Judge signs off on steps troubled baby formula manufacturer must ...

(CNN) A federal judge has signed off on a legally binding agreement between the United States Food and Drug Administration and the baby formula manufacturer Abbott Nutrition, the company at the heart of a nationwide formula recall.

The 33-page agreement lays out steps the manufacturer must take to restart production at its manufacturing plant in Sturgis, MI. Once Abbott has completed the to-do list to the FDA's satisfaction, the company says it would take 2 weeks to resume production of baby formula at the facility.

"There are a number of steps to be taken once the plant can restart, including restarting equipment, test runs and multiple tests and checks on ingredients," said Abbott spokesperson Jonathon Hamilton, in an email to CNN.

The agreement requires Abbott to clean and sanitize its facility and all the equipment in it. The manufacturer must also hire an independent third party expert to review its processes. The company is also being asked to review and change its environmental monitoring program, its product sampling and testing plans, and its employee training programs.

After the production lines are running again, Abbott says it would take a minimum of six to eight weeks for new cans of formula to be delivered to stores, the company said in a press release.

Abbott restarts production of specialty formulas at Michigan plant ...

(CNN) Specialty formula production restarted Saturday at the Abbott plant in Sturgis, Michigan, that has been at the center of a recall and a factor in a nationwide formula shortage.

Abbott said it is starting with production of EleCare, an amino acid-based hypoallergenic product for babies who can't tolerate other formulas, as well as other specialty formulas. Abbott said the first batches of Elecare product are expected to be available to consumers around June 20.

Similac and other products made at the plant will take longer to become available.

"We're also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can," the company said in a Saturday statement

The Sturgis plant has been shut down for months following a US Food and Drug Administration inspection that found Cronobacter sakazakii bacteria -- which can be deadly to infants -- in several areas. Similac, Alimentum and EleCare powdered infant formulas made at the plant were recalled, and the closure exacerbated shortages caused by supply chain disruptions. Families across the United States have struggled to find formula for infants and for people with specific nutrition needs.

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A perfect storm hits baby formula - CNNPolitics

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(CNN) The baby formula shortage story has so many elements. But the top line is that the closure of the country's largest formula plant in February has many parents worried they might not be able to feed their babies.

There are no answers from government and business, other than parents who can't find formula should call their pediatricians.

The possible contamination of formula from Abbott Nutrition may have sickened four babies. Two died after consuming powdered formula manufactured by the company's facility in Sturgis, Michigan. Abbott has questioned whether the rare infections caused by Cronobacter sakazakii bacteria occurred because of its formula.

Parents are looking for alternatives to formula and wading through misinformation about how to feed their babies during the shortage. Don't try to make your own formula, experts have told CNN.

Business angles. Shutting down one single factory exacerbated pandemic-related supply chain issues and supercharged this nationwide shortage -- even though only certain batches of Similac, Alimentum and EleCare powdered infant formulas were actually recalled in February.

More than half of formula is out of stock in eight states and the District of Columbia, according to a new report from Datasembly, a real-time data tracking agency.

Abbott said on Wednesday that it could restart production at the Michigan facility, pending US Food and Drug Administration approval, within two weeks. Formula from the shuttered plant could be on shelves six to eight weeks after that.

Whistleblower angles. A former employee sent detailed allegations to the FDA that Abbott was hiding safety issues A former employee sent detailed allegationsto the FDA that Abbott was hiding safety issues months before formula was recalled

Transparency angles. The FDA was first aware of complaints about baby formula back in September, according to documents obtained through Freedom of Information Act requests but the Abbott recall didn't occur until four months later. The FDA was first aware of complaints about baby formula back in September, according to documents obtained through Freedom of Information Act requests by Consumer Reports and other news organizations,but the Abbott recall didn't occur until four months later.

following inspections dating back to 2019. In March, the FDA said Abbott had failed to take steps to prevent contamination at its Michigan plant, and noted a pattern of deficienciesfollowing inspections dating back to 2019.

Trade angles. The American baby formula market, for regulatory reasons and due to recent trade agreements, is relatively shut off from other countries, which is helping drive the product shortage in the US. The conservative Cato Institute looked in particular at the The American baby formula market, for regulatory reasons and due to recent trade agreements, is relatively shut off from other countries, which is helping drive the product shortage in the US. The conservative Cato Institute looked in particular at the effect of the US-Mexico-Canada trade agreement , which restricted imports of formula from Canada.

JUST WATCHED Hear from concerned parents affected by the baby formula shortage Replay More Videos ... MUST WATCH Hear from concerned parents affected by the baby formula shortage 02:30

Protection angles. The government bureaucracy's effort to protect babies, paired with tons of regulation and restriction on formula from other countries, has made adjusting to the shortage nearly impossible for many families.

The Biden administration is defending the FDA as Republicans seek to cast blame. The FDA's stringent requirements for formula mean that even formula from Europe, which has its own standards, often cannot be sold in the US.

Now, you knew it was coming ... politics angles. Senate Minority Leader Mitch McConnell was among the Republicans to blame President Joe Biden for the shortage.

"This problem has been developing in slow motion for several months now, but the Biden Administration has been characteristically sluggish and halting in response," McConnell said in a statement on Wednesday.

It is a shift for Republicans, normally arguing for less government intervention, to now be criticizing the White House for being slow to intervene.

Biden spoke with baby formula retailers and manufacturers on Thursday, and afterward White House officials described limited steps it could take, including increasing imports and looking for ways to cut administrative red tape. Details to follow, officials said.

This is the tradeoff. The federal regulators Americans expect to keep products safe also need to keep them available, White House press secretary Jen Psaki acknowledged this week.

She said the FDA is working with formula manufacturers to ensure their increased production, ease supply lines and get formula to those who need it most. But they won't be rushing things, she said.

"I'd go back to why this decision was made in the first place, which was to save babies' lives," Psaki told reporters on Thursday. "And the FDA is not going to approve manufacturing again unless they are certain of the safety."

But she had no concrete answers for parents running out of formula.

And no, there does not appear to be a strategic national reserve of baby formula like there is for personal protective equipment or petroleum.

Desperate searches. None of what's above is going to make Darice Browning feel any better. She's the Oceanside, California, woman who appeared on HLN's "Morning Express" on Wednesday to explain how her children, both of whom have severe allergies to dairy, will get the formula they need.

Browning said she's ignoring the FDA warnings and giving her kids EleCare infant formula, even though it has been recalled by Abbott.

"It will last maybe two or two-and-a-half weeks," she said. "Everybody is saying you might open these plants back up in six to eight weeks, but I don't have that kind of time. What am I going to do?"

The baby formula shortage is getting worse - CNN

New York (CNNBusiness) For months stores nationwide have been struggling to stock enough baby formula. Manufacturers say they're producing at full capacity and making as much formula as they can, but it's still not enough to meet current demand.

The out-of-stock rate for baby formula hovered between 2% and 8% in the first half of 2021, but began rising sharply last July. Between November 2021 and early April 2022, the out-of-stock rate jumped to 31%, data from Datasembly showed.

That rate increased another 9 percentage points in just three weeks in April, and now stands at 40%, the statistics show. In six states — Iowa, South Dakota, North Dakota, Missouri, Texas and Tennessee — more than half of baby formula was completely sold out during the week starting April 24, Datasembly said.

And although seven states had between 40-50% of baby formula products out of stock as of early April, 26 states are now struggling with supply.

"This issue has been compounded by supply chain issues, product recalls and historic inflation," Datasembly CEO Ben Reich said. "Unfortunately, given the unprecedented amount of volatility to the category, we anticipate baby formula to continue to be one of the most affected products in the market."

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Baby formula shortage: FDA, Abbott agree on terms to reopen factory

On Monday evening, baby formula producer Abbott announced it had reached a deal with the Food and Drug Administration, laying out a path to reopen a factory in Sturgis, Michigan, that shut down amid recalls earlier this year, contributing to the current shortage.

In a statement, the company confirmed that it has entered into a consent decree with the FDA, in which the agency and company agree on the benchmarks required to resume production and ensure the facility meets safety guidelines.

FDA officials said late Monday that if a court approves the agreement, the Michigan site could restart in two weeks.

The site would initially produce specialty metabolic formulas EleCare and Alimentum, followed by Similac and eventually other formulas, food and drug officials said.

"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility," said chairman and CEO Robert B. Ford. "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."

In a statement issued by the Department of Justice, Attorney General Merrick B. Garland said, “The actions we are announcing today will help to safely increase the supply of baby formula for families. The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”

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In a CNN interview earlier in the day, FDA commissioner Dr. Robert Califf had presented a somewhat rosy timeline for reopening the facility. He had predicted that once a deal was struck, the factory could reopen and resume producing formula within two weeks and be back to normal a few weeks later.

However, Abbott said things will not move quite that fast.

"From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves," the company noted in its statement.

Once it does, Abbott says it will start producing the formulas.

Can foreign formula fill the gap?

The FDA on Monday also confirmed it will allow the sale of foreign formula in the U.S.

The agency, which says it has already streamlined the process for distributing foreign formula once it arrives at U.S. ports, said it will also permit formula manufactured here but intended for export to be sold domestically.

While the U.S. produces 98% of the formula consumed here, it does currently import a small amount from Mexico, Ireland and the Netherlands.

“Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely," Califf said in a statement. "We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”

Califf, along with Susan Mayne, the FDA's director of the Center for Food Safety and Applied Nutrition and FDA deputy commissioner Frank Yiannas, told reporters late Monday that companies that want to take advantage of any "flexibilities" should submit information to the FDA which will evaluate if the foreign formulas provide "adequate nutrition."

Mayne said will include labeling that "needs to be English, if possible," and other information on the formula's nutritional adequacy and their facilities' inspection history.

"These are the types of flexibilities that we are communicating in this guidance," Mayne said.

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Califf said that while an adequate supply of formula needed to feed every baby is finally in place at this point, "it's not necessarily in the right place. And so we're needing to help parents find other formula."

He added, "We'll need to be watching this every step of the way because as you know, we don't want to be sending product out which is dangerous for infants. I have every anticipation that we've got a path forward now that will work."

The baby formula shortage began in November, when about 11% of popular brands were out of stock, according to data analytics firm Datasembly. As of May 8, 43% of baby formula was sold out at retailers across the U.S. because of recalls and supply chain strains. Retailers such as CVS, Target, and Walmart have put purchase limits on formula,

In the meantime, parents are being advised to contact their pediatricians to discuss the best course of action for their child, which could entail seeking samples of new formula brands or donated pasteurized breast milk.

Pediatricians update guidance on cow's milk, plant milk and premature formula

Although the FDA's moves offer a light at the end of the tunnel, the shortage is still raging. To that end, the American Academy of Pediatrics put out new guidance Tuesday on feeding babies, taking a relaxed stance on cow's milk, plant milk and formula intended for premature babies and toddlers.

Most notably, the professional assocation now says parents can give whole cow's milk to babies who are older than six months and don't have any allergies or other special health needs, as long as they supplement it with iron-rich solid foods. The change is intended as a stopgap to tide babies over until the shortage abates, with the Academy warning, "This is not ideal and should not become routine."

AAP also said premature formula can be safely given to full-term babies for several weeks if no other option is available. As for toddler formula, it would be safe to give to babies who are close to their first birthday as long as use does not exceed a few days.

The group also said that soy milk may be an acceptable temporary substitute for babies around a year old but advised parents to seek out brands that are fortified with protein and calcium.

The financial fallout

The shortage is quickly becoming a financial crisis for many families, especially those that are low-income. Because WIC is not yet equipped to handle online shopping and many families can no longer find eligible formulas in store, some are having to use Supplemental Nutrition Assistance Program benefits or pay out of pocket, which "puts stress on the rest of the household," explains Brian Dittmeier, senior director of public policy at the National WIC Association, the nonprofit advocacy arm of WIC.

Contributing: Terry Collins, USA Today.

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Abbott plans to restart plant at the heart of the baby formula recall on ...

(CNN) Abbott Nutrition said Tuesday that it plans to restart work at the Sturgis, Michigan, plant at the heart of the nationwide baby formula recall on June 4, with the first batches of new formula expected to be available to consumers on or around June 20.

When the plant resumes manufacturing formula, the company confirmed to the US Food and Drug Administration, it will start with EleCare and other specialty metabolic formulas.

Abbott will also release about 300,000 cans of EleCare Specialty Formula on a case-by-case basis to people who need it urgently. This is an amino acid-based hypoallergenic product for babies who can't tolerate cow's milk in other formulas due to an intolerance or allergy.

This formula was not a part of the company's recall earlier in the year, but it has been on hold at the Sturgis plant because the agency was concerned that it was produced under "insanitary conditions." The FDA said the formula will undergo enhanced testing to make sure it is safe.

The formula will be available immediately at no charge. Parents and caregivers can ask their doctors for more information or call Abbott at 1-800-881-0876.

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Baby formula shortage 2022 worsens after Abbott Similac recall

Less than two months after a baby formula recall, retailers are reporting shortages with some stores rationing sales.

Nearly 30% of popular baby formula brands may be sold out at retailers across the U.S., according to an analysis by Datasembly, which assessed supplies at more than 11,000 stores.

That's a higher level than other products, said Ben Reich, CEO of the Tysons, Virginia-based research firm.

"Inflation, supply chain shortages, and product recalls have brought an unprecedented amount of volatility to the category, and we expect to continue to see baby formula as one of the most affected categories in the market,” he said.

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The shortage comes after Abbott Nutrition voluntarily recalled in mid-February select batches of Similac, Alimentum and EleCare formulas manufactured in Sturgis, Michigan. The recall was expanded in late February to include one lot of Similac PM 60/40.

The Food and Drug Administration said two weeks ago that the formula maker failed to maintain sanitary conditions and procedures at that plant.

Baby formula supplies limited

But formula supplies were limited before the recall.

Krishnakumar Davey, president of strategic analytics at IRI, told The Wall Street Journal that formula shortages are intermittent and vary based on retailer and location. Davey said some of the nation’s 10 largest retailers had more than 20% of baby formula out of stock the week ended Jan. 2.

"Product supply challenges are currently impacting most of the retail industry," CVS Health, which owns the pharmacy chain, said in a statement to USA TODAY. "We’re continuing to work with our national brand baby formula vendors to address this issue and we regret any inconvenience that our customers may be experiencing."

Walgreens is limiting shoppers to three infant and toddler formula products per transaction "to help improve inventory," the company said in a statement to USA TODAY. "Due to increased demand and various supplier issues, infant and toddler formulas are seeing constraint across the country," its statement said.

Nearly 75% of infants get some formula by the 6-month mark, according to the Centers for Disease Control & Prevention.

'Full-time job trying to find Similac'

After she visited three different stores in one day, Elyssa Schmier, the vice president of government relations for advocacy group MomsRising, "all of a sudden realized my formula was nowhere to be found. … It's almost a full-time job trying to find Similac."

After experiencing the nationwide shortage firsthand, Schmier organized an Instagram Live discussion Friday with Brian Dittmeier, who is the senior director of public policy for the National WIC Association.

Manufacturers "are tuned into this and it is our understanding that across the board, folks are ramping up production," Dittmeier said.

"Now, it's not like flipping a switch," he said. "We will probably continue to see shortages in the next couple of weeks. But our hope is that as production ramps up, that later this spring it should be easier for families across the country."

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Formula out-of-stock rates increasing

Datasembly's analysis found that during the first seven months of 2021 baby formula supplies were "relatively stable" with out-of-stock supplies between 2-8%. But in subsequent months, it has continued to worsen, Reich said, as out-of-stock rates rose into double digits and reached 23% at the end of January.

The out-of-stock situation started to affect baby formula in July 2021, varying between 2-8% and has continued to worsen into 2022.

Among the states hit worst with baby formula supply shortages, according to Datasembly: Minnesota had the highest out-of-stock percentage for the week of March 13th at 54%, followed by Connecticut, Hawaii, Iowa, Louisiana, Maryland, North Dakota, Rhode Island, South Dakota and Texas, all at 40% or higher.

Cities with the highest out-of-stock rates: San Antonio (56%), Minneapolis (55%), and Des Moines (50%), for the week of March 13. Houston, New Orleans, and Oahu were above 45%.

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FDA announces it will make it easier to import some baby formulas ...

(CNN) The US Food and Drug Administration said Monday that it is making it easier to import certain infant formulas as it works to address a nationwide shortage .

The US ordinarily produces 98% of the infant formula it uses, with imported formula primarily coming from Mexico, Ireland and the Netherlands, the agency said in a statement. But because of the shortage, the FDA is outlining a process by which it "would not object to the importation of certain infant formula products intended for a foreign market," as well as the US distribution of products that were made domestically for export to other countries.

"Companies seeking to take advantage of these flexibilities should submit information for the FDA to quickly evaluate whether the product can be used safely and whether it provides adequate nutrition," the agency said. "For example, labeling, information on nutritional adequacy and safety testing, and information about facility inspection history."

The administration will prioritize applications "that stand a good chance of being successful, that indicate sort of clear quality and safety and nutritional adequacy and all of that, and that have potential to move significant product into the United States quickly," a White House official told CNN, including imports from countries like Ireland, Chile, Australia, New Zealand, the UK and the Netherlands, which feature safety inspection systems similar to those in the US.

The FDA said it is already in discussions with some manufacturers and suppliers regarding additional supply, but officials warn that even importing formula from abroad won't offer immediate relief.

"With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks," FDA Commissioner Dr. Robert Califf said in a statement.

Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, said on a media call Monday that "it depends in part on what kind of information we get in from others, but I think we're looking at weeks in terms of getting the imported product into the market."

The news comes as the White House is working with key manufacturers to help provide logistics support during the baby formula shortage, an official said in a statement on Monday.

"The White House is having ongoing conversations with the four major infant formula manufacturers -- Reckitt, Abbott, Nestle/Gerber, and Perrigo -- to work with them to identify transportation, logistical, and supplier hurdles to increasing production of formula at their US- and FDA-approved facilities, to expand the amount and speed of FDA-approved formula being shipped into the country, and ensure that formula is quickly moving to retailers from factories," the White House official said.

CNN reported earlier Monday that the Biden administration is confronting a barrage of questions and criticism for the national baby formula shortage that has anxious and angry parents hopping from store to store in search of baby food. The administration offered a new website, HHS.gov/formula , to provide resources to families in need, but when a CNN reporter tested out some of those options, the exercise resulted in apologetic customer service representatives, one hold time that lasted well over an hour and serious challenges in finding baby formula through some of the main suggestions listed on the new Health and Human Services website.

The White House is also in "ongoing communication" with Target, Amazon, Walmart and other major retailers, the official said, "to identify parts of the country that may be at risk of critically low supply of infant formula, and have offered to work with manufacturers and retailers to bring more formula to those parts of the country, including with US government transportation and logistics support."

President Joe Biden held virtual meetings Thursday with the leadership of Target and Walmart, as well as formula manufacturers Reckitt and Gerber, respectively. Officials have since been in "close communication to follow up on those conversations," per the official.

There are also efforts to shore up the supply chain, with outreach to formula manufacturers' suppliers.

"We are also contacting suppliers to infant formula manufacturers to inform them that their materials are critical for boosting U.S. infant formula production and they should prioritize their production and delivery," the official noted.

During an appearance on CNN's "New Day" on Monday, Califf said the administration is "doing everything we can" to resolve the shortage.

Califf pointed to efforts to work with manufacturers to increase production, to work on the supply chain and to work closely with Abbott to get its shuttered plant open as soon as possible.

After Abbott restarts the site, it will take six to eight weeks for the products to reach store shelves, the company said Monday.

Pressed on how much of an effect the move to make it easier to import some formulas will have, Califf said the situation more broadly will "gradually improve" over a "few weeks."

This Thursday, Califf testifies before the Agriculture Appropriations Subcommittee on the FDA's 2023 budget request and on the oversight of infant formula.

The baby formula shortage has been exacerbated by the shutdown of the country's largest formula plant, the Abbott Nutrition facility in Sturgis, Michigan.

Production halted at the facility in February after reports that four infants who consumed formula manufactured at the plant had fallen ill with rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. A whistleblower also detailed allegations to the FDA that Abbott was hiding safety issues months before the infant formula was recalled in February.

In the end, however, testing by the FDA and the US Centers for Disease Control and Prevention found that the genetic sequences of the Cronobacter samples from the plant did not match any of the bacteria isolated from the sick children or the formula inside their homes. Genetic samples from the sick babies also did not match each other, suggesting there was no link between their cases, Abbott said in a news release.

Additionally, Abbott said no baby formula distributed to consumers tested positive for Cronobacter or Salmonella.

Pressed on how soon supply will be back to normal, HHS Secretary Xavier Becerra declined to give specifics, saying on CNN Monday that "Abbott is the one that can tell you the timeline."

Becerra said the federal government is working with the company to make sure it's addressing the safety concerns raised to them and that "it should be done in a matter of weeks."

"We don't run their plants. Only they can address the safety concerns that were identified through our inspections. They have been working on this a while. We have been advising them of what they need to do," Becerra told CNN's Kate Bolduan on "At This Hour."

"We'll do everything we can, we'll pull all the levers we can to help them move quickly as possible, but they control their plant. They own and operate it. They're the ones that have to do the fix."

Abbott said last week that it could restart production at its Michigan facility, pending FDA approval, within two weeks, but it could be a few more weeks until the formula is made available on shelves.

On CNN, Becerra also defended the administration's response to the Abbott recall and complaint, saying, "We have been moving as quickly as we can."

"FDA moves with deliberate speed to make sure that if you're going to do something as drastic as urge a manufacturer to pull a product off the shelves, that there's good evidence for it. That's why it takes a little time," he said.

This story has been updated with additional reporting.

Betsy Klein
Katherine Dillinger
Veronica Stracqualursi

Whistleblower alerted FDA to alleged safety lapses at baby formula ...

(CNN) A former employee of Abbott Nutrition documented his concerns that the company was hiding safety problems at its Sturgis, Mich., production facility and sent a detailed complaint to the US Food and Drug Administration months before infant formula was removed from grocery store shelves.

The complaint was released Thursday by Rep. Rosa DeLauro, D-Connecticut, the chair of the House Appropriations Committee. The congresswoman said she had received the complaint this week and called its allegations "extremely disturbing."

Abbott recalled three popular brands of powdered infant formula in February after reports that four infants drinking formula manufactured at the facility had fallen ill with rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. Production at the facility was halted and remains paused.

In an April 15 statement posted to the company's website, Abbott said it was working closely with the FDA to restart operations at the plant.

The former employee, who worked at Abbott Laboratories' Sturgis site, stated that he saw records falsified "on multiple occasions," and in most situations, information was not disclosed when it should have been.

For instance, according to the complaint, the employee reported observing events that were understated or inaccurately described "to limit or avoid oversight" and then "failing to maintain accurate maintenance records."

After several samples of a batch of infant formula were found to contain microorganisms, or "micros," the whistleblower claims that the plant performed a time code removal, in which formula produced around the same time as the contaminated samples was discarded, but formula produced outside of those time codes was released to be sold without additional testing to make sure it was safe for consumption.

In 2020, the complaint says, product wasn't recalled from the market even after management became aware of a problem with the integrity of the packaging, an issue that the whistleblower said should have caused the manufacturer to take the product off shelves and conduct more testing.

"Abbott takes employee concerns very seriously and we foster a culture of compliance to produce the best and highest-quality formula," the company said in a statement Thursday. "We empower our employees to identify and report any issues that could compromise our product safety or quality, which comes before any other considerations.

"With regard to the document released by Congresswoman Rosa DeLauro (D-Conn.) this former employee was dismissed due to serious violations of Abbott's food safety policies. After dismissal, the former employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities. Abbott is reviewing this new document and will thoroughly investigate any new allegations."

The complaint says the employee was fired for raising safety concerns.

"Others also raised concerns, some with management but more often among colleagues at the Sturgis site. Given the overriding fear of retaliation, few were as outspoken as the Complainant," according to the complaint. "Ultimately despite an admirable employment record at Abbott and elsewhere, Complainant was terminated based upon his repeated elevation of compliance concerns."

The document says the man's termination is being investigated by the Occupational Safety and Health Administration.

The complaint also says that managers may have been "sanitizing" files before they reached FDA inspectors. "Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site," the document says. It goes on to claim that the Sturgis site has continued to permit lax practices around cleaning.

"I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility," DeLauro said in a statement read into the record of an Appropriations Committee hearing. "We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA.

"I am equally concerned that the FDA reacted far too slowly to this report," DeLauro said, noting that the agency had received the whistleblower's statement in October but did not interview the man until December and did not do an in-person inspection of the Sturgis facility until January.

DeLauro has asked the inspector general of the US Department of Health and Human Services to scrutinize the FDA's response.

The FDA responded to questions from CNN about the pace of its response with a statement:

"We know there have been questions about the timeline related to the Abbott Nutrition infant formula recall. However, this remains an open investigation with many moving parts. Our top priority is ensuring that any recalled product produced at the Sturgis, Mich. facility has been removed from the market. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.

"Once the immediate risk to the public has been addressed, we will conduct a review and, as outlined in our recently released Foodborne Outbreak Response Improvement Plan, we will build in performance measures across the FDA's foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities," the statement says.

Cronobacter infections in infants are almost always caused by drinking contaminated powdered baby formula. Cronobacter can be introduced during manufacturing but also after containers of formula are opened at home.

Formula types included in the recall include Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40, Alimentum and EleCare.

Abbott Nutrition is also the exclusive supplier for many state WIC programs. WIC, or Special Supplemental Nutrition Programs for Women, Infants, and Children, supplies food to low-income mothers and their young children.

Inspection reports obtained by CNN through a US Freedom of Information Act request revealed numerous deficiencies at the facility. FDA testing found Cronobacter sakazakii bacteria on equipment in the plant.

In a preliminary assessment, the FDA determined that Abbott did not take steps to prevent products from becoming contaminated during manufacturing.

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In a statement posted on its website in March, Abbott said it is reviewing the FDA's observations. "We're taking this seriously and are working closely with the FDA to implement corrective actions."

"It is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases," the statement says.

Abbott added in Thursday's statement, "A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility."

Baby formula: Abbott restarts plant linked to contamination

Matthew Perrone

Associated Press

WASHINGTON — Abbott Nutrition has restarted production at the Michigan baby formula factory that has been closed for months due to contamination, the company said Saturday, taking a step toward easing a nationwide supply shortage expected to persist into the summer.

The February shutdown of the largest formula factory in the country led to the supply problems that have forced some parents to seek formula from food banks, friends and doctor's offices.

Abbott said it initially will prioritize production of its EleCare specialty formulas for infants with severe food allergies and digestive problems who have few other options for nutrition. The company said it will take about three weeks before new formula from the plant begins showing up on store shelves.

"We will ramp production as quickly as we can while meeting all requirements," Abbott said in a statement.

The plant's reopening is one of several federal actions expected to improve supplies in the weeks ahead. President Joe Biden's administration has eased import rules for foreign manufacturers, airlifted formula from Europe and invoked federal emergency rules to prioritize U.S. production.

Abbott closed the Sturgis, Mich., factory in February after the Food and Drug Administration began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died. The company continues to state that its products have not been directly linked to the infections, which involved different bacterial strains.

FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols. The FDA has faced intense scrutiny for taking months to close the plant and then negotiate its reopening. Agency leaders recently told Congress they had to enter a legally binding agreement with Abbott to assure all the problems were fixed.

Abbott's February recall of several leading brands, including Similac, squeezed supplies that had already been strained by supply chain disruptions and stockpiling during COVID-19 shutdowns.

The shortage has been most dire for children with allergies, digestive problems and metabolic disorders who rely on specialty formulas. The Abbott factory is the only source of many of those products, providing nutrition to about 5,000 U.S. babies, according to federal officials.

Abbott is one of just four companies that produce about 90% of U.S. formula. The company's recalls and shutdown triggered a cascade of effects: Retailers have limited customer purchasing to conserve supplies and parents have been told to switch brands to whatever formula is in stock.

FDA Commissioner Robert Califf recently told lawmakers it could be about two months before formula supplies return to normal levels. The agency has waived many of its regulatory requirements to accept more formula from the United Kingdom, Australia and other nations.

U.S. manufacturers, including Reckitt and Gerber, have also stepped up production, running plants 24/7 and sourcing more formula from alternate facilities.

More:

Biden says he wasn't alerted to baby formula shortage until April. Companies knew 'from the beginning.'

Why can't some infants breastfeed during the formula shortage? What health experts want you to know

Biden invokes Defense Production Act to boost baby formula production


US Women's Open champion Minjee Lee reflects on a 'big step' for ...

(CNN) Records tumbled in Minjee Lee's wake at the US Women's Open on Sunday.

The Australian claimed the highest payout in women's golf history in Southern Pines, North Carolina, cruising to her second major triumph with a record-breaking performance worthy of the $1.8 million prize.

Lee headed into the last day riding the tide of an unprecedented first three rounds, shooting 67, 66, 67 to break Juli Inkster's 23-year-old record across 54 holes with a 13-under par 200.

The scintillating start meant that even a level-par 71 on the final round didn't stop the 26-year-old from breaking the 72-hole championship scoring record, pipping Inkster, In Gee Chun and Annika Sorenstam by one stroke with her 13-under 271 finish.

Leading by six shots at the 12th hole and finishing four strokes ahead of American Mina Harigae, her victory had looked to be a procession even before the Australian took to the final tee -- but not to Lee.

"I was nervous as hell," Lee admitted to CNN's World Sport. "But it was pretty cool.

"Walking down that 18th hole ... looking at all the crowd, looking at the finish line -- it was just a really special moment."

Lee cruised to victory with a dominant performance in Southern Pines.

'It's a great thing for the women's game'

In lifting the Harton S. Semple trophy, Lee became the first Australian to do so since Karrie Webb in 2001, and was rewarded for her efforts with a champagne shower courtesy of compatriot Hannah Green.

The other reward was the unprecedented $1.8 million prize pot. That sum alone eclipses Lee's winnings for her most profitable ever season in 2018, where 10 top five finishes over 27 LPGA events saw her claim over $1.5 million, based on figures from the LPGA website.

Second-placed Harigae earned the largest runner-up sum in women's golf history, taking home $1.08 million of the record $10 million overall prize purse.

Lee plays a shot on the 17th hole.

Though prize purses for women in the game still trail those of the men -- Jon Rahm earned $2.25 million from a total $12.5 million purse for his US Open triumph in June 2021 -- Lee sees progress being made.

"We're aiming for higher and higher each time," Lee said. "For the USGA and the US Open to step up and start that, it's a big step in the right direction.

"It's a great thing for the women's game and the LPGA."

Questions of money have dominated the golfing world this week with the lucrative inaugural LIV Golf Tournament set to tee off at the Centurion Club near London on Thursday.

The venture, backed by Saudi Arabia's Public Investment Fund, pledges to award $250 million in total prize money across eight tournaments. Former World No. 1 Dustin Johnson announced he was resigning from the PGA Tour to compete in the event.

While Lee admitted she hadn't been following the story closely, she understood the controversy the new event had attracted.

"I don't really know too much about that, obviously it's been a little bit controversial," Lee said.

"I guess it's just perspective on where you are in your life right now," she added.

Role model

Triumph in Southern Pines marked the second major of the Australian's career, adding to her triumph at the Evian Championship last year, and her eighth win on the LPGA Tour.

But despite the accolades, Lee is targeting a legacy beyond prize money and trophies -- inspiring the next generation of young golfers.

"Hopefully they can watch me on TV and I can be a great role model for all the girls and boys all around the world to follow your dreams," Lee said. "You can do it. Anybody can do it.

"As long as you stick to your plan and stick to what you love then I think you're always going to be doing the right thing."

Her rise to become the No. 3 golfer in the world has been aided by the encouragement of her family, none more so than younger brother Min Woo Lee, a golf pro himself on the PGA Tour.

Min Woo Lee smiles with his sister Minjee Lee during the par three contest prior to the Masters in April.

"This one hits hard. Tears in my eyes. So so proud," he tweeted following his sister's triumph, in just another example of the "great support" Lee's family have given her since she burst onto the scene with victory at the U.S Girls' Junior in 2012.

"They've been with me every step of the way and I've only always got encouragement from them," she said.

"If I wanted to practice, I could go practice. If I didn't then I didn't have to. They've just always been a great support and still are and it's just been a really great journey so far."

Minjee Lee wins US Women's Open - CNN

(CNN) Minjee Lee has won the US Women's Open, finishing four strokes ahead of American golfer Mina Harigae.

Lee, who is from Australia, took a three-shot lead into the final round over Harigae, having broken a 23-year-old record with her 54-hole score of 200 after shooting a 67 on Saturday.

The tournament took place at Pine Needles Golf Club in Southern Pines, North Carolina -- the fourth time the venue has hosted the event.

The 26-year-old got her final round off to an ideal start with a comfortable birdie on the first hole, followed by another on the second as she drained a 30-foot putt.

Lee wobbled slightly on holes five and seven as she made bogeys, but recovered her composure to follow those errors with four pars and a birdie.

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Why Annika Sorenstam is returning to U.S. Women's Open at Pine ...

SOUTHERN PINES – As a Hall of Famer and 10-time major champion, Annika Sorenstam has nothing left to prove on the golf course.

An eight-time LPGA Player of the Year and the only woman to shoot 59, Sorenstam won 72 LPGA events and competed in a men’s PGA tournament during her 16-year career.

She thought she was done with competitive golf in 2008. Then, after a 13-year break, she returned and won the 2021 U.S. Senior Women’s Open.

That victory opened up an opportunity to compete in the 2022 U.S. Women’s Open at Pine Needles Lodge and Golf Club, the site of her dominant win in 1996.

In just over a month, the 51-year-old Sorenstam will return to Southern Pines for her first U.S. Women’s Open appearance since she retired nearly 14 years ago.

During a conversation with reporters Tuesday at media day ahead of the championship, scheduled for June 2-5, Sorenstam highlighted several reasons for her return.

“Obviously, honored to get an invite. That is a nice gesture and I wanted to appreciate that,” Sorenstam said.

“Peggy (Kirk Bell) was next, coming here. And then, my kids wanted me to play. They’re like, ‘C’mon, Mommy.’ Also, I’m working with these young girls and many of them — these young ladies — have played in the Annika Invitational the last few years.

“To have them out there to continue to support and inspire, you’ve got to be in the mix to talk about what it’s like, so it keeps me a little more relevant when I mentor some of these girls. Now I can do that a bit more with ease.”

Favorite foursome

During her time away from professional golf, Sorenstam has formed a favorite foursome that includes her husband and caddie, Mike McGee, and their two children, 11-year-old Will and 12-year-old Ava.

“This isn’t necessarily about me trying to do a comeback, it was more about the family,” she said.

Prior to her eight-stroke win at the Senior Open last August, Sorenstam’s kids had only seen YouTube clips of her at the peak of her powers on the golf course. In June, they’ll get to see their mother compete against the best of the best.

“It’s pretty neat, especially our son who is very into sports. He knows every statistic there is. For him to just see it and live it is a big deal. He’s really been my practicing partner. We’re out there together hitting balls. I’m a righty, he’s a lefty, so I’ll toss a bucket in the middle and we can hit,” Sorenstam said.

“I want to inspire him, too. I want him to know you don’t wake up and there’s a trophy at the door. You have to put in the work. I think they see that. … I’m hoping that this will feed him and he can live his dream and do whatever he wants.

"The same thing with our daughter. It’s like when you have a passion you gotta do it, but you gotta put in the time. That’s hopefully the message I’m sending to, not only my kids but, hopefully, people in general who have some kind of hobby and want to pursue it. It’s never too late to continue.”

The pull of Pine Needles

Would Sorenstam have played in the U.S. Women’s Open this year if it had been at any other site?

“No, I would not have,” she said. “I’m pretty sure about that.”

A quarter-century after a six-stroke victory at Pine Needles, Sorenstam reflected on the place that allowed her the chance to form a lasting bond with the late Peggy Kirk Bell, who passed away in 2016 at the age of 95.

“Peggy couldn’t pronounce my name, so she called me 'Heineken' for some reason,” Sorenstam said. “I had to explain to her that I wasn’t from Germany and I don’t drink beer. That was our internal joke the whole time I knew Peggy.”

A World Golf Hall of Fame inductee and longtime Pine Needles owner, Bell continued to grow closer with Sorenstam every year.

Sorenstam, who felt she owed it to the Bell family and the USGA to compete in this year's championship, hasn’t forgotten some of those shared experiences.

“Mrs. Bell would drive up in a cart and she would park next to me and watch me hit balls and have a smart comment, and then she would leave and come back and I would meet her for lunch and she took me into her office,” she recalled.

“I didn’t know that much about her the first time I met her but she was showing me all these photos on the wall and she would fly around in a plane and I thought to myself, ‘She’s one tough cookie.' "

Inspiring the next generation

After leaving Pine Needles on Tuesday afternoon, Sorenstam made her way to Sunrise Theater for the premiere of “Becoming Annika,” a documentary that will debut May 10 on Golf Channel.

At the conclusion of the film, an all-female production that highlights Sorenstam’s career, she addressed a row of young girls in the crowd.

“I think that dreams do come true, if you put your mind to it and you put your effort into it. My dad told me a long time ago that there are no shortcuts to success,” she said.

“Golf turned out to be my vehicle, my story, and that’s why I give back to the ANNIKA Foundation. I want to inspire the next generation of young girls, just like yourself.”

Sorenstam’s ANNIKA Foundation, which she started in 2007 near the end of her career, focuses on supporting girls’ and women’s golf around the globe. A return to the major championship stage offers Sorenstam another opportunity to inspire that generation.

“I’ll never forget Will looked at me and said, ‘Don’t worry, Mommy, Jessica and Nelly Korda’s ages together is what you are.’ That really didn’t make it any better, but obviously the honor of being invited here is very special,” she said.

“Being a past champion here is very special and my relationship with Peggy and her family. The last 14 years has really been trying to inspire the next generation of girls. I figured if I tell them to get out of the box and try different things, and explore and live your dream, then I’ve got to do that too. You can’t just say and not do. So I think we just decided to let’s do this.”

US Women's Open golf: $10 million purse could change players' lives

Beth Ann Nichols

Golfweek

SOUTHERN PINES, N.C. — Stephanie Meadow finished third in her professional debut at the 2014 U.S. Women's Open on Pinehurst No. 2. She earned $285,102 for her efforts, a massive sum for a recent college graduate.

"I had a rough time in '16 and '17," said Meadow of the years immediately following her father Robert's death. "That money carried me through that."

The U.S. Women's Open purse has long had a life-changing impact, not just for winners, but for many like Meadow, who cash the biggest checks of their careers. Some, like her, won't yet be tour members.

This week, that will likely happen more than ever with an historic $10 million purse on the table thanks in large part to the addition of ProMedica, the championship's first presenting sponsor.

Brittany Lang echoes the thoughts of many of her peers when she says playing on the LPGA was never about the money. When she won this championship in 2016, she remembers walking in the parking lot with her mom and brother and asking, "What do you win for this? I don't even know."

It was always about the dream.

"Now that I'm close to hanging it up," said Lang, "and I have a daughter, and you start thinking about money and you play worse."

Lang made $810,000 when she won the Open at CordeValle.

The winner of this week's championship will earn $1.8 million. The player who finishes runner-up will earn $1,080,000. That's more than last year's winner, Yuka Saso, who earned $1 million.

U.S. WOMEN’S OPEN: Thursday first-round tee times, TV/streaming info

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"Honestly, the thought of a $10 million purse just absolutely blows my mind to be perfectly honest," said former major champ Karen Stupples. "I don't even know how to think about money in those terms and how - what it means going into your bank account, what the potential is there in one big chunk, even for like a 30th place or a 40th place."

Even those who miss the cut this week will receive $8,000, double last year.

Early on in her career, Matilda Castren had three seasons in which she lost money. She gave herself a five-year span to earn her LPGA card and make it.

"I remember looking at my bank account and there was $10 left," said Castren. "OK, I just have to survive until next month, and then I know I'm getting a check. That's a really common thing. I think a lot of people don't realize it. People just think you're living your dream playing golf every week. It's really not as simple as that."

Castren, 27, won seven times in college at Florida State and competed on the Epson Tour until earning her LPGA card for the 2020 season through Q-School. In 2021, she won LPGA Mediheal Championship to become the first player from Finland to win on tour. She earned $225,000 for her victory.

"It just felt so surreal," she said, "just logging into my mobile app and seeing all the zeroes."

A now-engaged Meadow would like to buy a house in the near future, but must weigh the risk of parting with a large chunk of money against the possibility that she might get injured or go through another rough patch where little money is coming in.

"I think the older you get," she said, "the more you realize how lucky the (PGA Tour) guys are."

How big is $10 million? Consider that next week's purse at the ShopRite LPGA Classic is $1,750,000. There are 15 events on the LPGA schedule with purses that are less than $2 million.

"We don't start playing golf for money," said veteran Carolina Masson. "That's not the incentive, that's not the reason. But when you come out here, especially as a young player, money is an issue because you need a lot of money to do what you do for a full season.

"Playing for this kind of money is huge; it gives so much opportunity."

U.S. Women's Open purse nearly doubles, USGA says

Beth Ann Nichols

Golfweek

The U.S. Women's Open just set a new benchmark for women's golf.

With the addition of the championship's first presenting sponsor in ProMedica, the purse has been elevated to $10 million for 2022, nearly doubling last year's purse of $5.5 million. There are plans to increase the purse to $12 million over the next five years.

The winner of the 2022 U.S. Women's Open will receive $1.8 million. As USGA CEO Mike Whan points out, only three players on the LPGA earned more than that all season in 2021.

"The USGA prides itself on conducting championships that not only provide an incredible stage for the athletes, but also give younger players something to dream about," Whan said in a release. "For more than 75 years, the U.S. Women's Open has been the one that every little girl, in every country around the world, has dreamed of winning.

"This partnership with ProMedica allows us to substantially grow the championship in every way, from its purpose, to its purse, to the places that host the event. While I'm incredibly proud of what we are announcing today, I know this is just the beginning, as together with ProMedica, we'll push to change the game and what it means to young women worldwide in order to reach new heights every year."

The standards in women's golf keep rising as big tournaments across the board invest more in the LPGA. Last summer, the AIG Women's British Open set a new record for women's golf with a $5.8 million prize fund. This year, when the event moves to Muirfield for the first time, players will compete for $6.8 million.

The winner of the CME Group Tour Championship in 2022 will earn the largest check in women's golf: $2 million.

The addition of a presenting sponsor enabled the USGA to take this next important step for America's biggest event. ProMedica, a mission-based, not-for-profit integrated health and well-being organization that serves communities in 28 states will use the platform of the U.S. Women's Open to generate charitable dollars for its ProMedica Impact Fund, which is now the official charity of the championship.

The excitement doesn't end with the purse, however, as where they're headed is just as impactful. With venues like Pebble Beach, Merion and Oakmont already announced as future sites, five more were added to an already impressive list:

Riviera Country Club in Pacific Palisades, California (2026)

Inverness Club in Toledo, Ohio (2027)

Pinehurst No. 2 in Village of Pinehurst, North Carolina (2029)

Interlachen Country Club in Edina, Minnesota (2030)

Oakland Hills Country Club in Bloomfield Hills, Michigan (2031 and 2042)

The 2022 U.S. Women's Open returns to Pine Needles Lodge & Golf Club June 2-5. In 2023, the championship will be contested for the first time at Pebble Beach Golf Links.

This will also be the first time the tournament will be staged at Riviera, where Ben Hogan won the first of his four U.S. Open Championships in 1948. Inverness has hosted eight USGA championships as well as the 2021 Solheim Cup and will also be hosting its first Women's Open along with Oakland Hills.

This will be the second U.S. Women's Open contested at Pinehurst No. 2. Michelle Wie won the first in 2014 when the men's and women's championships were first held back-to-back. That will happen again in 2029.

U.S. Women's Open: Minjee Lee cruises to second major title

Beth Ann Nichols

Golfweek

SOUTHERN PINES, N.C. — After three days of some of the lowest scoring in U.S. Women’s Open history, a fight broke out at Pine Needles.

Challenging hole locations, an uptick in wind and the biggest purse in women’s golf history finally brought things to a boil.

Only the battle wasn’t at the top, as no one could mount a charge to challenge the elegant and unflappable Minjee Lee, who entered the final round with a three-stroke lead and finished at 13 under, four ahead of American Mina Harigae to claim her second major title. The 26-year-old Lee became the first Australian to win the U.S. Women’s Open since Karrie Webb triumphed at Pine Needles 21 years ago.

“It’s been my dream since I was a little girl,” said Lee. “It’s the one that I always wanted to win on; now I’ve done it, and just feels amazing.”

When the Women’s Open was held here in 2001, World Golf Hall of Famer Peggy Kirk Bell, who won an LPGA major as an amateur and, along with her husband Warren “Bullet” Bell, built Pine Needles into what’s become a cathedral for women’s golf, invited Patty Berg, Louise Suggs and Kathy Whitworth to give a clinic.

The entire purse that week was $1.2 million, and Webb earned $212,500 for her efforts. Whitworth wrote in her memoir – The Gift of Golf – that it was money the legendary foursome couldn’t comprehend.

“We were amazed at the lifestyle these girls have on tour today,” Bell wrote. “They have babysitters, free meals and courtesy cars!”

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What would Mrs. Bell have said then, of a $10 million purse and Lee’s $1.8 million payday, the largest in women’s golf history to date? (The winner of CME Group Tour Championship in November will earn $2 million.) Coming into this week, no one on the LPGA had crossed the $1 million mark so far this season.

“It’s such a large sum,” said Lee, “and I’m really honored to be the first winner I guess of this sum. We’re only going to get better and better.”

The only real drama of the day centered on second place, as this marked the first time in women’s golf history that two women would earn seven-figure checks. As the back nine unfolded on Sunday over the revamped Donald Ross design, three players—Lydia Ko, Hyejin Choi and Harigae—battled over a $1,080,000 paycheck.

Harigae, who only two years ago felt the walls closing in as she fought to keep her tour card and pay the bills, delivered a clutch birdie on the par-5 15th hole to finish solo second. Her previous biggest payday on tour was $268,657.

“I’m not going to lie, my stomach hurt the last couple holes coming down,” said Harigae. “I was really stressed out, but I was really just focusing on one shot at a time, making solid contact, and just hitting good putts.”

Consider that while the LPGA took a hiatus during the COVID-19 pandemic, Harigae won $2,300 for winning a mini-tour event on the Cactus Tour by 16 shots with a closing 61.

Choi was solo third at 7 under. World No. 1 Jin Young Ko shot a 71 on Sunday to claim solo fourth. Lydia Ko bogeyed her last two holes to shoot 72 and finish solo fifth.

“I think this was the most challenging one this year,” said Jin Young, “and also at the same time I had the most amount of fun.”

World No. 2 Nelly Korda, competing in her first event since early February after being sidelined with a blood clod that required surgery, finished with a 73 to tie for eighth.

“In all, I’m pretty happy with how this week went,” said Korda. “Had no expectations. I actually had my best finish in the Women’s Open, so maybe I should just keep that going.”

Born in Perth, Australia, Lee was introduced to the game by her parents. Her mother, Clara, was a teaching professional near their home and her father, Soonam, was a fine player in his own right. Her younger brother Min Woo, 23, will compete in his first U.S. Open later this month at The Country Club in Brookline, Massachusetts.

A two-time winner on the DP World Tour, Min Woo tied for 14th in his Masters debut in April, where Minjee caddied for him in the Par 3 Contest.

Minjee and Min Woo are the only brother-sister pair to win USGA titles, with Minjee winning the 2012 U.S. Girls’ Junior and Min Woo claiming the 2016 U.S. Junior Amateur.

Minjee now has eight LPGA titles worldwide, including the 2021 Amundi Evian Championship, where she came from an LPGA record-tying seven strokes back to win in a playoff.

Lee joins Webb (7) and Jan Stephenson (3) as the only Aussie female golfers with multiple major titles.

Pine Needles is now the first venue to ever host four Women’s Opens, and the previous three winners, Annika Sorenstam, Cristie Kerr and Webb, were first-class world-beaters.

Lee, who is currently No. 4 in the world and has been as high as No. 2, is the only player on tour who has won multiple events this season and, if she maintains this pace, could become the first Australian to become No. 1 since the Rolex Rankings debuted in 2006.

She’s now tied with Rachel Hetherington as the the third-winningest Australian player, following Webb (41) and Stephenson (16).

“I think this will be huge for all the little girls and even the boys and the children watching,” said Lee. “I know there’s been a really big boom in WA (Western Australia). The girls have been a lot more interested in playing, so hopefully they watch me on TV and I can be a good role model to them and they’ll start getting more involved.”

Bound for the Women's U.S. Open, Alexandra Forsterling looks to ...

Following the conclusion of Arizona State's second round at the NCAA Championships, head coach Missy Farr-Kaye went to find Alexandra Forsterling.

She felt like the senior wasn't playing like "her normal self" and trusting her game after finishing four-over-72 and three-over-72 during the event's first two days.

So Farr-Kaye wanted to remind Forsterling that she is still the same player who qualified for the 2022 U.S. Women's Open and is a finalist for the ANNIKA Award, given to the top women's college golfer.

"I said, 'You're still the No. 1 player on this team and I just want you to relax and enjoy it and let all that great talent you have come out,'" Farr-Kaye said.

Even though she finished Sunday at six-over-72, Forsterling heeded her coach's advice by notching three birdies on the back nine during the third day of the NCAA Division I Women's Golf Championship.

It marked the continuation of her impressive 2022 season, which includes a win at the PING/ASU Invitational and an invite to the Augusta Women's National Amateur in Georgia.

She was also named the Pac-12 Women's Golf Scholar Athlete of the Year and earned a spot on the conference's first team.

The Berlin, Germany, native is preparing to take the next step of her career, with plans to play in the Arnold Palmer Cup and qualifying school for the LPGA Tour this summer. But before she heads to North Carolina for the U.S. Women's Open, Forsterling wants to win a national title, something that has evaded her so far during her time in Tempe.

"That's the one huge thing you're working for all year," Forsterling said. "You want to get a ring on your finger."

Only time will tell whether Forsterling concludes her ASU tenure with a trophy, but her focus will soon shift to the Open, which runs from June 2-5. Forsterling was one of three golfers to clinch a spot in the event after shooting two-under-par over 36 holes during an April qualifier at Gainey Ranch Golf Club in Scottsdale.

She beat out more than 75 players, one of the more recent triumphs in a string of high-profile victories.

This season for ASU, Forsterling has seven top-10 finishes. Additionally, she flourished across the Atlantic this summer by winning the German Women's Amateur and earning runner-up in the European Ladies' Amateur.

"These tournaments really got my confidence back up," Forsterling said. "I got more consistent, changed my putter. All those little things came together and then (I) started off my senior year really good and kept going."

Farr-Kaye looks forward to Forsterling returning to that form, and believes she will. Her faith in the German native has been strong since the recruiting process, when Farr-Kaye took the word of an American coach in the country to look at her performances.

Even though Forsterling "was an exception" because Farr-Kaye didn't watch her play live in high school, hearing about her amateur success was enough.

"A lot can be said when you make Federations teams in Europe," said the Sun Devils' head coach. "You (have) got to be a good player."

Forsterling lived up to that when she arrived in the Grand Canyon State, gradually improving in 18 events across her first two seasons in Tempe. But just before the COVID-19 pandemic, her father passed away unexpectedly.

Farr-Kaye supported Forsterling during this time, and remembers how last summer marked a turning point in her career.

"I said to her one day, 'Your dad wants you to have fun and play,'" Farr-Kaye said. "I said, 'You don't have to play for your dad, but just know that he would want you to be happy and it's okay to move to that space.' She came back, she had a great summer... and all of a sudden I'm like 'Oh my gosh, she has a chance at Augusta National.'

"Everything started to fall into place, so it's been really fun to watch."

That success is making an impact inside ASU's facility at Papago Golf Course, where a maroon-and-gold board lists goals for the program's golfers.

Top-100 player on Golfstat. All American. Academic All American. Play in the Palmer Cup.

Forsterling, currently No. 6 in the Golfweek/Sagarin Women's Golf rankings, has achieved some of these marks throughout her career in Tempe. This has impacted fellow Sun Devils, including freshman Grace Summerhays, to push to qualify for events including the Augusta Women's National Amateur.

"Just being able to learn off her is great," Summerhays said. "Honestly, just having her as my friend is pretty cool, too. I get to see how she plays on the course, how she reacts to things."

Since this week marks Forsterling's final college event, Farr-Kaye is making sure to tell her to enjoy all the experiences from the course to the van rides and the team dinners, and not worry about the future.

Whether that future includes a title remains to be seen, but Forsterling is ready to do whatever she can to make it happen in her last time donning maroon and gold.

"It would mean so much to me, especially for the team," Forsterling said. "We're getting along so well and I think we would all really deserve it."

ASU women's golf struggles during third round, but advances to top-15

Roughly 90 minutes after finishing its third round, ASU went to work.

The Sun Devils, who finished 14-over-par on Sunday, hit the driving range and putting green to practice as the leaderboard of the NCAA Division I Women’s Golf Championship continued to change.

“We’ll see how the day shakes out,” Farr-Kaye said. “They’re beating themselves up a lot right now and we’ll have a good afternoon. We’ll see where it all ends up.”

It ended up great for the Sun Devils, who made the 15-team cut to keep their hopes for a ninth national title alive.

Freshman Calynne Rosholt and senior Alessandra Fanali both shot one-over-72, while programs including Texas, Virginia and TCU dropped multiple spots to help ASU solidify its place in the fourth round.

Farr-Kaye belives that her squad, currently No. 12 in the standings, will grow from today’s performance, which included 17 bogeys to nine birdies. She also hopes their mindsets shift from focusing on the mistakes they made to their successes at Grayhawk Golf Club so far.

“What I said to them was that, ‘Everybody has contributed in the last three days with some great things,’” ASU’s head coach said. “That’s what they need to focus on. Not what they’re not doing, not what they’re not missing, but what they’ve done and what hopefully we’ll have a chance to continue to do.”

Tomorrow comes with high stakes since the field is reduced to eight and it is the last day of individual play. Rosholt is the Sun Devils’ only player in the top 25, currently tied for 15th at +4.

“They want to represent Arizona State well,” Farr-Kaye said. “They want to represent their families well (and) everybody out watching. It’s really easy to put a little extra pressure on yourself and so I think… we just need to play our regular game and not get too stressed out.”

Wisconsin to host 2025 U.S. Women's Open

AP

MILWAUKEE (AP) — The U.S. Golf Association announced Tuesday that Erin Hills in Wisconsin will host the 2025 U.S. Women's Open, as well as the 2022 U.S. Mid-Amateur.

The golf course northwest of Milwaukee hosted the U.S. Open in 2017. It will be the first Women's Open to be held at Erin Hills and the third the state has hosted.

Hall of Famer Se Ri Pak globalized the women's game with a playoff victory over amateur Jenny Chuasiriporn in 1998 at Blackwolf Run, north of Milwaukee. And, Na-Yeon Choi won her only major in a return to Blackwolf Run in 2012.

The Women's Open will be held May 29 through June 1, 2025. The Mid-Amateur championship featuring the top amateur golfers who are done playing collegiately will be held Sept. 10-15, 2022.

Lee wins U.S. Women's Open, Horschel takes Memorial

AP

SOUTHERN PINES, N.C. (AP) — Minjee Lee won the U.S. Women’s Open by four strokes over Mina Harigae at Pine Needles on Sunday to earn $1.8 million, the largest payout in the history of women’s golf.

Lee closed with an even-par 71 to finish at 13-under 271 after the Australian flirted with the tournament record of 16 under set by Juli Inkster in 1999 at Old Waverly. Lee’s winnings came from a record $10 million purse.

Harigae shot a 72 for her best finish in a major and a check of slightly more than $1 million.

South Korea’s Hye-Jin Choi was one of only two players to break par Sunday, carding a 70 to finish third at 7 under. South Korea’s Jin Young Ko, the world’s No. 1-ranked player, was fourth at 6 under after a 71.

The 26-year-old Lee was never challenged on a course that played significantly tougher than the previous three days. She opened with rounds of 67, 66 and 67.

Lee became the sixth straight international player to win the U.S. Women’s Open and the first from Australia since mentor Karrie Webb in 2001. It was her second win at a major championship overall after winning the Evian Championship last July. Her previous best finish at the U.S. Open was a tie for 11th in 2017.

Lee, who entered the week ranked No. 4 in the world, has won eight LPGA Tour events and became the first repeat winner this year following her victory at the Founders Cup three weeks ago in New Jersey.

PGA TOUR

DUBLIN, Ohio (AP) — Billy Horschel ended any doubt about his victory at Muirfield Village with an eagle putt from one end of the green to the other on the 15th hole, sending him to a four-shot victory at the Memorial.

Horschel was staked to a five-shot lead at the start of a sun-soaked final round and no one ever got closer than two shots. He closed with an even-par 72.

Horschel finished at 13-under 275 and won $2.16 million, the largest paycheck of his career. As an elevated event, the win comes with a three-year exemption.

Aaron Wise shot a 71 to finish second. The consolation prize was a day off on Monday. Wise moved from No. 88 to No. 44 in the world ranking and is now exempt from 36-hole U.S. Open qualifying.

PGA TOUR CHAMPIONS

DES MOINES, Iowa (AP) — Jerry Kelly birdied the first hole of a playoff with Kirk Triplett on Sunday to win the PGA Tour Champions’ Principal Charity Classic.

Kelly hit his approach to 4 feet on the par-4 18th to set up the winning putt. The 55-year-old from Wisconsin has nine victories on the 50-and-over tour after winning three times on the PGA Tour.

Kelly and Triplett each shot 5-under 67 to finish at 18-under 198 at Wakonda Club, two strokes ahead of Steven Alker (69) and Hall of Famer Bernhard Langer (68).

The 60-year-old Triplett won the last of his eight senior titles in 2019.

EUROPEAN TOUR

WINSEN, Germany (AP) — Kalle Samooja of Finland finished with back-to-back birdies and set the course record with an 8-under 64 to win the Porsche European Open for his first European tour title and a spot in the U.S. Open.

The 34-year-old Samooja finished at 6-under 28, two shots ahead of Wil Besseling (71).

Samooja's win and Besseling's runner-up finish put them among the top 10 players not already eligible who earned U.S. Open spots based on a four-tournament money list.

KORN FERRY TOUR

RALEIGH, N.C. (AP) — Davis Thompson won the REX Hospital Open on his 23rd birthday for his first Korn Ferrry Tour victory, closing with a 2-under 69 to beat Andrew Yun and Vincent Norrman by a stroke.

The No. 2-ranked player from the inaugural PGA Tour University, Thompson finished at 17-under 268. Yun and Norrman closed with 68s.

OTHER TOURS

Scott Vincent of Zimbabwe closed with a 5-under 66 for a one-shot victory over Travis Smyth in the International Series-England on the Asian Tour. Vincent earned $360,000 from the $2 million purse, part of the $300 million infusion in the Asian Tour from Saudi-funded LIV Golf Investments. ... Kazuki Higa won for the second time this year on the Japan Golf Tour. He closed with a 4-under 67 for a one-shot victory over Tomoharu Otsuki in the BMW Japan Golf Tourr Championship Mori Building Cup. ... Nicolai Kristensen shot a 4-under 66 and beat Ugo Coussaud (68) in a playoff in the D+D Real Czech Challenge on the European Challenge Tour. ... Morgane Metraux of Switzerland won her first Ladies European Tour title when she made eagle on the first playoff hole to win the Ladies Italian Open over Meghan MacLaren and Italian amateur Alessandra Fanali. ... Rourke van der Spuy shot a 3-underr 69 for a three-stroke victory over Hennie Otto and Louis de Jager in the SunBet Challenge on the Sunshine Tour in South Africa. ... Olympic silver medalist Mone Inami closed with a 1-under 71 for a two-shot victory over Saiki Fujita in the Richard Mille Yonex Ladies on the Japan LPGA. ... Yu Jin Sung had a 2-under 70 and won the Lotte Open by four shots over Su Ji Kim on the Korean LPGA. ... Scott Stevens birdied the par-4 18th hole four straight times — the first in regulation and the last three in a playoff with Jake Knapp — to win the PGA Tour Canada-Mackenzie Tour’s season-opening Royal Beach Victoria Open in British Columbia. Stevens closed with a 3-under 67 to match Knapp (63) at 16-under 264. ... Chile’s Cristóbal Del Solar overcame a double bogey on the par-3 16th to beat Mitchell Meissner by a stroke in the PGA Tour Latinoamerica’s Volvo Golf Championship in Colombia. The former Florida State player closed with a 6-under 69 to finish at 16 under.

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Kentucky junior Jensen Castle wins US Women's Amateur

AP

HARRISON, N.Y. (AP) — Kentucky junior Jensen Castle won the U.S. Women’s Amateur on Sunday, beating Arizona junior Hou Yu-chiang of Taiwan 2 and 1 in the 36-hole final at Westchester Country Club.

Castle, from West Columbia, South Carolina, won after opening with a 7-over 79 on Monday in the first round of stroke play and surviving a 12-for-2 playoff late Tuesday to get into the 64-player field for match play.

“Still hasn’t registered,” Castle said. “It feels like just another tournament, but then I step back and I’m like, this is a USGA event with so much history.”

She’s the third No. 63 seed to win a USGA title, following Clay Ogden in the 2005 U.S. Amateur Public Links and Steven Fox in the 2012 U.S. Amateur.

After Hou won the 30th and 31st with birdies to pull within one, Castle took the par-4 33rd with a par, lost the par-3 34th to Hou’s birdie and finished off the match with a birdie on the par-4 35th.

Ranked 248th in the world amateur ranking, Castle wrapped up an automatic spot on the U.S. Curtis Cup team this month in Wales. She also earned spots in the Women’s British Open at Carnoustie in two weeks, and the 2022 ANA Inspiration, U.S. Women’s Open, Evian Championship and Augusta National Women’s Amateur.

“I don’t even know where (Wales) is, but I’m so excited," Castle said. "I’ve never been out of the country so that’s really exciting. I’m just excited to represent the United States. That’s always been a dream of mine.”

Castle hadn't played any competitive golf since her U.S. Women’s Amateur qualifier in Dayton, Ohio, on July 8 because of a stress fracture in her ribs.

Hou hadn’t played a competitive event since the NCAA Championships in late May due to a partially torn labrum in her left hip.

“This is golf, and I am really looking forward to what’s next for me,” said Hou, who has entered the first stage of LPGA Tour Qualifying School. “Congratulations to the champion. She played really well.”