{"id":5843,"date":"2024-11-17T17:06:47","date_gmt":"2024-11-17T17:06:47","guid":{"rendered":"https:\/\/regtechafrica.com\/healthcare\/?p=5843"},"modified":"2024-11-17T17:06:47","modified_gmt":"2024-11-17T17:06:47","slug":"global-u-s-fda-proposes-ban-on-popular-decongestant-in-cold-medicines","status":"publish","type":"post","link":"https:\/\/regtechafrica.com\/healthcare\/global-u-s-fda-proposes-ban-on-popular-decongestant-in-cold-medicines\/","title":{"rendered":"Global: U.S. FDA Proposes Ban on Popular Decongestant in Cold Medicines"},"content":{"rendered":"

The U.S. Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine<\/strong>\u2014a common active ingredient in many over-the-counter cold and cough medicines\u2014from products marketed as treatments for nasal congestion, citing its lack of effectiveness.<\/p>\n

Phenylephrine is widely used in household brands such as Benadryl<\/strong>, Advil<\/strong>, and Tylenol<\/strong>, among others. While the ingredient is also present in nasal sprays, the FDA’s proposal applies only to orally administered phenylephrine<\/strong> and not to nasal spray formulations.<\/p>\n

Expert Panel\u2019s Verdict<\/h3>\n

This move follows a unanimous decision last year by an external panel of experts, which concluded that oral phenylephrine is ineffective as a nasal decongestant. The panel deemed additional clinical trials unnecessary to reaffirm this finding.<\/p>\n

Legal and Consumer Implications<\/h3>\n

Pharmaceutical giants, including Procter & Gamble<\/strong> and GSK<\/strong>, have faced lawsuits alleging they misled consumers by marketing products containing oral phenylephrine as effective treatments for congestion.<\/p>\n

The FDA has opened the proposal for public comment<\/strong>, inviting stakeholders to share their perspectives on the matter.<\/p>\n

Next Steps for Manufacturers<\/h3>\n

For now, companies may continue to sell over-the-counter products containing oral phenylephrine. However, the FDA plans to provide manufacturers with a transition period to either reformulate their products<\/strong> or withdraw them from the market.<\/p>\n

In response, the Consumer Healthcare Products Association<\/strong> expressed disappointment, stating:<\/p>\n

“We are disappointed in the FDA’s proposal to reverse its long-standing view of oral phenylephrine. We will thoroughly review the proposed order and submit our comments.”<\/p><\/blockquote>\n

Leading manufacturers, including Kenvue<\/strong>, GSK<\/strong>, Haleon<\/strong>, and Procter & Gamble<\/strong>, have yet to issue public statements on the proposal.<\/p>\n

This development could signal significant changes in the over-the-counter cold medicine market, impacting both manufacturers and consumers as the industry adapts to the FDA\u2019s proposed regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine\u2014a common active ingredient in many over-the-counter cold and cough medicines\u2014from products marketed as treatments for nasal…<\/p>\n","protected":false},"author":1,"featured_media":5844,"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":[1],"tags":[],"class_list":["post-5843","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-adventure"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/regtechafrica.com\/healthcare\/wp-content\/uploads\/2024\/11\/U.S.-FDA-Proposes-Ban-on-Popular-Decongestant-in-Cold-Medicines.jpg?fit=1920%2C1080&ssl=1","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/5843","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/comments?post=5843"}],"version-history":[{"count":1,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/5843\/revisions"}],"predecessor-version":[{"id":5845,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/5843\/revisions\/5845"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media\/5844"}],"wp:attachment":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media?parent=5843"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/categories?post=5843"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/tags?post=5843"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}