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On December 17, 2025, anti-trans psychiatrist Lauren Schwartz and a coaltion of anti-trans hate groups submitted a citizen petition to the US Food and Drug Administration with the goal to restrict or ban off-label use of prescription hormones for trans women and transfeminine people.
The petition seeks to:
- “Establish a distinct public docket specifically focused on the safety and effectiveness of this off-label use of estrogen in natal males.This docket will serve as a central repository for scientific evidence, clinical experience, patient testimony, and public comment necessary for a thorough regulatory evaluation.”
- “Schedule and conduct a public hearing pursuant to 21 C.F.R. Part 15 to gather testimony and information from scientific experts, medical practitioners, patients (including detransitioners), ethicists, and the public regarding the risks, potential benefits, and scientific uncertainties associated with this off-label use.”
Organizations
- Partners for Ethical Care
- Our Duty USA
- LGB Courage Coalition
- The Center for Bioethics and Culture
- Colorado Principled Physicians
- Genspect International
- Genspect USA
- PITT Parents
- Texas Principled Physicians
- Parents of Desisters
- Family Institute of Connecticut Action
- American College of Pediatricians
- Democrats for an Informed Approach to Gender
- Women’s Liberation Front
- Do No Harm
Medical / Psychological Professional and/or Researcher
[reordered alphabetically by surname]
- “Dr. Chad”
- “J. Cohn”
- Lori Addesa
- Maria Arana
- Evelyn Ball
- Sharon Barnes
- David Boettger
- Jill Butler
- Greg Carter
- Sandy Casciato
- Michelle Cretella
- Melanie Crites-Bachert
- Callie Dagen
- Jessica Dawson
- Arthur J. de Lorimier
- Stephen Doane
- Evelyn Duvivier
- Roy Eappen
- Lisa Ehrlich
- W. Anthony Gerard
- Kathleen Goonan
- Susan Green
- Miriam Grossman
- Eithan Haim
- Victoria Hall
- Laura J. Haygood
- Mark Hickman
- Patrick Hunter
- Whitney Jones
- Jennifer Lahl
- Patrick Lappert
- January Littlejohn
- Katherine Locke
- Justin McCoy
- Carrie D. Mendoza
- Greg Merrell
- Tim Millea
- Travis J. Morrell
- Kinloch Nelson
- Alfonso Oliva
- Javier Perez
- Jennifer Petrillo
- Lauren Phillips
- Kathy Platoni
- Molly Plautz
- Matthew Clark Poling
- D. Michael Ready
- Kristine M. Rivera
- Alice Rose-McDonald
- Jared L. Ross
- Richard H. Sandler
- Marcia Schor
- Lauren Schwartz
- Joanne Sinai
- Anupam K. Singhal [signed as “A. Singhal”]
- Brenda Smith
- Liza Saplala Stanton
- Patrice N. Stevenson
- Gus Toma
- Frank M. Tursi
- Kimberly A. Vacca
- Andre Van Mol
- Daniel Weiss
- Katherine Welch
- Tara Simone Williams
Legal Professionals
[reordered alphabetically by surname]
- Victoria Albanesi
- Kathleen H. Dooley
- Linda Kristina Palumbo
- Nancy Stade
- Phillip Stanton
- Tena Zara
Academic / Educator
[reordered alphabetically by surname]
- Karole Fedrick
- Nicole Kaucher
- Rebecca van Kniest
Impacted Patients
[reordered alphabetically by surname]
- Billie Burleigh
- Cori Cohn
- Rene Jax
- Forrest Smith
- Jeff Tooley
Concerned Parent or Family Member
[reordered alphabetically by surname]
- “A Carnes”
- “A. Hariri”
- “Brain Tumor Brandon”
- “Concerned Parent”
- “D. Singhal”
- “DP”
- “EA Dolan”
- “Hayley Meagan”
- “K. Mulligan”
- “K. Quigley”
- “L Forte”
- “Lisa E.”
- “Lost Boy Mom”
- “Monique vT”
- “Nonna S.”
- “Parent of male taking estrogen”
- “Ragnhild”
- “Rebecca K.”
- “Roberta S.”
- “Sarah A.”
- “SS”
- “Stephanie G”
- “Stephanie M”
- Gregory Araya
- David Atkinson
- PM Bailey
- Gary Barnes
- Stephanie Barnes
- Laureen Boll
- Beth Bourne
- Camela Bryan
- Susan Lee Cary
- Christine Chang
- Kathleen Chitwood
- Carolynn Christenson
- Mark Christenson
- Suzanne Counsel
- Erin Darlington
- Gary Duehr
- Violet Dunai-Orlesky
- Christy Emory
- Melanie Erdmann
- Victor Esterlit
- Julie Framingham
- John Furton
- Cally Furton
- Melody Glazer
- Christine Goff
- Jaclyn Gouge
- Cathy Hoover Groen
- Katie Guy
- Catherine Henderson
- Garth Hill
- Dale Hoard
- Windy Horton
- Kristin Jackowick
- BJ Jackson
- Charlotte Johnson
- Kim Johnson
- David Johnston
- Ruth Johnston
- Joanna Kingsbury
- Lynnanne Knippel
- Shyam Krishnamurthy
- Jessica Ludeke
- Mae Lyle
- Cynthia MacAdam
- Scott MacAdam
- Christin Manning
- Denise Menagh
- Fiona Miller
- Leslie Miller
- Angela Molin
- Laci Olson
- William Palaia
- Stephanie Peecher
- John Petersen
- Debbie Popovchak-Erickson
- Amanda Quick
- Tom Quigley
- Amy Raf
- Patricia Riefenstein
- Rosanna Rodriguez
- Laurie E. Samuelson
- Erin Sardiello [listed twice]
- Sheila Scheve
- Amy M. Scott
- Lisa Shultz
- Joanne Smart
- David Smith
- Nicole Sorem
- Mark Stewart
- Mary Stout
- Diana Terlato
- Doug Throckmorton
- Julianne Verhagen
- Ann Von Lehmen
- Kelly Wehrer
- Natalie Wheeler
- Miles Winslow
- Katherine Winslow-Duehr
- Vicki Wooledge
- Summer Yule
- Susan Zamecnik
- Juliann Zoetmulder
Concerned Citizens
- “Ruby M.”
- “Sam Adam”
- “Sue D.”
- “T. Debolt”
- Laura Becker
- Tami Blayney
- Catherine Bowen
- James Brown
- Melissa Brown
- Aida Cerundolo
- Eileen Christian
- Ben Davis
- Michelle DeAlmeida
- Richard C. Guggenheim
- Connie Hahn
- Brook Hines
- Dedra Jones
- Maureen Killoran
- Vasanth Krishnamurthy
- Stacey Layne
- David Ness
- Theresa Orlando
- Jennifer Patt
- Brenda Ragosta
- Vincent Ragosta
- Ken Rankin
- Bob Renate
- Karen Riordan
- Cari Roundy
- Roland Samuelson
- Sven Scharpen
- Hayley Steen
- Emma Stewart
- Mary Stout
- Marlene Suzuki
- Donna Squires
- Jennifer Stanley
- Teresa Winship
- Cecelia Wu
Resources
Schwartz, Lauren and signatories (December 17, 2025). Subject: Citizen Petition Pursuant to 21 C.F.R. § 10.30 Requesting the FDA (A) Open aDocket, (B) Hold a Part 15 Public Hearing Regarding the Off-Label Use of Estrogen inNatal Males for Gender Affirmation, and (C) Consider Regulatory Action Including aBoxed Warning Under 21 C.F.R. § 201.80(e). https://embed.documentcloud.org/documents/27871234-fda-2025-p-7321-0001-attachment-public-fda/?ref=theneedlenews.com