{"id":219,"date":"2026-05-08T13:04:16","date_gmt":"2026-05-08T13:04:16","guid":{"rendered":"https:\/\/denvermovingchronicle.com\/?p=219"},"modified":"2026-05-08T13:04:16","modified_gmt":"2026-05-08T13:04:16","slug":"fdas-new-playbook-lots-of-media-announcements-but-not-much-rulemaking","status":"publish","type":"post","link":"https:\/\/denvermovingchronicle.com\/?p=219","title":{"rendered":"FDA\u2019s new playbook: Lots of media announcements but not much rulemaking"},"content":{"rendered":"<div>\n<div>\n<div>\n<ul><\/ul>\n<\/div>\n<\/div>\n<p><strong>WASHINGTON<\/strong> | In one of his first major announcements as health secretary, Robert F. Kennedy Jr. called a news conference to unveil a plan to \u201cphase out\u201d synthetic food dyes.<\/p>\n<p>Food and Drug Administration Commissioner Marty Makary opened the event by saying his agency was \u201cremoving all petroleum-based food dyes\u201d from U.S. foods. But the specifics did not become clear until the final minutes, when Kennedy revealed that the government had \u201can understanding\u201d with foodmakers to voluntarily stop using the chemicals. A \u201cnational standard and timeline\u201d for completing the process would soon follow, according to an FDA statement.<\/p>\n<p>More than a year later, the FDA has not introduced any of the detailed, scientific regulatory documents needed to establish a safety issue with the half-dozen widely used dyes. Instead, the FDA maintains an online list of manufacturers that have pledged to phase out the chemicals.<\/p>\n<p>The administration\u2019s handling of food dyes reflects its approach to a number of health priorities. Instead of using the time-consuming process of federal rulemaking, which can stretch across multiple administrations, officials working under Republican President Donald Trump have found a quicker approach: Announce sweeping changes first and deal with the regulations later.<\/p>\n<div><\/div>\n<p>\u201cIt speaks volumes that the administration has yet to produce a document articulating the scientific basis for the voluntary request,\u201d said Susan Mayne, a Yale University public health expert and former director of the FDA\u2019s food program. Meanwhile, the FDA\u2019s website continues to carry the government\u2019s longtime conclusion that \u201cthe totality of scientific evidence\u201d does not show a link between synthetic dyes and health problems.<\/p>\n<p>\u201cIf FDA has changed its position, then FDA should document why and pursue a ban,\u201d Mayne said.<\/p>\n<p>A spokesperson for Kennedy said the administration has used \u201cmultiple approaches\u201d to quickly make more progress on food dyes \u201cthan at any point in the past.\u201d<\/p>\n<p>\u201cFDA engaged industry early in this effort to encourage timely changes while continuing its scientific and regulatory work,\u201d said Emily Hilliard of the U.S. Department of Health and Human Services. \u201cThe agency maintains its role in evaluating safety and will continue to use its regulatory authorities, guidance, and review processes as appropriate.\u201d<\/p>\n<p>The lack of initiative in drafting new regulations is particularly striking at the FDA. Under federal law, the agency is supposed to refrain from making major policy announcements in news releases, speeches or other informal settings.<\/p>\n<p>But a string of changes from Makary and his deputies have appeared first in medical journal op-eds, television interviews or online posts, including new restrictions on COVID-19 vaccines and other therapies.<\/p>\n<p>Traditionally, those changes would be published first in the Federal Register, giving consumers, experts, and companies a chance to comment and suggest revisions to FDA proposals.<\/p>\n<p><strong>FDA has faced little pushback from industry<\/strong><\/p>\n<p>Almost as surprising as the agency\u2019s shift away from rulemaking is the fact that the powerful companies FDA regulates have put up little resistance.<\/p>\n<p>The FDA has faced hundreds of lawsuits over the decades \u2014 from drugmakers, pharmacies, tobacco companies and others \u2014 that accused the agency of failing to follow the legally required steps for new regulations and guidelines.<\/p>\n<p>But drugmakers and other multibillion-dollar companies are sitting on the sidelines, at least for now.<\/p>\n<p>\u201cDoes the government have the ability to basically bully companies?\u201d asked Dan Troy, the FDA\u2019s former chief counsel. \u201cYes, and I think we\u2019re seeing that.\u201d<\/p>\n<p>One of the biggest changes came last May, when Makary and then-FDA vaccine chief Dr. Vinay Prasad published a medical journal article announcing that the FDA would no longer routinely approve COVID-19 shots for healthy adults under age 65 and children without underlying health problems. To win approval for that group, vaccine manufacturers would need to conduct large studies that many experts say may not be feasible in today\u2019s post-pandemic environment.<\/p>\n<p>As with other vaccine decisions, Makary and Prasad bypassed the agency\u2019s outside experts, who had traditionally been consulted on major decisions involving the shots. Makary says FDA advisory panels are often biased and take too much time and money to convene.<\/p>\n<p>\u201cWe had all of this experience looking at the safety of how these vaccines work, and then these two cowboys come and say: \u2018We\u2019re going to make this policy\u2019,\u201d said Dr. Kathryn Edwards, who previously led the FDA\u2019s vaccine panel.<\/p>\n<p>Edwards and other experts say the lack of pushback from vaccine manufacturers may reflect the tremendous power the FDA holds over them.<\/p>\n<p>\u201cUltimately, you need the FDA to license your product,\u201d said Edwards, a retired vaccine scientist at Vanderbilt University. \u201cIf you\u2019re going to try and buck the FDA \u2014 especially in this environment \u2014 the likelihood of your product getting a positive review is going to be pretty low.\u201d<\/p>\n<p>Earlier this year, the FDA briefly refused to consider a new mRNA flu shot from Moderna. The agency reversed its decision after pushback from the company and the White House.<\/p>\n<p><strong>Recent FDA changes may have little staying power<\/strong><\/p>\n<p>There may be other reasons why normally litigious companies are not challenging the agency.<\/p>\n<p>Some FDA initiatives have the potential to benefit companies, including a program that awards ultrafast reviews to drugs favored by the Trump administration.<\/p>\n<p>Even seemingly burdensome changes may have little staying power because the agency is not going through the process to enshrine them in federal rules or guidelines. That includes stringent new standards to win approval for CAR-T therapies that were previously approved for various forms of cancer, based on early results.<\/p>\n<p>\u201cAnything that this administration does that they don\u2019t embody in law can easily be undone by a future administration,\u201d Troy said.<\/p>\n<p>Still, with more than two years remaining under Trump, there are signs at least some companies may be willing to raise objections.<\/p>\n<p>The FDA last year began releasing rejection letters for drugs it declined to approve. Previously, that information was considered confidential and the property of drugmakers.<\/p>\n<p>Last month, an unnamed drugmaker filed a formal petition challenging the practice, noting the FDA had provided \u201conly a two-sentence explanation addressing its purported legal authority\u201d to release the letters.<\/p>\n<p>The petition does not carry the force of a lawsuit, but it invokes the same language as numerous legal challenges to the agency, calling the FDA\u2019s action \u201carbitrary and capricious.\u201d<\/p>\n<p>The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/p>\n<p>Read more <a href=\"https:\/\/denvermovingchronicle.com\/?p=215\">Italy tells Rubio that Europe needs America and vice versa on Day 2 of US fence-mending visit<\/a><\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<p>Read more <a href=\"https:\/\/denvermovingchronicle.com\/?p=217\">Indigenous people honor and raise awareness for relatives who are missing or have been killed<\/a><\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<p>Read more <a href=\"https:\/\/denvermovingchronicle.com\/?p=218\">Georgia officials knew chemicals from carpet mills were polluting local water. The people did not<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>WASHINGTON | In one of his first major announcements as health secretary, Robert F. Kennedy Jr. called a news conference to unveil a plan to \u201cphase out\u201d synthetic food dyes. Food and Drug Administration Commissioner Marty Makary opened the event by saying his agency was \u201cremoving all petroleum-based food dyes\u201d from U.S. foods. But the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,136,67,137,135,245,242,243],"tags":[45,408,409,410,411,412],"class_list":["post-219","post","type-post","status-publish","format-standard","hentry","category-interesting","category-nation-2","category-nation","category-nation-and-state","category-no-apple-publish","category-ntl-galley","category-recent-headlines","category-trending","tag-donald-trump","tag-emily-hilliard","tag-food-and-drug-administration","tag-marty-makary","tag-robert-f-kennedy-jr","tag-susan-mayne"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA\u2019s new playbook: Lots of media announcements but not much rulemaking - Denver Moving Chronicle<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/denvermovingchronicle.com\/?p=219\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA\u2019s new playbook: Lots of media announcements but not much rulemaking - Denver Moving Chronicle\" \/>\n<meta property=\"og:description\" content=\"WASHINGTON | In one of his first major announcements as health secretary, Robert F. 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