{"id":1419,"date":"2026-07-25T01:34:47","date_gmt":"2026-07-25T01:34:47","guid":{"rendered":"https:\/\/valutednews.com\/?p=1419"},"modified":"2026-07-25T01:34:47","modified_gmt":"2026-07-25T01:34:47","slug":"fda-advisory-panel-rejects-compounding-of-one-peptide-backs-another","status":"publish","type":"post","link":"https:\/\/valutednews.com\/?p=1419","title":{"rendered":"FDA advisory panel rejects compounding of one peptide, backs another"},"content":{"rendered":"<div style=\"text-align:center\"><img decoding=\"async\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/07\/AdobeStock_2013109051-1024x576.jpeg\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"FDA advisory panel rejects compounding of one peptide, backs another\" title=\"FDA advisory panel rejects compounding of one peptide, backs another\" \/><\/div><p><\/p>\n<div>\n<p class=\"wp-block-paragraph\">WASHINGTON \u2014 A Food and Drug Administration advisory panel recommended on Friday that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">The votes, which followed the panel\u2019s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring health secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides, which are short-chain amino acids, have become <a href=\"https:\/\/www.sermo.com\/press-releases\/sermo-barometer-finds-nearly-half-of-physicians-report-patients-are-using-non-fda-regulated-peptides\/\" target=\"_blank\" rel=\"noopener\">increasingly popular<\/a> in the U.S., driven by endorsements from social media influencers.<\/p>\n<p class=\"wp-block-paragraph\">The two-day meeting highlighted broader tensions between the Make America Healthy Again movement and mainstream scientists. The fundamental question facing panelists was whether it is acceptable to let individuals take medicines of unclear safety or efficacy.\u00a0<\/p>\n<aside class=\"alignleft wp-block-stat-article-recirc-single\">\n<div class=\"recirc-single-image\" data-href=\"https:\/\/www.statnews.com\/2026\/04\/06\/rfk-jr-apparent-contradiction-peptides-vaccines-medical-libertarianism\/\">\n\t\t\t<img decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-768x432.jpg\" class=\"attachment-article-main-medium-large size-article-main-medium-large\" alt=\"\" loading=\"lazy\" sizes=\"auto, (min-width: 540px) and (max-width: 767px) 288px, (min-width: 768px) and (max-width: 1023px) 257px, (min-width: 1024px) and (max-width: 1199px) 287px, (min-width: 1200px) 245px, 246px\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-768x432.jpg 768w, https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-328x185.jpg 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-1024x576.jpg 1024w, https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-500x281.jpg 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-1600x900.jpg 1600w, https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2-640x360.jpg 640w, https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/04\/rfk-peptides-2.jpg 1920w\"\/>\t\t<\/div>\n<h3 class=\"recirc-single-heading\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/2026\/04\/06\/rfk-jr-apparent-contradiction-peptides-vaccines-medical-libertarianism\/\" rel=\"\">What the peptide craze reveals about Americans\u2019 relationship with risk<\/a><br \/>\n\t\t<\/h3>\n<\/aside>\n<p class=\"wp-block-paragraph\">The FDA does not have to listen to the panel\u2019s advice. For each peptide under consideration, FDA staff told the panelists they recommended against giving compounders the green light due to a lack of clinical evidence demonstrating safety and efficacy.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">Typically this type of decision would be made by those same career staff members. But given Kennedy\u2019s interest in the matter and the Trump administration\u2019s propensity to allow politics to influence science, it is possible that he or acting FDA commissioner Kyle Diamantas could overrule career employees. The administration will publish its decision as a proposed rule and give the public the opportunity to comment.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">FDA experts repeatedly stressed that adding the peptides to the section 503A bulk drug substances list would be a dangerous experiment, with physicians flying blind as far as dosing data and best prescription practices. They said the agency has no authority to require compounders to submit safety or efficacy data once a substance is added to the list.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">\u201cIn the grey market, that\u2019s not a requirement to be sent to us,\u201d said Mary Thanh Hai, director of the Office of New Drugs. \u201cEven getting on to the 503A compounding list, that isn\u2019t a requirement.\u201d\u00a0<\/p>\n<p class=\"wp-block-paragraph\">But the panelists who voted yes, most of whom had ties to the peptide industry and were appointed by the Health and Human Services Department, saw things differently. They said because they were not voting to approve a drug, they did not have to consider the lack of robust clinical data. Several said they wanted to satisfy their individual patients who have been clamoring for these substances.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">\u201cWe\u2019re talking about dosing and efficacy and safety, and it doesn\u2019t look like that\u2019s what we\u2019ve been asked to do,\u201d said Asare Christian, founder of wellness clinic Aether Medicine. \u201cAs a physician, my view is through the lens of the patient in front of me.\u201d<\/p>\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\">\n<p>\n<iframe loading=\"lazy\" title=\"Inside the world of internet peptides\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/xX7rWXK5ME0?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe>\n<\/p>\n<\/figure>\n<p class=\"wp-block-paragraph\">On Thursday, <a href=\"https:\/\/www.statnews.com\/2026\/07\/23\/fda-panel-okays-peptides-compound-pharmacies-bpc-157-kpv\/\">the panel voted 8-6<\/a> to add BPC-157 to the list for treating ulcerative colitis, to add KPV for wound healing and inflammatory conditions, and to add TB-500 for wound healing. The panel voted 7-5 to add MOTS-c to the list for obesity and osteoporosis. The dissenting panelists were largely physicians from academic institutions and patient representatives.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">On Friday, the panel voted 7-4 to add epitalon to the list for insomnia, again voting along similar lines. The vote on adding semax, for migraines as well as the neurological conditions cerebral ischemia and trigeminal neuralgia, was 8-5.<\/p>\n<p class=\"wp-block-paragraph\">But emideltide, under consideration for opioid withdrawal, chronic insomnia, and narcolepsy, failed voting passage by a tally of 6-7.<\/p>\n<p class=\"wp-block-paragraph\">David Pope, the chief pharmacy officer at XiFin Pharmacy Solution, joined the dissenters after voting with the majority for the previous peptides. He said he was concerned about emideltide\u2019s \u201cpotentially dangerous downstream consequences.\u201d<\/p>\n<p class=\"wp-block-paragraph\">During public comments, the peptide semax had some especially vociferous supporters, who noted that there is more data on the drug than many other peptides under discussion because it\u2019s approved in Russia for clinical use. But FDA staffers said their review of research found insufficient evidence to support its use for the conditions in question.<\/p>\n<p class=\"wp-block-paragraph\"><em>This article has been updated to add the vote on semax.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>WASHINGTON \u2014 A Food and Drug Administration advisory panel recommended on Friday that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide.\u00a0 The votes, which followed the panel\u2019s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring health secretary Robert F&#8230;.<\/p>\n","protected":false},"author":1,"featured_media":1420,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/www.statnews.com\/wp-content\/uploads\/2026\/07\/AdobeStock_2013109051-1024x576.jpeg","fifu_image_alt":"","footnotes":""},"categories":[18],"tags":[2815,1941,2817,2814,2816,1428,288],"class_list":["post-1419","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health","tag-advisory","tag-backs","tag-compounding","tag-fda","tag-panel","tag-peptide","tag-rejects"],"_links":{"self":[{"href":"https:\/\/valutednews.com\/index.php?rest_route=\/wp\/v2\/posts\/1419","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/valutednews.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/valutednews.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/valutednews.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/valutednews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1419"}],"version-history":[{"count":0,"href":"https:\/\/valutednews.com\/index.php?rest_route=\/wp\/v2\/posts\/1419\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/valutednews.com\/index.php?rest_route=\/wp\/v2\/media\/1420"}],"wp:attachment":[{"href":"https:\/\/valutednews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1419"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/valutednews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1419"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/valutednews.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1419"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}