{"id":482695,"date":"2022-08-09T02:34:23","date_gmt":"2022-08-08T23:34:23","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/biden-must-demand-timid-fda-act-as-baby-formula-shortage-grows-even-worse\/"},"modified":"2022-08-09T02:34:23","modified_gmt":"2022-08-08T23:34:23","slug":"biden-must-demand-timid-fda-act-as-baby-formula-shortage-grows-even-worse","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/biden-must-demand-timid-fda-act-as-baby-formula-shortage-grows-even-worse\/","title":{"rendered":"#Biden must demand timid FDA act as baby-formula shortage grows even worse"},"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-6a40f1a171237\" 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-6a40f1a171237\" 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\/biden-must-demand-timid-fda-act-as-baby-formula-shortage-grows-even-worse\/#%E2%80%9CBiden_must_demand_timid_FDA_act_as_baby-formula_shortage_grows_even_worse%E2%80%9D\" >&#8220;Biden must demand timid FDA act as baby-formula shortage grows even worse&#8221;<\/a><\/li><\/ul><\/nav><\/div>\n<h1><span class=\"ez-toc-section\" id=\"%E2%80%9CBiden_must_demand_timid_FDA_act_as_baby-formula_shortage_grows_even_worse%E2%80%9D\"><\/span>&#8220;Biden must demand timid FDA act as baby-formula shortage grows even worse&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h1>\n<div>\n<aside class=\"single__inline-module alignleft\">\n<\/aside>\n<p>Half a year in, the baby-formula shortage keeps\u00a0getting worse\u00a0with no end in sight. Unlike the global semiconductor and grain shortages, the formula shortfall is an America-only phenomenon. This means the solution can be found here at home. <\/p>\n<p>But by focusing on importing limited amounts of Food and Drug Administration-<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>roved foreign formula, President Joe Biden is addressing only the problem\u2019s symptom, not the root cause. He needs to cut the ridiculous red tape that\u2019s keeping store shelves bare.<\/p>\n<p>Baby formula has a 30% out-of-stock rate \u2014 higher than when parents began panicking months ago and stratospheric compared with the typical 5% to 7% pre-pandemic. <\/p>\n<p>The shortage was precipitated by Abbott Nutrition\u2019s February recall after five infants came down with severe infections after consuming formula produced at the company\u2019s Sturgis, Mich., plant. An FDA inspection found unsanitary conditions and other violations, leading Abbott to recall the formula and halt production. The infection-causing bacteria were not found in the Abbott formula, though.<\/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\/08\/1407581605.jpg?w=1024\" alt=\"Baby formula\" class=\"wp-image-23379707\"\/><figcaption>As of now 80% of all US baby formula comes from two companies.<\/figcaption><figcaption><span class=\"credit\">Getty Images\/Brandon Bell<\/span><\/figcaption><\/figure>\n<aside class=\"single__inline-module alignright\">\n    <\/aside>\n<p>Usually, a recall wouldn\u2019t cause such severe disruption. But the US baby-formula market is extremely concentrated: 80% of all formula comes from just two companies, one being Abbott, which had 48% of the market when the recall started. The company also dominates the formula purchased for the US Department of Agriculture\u2019s Women, Infants, and Children program, holding government contracts in 34 states and the District of Columbia.<\/p>\n<p>Because of its market dominance, there were bound to be repercussions once Abbott recalled formula and halted production at one of its largest plants. Action was needed to prevent a shortage, especially for babies who require a specialized formula for survival. But rapid action was not taken.<\/p>\n<p>The FDA\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-encourages-importation-safe-infant-formula-and-other-flexibilities-further-increase-availability\">reports<\/a>\u00a0that \u201cthe U.S. normally produces 98% of the infant formula it consumes.\u201d That\u2019s partly thanks to\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/crsreports.congress.gov\/product\/pdf\/IN\/IN11932\">tariffs<\/a>\u00a0of up to 17.5% on imported baby formula that put foreign competitors at a distinct competitive disadvantage. Few even bother going through the FDA\u2019s approval process. With a massive shortage in such a large market, however, many foreign companies began wanting to sell to the United States but needed FDA approval to do so.<\/p>\n<aside class=\"single__inline-module alignleft\">\n    <\/aside>\n<p>Despite the urgency, the FDA took three months to issue guidance on\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-infant-formula-enforcement-discretion-policy\">relaxing<\/a>\u00a0restrictions on foreign formula. And even after that May guidance, approval still requires extensive documentation and analysis \u2014 so the FDA is still causing delays.<\/p>\n<p>Indeed, Reuters\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/baby-formula-makers-raced-fda-approval-they-may-be-waiting-while-2022-06-15\/\">reports<\/a>\u00a0foreign formula companies Nature\u2019s One and Holle are ready to ship massive amounts of formula, but \u201cthey may be waiting a while\u201d due to the FDA\u2019s \u201cslow responses.\u201d<\/p>\n<p>Parents desperate for formula don\u2019t have the luxury of time.<\/p>\n<p>These delays are unacceptable, and Americans deserve to know why the FDA has been so slow and unresponsive. Advocacy group Americans for Prosperity recently\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/americansforprosperity.org\/afp-submits-foia-to-investigate-the-food-and-drug-administrations-failures-in-baby-formula-crisis\/\">submitted<\/a>\u00a0a Freedom of Information Act request for documentation on the FDA\u2019s mishandling of this matter. Perhaps what AFP uncovers will shed light on the reasons the FDA did not respond more quickly.<\/p>\n<p>Fortunately, Congress is taking action to break down barriers for foreign suppliers. In May, lawmakers passed the Access to Formula Act to let WIC programs buy alternative formulas. Last month, they passed legislation to waive all tariffs on formula temporarily. But all that will be for naught if the FDA doesn\u2019t speed up its approvals.<\/p>\n<p>The FDA\u2019s primary concern, as it should be, is safety. But while foreign formulas may not have gone through the agency\u2019s approval process, they are regulated by the European Commission. Pediatrics professor Bridget Young <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.nytimes.com\/wirecutter\/blog\/us-parents-european-baby-formula\/\">notes that<\/a> the European Commission\u2019s formula regulations are stricter than ours, including bans on certain added sugars.<\/p>\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"678\" src=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/08\/SUPPLY-CHAIN_BABY-FORMULA-RECKITT.jpg?w=1024\" alt=\"Baby formula\" class=\"wp-image-23379699\"\/><figcaption>Foreign formulas are willing to ship off their products but the FDA\u2019s slow response is delaying the process and becoming a pain for parents.<\/figcaption><figcaption><span class=\"credit\">Reuters\/Bing Guan<\/span><\/figcaption><\/figure>\n<p>A 2019 study\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/31107795\/\">found<\/a>\u00a0that among popular European brands, \u201call formulas except one met the [examined] FDA nutrient requirements.\u201d The problem? \u201cNone met all FDA label requirements.\u201d These foreign formulas are healthier than many domestic brands and meet nutritional requirements, yet the FDA shuts them out of the US market because of <em>labeling<\/em>.<\/p>\n<p>The FDA\u2019s response has been bureaucratic, timid and slow. In a time of crisis, it should have been an easy call to grant Emergency Use Authorization to formulas approved abroad without another onerous and drawn-out process. In May, FDA Commissioner Robert Califf told lawmakers that \u201csome decisions in retrospect were not optimal.\u201d No kidding.<\/p>\n<p>And now it\u2019s\u00a0<em>August<\/em>, and the FDA still won\u2019t budge.<\/p>\n<p>Given the FDA\u2019s poor track record on COVID testing, baby formula and the monkeypox vaccine, Americans are right to wonder whether the FDA is up to the job. Reforming the agency to speed approvals while maintaining safety can\u2019t wait; it\u2019s a matter of life and death.<\/p>\n<p><em>Marion\u00a0Mass is a Philadelphia-area pediatrician who trained at Duke University Medical School and Northwestern University and the co-founder of Practicing Physicians of America.<\/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\/08\/08\/biden-must-demand-timid-fda-act-as-baby-formula-shortage-grows-even-worse\/\" target=\"_blank\" rel=\"noopener\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8220;Biden must demand timid FDA act as baby-formula shortage grows even worse&#8221; Half a year in, the baby-formula shortage keeps\u00a0getting worse\u00a0with no end in sight. Unlike the global semiconductor and grain shortages, the formula shortfall is an America-only phenomenon. This means the solution can be found here at home. But by focusing on importing limited&#8230;<\/p>\n","protected":false},"author":1,"featured_media":482696,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2022\/08\/newspress-collage-23376812-1659999870614.jpg?quality=75&strip=all&1659985545&w=1024","fifu_image_alt":"","footnotes":""},"categories":[70897],"tags":[132134,129493,52214,74873,991],"class_list":["post-482695","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-8-8-22","tag-baby-formula","tag-congress","tag-fda","tag-joe-biden"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/482695","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=482695"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/482695\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/482696"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=482695"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=482695"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=482695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}