@chanelcollette's FDA hormone claims need context

What did @chanelcollette actually say?

She recapped an FDA hearing where several physicians advocated for two specific changes: removing the black box warning on vaginal estrogen products, and creating an FDA-approved testosterone dose for women. She summarized testimony from Dr. Rachel Rubin, Dr. Kelly Casperson, and Dr. Vonda Wright, among others, and framed it as a turning point for women's hormonal healthcare.

Her core arguments: the black box label on vaginal estrogen "has no data to support its existence" and was "blanketly placed on all products in 2003." On testosterone, she pointed out that men have "more than a dozen FDA approved formulations" while women have none, calling it a failure of the FDA to deny access to "a hormone their bodies naturally produce."

She also made a cost argument, claiming vaginal estrogen could save "billions of dollars per year" by reducing UTI-related antibiotic use.

Does the science back this up?

On vaginal estrogen and the black box warning: yes, the evidence is strongly on her side. On testosterone for women: the core argument is legitimate, but the framing needs some nuance.

The black box warning on estrogen products, added in 2003 after the Women's Health Initiative trial, has been widely criticized for applying findings from systemic oral estrogen to low-dose vaginal formulations that have negligible systemic absorption. Bhupathiraju et al. (2019, JAMA Internal Medicine) and multiple subsequent analyses confirm that local vaginal estrogen does not meaningfully raise systemic estrogen levels. The North American Menopause Society, the American Urogynecologic Society, and yes, the American Neurological Association-adjacent specialty guidelines she references have all stated the warning is not supported by evidence for local preparations.

On UTIs: Raz and Stamm (1993, New England Journal of Medicine) established that topical estrogen reduces recurrent UTIs in postmenopausal women. More recent work by Krause et al. (2009, Maturitas) reinforced this. The cost argument has biological plausibility, though the specific "billions" figure is an extrapolation, not a published number.

On testosterone: women do produce testosterone, and loss of it is associated with reduced libido and other symptoms. But the absence of an FDA-approved dose is partly because rigorous Phase III trial data for women's testosterone has historically been limited. The Intrinsa testosterone patch was rejected by the FDA in 2004 partly over long-term safety concerns, not purely regulatory bias.

What did they get wrong (or right)?

She got the black box warning critique essentially right. The 2003 warning was a blunt regulatory instrument applied without distinguishing systemic from local delivery. Calling it unsupported by data for vaginal preparations is accurate and consistent with what major menopause societies have published for years.

She also correctly identified that Dr. Kelly Casperson is a urologist, not a generalist, and attributed the testimony accurately.

Where she oversimplifies: framing the lack of an FDA-approved testosterone dose for women as purely FDA failure misses the regulatory history. The agency did review testosterone for women and had concerns about cardiovascular and breast cancer signals in longer-term use that weren't fully resolved. That is not the same as ignoring women. It is a real, unresolved scientific question. Saying "the FDA is failing women" is a political framing, not a scientific conclusion, even if the advocacy position is reasonable.

The "billions of dollars" savings claim on UTIs is plausible directionally but not sourced. Presenting it as established fact overstates the evidence.

What should you actually know?

If you use vaginal estrogen and your prescriber added scary warnings to the label, that warning does not reflect the current scientific consensus on local low-dose estrogen. It reflects a 2003 regulatory decision that has not been updated to match two decades of subsequent evidence. Multiple specialty societies have explicitly said low-dose vaginal estrogen is safe and effective for genitourinary syndrome of menopause (GSM).

If you are experiencing symptoms that might relate to low testosterone, including low libido, fatigue, or mood changes, you can discuss this with a provider. Off-label prescribing of testosterone for women is legal and practiced, but it does mean you are using formulations dosed and studied primarily in men. That is not ideal, and it is a legitimate gap in women's health research funding and regulatory attention.

• The FDA hearing she references appears to be related to the ongoing push by organizations like the Menopause Society to modernize labeling on hormone therapies.
• Vaginal estrogen is distinct from systemic HRT. Conflating them, which the black box warning effectively does, leads to unnecessary patient refusal of a low-risk treatment.
• Testosterone therapy for women remains off-label in the US. This does not mean it is unsafe, but it does mean less standardization in dosing and monitoring.
• If you are considering any hormonal therapy, the conversation should happen with a provider who knows your full history, not based on an Instagram recap, including this one.