Recalled Gerber baby formula was sent to US retailers after recall began, wholesaler says; Contaminated product not distributed to South Dakota

MAY 16, 2023:

NEW YORK (AP) — An infant formula recalled over potential bacteria contamination was distributed to retailers across eight states even after the recall begun, according to a release published by the U.S. Food and Drug Administration this week.

In March, Perrigo Co. issued a voluntary recall of certain lots of its Gerber Good Start SootheProTM Powdered Infant Formula “out of an abundance of caution” due to the possible presence of Cronobacter sakazakii, a germ that can cause serious or deadly infections in infants.

The recall impacted Gerber Good Start formula manufactured between Jan. 2 and Jan. 18, 2023, at the Perrigo’s Gateway Eau Claire, Wisconsin, facility. The recalled formula was sold in three different sizes at retailers nationwide, according to a March 17 recall notice.

Cooperative food wholesaler Associated Wholesale Grocers, however, distributed the 12.4-ounce verison of the recalled product to its Nashville Division retailers after Perrigo’s initial recall notice was published.

As a result, the recalled product was distributed to supermarkets across Alabama, Georgia, Indiana, Kentucky, Ohio, Tenneessee, Virginia and West Virgina, Associated Wholesale Grocers said Saturday (May 13, 2023).

The wholesaler is urging consumers who purchased Gerber Good Start formula at impacted locations to check their products. The recalled formula sold beyond the start of the recall can be identified by its lot codes and “use by” dates — which range from July 4, 2024 to July 12, 2024.

“Any consumers who purchased product with matching codes should discontinue use and dispose of the product,” Associated Wholesale Grocers’ Saturday notice reads, adding that consumers can request a refund by contacting the Gerber Parent Resource Center on behalf of Perrigo.

In a statement to The Associated Press on Tuesday, Perrigo said that the company informed all customers at the time of the March recall. The Saturday notice from Associated Wholesale Grocers, which Perrigo identifies as a customer, is “not directly associated with Perrigo and has no impact on the company,” Perrigo said.

The company also maintained that the March recall was initated “out of an abundance of caution” — adding that “no Cronobacter sakazakii bacteria has been found in any product distributed for sale and no adverse events have been reported.”

The Associated Press also reached out to Associated Wholesale Grocers for further comment Tuesday morning.

Infections caused by Cronobacter sakazakii are rare, but they can be life-threatening for newborns, the Centers for Disease Control and Prevention writes — noting that the bacteria can cause sepsis and meningitis.

Cronobacter sakazakii was same germ that sparked Abbott Nutrition’s recall and following nationwide shortage of powdered infant formula last year. According to the FDA and CDC, Cronobacter sakazkii is found naturally in the environment and is “particularly good” at surviving in dry foods like infant formula — which can get contaminated at home or in processing facilities.

The bacteria can also live on home surfaces and other feeding equipment. Experts stress the importance of taking everyday sanitation measures for safety.

“There are steps that people can take to prevent infections,” Dr. Julia Haston, a CDC expert in pediatric infectious diseases, previosuly told The Associated Press — including thoroughly washing, sanitizing and drying hands, equipment and all surfaces before feeding a baby.

OCTOBER 14, 2022:

The U.S. Department of Agriculture is extending a key funding flexibility in the WIC program that has allowed state agencies and their infant formula manufacturers to work together to provide more options for WIC families in need of formula. Under this flexibility – which is now extended through the end of December – USDA is covering the added cost of non-contract formula to make it financially feasible for states to allow WIC participants to purchase alternate sizes, forms, or brands of infant formula.

“USDA, in partnership with the Biden-Harris Administration, remains committed to using every tool we have available to support WIC families as we improve the supply of infant formula,” said Agriculture Secretary Tom Vilsack. “By maximizing flexibilities and providing ongoing support, we can continue to ensure WIC families are able to access the formula they need for their infants.”

In general, WIC state agencies have contracts with one of three manufacturers to provide formula to WIC infants who are partially or fully formula fed. Using the new authority provided by the Access to Baby Formula Act, USDA recommended in May that state agencies that contract with Reckitt Mead Johnson (RMJ) or Gerber seek contract flexibility to allow alternate formulas if the contracted size, form, or brand of formula is unavailable. To help make this financially feasible, USDA is covering the additional costs of these alternate formulas while supplies remain impacted and will continue to do so through December 31, 2022.

USDA also previously provided flexibility to temporarily allow alternate formula in states that contract with Abbott, the third formula manufacturer and the subject of the voluntary formula recall in February. Abbott is currently covering that cost difference through December 31, 2022.

USDA’s Food and Nutrition Service continues to work tirelessly to ensure WIC participants and stakeholders have the information they need to keep infants fed and safe. Within hours of the recall, the agency provided guidance to WIC state agencies and offered flexibilities to help them respond. FNS continues to provide ongoing assistance and support to states so they can adapt to the situation as it unfolds, approving nearly 500 waiver requests to date.

Working closely with the Department of Health and Human Services, FDA, and the Biden-Harris Administration, recent USDA actions include:

• Coordinating cross-government to rapidly transport safe specialty and regular formula into the country through Operation Fly Formula.
• Providing a toolkit and guidance to WIC state agencies and stakeholders to assist with distributing imported formula.
• Calling on states to take advantage of all available WIC flexibilities and waivers that could help those they serve and providing extensive, tailored technical assistance to facilitate the process. Now, nearly all state agencies have applicable waivers in place.
• Extending infant formula waivers in WIC through December 31, 2022. These waivers work in concert with the funding flexibility extension announced today to provide flexibility for WIC state agencies to offer different formula products and waive certain medical documentation requirements.
• Providing guidance to Child and Adult Care Food Program operators that may provide formula to infants in their care to help them navigate the impacts of the shortage.

More information about USDA’s response can be found on Food and Nutrition Service’s Infant Formula Shortage Response webpage.

AUGUST 25, 2022:

The U.S. Department of Agriculture has extended a series of waivers to provide WIC families with additional formula options through the end of the year. The waivers, which were previously set to expire at the end of September, will now be available through the earlier of either Dec. 31, 2022, or 60 days after the expiration of the state’s COVID-19 major disaster declaration, ensuring WIC families have continued access to the formula they need.

“USDA recognizes the flexibilities provided by these waivers remain necessary as we continue to pull every lever to address infant formula supply issues and provide certainty for families,” said Agriculture Secretary Tom Vilsack. “We will continue to work all hands on deck to ensure families can access infant formula, as part of the Biden-Harris Administration’s whole-of-government approach to get more safe formula on store shelves nationwide.”

The waivers extended today allow WIC state agencies, with the necessary agreements from their infant formula contract manufacturers, to offer participants additional infant formula options, such as alternate sizes, forms and brands. The planned Dec. 31 expiration date will provide state agencies with continued flexibility while the nationwide supply of infant formula recovers.

USDA began offering waivers immediately after the Feb. 17, 2022, voluntary recall of certain Abbott powder infant formulas, which exacerbated existing supply chain issues caused by the COVID-19 pandemic. Since then, FNS has granted nearly 500 waivers to WIC state agencies, providing flexibilities to better serve WIC participants receiving benefits for infant formula.

USDA’s Food and Nutrition Service continues to work tirelessly to ensure WIC participants and stakeholders have the information they need to keep infants fed and safe. Working closely with the White House, recent USDA actions include:

• Recommending that state agencies in contracts with Reckitt Mead Johnson or Gerber – two of the three infant formula manufacturers for WIC, the third being Abbott – seek contract flexibility to allow alternate formulas if the contracted size, form or brand of formula is unavailable, with USDA paying the cost difference.
• Leveraging new authority from the Access to Baby Formula Act to allow states to make imported formulas available to WIC participants, as well as participating in the cross-government effort through Operation Fly Formula to rapidly transport safe specialty and regular formula into the country.
• Providing a toolkit and guidance to WIC state agencies and stakeholders to assist with distributing imported formula.
• Calling on states to take advantage of all available WIC flexibilities and waivers that could help those they serve and providing extensive, tailored technical assistance to facilitate the process. Now, nearly all state agencies have applicable waivers in place.

More information about USDA’s response can be found on Food and Nutrition Service’s Infant Formula Shortage Response webpage.

JUNE 2022:

The U.S. Department of Agriculture is offering nationwide waivers to increase access to infant formula for families in need as states receive and distribute imported infant formula made available by the Biden-Harris Administration’s Operation Fly Formula.

USDA is leveraging new authority from the recently passed Access to Baby Formula Act to offer this flexibility.

“USDA is committed to providing our WIC families with nutritious foods, and while we continue working with our many partners to bring the infant formula shortages to a speedy conclusion, we’re also going to keep looking for ways to help families here and now,” said Stacy Dean, USDA’s deputy undersecretary for food, nutrition, and consumer services. “We’re maximizing flexibility, encouraging action, and providing ongoing support so we can all overcome this obstacle together.”

The action builds on existing flexibilities to provide widest access to available infant formula for WIC families. Within days of the recall, USDA offered WIC state agencies waivers to maximize formula options for WIC participants and ensure they could exchange or return any recalled formula. To date, USDA has approved well over 250 state waiver requests.

In addition, Food and Nutrition Service recently encouraged state agencies to work with their infant formula manufacturers to identify and implement temporary flexibility in their contracts to allow WIC participants to purchase alternate sizes, forms, or brands of infant formula during the ongoing shortage. North Carolina and its formula manufacturer, Nestle Gerber, are the first to have put this into action by agreeing to a contract modification that expands access to formula for WIC participants in the state.

USDA continues to work closely with HHS and FDA and the administration to support WIC families through this challenging time and to bring to a swift end to the shortage. Recent USDA actions include:

• Coordinating cross-government to rapidly transport safe specialty formulas into the country for babies with special medical needs through Operation Fly Formula. More shipments, including regular formula, are on the way in the coming days.
• Calling on states to take advantage of all available WIC flexibilities that could help those they serve. Since May 13, when USDA wrote to state health commissioners on this issue, more than 50 new waivers have been requested and approved, with all 50 states now offering at least one flexibility to help WIC families get the formula they need.
• Engaging directly with WIC stakeholders including holding multiple listening sessions to better understand current needs and concerns.

USDA’s Food and Nutrition Service leverages its 15 nutrition assistance programs to ensure that children, low-income individuals, and families have opportunities for a better future through equitable access to safe, healthy, and nutritious food, while building a more resilient food system. Under the leadership of Secretary Tom Vilsack, FNS is fighting to end food and nutrition insecurity for all through programs such as SNAP, school meals, and WIC. FNS also provides science-based nutrition recommendations through the co-development of the Dietary Guidelines for Americans. To learn more, visit www.fns.usda.gov and follow @USDANutrition.

Additional resources:

• Addressing the Infant Formula Shortage | The White House
• Additional WIC Flexibilities – Imported Infant Formula under FDA’s Infant Formula Enforcement Discretion | Food and Nutrition Service (usda.gov)
• Follow-up Letter to State Health Commissioners | Food and Nutrition Service (usda.gov)

MAY 26, 2022:

In its continued efforts to get formula to families in need, the U.S. Department of Agriculture is encouraging state agencies and their infant formula manufacturers to consider seeking temporary flexibility in their infant formula contracts to allow WIC participants to purchase alternate sizes, forms, or brands of infant formula during the current shortage.

State agencies have contracts with one of three manufacturers to provide specific formula to WIC infants who are partially or fully formula fed. To maximize access for WIC participants, USDA is recommending state agencies, Rickett Mead Johnson (RMJ), and Gerber work together to consider temporarily allowing alternate brand formulas. To help make this financially feasible, USDA is quickly leveraging the new Access to Baby Formula Act signed by President Biden and will cover the additional costs of alternate brand formulas in states that have contracts with RMJ or Gerber, if the contracted size, form, or brand of formula is unavailable. In states with Abbott contracts, Abbott is currently covering that cost difference.

“Responding to the infant formula shortage has been – and will continue to be – a team effort. We encourage states and their formula manufacturers to work together to maximize access to infant formula for WIC participants, and USDA will provide the funding to make that possible,” said Agriculture Secretary Tom Vilsack. “WIC families are depending on us for the vital nourishment their babies and children need to thrive. We cannot let them down.”

WIC participants under 12 months of age consume an estimated 56% of infant formula in the U.S. Approximately half of all state agencies have contracts with Abbott, which voluntarily recalled several formula products in February. Though RMJ and Gerber were not subject to the recall, WIC participants in some states in contracts with the companies are beginning to have difficulty finding their typical formula in stock due to the lengthy closure of a major Abbott facility. USDA previously provided waivers flexibility to allow WIC state agencies to provide alternate sizes, forms, and brands of formula, if permitted under their contract, and is now taking action to ensure it is a financially viable option for all states.

Since the recall was first announced, USDA’s Food and Nutrition Service has been working tirelessly to ensure WIC participants and stakeholders have the information they need to keep infants safe. The agency immediately provided guidance to WIC state agencies and, within days, offered flexibilities, including waivers to help them respond to the impacts of the recall. In the months since, FNS has been providing ongoing assistance and support to help states put those flexibilities to best use and adapt to the rapidly-changing situation, approving well over 200 waiver requests to date.

The department continues to work closely with HHS and FDA and the administration to support WIC through this challenging time and contribute to a swift end to the shortage. Recent actions include:

• Coordinating cross-government to rapidly transport safe specialty formulas into the country for babies with special medical needs through Operation Fly Formula. The first shipment arrived in the U.S. on May 22 with 132 pallets of a crucial specialty formula; the second is expected to arrive today with 114 pallets of another specialty formula, also in high need.
• Calling on states to take advantage of all available WIC flexibilities that could help those they serve. Since May 13, when USDA wrote to state health commissioners on this issue, 33 new waivers have been requested and approved, with all 50 states now offering at least one flexibility to help WIC families get the formula they need.
• Engaging directly with WIC stakeholders including holding multiple listening sessions to better understand current needs and concerns.

More information about USDA’s response can be found on Food and Nutrition Service’s Infant Formula Safety webpage.