{"id":63140,"date":"2026-05-07T09:41:08","date_gmt":"2026-05-07T13:41:08","guid":{"rendered":"https:\/\/tvdelmarva.com\/wp\/fda-changes-course-public-announcements-replace-traditional-rulemaking-process\/"},"modified":"2026-05-07T09:41:08","modified_gmt":"2026-05-07T13:41:08","slug":"fda-changes-course-public-announcements-replace-traditional-rulemaking-process","status":"publish","type":"post","link":"https:\/\/tvdelmarva.com\/wp\/fda-changes-course-public-announcements-replace-traditional-rulemaking-process\/","title":{"rendered":"FDA Changes Course: Public Announcements Replace Traditional Rulemaking Process"},"content":{"rendered":"\n
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WASHINGTON \u2014 Health Secretary Robert F. Kennedy Jr. held a press conference early in his tenure to announce plans for eliminating synthetic food dyes from American food products.<\/p>

FDA Commissioner Marty Makary began the event by stating his agency would be “removing all petroleum-based food dyes” from the nation’s food supply. However, the details remained unclear until Kennedy disclosed in the closing moments that officials had reached “an understanding” with food manufacturers to voluntarily discontinue use of these chemicals. According to an FDA statement, a “national standard and timeline” for completion would be established soon.<\/p>

Over a year has passed since that announcement, yet the FDA has not released any comprehensive, science-based regulatory documentation required to establish safety concerns with the approximately six commonly used dyes. The FDA instead maintains a web-based list of companies that have committed to eliminating these chemicals.<\/p>

This approach to food dye regulation exemplifies the administration’s strategy for various health initiatives. Rather than pursuing the lengthy federal rulemaking process that often spans multiple presidential terms, officials under Republican President Donald Trump have adopted a different method: make broad policy announcements first, then address regulatory details afterward.<\/p>

“It speaks volumes that the administration has yet to produce a document articulating the scientific basis for the voluntary request,” said Susan Mayne, a Yale University public health expert and former director of the FDA’s food program. The FDA’s website still displays the government’s longstanding position that “the totality of scientific evidence” demonstrates no connection between synthetic dyes and health issues.<\/p>

“If FDA has changed its position, then FDA should document why and pursue a ban,” Mayne said.<\/p>

A Kennedy spokesperson stated the administration has employed “multiple approaches” to achieve more rapid progress on food dyes “than at any point in the past.”<\/p>

“FDA engaged industry early in this effort to encourage timely changes while continuing its scientific and regulatory work,” said Emily Hilliard of the U.S. Department of Health and Human Services. “The agency maintains its role in evaluating safety and will continue to use its regulatory authorities, guidance, and review processes as appropriate.”<\/p>

The absence of formal regulation development is especially notable at the FDA. Federal law requires the agency to avoid announcing major policy changes through press releases, speeches or other unofficial channels.<\/p>

However, numerous policy shifts from Makary and his team have first appeared in medical journal opinion pieces, television appearances or social media posts, including new limitations on COVID-19 vaccines and other treatments.<\/p>

Conventionally, such changes would first be published in the Federal Register, allowing consumers, experts, and companies opportunities to provide feedback and suggest modifications to FDA proposals.<\/p>

Equally surprising as the agency’s departure from standard rulemaking is the minimal resistance from the powerful companies under FDA oversight.<\/p>

Throughout decades, the FDA has faced hundreds of legal challenges from pharmaceutical companies, pharmacies, tobacco manufacturers and others claiming the agency failed to follow legally mandated procedures for new regulations and guidelines.<\/p>

Yet pharmaceutical companies and other multibillion-dollar corporations are remaining passive, at least currently.<\/p>

“Does the government have the ability to basically bully companies?” asked Dan Troy, the FDA’s former chief counsel. “Yes, and I think we’re seeing that.”<\/p>

A significant policy shift occurred last May when Makary and then-FDA vaccine director Dr. Vinay Prasad published a medical journal piece announcing the FDA would discontinue routine approval of COVID-19 vaccines for healthy adults under 65 and children without underlying medical conditions. For approval in that demographic, vaccine manufacturers would need to conduct extensive studies that many experts believe may not be practical in the current post-pandemic landscape.<\/p>

Similar to other vaccine decisions, Makary and Prasad circumvented the agency’s external advisors, who traditionally provided consultation on major vaccine-related choices. Makary contends FDA advisory panels often exhibit bias and require excessive time and resources to organize.<\/p>

“We had all of this experience looking at the safety of how these vaccines work, and then these two cowboys come and say: ‘We’re going to make this policy’,” said Dr. Kathryn Edwards, who previously chaired the FDA’s vaccine panel.<\/p>

Edwards and other specialists suggest the lack of resistance from vaccine manufacturers may reflect the substantial authority the FDA wields over them.<\/p>

“Ultimately, you need the FDA to license your product,” said Edwards, a retired vaccine researcher at Vanderbilt University. “If you’re 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.”<\/p>

Earlier this year, the FDA temporarily declined to review a new mRNA influenza vaccine from Moderna. The agency changed its position following objections from the company and the White House.<\/p>

Additional factors may explain why typically litigation-prone companies are not confronting the agency.<\/p>

Several FDA initiatives could potentially benefit companies, including a program providing expedited reviews for medications favored by the Trump administration.<\/p>

Even apparently restrictive changes may lack permanence since the agency is not pursuing formal processes to establish them as federal regulations or guidelines. This includes rigorous new approval standards for CAR-T therapies previously authorized for various cancer types based on preliminary data.<\/p>

“Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” Troy said.<\/p>

Nevertheless, with over two years remaining in Trump’s term, indications suggest some companies may be prepared to voice concerns.<\/p>

The FDA began publishing rejection letters for disapproved medications last year. This information was previously confidential and belonged to pharmaceutical companies.<\/p>

Last month, an unidentified pharmaceutical company submitted a formal petition challenging this practice, noting the FDA had provided “only a two-sentence explanation addressing its purported legal authority” to release the correspondence.<\/p>

While the petition lacks the authority of a lawsuit, it uses identical language found in numerous legal challenges against the agency, describing the FDA’s action as “arbitrary and capricious.”<\/p>","protected":false},"excerpt":{"rendered":"

The Food and Drug Administration under the Trump administration is prioritizing media announcements over formal regulatory procedures for major policy changes. Health Secretary Robert F. Kennedy Jr. announced plans to eliminate synthetic food dyes through voluntary industry agreements rather than mandatory regulations.<\/p>\n","protected":false},"author":4,"featured_media":63139,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[833],"tags":[],"class_list":["post-63140","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politics"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/tvdelmarva.com\/wp\/wp-content\/uploads\/2026\/05\/news-1778161268634.jpg?fit=1000%2C666&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/pbtNqq-gqo","jetpack-related-posts":[{"id":28687,"url":"https:\/\/tvdelmarva.com\/wp\/major-food-brands-removing-artificial-colors-and-sweeteners-by-2027\/","url_meta":{"origin":63140,"position":0},"title":"Major Food Brands Removing Artificial Colors and Sweeteners by 2027","author":"Admin","date":"February 27, 2026","format":false,"excerpt":"Responding to health concerns and changing consumer demands, major food companies including Target, Mars, and Hershey are committing to eliminate synthetic dyes and artificial sweeteners from their products. 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