutions list, and added to website. Distributed new list to LAs, participants, and authorized vendors. |
Gerber system (parent organization’s name vs. vendor’s name). In addition, a South Carolina distribution center was feeding some NC counties. We had to work to get system changes so these could be established to have priority. 6th: USDA FNS implements ABFA provisions via a letter to WIC state agencies (USDA, 2022h). 55 additional standard products became available to NC families; 8 imported formulas were also added to the APL. |
9th: USDA approved Texas WIC’s request for waiver to 7 CFR § 246.10(e)(9) for Food Package III, which requires an MMA for infant formula. This includes 7 CFR § 246.10(e)(9) Table 1 footnote 7, which requires state agencies to issue containers that are all the same size of the same physical form. |
New York State WIC program released Local Agency Memo 06/22 #25: Temporary Contract Formula Larger Sizes and Store Brands” to communicate this update to LAs and “Vendor Bulletin #12: Temporary Redemption of Formula Larger Sizes - No Action Required” to authorized WIC vendors. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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22nd: USDA FNS provides a WIC Infant Formula Distribution Toolkit for state agencies and stakeholders (USDA, 2022i). It includes a list of state agencies authorizing imported formula, relevant USDA and FDA guidance, charts of the top retailers, and maps indicating the prevalence of retailers across each region. |
12th: Texas WIC began adding imported formulas to the APL. |
The mobile shopping application (WIC2Go) broadcast message was updated to inform participants of the ongoing formula additions and referred them to the Temporary Shopping Guide, which was a pictorial guide informing participants what temporary formulas could be purchased based on the formula they were issued. 3rd: The New York State WIC program opted in to Imported Infant Formula Under FDA enforcement discretion waiver. 6th: USDA FNS implemented ABFA provisions via a letter to WIC state agencies (USDA, 2022h). |
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9th: The New York State WIC program temporarily added larger sizes of Nutramigen powdered formula to the New York State WIC Formulary under the MMAs for Food Package III waiver. Additional store brand alternatives to Enfamil Infant, Enfamil AR, Enfamil Gentlease, and Similac Soy Isomil were added. “Local Agency Memo 06/22 #26: Temporary Exempt Formula Larger Sizes and Additional Store Brands Walgreens, CVS and Target” was released to share this update with LAs and “Vendor Bulletin #13: Temporary Redemption of Formula Larger Sizes and Additional Store Brands—No Action Required” was distributed to WIC authorized vendors. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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USDA denied medical documentation waiver Request: waive the medical documentation requirement to provide maximum flexibility for WIC clinic staff to ensure that participants have access to the necessary formula requested on May 24, 2022. 16th: The New York State WIC program released “Vendor Bulletin #14: Temporary Redemption of Contract Formula Larger Sizes and Additional Brands—Week 3 Updates—No Action Required” to WIC authorized vendors. 17th: The New York State WIC program added additional larger sizes and store-brand alternatives to Enfamil Infant, Enfamil AR, Enfamil Gentlease, Enfamil Reguline, and |
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Similac Soy Isomil to the New York State WIC Formulary. “Local Agency Memo 06/22 #29: Temporary Contract Formula Larger Sizes and Additional Brands Week 3 Updates” was released to communicate this update to LAs. 22nd: USDA FNS provides a WIC Infant Formula Distribution Toolkit for state agencies and stakeholders. It includes a list of state agencies authorizing imported formula, relevant USDA and FDA guidance, charts of the top retailers, and maps indicating the prevalence of retailers across each region (USDA, 2022i). 23rd: The New York State WIC program added additional larger sizes of Mead Johnson contract formulas and exempt formulas to New York State WIC Formulary. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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Imported alternatives and additional store-brand alternatives to Mead Johnson contract formulas were also added. “Local Agency Memo 06/22 #31: Temporary Formula Larger Sizes and Additional Brands—Week 4 Updates” was released to communicate this update to LAs and “Vendor Bulletin #15: Temporary Redemption of Contract Formula Larger Sizes and Additional Brands “Week 4 Updates—No Action Required” was distributed to WIC authorized vendors. |
| July 2022 | N/A |
5th: CT WIC joined CCMC’s “infant formula task force” designed for pediatric dietitians in CT to discuss infant formula shortage issues. Met weekly initially; moved to monthly or as needed. 19th: Abbott extended rebates of non-contract formulas through September 30, 2022. 20th: CT WIC updated list to reflect new end date, updated website, shared update with LAs, participants, and authorized vendors |
N/A |
8th: Texas WIC met with new milk-based contractor Reckitt/Mead Johnson to discuss details of transition and to establish a cadence of communication about product supply. 18th: Texas WIC announced extension of authorization of non-contract alternative-brand formulas through September 2022 to agency staff and vendors. Notified local agency staff and WIC-approved vendors. 27th: USDA FNS sent a letter to state WIC directors who were transitioning from an Abbott Laboratories contract to another manufacturer confirming continued availability of waivers and the approved use of WIC food funds for non-contract formula. |
N/A |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
18th-19th: Lyons Magnus issued a voluntary recall of certain batches of Kate Farms Pediatric Standard 1.2 vanilla products.
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| August 2022 | N/A |
19th: USDA FNS extends flexibilities to allow formula imported under FDA’s enforcement discretion nationwide through November 30, 2022 (USDA, 2022j). 23rd: USDA FNS extends most WIC waivers through December 31, 2022, to address the nationwide infant formula shortage under authority from the ABFA, previously under Stafford Act authority (USDA, 2022k). |
9th: Texas WIC updated Policy FD:19.0 with approval from USDA and in consultation with the Department of State Health Services to allow LAs, at their discretion, to reissue unopened containers of returned formula that had not been impacted by a recall to WIC participants during events that impact access to formula, such as natural disasters and supply chain disruptions (Texas WIC, 2022b). |
10th: Lyons Magnus expanded recall to include additional batches and formulations of Kate Farms products.
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19th: USDA FNS extends flexibilities to allow formula imported under FDA’s enforcement discretion nationwide through November 30, 2022 (USDA, 2022j). 23rd: USDA FNS extends most WIC waivers through December 31, 2022, to address the nationwide infant formula shortage under authority from the ABFA, previously under Stafford Act authority (USDA, 2022k). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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28th: Abbott extended rebates of non-contract formulas through October 31, 2022. 29th: CT WIC updated list to reflect new end date, updated website, shared update with LAs, participants, and authorized vendors |
19th: USDA FNS extends flexibilities to allow formula imported under FDA’s enforcement discretion nationwide through November 30, 2022 (USDA, 2022j). 23rd: USDA FNS extends most WIC waivers through December 31, 2022, to address the nationwide infant formula shortage under authority from the ABFA, previously under Stafford Act authority (USDA, 2022k). |
20th: Texas WIC announced extension of authorization of non-contract alternative-brand formulas through September 2022 to the public. Updated public and health care provider websites and WIC app. 22nd: E-mailed health care partner organizations. 24th and 30th: Sent text messages notifying WIC clients. |
26th: The New York State WIC program consulted with milk-based contract formula manufacturer to confirm support of the execution and extension of all USDA waivers to align with the expiration dates released by USDA FNS on August 23, 2022. 30th: “Vendor Bulletin #17: Temporary Redemption of Formula” distributed to authorized WIC vendors announcing the addition of exempt formulas to the New York State Formulary. |
| September 2022 | N/A |
9th: Abbott extended rebates of non-contract formulas through November 30, 2022. Notification from Abbott that Similac for Spit-Up was being discontinued, except the 2-oz RTF used in hospitals. Spit-Up comparable products would only receive rebate until November 30, 2022. 12th-13th: CT WIC updated list to reflect new end date, updated website, shared update with LAs, participants, and authorized vendors. CT WIC added Enfamil AR to APL to replace Similac for Spit-Up because Abbot no longer has a similar product. |
22nd: FDA announces plans to provide a pathway for infant formula manufacturers under enforcement discretion to remain on the market (FDA, 2022f). |
26th: Texas WIC announced plans to continue allowing non-contract formula alternatives and large can sizes at the onset of the Mead Johnson contract transition. Notification (Texas WIC, 2022c) was sent to local agency staff, vendors (Texas WIC, 2022d). Updated public and health care provider websites and WIC app. Sent text notification to clients. |
n.d.: FDA announces plans to provide a pathway for infant formula manufacturers under enforcement discretion to remain on the market (FDA, 2022f). 1st: In response to continued infant formula supply chain issues and to reduce the burden on the supply of hypoallergenic formulas currently on the New York State WIC Formulary, the New York State WIC program added three additional hypoallergenic formulas to the formulary temporarily. “Local Agency Memo 09/22 #Temporary Hypoallergenic Formulas” was distributed to LAs to communicate this update. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| October 2022 | N/A |
14th: Abbott announced a voluntary recall of certain lots of 2 fl oz/59 mL bottles of RTF liquid products for infants and children, including the brands Similac Pro-Total Comfort, Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure, Similac Water (Sterilized), and Pedialyte Electrolyte Solution. Abbott extended rebates of non-contract competitor products through December 31, 2022. 19th: CT WIC updated list to reflect new end date, updated website, shared update with LAs, participants, and authorized vendors. |
13th: Correspondence received—FNS approved the use of WIC food funds for non-contract formula redeemed prior to December 31, 2022, as long as appropriate agreement in place. |
1st: Texas WIC transitioned the cost-containment contract for infant milk-based formula to Reckitt/Mead Johnson. The primary formula issued to client’s shopping list changes to Mead Johnson products, Enfamil Infant, Gentlease, AR, or Reguline. However, with continued supply challenges nationwide and extension of federal waivers, Texas WIC continued to offer a variety of non-contract options, including alternative can sizes, at the point of redemption, as communicated on September 26. 8th and 9th: Posted on HHSC social media information regarding contract change and availability of alternatives. |
18th: The New York State WIC program released “Local Agency Memo 10/22 #51—Nutramigen Concentrate Supply Interruption” to notify LAs of Mead Johnson’s decision to prioritize manufacturing other products over Nutramigen Concentrate, resulting in limited supply. |
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17th: Based on continued evidence of inadequate supply of contract formulas, Texas WIC announced extension of authorization of non-contract alternative-brand formulas through November 2022 and activated communication plan. Notified LA WIC staff. 18th: Updated public and health care provider websites and WIC app and notified WIC-approved vendors. 25th and 26th: Sent text messages to client. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| November 2022 | N/A |
8th: USDA FNS extends regulatory flexibilities for WIC state agencies through January 31, 2023 (USDA, 2022l). 9th: Abbott extended rebates on competitor products through January 31, 2023 and on non-contract Abbott products through March 31, 2023. 18th: CT WIC issued guidance to local agency staff about the discontinuation of Similac for Spit Up and availability of Enfamil AR products for participants requiring added rice starch products |
8th: USDA FNS extends regulatory flexibilities for WIC state agencies through January 31, 2023 (USDA, 2022l). 22nd: USDA FNS publishes the WIC Eligibility Requirements to Bid on State Agency Infant Formula Contracts webpage with information and current contract holders (USDA, 2022m). |
17th: Based on continued evidence of inadequate supply of contract formulas, Texas WIC announced extension of authorization of alternative brand formulas through December 2022 and activated communication plan. Notified WIC-approved vendors. 21st: Notified WIC LA staff. 28th: Updated public and health care provider websites and WIC app. 29th: Sent text messages to clients. |
8th: USDA FNS extends regulatory flexibilities for WIC state agencies through January 31, 2023 (USDA, 2022l). 9th: New York State WIC program consulted with contracted soy formula manufacturer and confirmed extension of rebates for competitive soy products redeemed on/prior to January 31, 2023, and on alternative sizes of contract soy products redeemed on/prior to March 31, 2023. 10th: New York State WIC program received confirmation from contracted milk-based formula manufacturer that rebates on alternative milk-based products would continue until January 31, 2023. |
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22nd: USDA FNS publishes the WIC Eligibility Requirements to Bid on State Agency Infant Formula Contracts webpage with information and current contract holders (USDA, 2022m). |
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| December 2022 | N/A |
16th: Abbott added products available for rebate to assist with shortages and extended rebates for non-contract and competitor formulas:
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19th: USDA FNS discusses unwinding and impacts of the infant formula shortage in a letter to WIC state agencies. End of 2022 – Gerber sold formula line to Perrigo. |
5th: Posted on HHSC social media. 15th: Based on continued evidence of inadequate supply of contract formulas, Texas WIC announced extension of authorization of alternative-brand formulas through January 2023 and activated communication plan. Notified LA WIC staff. |
19th: USDA FNS discusses unwinding and impacts of the infant formula shortage in a letter to WIC state agencies (USDA, 2022n). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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19th: USDA FNS discusses unwinding and impacts of the infant formula shortage in a letter to WIC state agencies (USDA, 2022n). This guidance extended waiver authority for standard formulas to correspond with Abbott rebate extension dates announced on December 16, 2022, and extended two waivers related to special/exempt formulas through June 30, 2023:
23rd: CT WIC provided guidance to LAs about the extended rebate and waiver authority dates. |
16th: Updated public and health care provider websites and WIC app and notified WIC-approved vendors. 19th: USDA FNS announced plans for unwinding of formula flexibilities in a letter to WIC state agencies (USDA, 2022n). Waiver authority to provide non-contract alternative formulas would end February 28, 2023, along with a state’s authority to use federal food funds to pay for alternatives. 28th and 29th: Sent text messages to clients. |
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23rd-28th: CT WIC updated end dates on all products according to waiver/rebate extensions, updated substitutions lists, published updates to the website, and started participant communication messages. 28th: CT WIC sent updated substitutes list with extension of rebate dates to authorized vendors. |
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| January 2023 | N/A | N/A |
4th: OMB’s spring regulatory agenda is published, including the initial timeline for USDA FNS’s final rule implementing the provisions of the ABFA. Current spring 2023 regulatory agenda projects December 2023 publication (U.S. General Services Administration, 2023). |
3rd and 4th: Posted on HHSC social media. 12th: Texas HHSC notified Mead Johnson of USDA’s December 19, 2022, guidance, including the alternative formula expiration. |
4th: OMB’s spring regulatory agenda is published, including the initial timeline for USDA FNS’s final rule implementing the provisions of the ABFA. Current spring 2023 regulatory agenda projects December 2023 publication (U.S. General Services Administration, 2023; USDA, 2022n). |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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9th: FDA provides a plan for infant formula manufacturers that imported/sold/distributed product under enforcement discretion to continue marketing their products while they work toward meeting all applicable FDA requirements (FDA, 2023a). |
16th: Based on continued evidence of inadequate supply of contract formulas, Texas WIC announced extension of authorization of alternative-brand formulas through February 2023 and activated communication plan. Notified WIC-approved vendors. 23rd: Notified LA WIC staff and updated public and health care provider websites and WIC app. Text messages were sent to clients on the 24th. 25th: E-mailed health care partner organizations. |
9th: FDA provides a plan for infant formula manufacturers that imported/sold/distributed product under enforcement discretion to continue marketing their products while they work toward meeting all applicable FDA requirements (FDA, 2023a). 26th: The New York State WIC program notified LAs and authorized WIC vendors notified of the USDA’s planned transition away from infant formula flexibilities and back to normal program operations as nationwide supply chain issues improve, including expected waiver expiration dates via “Local Agency Memo 01/23 #4: Temporary Formula Discontinuation” and “Vendor Bulletin #2: Discontinuation of Temporary Formulas Update.” |
| February 2023 | N/A |
1st: USDA FNS publishes the “Unwinding of Infant Formula Flexibilities” in WIC policy memo to match the Abbott infant formula recall waiver expiration schedule (USDA, 2023a). 6th: CT WIC issued guidance and information to LAs, authorized vendors, and participants about infant formula transition and the end of non-contract competitor formulas effective February 28, 2023. 7th: CT WIC attended USDA briefing webinar on “Unwinding of Infant Formula Flexibilities” in WIC policy memo. 9th: CT WIC added Alimentum RTF 8-oz six-packs to increase availability considering shortages. Issued LA notification and guidance. |
1st: USDA FNS publishes the Unwinding of Infant Formula Flexibilities in WIC policy memo, which provided updates to the Abbott infant formula recall waiver expiration schedule published on November 8 (USDA, 2023a). 14th: NC requested an extension of waiver for non-contract formulas and documented ongoing supply shortages. 19th: Reckitt/Mead Johnson issued a voluntary recall of certain batches of ProSobee Simply Plant Based Infant Formula. |
1st: USDA FNS published the “Unwinding of Infant Formula Flexibilities” in WIC policy memo, which provided updates to the Abbott Laboratories infant formula recall waiver expiration schedule published on November 8 (USDA, 2023a). 4th-6th: Posted on HHSC social media. 16th: Texas HHSC communicated with both Mead Johnson and USDA about inadequate supply of contract formula. 17th: USDA FNS provided a process for states to request an extension of federal waivers on a case-by-case basis. |
1st: USDA FNS publishes the “Unwinding of Infant Formula Flexibilities” in WIC policy memo, which provided updates to the Abbott infant formula recall waiver expiration schedule published on November 8 (USDA, 2023a). 24th: The New York State WIC program consulted with milk-based contract formula manufacturer to confirm support of New York applying for an extension to the USDA waiver of medical documentation for Food Packages I and II. 27th: The New York State WIC program requested a 2-month extension of the waivers for medical documentation for Food Packages I and II and Imported Infant Formula under USDA FNS enforcement discretion. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
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15th: CT WIC staff met to review infant formula transition and discuss prep for February 28, 2023 change to APL (removal of all non-contract competitor products). 16th-17th: CT WIC distributed information to key stakeholders (state agency and nonprofit partners, CT Chapter of the American Academy of Pediatrics, etc.) about the transition to normal formula operations. 21st-22nd: FNS NERO notified states of Mead Johnson Voluntary Recall of Prosobee 12.9-oz Infant Formula. CT WIC issued information and guidance to LAs, updated website with information for participants, and posted notice on WIC Shopper App. |
19th: Reckitt/Mead Johnson issued a voluntary recall of certain batches of ProSobee Simply Plant Based Infant Formula.
|
20th: Notified LA WIC staff, WIC-approved vendors, and added information for clients and health partners on TexasWIC.org. 21st: Sent text messages to all clients issued soy-based formula and e-mailed health care partner organizations. 27th to March 1st: USDA FNS approved Texas WIC’s request to extend waiver flexibility through March 31, 2023, for 7 CFR § 246.10(d)(1)(i), which requires medical documentation for the issuance of non-contract-brand infant formula.
|
28th: USDA (FNS) approved New York State WIC’s request to extend the waiver for medical documentation for Food Packages I and II and Imported Infant Formula until April 30, 2023. New York State WIC’s request to extend the waiver for imported infant formula was denied by USDA FNS. USDA FNS further required New York WIC to develop and implement a plan for transitioning to normal operations beginning May 1, 2023. Informational e-mail: “Revisions to New York State WIC Formulary” was distributed to LAs to notify them of these decisions. |
|
27th: Abbott requested that NEATO states share messaging on formula unwinding. CT WIC provided the information to Abbott as requested. 28th: Initial flexibilities end (waiver and rebates for non-contract competitor products). CT WIC staff ensure initial transition is complete and all products are removed from APL. |
invoice for rebates on these products. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
| March 2023 | N/A |
9th: FNS NERO held a formula unwinding call to check in with NERO states. CT WIC attended. 14th-21st: CT WIC received an inquiry from the Government Accountability Office about the infant formula recall/shortages. A response was prepared and shared on March 21, 2023. 18th-20th: FNS NERO notified states of Voluntary Recall of Limited Amount of Gerber Good Start SoothePro Infant Formula. CT WIC issued information and guidance to LAs, updated website with information for participants, and posted notice on WIC Shopper app. |
18th: Perrigo Company voluntary recall of certain containers of Gerber Soothe 12.4 oz, 19.4 oz and 30.6 oz. |
14th: Based on continued evidence of inadequate supply of contract formulas in Texas, USDA FNS approved Texas WIC’s request to extend the waiver for 7 CFR § 246.10(d)(1) (i) for Food Packages I and II, which requires medical documentation for the issuance of noncontract-brand infant formula, through April 30, 2023.
17th: Notified WIC-approved vendors. 17th-20th: Perrigo announced a voluntary recall of certain batches of Gerber Good Start SoothePro powdered infant formula. |
1st: The New York State WIC program met with contracted soy formula manufacturer to confirm alternative-product discontinuation plan. Imported infant formulas and non-contract soy formulas were removed from the New York State WIC Formulary. “Vendor Bulletin #5: Discontinuation of Some Temporary Formulas” distributed. A mobile shopping application (WIC2Go) broadcast message was added to notify participants of the formulas being removed. 6th: The New York State WIC program released “Local Agency Memo 03/23 #10: Infant Formula Waiver Update” to LAs providing a timeline of when temporary formulas will be removed from the New York State WIC formulary. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
28th-April 30th: CT WIC set discontinuation dates for non-contract products on the APL. Staff also planned for, developed, and distributed updates to DPH leadership, stakeholders, LAs, vendors, and participants about the second phase of the transition to infant formula operations, wherein non-contract Similac products in a variety of sizes were removed. Effective April 30, 2023, all non-contract products were discontinued from the APL and unavailable for purchase except Similac products that Abbott added to the contracts list related to supply issues with liquid products. |
20th: Updated public and health care provider websites and WIC app. |
|
21st and 22nd: E-mailed health care partner organizations on the 21st; Sent text messages to clients and posted on HHSC social media on the 22nd. |
|||||
| April 2023 | N/A | N/A | n.d.: FNS grants extension of waivers for medical documentation for Food Packages I and II and MMA for Food Packages I and II through June 30, 2023. |
24th: Based on continued evidence of inadequate supply of contract formulas in Texas, USDA FNS approved Texas WIC’s request to extend the waiver for 7 CFR § 246.10(d)(1)(i) for Food Packages I and II, which requires medical documentation for the issuance of noncontract-brand infant formula, through May 31, 2023.
|
14th: New York State WIC consulted with contracted milk-based formula manufacturer and confirmed support to request a 2-month extension of the waivers for medical documentation for Food Packages I and II and MMA for Food Packages I and II. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
|
25th: Updated public and health care provider websites and WIC app notified LA WIC directors and WIC-approved vendors, and sent text messages to clients. 30th: E-mailed health care partner organizations. |
20th: The New York State WIC program requested a 2-month extension of the USDA FNS waivers for medical documentation for Food Packages I & II and MMA for Food Packages I and II to maximize access to contract formulas and comparable alternative products. 27th: USDA FNS approved the New York State WIC program’s request to extend medical documentation for Food Packages I and II waiver until May 31, 2023 (1 month extension) and MMA for Food Packages I and II waiver until June 30, 2023. |
|
28th: “Local Agency Memo 04/23 #20: Infant Formula Waiver Update” released, notifying LAs that New York State WIC’s request to extend the medical documentation for Food Packages I and II and MMA for Food Packages I and II waivers were extended to May 31, 2023, and June 30, 2023, respectively. The program released “Vendor Bulletin #8: Discontinuation of Some Temporary Formulas” distributed. The bulletin notified vendors that currently approved alternative formulas would remain on the APL through May 31, 2023 and alternative can sizes of contract formula would remain through June 30, 2023. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| May 2023 | N/A |
5th: CT WIC issued guidance to LA staff about updates related to Enfamil AR and comparable due to continued product shortages. 25th: CT WIC provided updates to local agency staff about continued availability of products as part of the contract due to supply issues with liquid products; waiver authority expiration for special formula flexibilities effective June 30, 2023; and availability updates of special formulas. |
N/A |
2nd and 5th: Posted on HHSC social media. 13th: Texas WIC notified Mead Johnson of intent to end authorization of non-contract alternatives, ending all flexibilities provided in the contract under inadequate supply provisions and federal waivers. 16th and 17th: Texas WIC implemented communication strategy to announce the ending of formula redemption flexibilities and return to standard business operations. Notified LA WIC staff on the 16th and WIC-approved vendors on the 17th. |
n.d.: The New York State WIC program submitted to USDA FNS a transition plan that focused on educating participants and retailers about the changes that will occur as New York State WIC transitions back to the issuance of formula in WIC-approved container sizes. 26th: “Vendor Bulletin #10: Discontinuation of Some Temporary Formulas” was distributed notifying vendors of the list of temporary formulas that would be removed from the APL on June 1. |
|
22nd: Updated Client Facing and Healthcare Partners pages on TexasWIC.org. May 24th and 26th: Text message sent to clients on the 24th and e-mail sent to health care partner organizations. 25th: Posted on HHSC social media. |
| Date | Maine CDC WIC | Connecticut WIC | North Carolina WIC | Texas WIC | New York WIC |
|---|---|---|---|---|---|
| June 2023 |
9th: CT WIC received Freedom of Information inquiry for all documents related to infant formula system. Referred inquirer to Massachusetts website on procurement and to the contract lead for followup if needed (MA is lead NEATO state). 14th: USDA FNS provides information to WIC state agencies on infant formula flexibilities for Food Package III (USDA, 2023b). 30th: Final waiver authority ends for infant formula flexibilities. |
14th: USDA FNS provides information to WIC State agencies on infant formula flexibilities for Food Package III (USDA, 2023b). 30th: Infant formula waivers expired that allowed for non-contract-brand formulas and the MMA to be exceeded. |
1st: Text messages sent to clients. Texas WIC returned to normal operations. |
1st: The New York State WIC program removed all of the store-brand formulas from the New York State WIC Formulary due to the medical documentation for Food Packages I and II waiver expiration. A WIC2Go broadcast message was added to notify participants of the formulas being removed. 10th: “Vendor Bulletin #11: Discontinuation of Temporary Formulas” was distributed, notifying vendors of the list of temporary formulas that would be removed from the APL on July 1. 14th: USDA FNS provides information to WIC state agencies on infant formula flexibilities for Food Package III (USDA, 2023b). |
|
16th: “Local Agency Memo 06/23 #29 Formula Updates Summer 2023” distributed to LAs. This memo notified LAs that some temporary hypoallergenic formulas would remain on the New York State WIC Formulary and reminded them that alternative container sizes would no longer be available July 1, 2023. 30th: The New York State WIC program removed all temporary alternative formulas from New York State WIC Formulary due to expiration of waivers for MMA for Food Packages I, II, and III. A mobile shopping application (WIC2Go) broadcast message was added to notify participants of the formulas being removed. |
| July 2023 | N/A | N/A | 1st: Due to Gerber agreeing that NC is still facing supply issues, they agreed to continue paying for standard-size non-contract formulas. (This was due to supply language in the contract.) However, NC had to discontinue the availability of expanded can sizes due to the MMA waiver expiring. | N/A | n.d.: The New York State WIC program began internal review process of New York State WIC Formulary to expand comparable options for exempt formulas and WIC-eligible nutritionals to give WIC participants more flexibility in the event of future supply issues. |
| September 2023 | N/A | N/A |
8th: USDA FNS provides technical assistance on the Requirements and Best Practices for Oversight of the Infant Formula Suppliers List in the WIC program (USDA, 2023c). USDA FNS issues guidance on the oversight of infant formula purchase requirements in WIC, which discusses stolen infant formula which may be offered for resale to online platforms, warehouses, and retail stores and related WIC regulations (USDA, 2023d). |
N/A |
8th: USDA FNS provides technical assistance on the Requirements and Best Practices for Oversight of the Infant Formula Suppliers List in the WIC program (USDA, 2023c). USDA FNS issues guidance on the oversight of infant formula purchase requirements in WIC, which discusses stolen infant formula which may be offered for resale to online platforms, warehouses, and retail stores and related WIC regulations (USDA, 2023d). |
|
21st: USDA FNS updated the Federal Actions to Support Access to Infant Formula webpage, which provides information on FDA’s infant formula strategies and USDA’s response actions (USDA, 2024b). |
21st: USDA FNS updated the Federal Actions to Support Access to Infant Formula webpage, which provides information on FDA’s infant formula strategies and USDA’s response actions (USDA, 2024b). |
NOTES: The state WIC timelines from Maine CDC, Connecticut, North Carolina, Texas, and New York were developed specifically for the committee’s use. APL = approved products list; CCMC = Connecticut Children’s Medical Center; CDC = Centers for Disease Control and Prevention; CT OEC = Connecticut Office of Early Childhood; FNS = Food and Nutrition Service; HHS = U.S. Department of Health and Human Services; HHSC = Health and Human Services Commission; ITO = inter-tribal organization; LA = local agency; MMA = maximum monthly allowance; NEATO = New England and Tribal Organizations; NERO = Northeast Regional Office; RTF = ready to feed; USDA = U.S. Department of Agriculture; WIC = Special Supplemental Nutrition Program for Women, Infants, and Children.
a Updated letters replaced the initial letters issued on February 20, 2022.
SOURCES: Maine CDC WIC, 2022a; Connecticut WIC Program, 2024; North Carolina WIC Program, 2023; Texas WIC, 2023; New York State WIC Program, 2024.
TABLE C-3 Timeline of the Inter Tribal Council of Arizona (ITCA), Inc. and the Chickasaw Nation WIC: 2022 Abbott Formula Recall
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
| March to April 2020 COVID-19 |
N/A | WIC participants experienced some formula shortages in the early days of the pandemic largely due to supply chain issues. Most participants were able to locate and purchase our contract formulas as well as medical formulas but had to make more trips to the grocery store due to limits imposed by the stores. |
| November 2021 | While this was before the official recall, issues with supply started around this time. 19th: Notified local agencies about the supply issues with Similac Total Comfort; worked with stores and suppliers to identify product and/or alternatives; worked with clients to identify alternatives and voided and reissued benefits for Total Comfort as needed; communicated with manufacturer about supply issues. |
N/A |
| January 2022 | N/A | n.d.: Experienced limited availability of the Enfamil protein hydrolysate formula Nutramigen. |
| February 2022 |
17th: Received notification that Abbott recalled Similac, Alimentum, and EleCare powdered infant formulas. 18th: First notification and guidance to local agencies about nationwide recall of Similac products:
|
17th: Abbott (Similac) announced a large recall that affected nearly all of their formulas, including their powdered protein hydrolysate and elemental. We were not on an Abbott contract, so this recall did not affect our contract formulas. We immediately contacted all families receiving Alimentum powder and Elecare. We issued Alimentum in RTF form if available or asked participants to speak to their doctor about similar formulas from other companies. |
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
20th: Applied for and received approval from USDA on waivers for providing non-contract formulas without medical documentation, container size flexibilities, and vendor exchanges.
21st: Sent letter to Abbott notifying them that we would be issuing non-contract-brand formula. 22nd: Meeting with local agency Managers to preview upcoming guidance on new replacement options and client materials. 23rd: Implemented options for available formulas that included non-contract formulas based on waivers available and released new guidance for local agencies.
25th: Expanded available non-contract formulas allowable and released new guidance for local agencies. |
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
|
||
| March 2022 | N/A | N/A |
| April 2022 |
25th: Webinar for local agency staff on navigating the formula recall and how to best assist clients.
|
|
| May 2022 | n.d.: WIC alert to stores on new subcategories for larger cans of soy formula. |
During the summer months, it became very difficult for WIC participants to find protein hydrolysate and premature formulas on the shelves of their local stores.
|
| June 2022 | 17th: Provided updated guidance to local agencies on available formulas with expanded list. | |
| July 2022 |
18th: Provided updated guidance to local agencies on available formulas and timeline.
|
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
| August 2022 | N/A | N/A |
| September 2022 |
2nd: Final guidance to local agencies with information on ending formula alternatives with flowsheet to guide staff on what to issue and how long clients could redeem issued benefits.
12th: Updated information in Shopper app and on website about the end date of alternatives. 14th: Text message sent to clients about the end date of alternatives.
30th: Phased out most milk and soy-based non-contract formula. |
By the fall and winter of 2022, supply levels were reasonable for all types of formulas, and we felt we had made it through the crisis. We were wrong. |
| October 2022 | 31st: Added imported formula substitution. | |
| November 2022 | 1st: Phased out some larger-can-size formulas. | |
| December 2022 | N/A | |
| January 2023 | 26th: WIC alert to notify stores of plan to phase out additional non-contract formulas. | |
| February 2023 | 18th: Phased out remaining non-contract-brand Total Comfort substitutions. |
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
| March 2023 | N/A |
We experienced a recall of our contract formula, Gerber Good Start SoothePro. Approximately one-third of the formula fed infants we serve are issued that formula. We requested a waiver that would allow us to issue non-contract formulas without a prescription and were granted that waiver through April 30, 2023. Also added larger can sizes of both contract and non-contract formulas to our food items. We continue to offer the larger can sizes because we utilize rounding-up for formula issuance. Most of our participants chose to receive the other contract milk-based formula, so the waiver was only used for a handful of families. To extend the waiver past that date, we had to prove that there was a limited supply of contract formula available. |
| April 2023 | 30th: Phased out large container size of Total Comfort | The impact of the recall had not been fully realized. |
| May 2023 | N/A |
18th: Checked the shelves of the WIC-authorized store in Duncan, Oklahoma that was only 1 block from our office, only to find no contract milk-based formulas on the shelves. None. Could you imagine being a parent with only one-half can of formula left at home, nine cans available in your WIC benefit, and seeing what I saw in the store. I contacted my director who in turn called our regional office. They no longer had any authority to grant waivers. Our only option to be able to issue non-contract formulas was to get a prescription. It sounds easy to get a prescription for these formulas, but it could necessitate extra doctor visits (costing the Medicaid system extra money), extra trips by the family, and a delay in the baby obtaining the needed formula. |
| June 2023 | N/A | N/A |
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
| July 2023 | N/A | From June to July, supplies improved. We continued to experience shortages of medical formulas in some communities, but supply levels of contract formulas improved for a while. |
| September 2023 | N/A |
In September 2023, we were notified that we would be experiencing shortages of our contract soy formula due to a discontinuation of the 12.9-ounce can size. Staff have been instructed to follow these steps when a participant requests soy formula:
|
| November 2023 | N/A | Nutramigen powder was again in short supply. Families were able to find Nutramigen RTF in most stores and our pharmacy vendor had an ample supply of Nutramigen RTF that could be shipped. The RTF formula is not as convenient for families to use as the powder, so families had to forgo convenience to provide a formula their babies could tolerate. |
| December 2023 | N/A | 31st: Mead Johnson announced a recall of Nutramigen powder. Our WIC program contacted all families who had redeemed Nutramigen powder in the past month to let them know about the recall. The number of families was insignificant due to the ongoing shortage of Nutramigen powder. |
| Date | ITCA WIC | Chickasaw Nation WIC |
|---|---|---|
| January 31, 2024 to May 2024 | N/A | There is no contract soy formula available, and we continue to issue alternative brands. Supply levels of Nutramigen powder have improved. |
NOTES: APL = approved products list; MIS = management information system; RTF = ready to feed; WIC = Supplemental Nutrition Program for Women, Infants, and Children.
SOURCES: ITCA WIC, 2023; Chickasaw Nation WIC, 2023.
AAP (American Academy of Pediatrics). 2022. Are there shortages of infant formula due to COVID-19? https://www.healthychildren.org/English/tips-tools/ask-the-pediatrician/Pages/Are-there-shortages-of-infant-formula-due-to-COVID-19.aspx (accessed April 3, 2024).
Abbott Nutrition. 2022. Press release: Abbott enters into consent decree with U.S. Food and Drug Administration for its Sturgis, Mich., plant; Agreement creates pathway to reopen facility. https://abbott.mediaroom.com/2022-05-16-Abbott-Enters-into-Consent-Decree-with-U-S-Food-and-Drug-Administration-for-its-Sturgis,-Mich-,-Plant-Agreement-Creates-Pathway-to-Reopen-Facility (accessed April 3, 2024).
Chickasaw Nation WIC. 2023. Timeline of formula shortage for Chickasaw Nation WIC. (See Public access file. https://www8.nationalacademies.org/pa/managerequest.aspx?key=HMD-FNB-23-04 (accessed August 28, 2024).
Connecticut WIC Program. 2024. Response and timeline for the Abbott infant formula recall and shortages. See Public Access File. https://www.nationalacademies.org/our-work/challenges-in-supply-market-competition-and-regulation-of-infant-formula-in-the-united-states#sectionProjectScope (accessed September 20, 2024).
CT OEC (Connecticut Office of Early Childhood). 2022. Infant formula shortage: Tips and support for CT families. https://www.ctoec.org/wp-content/uploads/2022/05/OEC_FormulaShortage_5_18_22.pdf (accessed April 3, 2024).
FDA (U.S. Food and Drug Administration). 2022a. Timeline of infant formula related activities. https://www.fda.gov/media/158737/download (accessed February 15, 2024).
FDA. 2022b. Abbott voluntarily recalls powder formulas manufactured at one plant. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant (accessed February 26, 2024).
FDA. 2022c. FDA investigation of Cronobacter infections: Powdered infant formula (February 2022). https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022 (accessed March 21, 2024).
FDA. 2022d. Abbott voluntarily expands recall of powder formulas manufactured at one plant. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-expands-recall-powder-formulas-manufactured-one-plant (accessed March 21, 2024).
FDA. 2022e. Guidance for industry: Infant formula enforcement discretion policy. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy (accessed February 15, 2024).
FDA. 2022f. Guidance for industry: Infant formula transition plan for exercise of enforcement discretion. https://www.fda.gov/media/161904/download?attachment (accessed February 15, 2024).
FDA. 2022g. FDA investigation of Cronobacter and Salmonella complaints: Powdered infant formula (February 2022). https://portal.ct.gov/-/media/Departments-and-Agencies/DPH/dph/WIC-2018/Bulletins/FDA-Investigation-of-Cronobacter-and-Salmonella-Complaints-Powdered-Infant-Formula-February-2022--FD.pdf (accessed April 3, 2024).
FDA. 2023a. Enforcement discretion to manufacturers to increase infant formula supplies. https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies (accessed February 15, 2024).
ITCA WIC (Inter Tribal Council of Arizona, Inc. WIC). 2023. ITCA infant formula recall response timeline. See Public Access File. https://www8.nationalacademies.org/pa/managerequest.aspx?key=HMD-FNB-23-04 (accessed August 28, 2024).
Maine CDC WIC. 2022a. 2022 Abbott formula recall timeline. See Public access file. https://www8.nationalacademies.org/pa/managerequest.aspx?key=HMD-FNB-23-04 (accessed August 28, 2024).
Maine CDC WIC. 2022b. Maine WIC relactation in postpartum birthing parents with Paula Norcott. https://www.youtube.com/watch?v=ltTqxZVfHnk (accessed April 3, 2024).
Maine CDC WIC. 2022c. Infant formula shortage survey. https://docs.google.com/forms/d/e/1FAIpQLSfGaJH9uiBLqJBTh7QjyNZPe2_epEzF6bCWWWfOc77Ghv7RzQ/view-form (accessed April 3, 2024).
Maine CDC WIC. 2022d. Infant formula shortage survey (responses). https://docs.google.com/spreadsheets/d/1cqMH5l5bybktXpXSJkuoB-W5ylcIZgLhTTofPor4o1g/edit#gid=534135042 (accessed February 26, 2024).
New York State WIC Program. 2024. The timeline of steps the New York state WIC program took during the infant formula supply chain disruption. See Public access file. https://www8.nationalacademies.org/pa/managerequest.aspx?key=HMD-FNB-23-04 (accessed August 28, 2024).
North Carolina WIC Program. 2023. The timeline of steps USDA took during the infant formula supply chain disruption. See Public access file. https://www8.nationalacademies.org/pa/managerequest.aspx?key=HMD-FNB-23-04 (accessed August 28, 2024).
Texas WIC. 2022a. Memorandum #22-014: Local agency WIC clinic guidance: Abbott formula recall. https://www.hhs.texas.gov/sites/default/files/documents/wic-22014.pdf (accessed April 3, 2024).
Texas WIC. 2022b. Policy No. FD:19.0: Managing returned formula. https://www.hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/wic/policy/fd-19-0.pdf (accessed April 3, 2024).
Texas WIC. 2022c. Memorandum #22-077: Contract formula update and authorization of temporary alternatives. https://www.hhs.texas.gov/sites/default/files/documents/wic-22077.pdf (accessed April 3, 2024).
Texas WIC. 2022d. Vendor news flash: Alternate formulas available starting October. https://www.hhs.texas.gov/sites/default/files/documents/wic-vnf-alternate-formulaseff-10-01-22.pdf (accessed April 3, 2024).
Texas WIC. 2023. Texas WIC response timeline to the nationwide infant formula shortage. See Public access file. https://www8.nationalacademies.org/pa/managerequest.aspx?key=HMD-FNB-23-04 (accessed August 28, 2024).
USDA (U.S. Department of Agriculture). 2022a. Voluntary recall of certain Abbott powder formulas, including Similac, Alimentum and Elecare. https://www.fns.usda.gov/wic/voluntary-recall-certain-abbott-powder-formulas (accessed March 21, 2024).
USDA. 2022b. WIC infant formula MMA waiver for food packages I and II. https://www.fns.usda.gov/wic/supply-chain-Abbot-MMA (accessed March 21, 2024).
USDA. 2022c. WIC infant formula medical documentation waiver. https://www.fns.usda.gov/wic/suppy-chain-abbott-medical-documentation (accessed March 21, 2024).
USDA. 2022d. WIC infant formula vendor exchanges waiver. https://www.fns.usda.gov/wic/supply-chain-abbot-vendor-exchanges (accessed March 21, 2024).
USDA. 2022e. WIC infant formula vendor substitutions waiver. https://www.fns.usda.gov/wic/supply-chain-Abbott-formula-substitutions (accessed March 21, 2024).
USDA. 2022f. Letter to state directors regarding infant formula. https://www.fns.usda.gov/wic/state-director-letter-infant-formula (accessed March 21, 2024).
USDA. 2022g. Letter to state health commissioner regarding infant formula. https://www.fns.usda.gov/wic/state-health-commissioner-infant-formula (accessed March 4, 2024).
USDA. 2022h. Follow-up letter to state health commissioners. https://www.fns.usda.gov/wic/state-health-commissioner-letter-june (accessed March 4, 2024).
USDA. 2022i. WIC infant formula distribution toolkit. https://www.fns.usda.gov/wic/formula-toolkit (accessed April 1, 2024).
USDA. 2022j. WIC infant formula imported infant formula under FDA’s infant formula enforcement discretion waiver. https://www.fns.usda.gov/wic/flexibilities-formula-enforcement-discretion (accessed April 1, 2024).
USDA. 2022k. Abbott infant formula recall waiver expiration schedules. https://www.fns.usda.gov/wic/abbott-infant-formula-recall-waiver-expiration-schedules (accessed February 15, 2024).
USDA. 2022l. Abbott infant formula recall waiver expiration memo. https://www.fns.usda.gov/wic/abbott-infant-formula-recall-waiver-expiration-memo (accessed April 1, 2024).
USDA. 2022m. WIC eligibility requirements to bid on state agency infant formula contracts. https://www.fns.usda.gov/wic/requirements-infant-formula-contracts (accessed April 1, 2024).
USDA. 2022n. Letter to WIC state agencies on unwinding and impacts of infant formula shortage. https://www.fns.usda.gov/wic/letter-infant-formula-transition-plan (accessed March 4, 2024).
USDA. 2023a. WIC policy memorandum #2023-3 unwinding infant formula flexibilities in WIC. https://www.fns.usda.gov/wic/policy-memorandum-2023-3-unwinding-infant-formula-flexibilities (accessed March 4, 2024).
USDA. 2023b. Letter to WIC state agencies on infant formula flexibilities for food package III. https://www.fns.usda.gov/wic/flexibilities-food-package-iii (accessed March 4, 2024).
USDA. 2023c. Requirements and best practices for oversight of the infant formula suppliers list. https://www.fns.usda.gov/wic/infant-formula-suppliers-tip-sheet (accessed April 1, 2024).
USDA. 2023d. Oversight of infant formula purchase requirements in WIC. https://www.fns.usda.gov/wic/oversight-infant-formula-purchase-requirements (accessed April 1, 2024).
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