{"id":7064157,"date":"2026-09-22T16:19:07","date_gmt":"2026-09-22T16:19:07","guid":{"rendered":"https:\/\/som2nypost.com\/activist\/fda-finally-moves-to-comply-with-2022-law-ending-animal-testing-mandate\/"},"modified":"2026-09-22T16:19:07","modified_gmt":"2026-09-22T16:19:07","slug":"fda-finally-moves-to-comply-with-2022-law-ending-animal-testing-mandate","status":"publish","type":"post","link":"https:\/\/som2nypost.com\/?p=7064157","title":{"rendered":"FDA finally moves to comply with 2022 law ending animal testing mandate"},"content":{"rendered":"


\n<\/p>\n

\n
\"FDA,<\/p>\n

\"FDA,<\/p>\n

<\/a> (Beth Clifton collage)<\/strong><\/em><\/div>\n

Compliance with FDA Modernization Act 2.0 comes only after FDA Modernization Act 3.0,\u00a0 compelling compliance,\u00a0 has already passed U.S. Senate & House of Representatives<\/em><\/span><\/h2>\n

WASHINGTON D.C.\u2013\u2013<\/strong>The U.S. Food & Drug Administration [FDA] on September 21,\u00a0 2026 issued a long delayed \u201cdirect final rule,\u201d \u00a0\u00a0it announced,\u00a0 \u201cthat updates regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use.\u201d<\/p>\n

The FDA announcement came with the Donald Trump administration under pressure from Congress through passage of both U.S. Senate and House of Representatives versions of the FDA Modernization Act 3.0,\u00a0 yet to be reconciled and ratified by both, \u00a0\u00a0which would have compelled the FDA to produce the \u201cdirect final rule.\u201d<\/p>\n

\"March<\/p>\n

\"March<\/p>\n

<\/a> (Beth Clifton collage)<\/strong><\/em><\/div>\n

Something for marchers to celebrate<\/h2>\n

The FDA announcement also came 11 days after the conservative anti-vivisection organization White Coat Waste embarrassed the White House by exposing the failure of Robert F. Kennedy Jr.,\u00a0 appointed by Trump to head the U.S. Department of Health & Human Services, \u00a0to fulfill repeated Trump administration promises to reduce dog and cat use in federally funded biomedical research.<\/p>\n

(See Dogs & cat use in labs is up under Trump\/Kennedy, says White Coat Waste<\/a>.)<\/em><\/strong><\/p>\n

The FDA announcement further came with a two-week \u201cMarch to Abolish Animal Testing\u201d traversing a 207-mile route from Albany,\u00a0 New York to the Marshall BioResources headquarters in North Rose, New York within five days of conclusion.<\/p>\n

(See Can 15-miles-a-day march on the Erie Canal save Marshall Farms beagles?)<\/a><\/strong><\/em><\/p>\n

\"Peter<\/p>\n

\"Peter<\/p>\n

<\/a> (Beth Clifton collage)<\/strong><\/em><\/div>\n

Removes \u201clanguage that could suggest that animal testing is the only acceptable way to generate safety information\u201d<\/h2>\n

\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/em><\/strong>The \u201cdirect final rule,\u201d\u00a0 the FDA said,\u00a0 \u201creplaces terms like \u2018animal tests\u2019 and \u2018animal studies’\u201d in regulatory language \u201cwith the terms \u2018nonclinical tests\u2019 and \u2018nonclinical studies.\u2019<\/p>\n

\u201cRelated terms, including \u201cpreclinical\u201d and \u201cin vitro,\u201d are also replaced. \u00a0The rule defines \u2018nonclinical test\u2019 and \u2018nonclinical study\u2019 in line with the Food & Drug Omnibus Reform Act of 2022,\u201d which included the FDA Modernization Act 2.0,\u00a0 a priority bill for many animal advocacy groups that ended the 1938 federal mandate requiring animal tests for every new drug before the drug entered human clinical trials.<\/p>\n

The new \u201cdirect final rule,\u201d\u00a0 the FDA continued,\u00a0 \u201cremoves language that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions in products intended for human use. \u00a0It does not eliminate or prohibit animal studies, \u00a0change evidentiary standards, \u00a0or impose new costs or requirements on drug developers.\u201d<\/p>\n

The FDA also announced the launch of an online database \u201cfeaturing 25 specific uses of New Approach Methodologies that might be used in place of animal tests.\u201d<\/p>\n

\"Tami<\/p>\n

\"Tami<\/p>\n

<\/a> Tami Drake.<\/strong><\/em>
(Beth Clifton collage based on Tami Drake Facebook photos.)<\/strong><\/em><\/div>\n

\u201cWe\u2019ve been pushing this action\u201d<\/h2>\n

Responded Animal Wellness Action and Center for a Humane Economy president Wayne Pacelle,\u00a0 \u201cWe\u2019ve been pushing this action since we passed the FDA Modernization Act 2.0.\u00a0 And we passed 3.0 in the House and Senate,\u201d\u00a0 Pacelle reminded.<\/p>\n

\u201cIt finally all came together.\u201d<\/p>\n

Pacelle and Tamara Drake,\u00a0 research and regulatory policy director for the Center for a Humane Economy,\u00a0 recalled in a blog posting that the FDA Modernization Act 2.0 \u201cremoved a statutory barrier that had, \u00a0for 84 years, \u00a0mandated animal testing in drug development,\u201d\u00a0 but the FDA slow-walked implementation, \u00a0in steps not announced until April 2025, \u00a0December 2025, \u00a0and March 2026.<\/p>\n

The March 2026 FDA \u201cguidance,\u201d\u00a0 Pacelle and Drake explained,\u00a0 \u201caddressed one of the most important questions facing drug developers: \u00a0what evidence the FDA needs to determine that a new method is fit for a particular regulatory purpose.\u201d<\/p>\n

\u201cThe FDA\u2019s new rule,\u201d\u00a0 Pacelle and Drake assessed, \u00a0\u201caccomplishes nearly all the specific regulatory modernizations called for in the House [version of the FDA Modernization Act 3.0] and makes additional conforming changes of its own.<\/p>\n

\u201cOne more small action by Congress and the president on 3.0 will punctuate these epic gains,\u201d\u00a0 Pacelle and Drake concluded.<\/p>\n

\"Kitty<\/p>\n

\"Kitty<\/p>\n

<\/a> (<\/strong>Beth Clifton collage)<\/strong><\/em><\/div>\n

\u201cSubstantial implications for millions of animals\u201d<\/h2>\n

Humane World for Animals president Kitty Block and Humane World Action Fund president Sara Amundson agreed in a jointly signed blog post that the new FDA \u201cdirect final rule\u201d will \u201ceventually have substantial implications for millions of animals used in testing.<\/p>\n

\u201cBecause the U.S. is the world\u2019s largest pharmaceutical market,\u201d\u00a0 Block and Amundson wrote, \u00a0\u201cwhat the FDA does has consequences for animals in laboratories all over the world.<\/p>\n

\u201cOver the last few years,\u201d\u00a0 Block and Amundson recounted,\u00a0 \u201cwe have seen\u00a0major shifts away\u00a0from using animals in experiments throughout the U.S.<\/p>\n

\"Kool-aid<\/p>\n

\"Kool-aid<\/p>\n

<\/a> (Beth Clifton collage)<\/strong><\/em><\/div>\n

\u201cAmbiguity\u201d<\/h2>\n

\u201cBut despite this momentum, \u00a0those of us who have been dedicated to ending animal testing and research have been very aware of ambiguity in the very language that regulates and directs testing that, \u00a0in effect, \u00a0slows or even prevents tangible progress away from animal testing.<\/p>\n

\u201cThe FDA has been a locus for some of this ambiguity,\u201d\u00a0 Block and Amundson observed.<\/p>\n

\u201cOn the one hand, \u00a0the agency was encouraging companies to shift away from using animal testing data when submitting drugs for approval,\u201d\u00a0 Block and Amundson acknowledged.<\/p>\n

\u201cBut at the same time, \u00a0the industry was hesitant to make this shift because the FDA\u2019s own regulations still suggested that the agency required data from animal tests in certain situations to approve new drugs.\u201d<\/p>\n

\"Robert<\/p>\n

\"Robert<\/p>\n

<\/a> (Beth Clifton collage)<\/strong><\/em><\/div>\n

\u201cNew NIH spending on dog testing at pharmaceutical companies\u201d<\/h2>\n

A variety of Donald Trump administration appointees have promised policy changes leading to huge reductions in animal use for biomedical research, \u00a0including Robert F. Kennedy Jr.,\u00a0 who as Secretary of Health & Human Services has the three major agencies involved in animal-based biomedical research under his authority:\u00a0 the FDA,\u00a0 the Centers for Disease Control & Prevention,\u00a0 and by far the biggest,\u00a0 the National Institutes of Health.<\/p>\n

The September 10,\u00a0 2026 publication of MAHA Betrayed<\/em>,\u00a0 however,\u00a0 a downloadable 29-page report from White Coat Waste,\u00a0 exposed \u00a0\u201cmore than $225 million in National Institutes of Health (NIH) funding supporting dog and cat experiments,\u201d since Kennedy\u2019s appointment,\u00a0 much of it \u201cnew spending that began during the current Trump administration,\u201d\u00a0 a White Coat Waste media release summarized.<\/p>\n

\"Beth<\/p>\n

\"Beth<\/p>\n

<\/a> Beth & Merritt Clifton.<\/strong><\/em>
(Beth Clifton photo\/collage)<\/strong><\/em><\/div>\n

\u201cApproximately 44% of the total identified since Secretary Kennedy took office \u2014 more than $98 million \u2014 consists of new NIH spending on dog testing at pharmaceutical companies,\u201d\u00a0 White Coat Waste added,\u00a0 backing up the allegation with line item details including grant numbers,\u00a0 titles,\u00a0 institutional names,\u00a0 grant starting and ending dates,\u00a0 species involved,\u00a0 and the amount of money for each grant.<\/p>\n

Please donate to help our work:\u00a0<\/strong><\/h2>\n

More related posts:<\/em><\/h3>\n<\/p>\n
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Subscribe to get the latest posts sent to your email.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"

(Beth Clifton collage) Compliance with FDA Modernization Act 2.0 comes only after FDA Modernization Act 3.0,\u00a0 compelling compliance,\u00a0 has already passed U.S. Senate & House of Representatives WASHINGTON D.C.\u2013\u2013The U.S. Food & Drug Administration [FDA] on September 21,\u00a0 2026 issued a long delayed \u201cdirect final rule,\u201d \u00a0\u00a0it announced,\u00a0 \u201cthat updates regulations to clarify that non-animal […]<\/p>\n","protected":false},"author":1,"featured_media":7064158,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12022],"tags":[1330,17815,12795,19889,7385,54586,12685,9018,13483,11379,42814,72294,12632,37293],"dealstore":[],"offerexpiration":[],"class_list":["post-7064157","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-activist","tag-animal","tag-comply","tag-donald-trump","tag-fda","tag-finally","tag-kitty-block","tag-law","tag-mandate","tag-merritt-clifton","tag-moves","tag-robert-f-kennedy-jr","tag-sara-amundson","tag-testing","tag-wayne-pacelle"],"yoast_head":"\nFDA finally moves to comply with 2022 law ending animal testing mandate - Som2ny Network<\/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:\/\/som2nypost.com\/?p=7064157\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA finally moves to comply with 2022 law ending animal testing mandate - Som2ny Network\" \/>\n<meta property=\"og:description\" content=\"(Beth Clifton collage) Compliance with FDA Modernization Act 2.0 comes only after FDA Modernization Act 3.0,\u00a0 compelling compliance,\u00a0 has already passed U.S. Senate & House of Representatives WASHINGTON D.C.\u2013\u2013The U.S. Food & Drug Administration [FDA] on September 21,\u00a0 2026 issued a long delayed \u201cdirect final rule,\u201d \u00a0\u00a0it announced,\u00a0 \u201cthat updates regulations to clarify that non-animal […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/som2nypost.com\/?p=7064157\" \/>\n<meta property=\"og:site_name\" content=\"Som2ny Network\" \/>\n<meta property=\"article:published_time\" content=\"2026-09-22T16:19:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/som2nypost.com\/wp-content\/uploads\/2026\/09\/Picsart_26-09-21_20-33-16-786-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/som2nypost.com\/?p=7064157#article\",\"isPartOf\":{\"@id\":\"https:\/\/som2nypost.com\/?p=7064157\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/som2nypost.com\/#\/schema\/person\/a66cfe5cdcbceba9b5562fe085bcaba4\"},\"headline\":\"FDA finally moves to comply with 2022 law ending animal testing mandate\",\"datePublished\":\"2026-09-22T16:19:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/som2nypost.com\/?p=7064157\"},\"wordCount\":1107,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/som2nypost.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/som2nypost.com\/?p=7064157#primaryimage\"},\"thumbnailUrl\":\"https:\/\/som2nypost.com\/wp-content\/uploads\/2026\/09\/Picsart_26-09-21_20-33-16-786-1.jpg\",\"keywords\":[\"Animal\",\"Comply\",\"Donald Trump\",\"FDA\",\"Finally\",\"Kitty Block\",\"law\",\"Mandate\",\"Merritt Clifton\",\"Moves\",\"Robert F. 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