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Abbott says agreement reached to reopen baby formula plant

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Abbott says agreement reached to reopen baby formula plant

By ZEKE MILLER and MATTHEW PERRONE

WASHINGTON (AP) — Infant formula maker Abbott says it’s reached an agreement with U.S. health officials to restart production at its largest domestic factory, a key step toward easing a nationwide shortage tied to the plant’s shutdown earlier this year.

Abbott did not immediately detail the terms of the agreement reached with the Food and Drug Administration, which has been investigating safety problems at the Sturgis, Michigan, facility. The consent decree is a binding legal agreement between the company and the federal government.

After production resumes, Abbott has said it will take at least eight weeks to begin shipping new product to stores.

The Biden administration has come under intense pressure over the last week to do more to ease the shortage of formula that has forced parents of infants to go to significant lengths to feed their children.

Abbott’s plant came under scrutiny earlier this year after four infants became sick with bacterial infections after consuming powdered formula from the Michigan factory. Two of the babies died.

In February, the company halted production and recalled several brands of formula. Those steps squeezed supplies that were already strained by supply chain disruptions and parents stockpiling during COVID-19.

THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

WASHINGTON (AP) — Under fire from parents and politicians, President Joe Biden’s administration on Monday is expected to announce an agreement to reopen the largest domestic manufacturing plant of infant formula and to ease import rules to allow supplies in from overseas, amid a nationwide shortage spurred by the Michigan plant’s shutdown earlier this year over safety issues.

A consent decree between the producer, Abbott, and the Food and Drug Administration that would pave the way for reopening the plant is “forthcoming,” said Brian Deese, the director of the White House’s National Economic Council. He added the agency would also take steps Monday to allow more foreign imports into the U.S. to address the urgent supply constraints.

It comes as the Biden administration has come under intense pressure over the last week to do more to ease the shortage of formula that has forced parents of infants to go to significant lengths to feed their children.

Over the weekend, the White House offered formula manufacturers and retailers transportation and logistics support, and working with all major formula producers to boost production, including reaching out to their suppliers to encourage them to prioritize production and delivery of formula ingredients.

Deese said the administration “made clear to all of them that federal resources, including transportation and logistics resources, are available and on call and we are prepared to move assets in coordination with them as and when we identify need.”

The shortage stems from a February recall by Abbott, the nation’s largest formula maker, that shuttered the company’s Michigan plant and exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on stores shelves across much of the country. The shortage has led retailers like CVS and Target to limit how many containers customers can purchase per visit and forced some parents to swap and sell formula online.

On Monday, FDA Commissioner Robert Califf told ABC News’ “Good Morning America” that the federal agency is “working really closely with Abbott” to reopen the closed Michigan factory and he expects that “in a very short period of time we’re going to have an announcement about the path forward.”

Califf said an announcement is forthcoming about importing baby formula from abroad, noting that the key is making sure the instructions for the formula are in languages that mothers and caregivers can understand.

The FDA warned families against making their own baby formula because it has 30 distinct constituents that have to be in the right amount, otherwise the formula can possibly be dangerous to consume.

Abbott’s voluntary recall was triggered by four illnesses reported in babies who had consumed powdered formula from the Michigan plant. All four infants were hospitalized with a rare type of bacterial infection and two died.

Abbott is one of just four companies that produce roughly 90% of U.S. formula, so its shutdown squeezed already tight supplies.

After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.

But Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from the babies by federal investigators. The company has repeatedly stated it is ready to resume manufacturing, pending an FDA decision.

The terms of the consent decree were not immediately clear, including what steps Abbott was taking to remediate issues raised by the FDA or how quickly production at the plant would be restarted.

Former FDA officials say fixing the type of problems uncovered at Abbott’s plant takes time, and infant formula facilities receive more scrutiny than other food facilities. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.

Even if the facility reopens soon, the FDA will still face scrutiny for its handling of the issues at the plant.

FDA inspectors visited the factory in September for a routine inspection, around the time that the first bacterial infection was reported in an infant. Although inspectors uncovered several violations— including standing water and unsanitary conditions— the FDA did not shut down the plant or issue any formal warning.

Only after several more illnesses were reported did the FDA return to the plant in January, this time finding a history of bacterial contamination in several parts of the plant. Abbott then shut down the facility and recalled several powdered formulas in mid-February.

Congresswoman Rosa DeLauro reported last month that a whistleblower had contacted the FDA in October about unsafe conditions and practices at the plant, including falsifying plant records and failing to properly test formula for contamination.

She and other lawmakers are set to question FDA Commissioner Califf about that issue and others at a hearing scheduled for Thursday.

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Minnesota United gives away late lead in Miami

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Minnesota United gives away late lead in Miami

For so much of the second half, Minnesota looked comfortable and ready to take a much-needed victory.

Shockingly, Inter Miami, the second-worst goal-scoring team in MLS notched two goals in the final three minutes to flip the script and take a 2-1 victory in the first MLS meeting between the two teams.

“[We] put ourselves in a great spot,” manager Adrian Heath said. “Put ourselves in a really good position. We’re not doing enough, it doesn’t look as though it’s enough to concede goals and lose games.”

Inter Miami forward Indiana Vassilev only made it into the game as a late-game bench substitution, but he made the most of his opportunity scoring in the 87th and 90th minute to give his team a victory, surpassing Minnesota’s one-goal lead it held since the 65th minute.

The Loons’ defense had kept Minnesota in the game for each chance Inter Miami had for the first 86 minutes, but the team couldn’t get the stops near the end to come up with the victory.

“At those times of the game, you need to do whatever you can to just beat your man,” Loons defender Michael Boxall said.

Minnesota’s victory looked nearly locked up as the Loons held the 1-0 difference into the final five minutes of the game. That goal followed a resilient start to the second half after many chances weren’t finished.

The Minnesota goal scorer was Luis Amarilla, who put the ball past the Inter Miami goalkeeper in tight in the 65th minute. It was his first goal in MLS play since March 19.

Amarilla was in such a position to score the goal so close to the keeper because of an acrobatic one-touch centering pass from Franco Fragapane. The play all began from Emmanuel Reynoso getting the ball on the right side of the attacking zone. He cut towards the middle and sent a lofting kick that found the airborne Fragapane for his assist.

While Minnesota finally found the back of the net in the back half of the game, there was no shortage of missed opportunities earlier in the contest.

“We’re not good enough at one end, and we’re not good enough at the other, and that’s not a good recipe,” Heath said. “We’ve got to get more and more determination to get on the things in the box and we’ve certainly got to defend the goal better.”

By the end of the game, Inter Miami had eight shots on target, while Minnesota had just one, the Amarilla goal.

The loss marks the first since Minnesota announced Heath’s two-year contract extension through 2024 on Thursday. The defeat also adds to a 1-6-1 stretch over the Loons’ last eight games, including Saturday night.

Heath said on Wednesday that the goal was to come away with four points in this road trip at Inter Miami on Saturday and on Wednesday at L.A. Galaxy. With the loss to Inter Miami, that goal is no longer possible.

The Loons must keep looking forward to get back on track and into playoff contention. After the loss on Saturday, Minnesota sits 11th in the Western Conference Standings, five points outside of the seventh spot, the cutoff for the playoffs.

“The good thing is that it’s a quick turnaround,” Boxall said. “Not quite looking ahead to L.A. just yet, we still need to process this game and figure out what we need to address, because that should be three points we’re taking home tonight.”

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Twins record second shutout in three days in win over Rockies

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Twins record second shutout in three days in win over Rockies

Puffy white clouds filled the blue skies above Target Field and sunlight bounced off buildings that make up the Minneapolis skyline. It was the kind of summer night at the ballpark that Minnesotans dream about throughout the long winter months.

It was the perfect night at Target Field and the hometown team, well, they were nearly perfect, too. Twins pitchers gave up just one hit (and five walks), and the team captured a first-inning lead on its way to a 6-0 win over the Colorado Rockies on Saturday night at Target Field.

A day after getting shut out for the 10th time this season, tying the league lead, Luis Arraez and Byron Buxton made sure early on that the Twins wouldn’t suffer the same fate. Arraez snapped an 0-for-11 stretch to begin the game and Buxton, back in the lineup for the first time since Tuesday, followed that up with his first triple since 2019.

After missing time this week after his knee flared up, Buxton turned on the burners, with a sprint speed of 29.3 feet/second (30 ft/sec is elite) on the triple, losing his helmet along the way. When he reached the base, he pounded his chest a couple times, smacked his hands together and let out a roar.

While the Twins left Buxton on third, they added on throughout the game, tacking on a run in the second on Arraez’s second hit of the game, two more in the fifth and two more in the seventh.

Alex Kirilloff drove in three of those runs, one on a sacrifice fly and the other on a double off the right field wall, bringing home Max Kepler — who walked three times in the game — and Kyle Garlick. The double was his fourth in eight games since being recalled from Triple-A.

All that offense came in support of Chris Archer, who worked five innings and allowed just one hit — a single to former Twin C.J. Cron in the second inning — and a walk in his outing.  Archer pitched out of that second-inning jam, retiring the next three batters in a row, the first of 12 straight that he sent down to conclude his start.

His start was followed by a scoreless inning each from Jharel Cotton and Griffin Jax and two from Tyler Thornburg. Twins pitchers have now thrown two shutouts in their past three games, and in Friday’s loss, they gave up just one run.

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A Pride timeline: Gay rights in Minnesota from 1858-2022

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A Pride timeline: Gay rights in Minnesota from 1858-2022

1858: Joseph Israel Lobdell, born Lucy Lobdell, is arrested for “impersonating a man.” A judge in the rural camp community of Forest City, Minn., sided with Lobdell, ruling that he did not act unlawfully.

1877: Minneapolis rules crossdressing as illegal, putting gender-nonconforming Minnesotans at risk for imprisonment.

1969: The Stonewall riots begin in New York City after police raids occur in the gay-friendly bars and community spaces of Lower Manhattan. These riots serve as a public turning point in American LGBTQ+ history.

May 18, 1969: University of Minnesota alumni found Fight Repression of Erotic Expression, or FREE, the first LGBTQ+ rights organization in the state. Founders Jack Baker and Michael McConnell become the first same-sex couple in the nation to apply for a marriage license, an application that is rejected by Hennepin County. Their legal case is dismissed by the U.S. Supreme Court in one sentence.

1972: The first Twin Cities Pride celebration is held in Minneapolis’ Loring Park.

Dec. 9, 1972: Minnesota state Sen. Allan Henry Spear indicates he is gay in an interview with the Minneapolis Star, making him the first openly gay state legislator in the United States.

June 1982: Bruce Brockway becomes the first documented recipient of an HIV diagnosis in Minnesota. After his diagnosis, he founded the Minnesota AIDS Project to provide resources to HIV-positive Minnesotans.

1993: Gender- and sexuality-based discrimination is outlawed in Minnesota, making it the first state in the nation to adopt the policy.

1997: Sicaŋgu Lakota man Nicholas Metcalf and his partner, Korean-American Edd Lee, found the Minnesota Men of Color, an organization that focuses on the well-being of men, women and gender-nonconforming people of color.

2012: Amendment 1, which limits marriage rights to only heterosexual couples, is rejected by the majority of Minnesota voters. Same-sex marriage is legalized in the state.

June 2015: The U.S. Supreme Court releases a decision in Obergefell v. Hodges finding that same-sex marriage cannot be banned in any state and must be recognized nationally. Gay marriage is legalized.

June 25-26, 2022: After two years of pandemic-related cancellations, the Twin Cities Pride parade and festival returns to Minneapolis.

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