{"id":457059,"date":"2022-06-03T05:11:13","date_gmt":"2022-06-03T02:11:13","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/how-the-fda-bungled-the-nations-baby-formula-supply\/"},"modified":"2022-06-03T05:11:13","modified_gmt":"2022-06-03T02:11:13","slug":"how-the-fda-bungled-the-nations-baby-formula-supply","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/how-the-fda-bungled-the-nations-baby-formula-supply\/","title":{"rendered":"#How the FDA bungled the nation&#8217;s baby-formula supply"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3667db9592d\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #dd3333;color:#dd3333\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #dd3333;color:#dd3333\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3667db9592d\" checked aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/buradabiliyorum.com\/en\/how-the-fda-bungled-the-nations-baby-formula-supply\/#%E2%80%9CHow_the_FDA_bungled_the_nations_baby-formula_supply%E2%80%9D\" >&#8220;How the FDA bungled the nation&#8217;s baby-formula supply&#8221;<\/a><ul class='ez-toc-list-level-2' ><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/buradabiliyorum.com\/en\/how-the-fda-bungled-the-nations-baby-formula-supply\/#The_FDA_must_answer\" >The FDA must answer:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/buradabiliyorum.com\/en\/how-the-fda-bungled-the-nations-baby-formula-supply\/#Path_forward\" >Path forward<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h1><span class=\"ez-toc-section\" id=\"%E2%80%9CHow_the_FDA_bungled_the_nations_baby-formula_supply%E2%80%9D\"><\/span>&#8220;How the FDA bungled the nation&#8217;s baby-formula supply&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h1>\n<div>\n<aside class=\"single__inline-module alignleft\">\n<\/aside>\n<p>Infant formula provides the sole source of nutrition for infants who are not being breast fed and often supplements breast milk for those who are. Only 47% of infants are exclusively breast fed in the first three months of life, a figure that declines to 26% by six months.\u00a0Specialty formulas are the only nutrition option for infants who, because of medical problems, cannot utilize standard formulas or breast milk.<\/p>\n<p>It\u2019s also one of the most regulated foods in our country. The Food and Drug Administration\u2019s strict nutritional and labeling requirements make it difficult for foreign producers to export formula to the US, despite evidence that their products are safe and nutritionally adequate. Tariffs \u2014 as high as 17.5% \u2014 further discourage importation. Consequently, nearly all the formula consumed in the US is produced domestically by four companies. This makes the supply vulnerable to closures of large domestic plants.<\/p>\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"682\" src=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-885.jpg?w=1024\" alt=\"FDA\" class=\"wp-image-22516876\" srcset=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-885.jpg?quality=75&amp;strip=all&amp;w=1535 1536w, https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-885.jpg?quality=75&amp;strip=all 1024w, https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-885.jpg?quality=75&amp;strip=all&amp;w=512 512w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\"\/><figcaption>The FDA\u2019s requirements make it difficult for foreign producers to export baby formula to the US.<\/figcaption><figcaption><span class=\"credit\">Getty Images\/Sarah Silbiger<\/span><\/figcaption><\/figure>\n<p>The FDA had \u201cconcerns about infant formula and special medical food shortages given their production at a small number of facilities controlled by a handful of firms\u201d over two years ago, internal reports show. Yet the agency did little to address formula shortages that began last summer and rapidly increased over the late fall and winter.\u00a0<\/p>\n<aside class=\"single__inline-module alignright\">\n    <\/aside>\n<p>The shortages were exacerbated by the FDA-encouraged February 2022 closure of Abbott\u2019s Sturgis, Mich., plant \u2014 one of the largest formula facilities in the country and one of the only producers of specialty preparations \u2014 in response to possible bacterial contamination.\u00a0<\/p>\n<p>The FDA conducted a routine inspection of the Sturgis plant on Sept. 20-24, 2021. It reported five observations \u2014 including standing water and inadequate hand washing \u2014 but nothing about bacteria. At the same time (Sept. 20), the FDA received a report of Cronobacter sakazakii illness in an infant who had consumed formula produced at the plant. Two additional complaints of Cronobacter illness possibly associated with the Sturgis plant arrived Dec. 1 and Jan. 11.\u00a0<\/p>\n<p>In late October, multiple FDA officials received a whistleblower report electronically and via FedEx alleging safety issues and record falsifications at the Sturgis plant. The informant was interviewed two months later. The FDA claims its leadership did \u201cnot receive direct copies of the complaint due to an isolated failure in FDA\u2019s mailroom\u201d and that leadership was only notified, four months later in mid-February, via email.<\/p>\n<p>It wasn\u2019t until Jan. 31 that the agency began a new inspection, lasting until March 18, of the Sturgis plant. When early samples from plant surfaces were positive for Cronobacter, the agency advised Abbott to recall products on Feb. 15. The company voluntarily closed the plant and recalled product. Days later, a fourth sick infant possibly connected to the plant\u2019s formula was reported.\u00a0<\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_FDA_must_answer\"><\/span>The FDA must answer:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>\u200aHow could a plant with few problems on a September 2021 inspection have \u2014 according to FDA head Robert Califf \u2014 \u201cegregiously unsanitary\u201d conditions, including cracks in equipment, a leaking roof and bacterial contamination on an inspection four months later? It doesn\u2019t inspire confidence in the agency\u2019s routine inspections.<\/li>\n<li>Why did the FDA essentially ignore a whistleblower complaint for four months? Blaming the mailroom is like claiming the dog ate my homework. Multiple FDA officials initially received the complaint, interviewed the whistleblower, and emailed the higher-ups.<\/li>\n<li>\u200aHow could the FDA allow three months to elapse between closure of the critical Sturgis plant and the agency\u2019s May 16 announcement that it would make case-by-case, enforcement discretion determinations to allow importation of safe foreign formula? Formula from Australia and the UK will be imported but could take weeks to reach store shelves. The agency will finally allow release of 300,000 cans of a specialty formula that it instructed Abbott to hold back in February \u2014 it has repeatedly tested negative for contamination.<\/li>\n<li>\u200aFinally, why did it take three months to conclude an agreement to reopen the Abbott plant? The FDA was aware of the formula shortage and the critical role the plant plays in the nation\u2019s supply. And it remains unclear whether the Abbott plant infected anyone: None of the product samples in the four cases tested positive for Cronobacter and genomic sequencing of the two available patient samples found no close genetic relation to the Cronobacter strains found at the factory.\u00a0<\/li>\n<\/ul>\n<p>The FDA had to move more rapidly. Even now, more than two weeks after the May 16 consent decree, the plant is not up and running.\u00a0<\/p>\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"682\" src=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-883.jpg?w=1024\" alt=\"Food and Drug Administration Commissioner Robert Califf\" class=\"wp-image-22516874\" srcset=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-883.jpg?quality=75&amp;strip=all&amp;w=1535 1536w, https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-883.jpg?quality=75&amp;strip=all 1024w, https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-883.jpg?quality=75&amp;strip=all&amp;w=512 512w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\"\/><figcaption>Food and Drug Administration Commissioner Robert Califf agrees the FDA could have responded faster to the issue.<\/figcaption><figcaption><span class=\"credit\">AP\/Jose Luis Magana<\/span><\/figcaption><\/figure>\n<p>Commissioner Califf claims the FDA is understaffed, with only nine employees to inspect formula plants domestically and abroad. A $6 billion agency could have hired additional inspectors to address a formula shortage, ongoing for 10 months.<\/p>\n<p>The FDA budget will increase by a third in FY 2023. In addition, the House of Representatives emergently <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">app<\/a>ropriated $28 million for the FDA to address the shortage.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Path_forward\"><\/span>Path forward<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Simply spending more, though, is not the answer. The FDA must make its newfound discretionary flexibility for importing foreign formulas permanent \u2014 it would increase supply, lower prices and provide redundancy. It must increase the number of inspectors so that complaints can be addressed in a timely and competent manner. And it must speed up its investigation and re<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/social-mediaa\/\" data-internallinksmanager029f6b8e52c=\"1\" title=\"Social Media\" target=\"_blank\" rel=\"noopener\">media<\/a>l processes so that alleged problems at key plants can be rapidly assessed and corrected.<\/p>\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"682\" src=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-884.jpg?w=1024\" alt=\"Baby formula\" class=\"wp-image-22516875\" srcset=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-884.jpg?quality=75&amp;strip=all&amp;w=1535 1536w, https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-884.jpg?quality=75&amp;strip=all 1024w, https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-884.jpg?quality=75&amp;strip=all&amp;w=512 512w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\"\/><figcaption>Over two years ago, the FDA had \u201cconcerns about infant formula and special medical food shortages given their production at a small number of facilities controlled by a handful of firms.\u201d <\/figcaption><figcaption><span class=\"credit\">EPA<\/span><\/figcaption><\/figure>\n<p>Commissioner Califf has acknowledged that the FDA\u2019s response was \u201ctoo slow\u201d and its decisions \u201cwere suboptimal.\u201d The agency must do better.<\/p>\n<p><em>Joel Zinberg, MD, is a senior fellow at the Competitive Enterprise Institute and director of public health and wellness at the Paragon Health Institute.\u00a0<\/em>\n                        <\/div>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. Follow us on\u00a0<span style=\"color: #ff0000;\"><a style=\"color: #ff0000;\" href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMLG0nwswvr63Aw\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Google News<\/a><\/span>\u00a0too, click on the star and choose us from your favorites.<\/span><\/strong><\/p><\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\">For forums sites go to <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/forum.buradabiliyorum.com\/\" target=\"_blank\" rel=\"noopener\">Forum.BuradaBiliyorum.Com<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\"><strong>If you want to read more <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/news\/\" data-internallinksmanager029f6b8e52c=\"2\" title=\"News\" target=\"_blank\" rel=\"noopener\">News<\/a> articles, you can visit our <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/en.buradabiliyorum.com\/news\/\" target=\"_blank\" rel=\"noopener\">News category.<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<p><span style=\"color: black;\"><a style=\"color: #ff9900;\" href=\"https:\/\/nypost.com\/2022\/06\/02\/how-the-fda-bungled-the-nations-baby-formula-supply\/\" target=\"_blank\" rel=\"noopener\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8220;How the FDA bungled the nation&#8217;s baby-formula supply&#8221; Infant formula provides the sole source of nutrition for infants who are not being breast fed and often supplements breast milk for those who are. Only 47% of infants are exclusively breast fed in the first three months of life, a figure that declines to 26% by&#8230;<\/p>\n","protected":false},"author":1,"featured_media":457060,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/06\/baby-formula-index.jpg?quality=75&strip=all&w=1024","fifu_image_alt":"","footnotes":""},"categories":[70897],"tags":[129841,70292,129493,8013,14580,74873],"class_list":["post-457059","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-6-2-22","tag-babies","tag-baby-formula","tag-baby","tag-children","tag-fda"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/457059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=457059"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/457059\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/457060"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=457059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=457059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=457059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}