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		<title>FDA could allow foreign-made formula to be shipped to US</title>
		<link>https://cincylink.com/2023/07/16/fda-could-allow-foreign-made-formula-to-be-shipped-to-us/</link>
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		<dc:creator><![CDATA[cincylink]]></dc:creator>
		<pubDate>Sun, 16 Jul 2023 08:51:17 +0000</pubDate>
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					<description><![CDATA[As the Biden administration tries to put an end to an infant formula shortage around the U.S., the Food and Drug Administration said it could soon allow foreign-made products to enter the market. Health and Human Services Secretary Xavier Becerra told CNN that certain products are not allowed to be sold in the U.S. He &#8230;]]></description>
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<p>As the Biden administration tries to put an end to an infant formula shortage around the U.S., the Food and Drug Administration said it could soon allow foreign-made products to enter the market.</p>
<p>Health and Human Services Secretary Xavier Becerra told CNN that certain products are not allowed to be sold in the U.S. He said that the FDA could allow in products as long as they meet safety requirements.</p>
<p>“What we are looking to do is make available that supply from abroad that we can assure people will be safe and make it more readily available,” he told CNN. “There are certain requirements that some manufacturers don't meet that don't have so much to do with nutrition or safety that prohibit us being able to allow to import it. We're going to do what we can to increase supply, work with importers so that supply, so long as it is safe, will make it to the U.S.<b>"</b></p>
<p>Another issue slowing supply was a February recall that subsequently caused a Michigan plant operated by Abbott to shut down. Abbott officials and the FDA have said they have been working together to reopen the plant.</p>
<p>The recall was prompted after two infants died and two others were hospitalized after consuming Abbott-made infant formula. Abbott said in a statement last week that it could not find any evidence that the infants were sickened by Abbott-made products.</p>
<p>“We conduct microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter or Salmonella,” Abbott said. “All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.”</p>
<p>Becerra said getting the Abbott plant fully operational is important for getting shelves restocked with formula.</p>
<p><b>"</b>We have to count on Abbott putting its production lines back in place. If they don't move quickly to address safety concerns that even they acknowledge because they shut down the plant and recalled some of their product, then it becomes difficult because they are a big manufacture - 40 percent - that comes from Abbott. So they have to get back online,” Becerra told CNN.</p>
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		<title>FDA allows more international formula to enter US market</title>
		<link>https://cincylink.com/2023/07/15/fda-allows-more-international-formula-to-enter-us-market/</link>
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		<dc:creator><![CDATA[cincylink]]></dc:creator>
		<pubDate>Sun, 16 Jul 2023 01:40:06 +0000</pubDate>
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					<description><![CDATA[The Food and Drug Administration said on Friday that Nestle will import about 1.3 million cans of Gerber Good Start Gentle formula into the U.S. from Mexico The formula is expected to reach U.S. markets in July. The announcement is part of an FDA initiative to allow foreign-made infant formula into the U.S. amid a &#8230;]]></description>
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<p>The Food and Drug Administration said on Friday that Nestle will import about 1.3 million cans of Gerber Good Start Gentle formula into the U.S. from Mexico</p>
<p>The formula is expected to reach U.S. markets in July.</p>
<p>The announcement is part of an FDA initiative to allow foreign-made infant formula into the U.S. amid a shortage. The U.S. government has imported three planeloads of formula from overseas in recent weeks as part of a federal strategy to bolster stock.</p>
<p>The severe shortage has been caused, at least partially, due to a Michigan plant, run by Abbott Laboratories, which shut down due to contamination fears, and disruptions in the supply chain.</p>
<p>Before relaxing rules on imports, nearly 98% of formula in the U.S. was produced domestically.</p>
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		<title>FDA warns against using certain powdered baby formulas tied to infections</title>
		<link>https://cincylink.com/2022/02/17/fda-warns-against-using-certain-powdered-baby-formulas-tied-to-infections/</link>
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		<dc:creator><![CDATA[cincylink]]></dc:creator>
		<pubDate>Fri, 18 Feb 2022 02:37:12 +0000</pubDate>
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					<description><![CDATA[U.S. health officials warned parents on Thursday not to use three popular powdered infant formulas manufactured at an Abbott plant in Michigan that investigators recently linked to bacterial contamination.The Food and Drug Administration said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died. The agency said &#8230;]]></description>
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<p>
					U.S. health officials warned parents on Thursday not to use three popular powdered infant formulas manufactured at an Abbott plant in Michigan that investigators recently linked to bacterial contamination.The Food and Drug Administration said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died. The agency said one of the cases involved salmonella and three involved Cronobacter sakazakiim, a rare but dangerous germ that can cause blood infections and other serious complications. Abbott, one of the country's largest infant formula makers, said it is recalling all potentially affected products manufactured at the facility. The recall affects certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022, or later. The product was distributed throughout the U.S. and overseas, the company said in a statement.FDA staff are now inspecting Abbott's plant in Sturgis, Michigan, where environmental samples tested positive for the Cronobacter bacteria. Inspectors have also uncovered potential manufacturing problems, and past records showing the destruction of formula due to bacterial contamination."We're working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible," said FDA Deputy Commissioner Frank Yiannas.The FDA said it is working with federal and local authorities in Minnesota, Ohio and Texas— the states where the infant infections were reported.Abbott could not specify how many units the recall includes, but brands like Similac are among the best-selling formulas in the U.S. and overseas."We value the trust parents place in us for high quality and safe nutrition and we'll do whatever it takes to keep that trust and resolve this situation," a company spokeswoman said in a statement.Abbott said parents can identify the recalled products by examining the number on the bottom of each container. The affected formulas have a number starting with 22 through 37, contain K8, SH, or Z2 and have an expiration date of April 1, 2022, or later. The company has also set up a website where parents can check if their products have been recalled: https://www.similacrecall.com/us/en/home.html.The company said its own testing of the finished product didn't detect any contamination. The recall does not affect liquid infant formulas or any other Abbott products.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.
				</p>
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					<strong class="dateline">WASHINGTON —</strong> 											</p>
<p>U.S. health officials warned parents on Thursday not to use three popular powdered infant formulas manufactured at an Abbott plant in Michigan that investigators recently linked to bacterial contamination.</p>
<p>The Food and Drug Administration said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died. The agency said one of the cases involved salmonella and three involved Cronobacter sakazakiim, a rare but dangerous germ that can cause blood infections and other serious complications. </p>
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<p>Abbott, one of the country's largest infant formula makers, said it is recalling all potentially affected products manufactured at the facility. The recall affects certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022, or later. The product was distributed throughout the U.S. and overseas, the company said in a statement.</p>
<p>FDA staff are now inspecting Abbott's plant in Sturgis, Michigan, where environmental samples tested positive for the Cronobacter bacteria. Inspectors have also uncovered potential manufacturing problems, and past records showing the destruction of formula due to bacterial contamination.</p>
<p>"We're working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible," said FDA Deputy Commissioner Frank Yiannas.</p>
<p>The FDA said it is working with federal and local authorities in Minnesota, Ohio and Texas— the states where the infant infections were reported.</p>
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		<img decoding="async" class=" aspect-ratio-original lazyload lazyload-in-view" alt="recalled&amp;#x20;baby&amp;#x20;formula" title="recalled baby formula" src="https://cdn.cincylink.com/pub/content/uploads/sites/27/2022/02/FDA-warns-against-using-certain-powdered-baby-formulas-tied-to.jpg"/></div>
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<p>Abbott could not specify how many units the recall includes, but brands like Similac are among the best-selling formulas in the U.S. and overseas.</p>
<p>"We value the trust parents place in us for high quality and safe nutrition and we'll do whatever it takes to keep that trust and resolve this situation," a company spokeswoman said in a statement.</p>
<p>Abbott said parents can identify the recalled products by examining the number on the bottom of each container. The affected formulas have a number starting with 22 through 37, contain K8, SH, or Z2 and have an expiration date of April 1, 2022, or later. The company has also set up a website where parents can check if their products have been recalled: https://www.similacrecall.com/us/en/home.html.</p>
<p>The company said its own testing of the finished product didn't detect any contamination. The recall does not affect liquid infant formulas or any other Abbott products.</p>
<p>___</p>
<p><em>The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.</em></p>
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