Weekly Briefing · Launch Edition
Men's Health Briefing: September 25, 2026
Covers September 9–25, 2026, plus key 2026 developments
Our first weekly briefing on the regulatory and policy news that affects men's health care. Each week we scan the FDA, DEA, FTC, federal telehealth policy, and the wider news for developments that matter to you, and explain what they mean in plain English.
This week
FDASeptember 18, 2026
FDA warns Empower Pharmacy over compounded GLP-1 "copies"
The FDA issued a warning letter to Empower Pharmacy, a large compounding pharmacy that supplies many telehealth companies. The letter covered its tirzepatide-plus-niacinamide and semaglutide-plus-vitamin B12 combination products. The FDA said the products appear to be essentially copies of FDA-approved semaglutide and tirzepatide, despite the added ingredients. It also cited deficiencies in sterile manufacturing practices.
What it means for youIf you get a compounded GLP-1 through a telehealth company, ask which pharmacy makes it and whether that's changed. Compounded versions aren't FDA-approved, and adding a vitamin doesn't make them a different drug in the FDA's eyes. This continues a crackdown that has included dozens of warning letters to telehealth sellers this year (see below).
Sources: Frier Levitt summary of the warning letter · Related: our GLP-1 guide
FDASeptember 17, 2026
FDA reopens the question of testosterone for women
The FDA held a public workshop on testosterone use in menopausal women, calling on drug developers to pursue an FDA-approved product. There's currently no FDA-approved testosterone product for women, though many use men's products off-label or compounded versions. FDA flagged cardiovascular disease, breast cancer, and safety beyond 24 months as key questions future trials must answer. Public comments are open through October 19, 2026.
What it means for youNot much directly for men, but it's part of a broader FDA re-examination of testosterone this year, following a December 2025 public meeting on TRT in men and this summer's label changes (below).
Sources: FDA meeting page · FDA Law Blog (Sept. 23) · Public comment docket
TelehealthSeptember 19–21, 2026
How telehealth companies handle your health data
An Associated Press report examined repeated cases of direct-to-consumer telehealth companies sharing customers' health information with advertising platforms. The report noted that HIPAA, the federal health privacy law, doesn't cover many of these platforms, leaving enforcement largely to the FTC and a handful of states. It also cited research finding that fewer than a third of GLP-1 providers studied required a real-time video or phone consultation.
What it means for youBefore signing up with an online clinic, read its privacy policy and look for whether it shares data with advertisers. Consider using a private browser window, and check whether you'll actually speak with a clinician before a prescription is written. Our
directory reviews note how each TRT provider handles consultations.
Sources: AP via WUSF · U.S. News
FTCSeptember 9, 2026
FTC withdraws an outdated health-app policy statement
The FTC rescinded its 2021 policy statement on data breaches by health apps and connected devices. The agency said it was no longer needed because the Health Breach Notification Rule, updated in 2024, now explicitly covers health apps and devices like fitness trackers.
What it means for youNo change in your protections. Health apps not covered by HIPAA are still required to notify you if your health data is breached or shared without authorization.
Source: FTC press release
Catching up: 2026's biggest developments
Since this is our first briefing, here are the major changes from earlier this year that still shape men's health care.
FDAJune 2026
FDA asks for major changes to testosterone labels
HHS and the FDA asked makers of testosterone products to update their prescribing information, citing the TRAVERSE trial and other research. The requested changes:
- Remove the "limitation of use" stating that safety and effectiveness haven't been established in men with age-related low testosterone, which has been on labels since 2015.
- Narrow the prostate cancer contraindication to metastatic prostate cancer.
- Revise warnings about benign prostatic hyperplasia (BPH), with continued caution for severe symptoms.
This is a request to manufacturers. Labels change as each company updates its prescribing information. It follows a 2025 labeling update that added TRAVERSE results and a blood pressure warning to all testosterone products.
What it means for youIt may become easier to be treated for low testosterone that comes with aging, but the basics don't change: a diagnosis should still require consistently low levels on repeat morning blood tests and symptoms, with ongoing monitoring of hematocrit, PSA, and blood pressure. TRAVERSE also found more atrial fibrillation, blood clots, and kidney injury with testosterone.
Sources: HHS announcement · Medical Xpress (June 23) · Harvard Health (Aug. 10) · Related: our TRT guide
DEADeadline: December 31, 2026
Telehealth prescribing of testosterone: the clock is ticking
Testosterone is a Schedule III controlled substance. Since 2020, temporary DEA rules have let clinicians prescribe controlled substances by telehealth without ever seeing the patient in person. The DEA and HHS extended those flexibilities a fourth time, through December 31, 2026. On August 25, 2026, the DEA sent its final "special registration" rule for telemedicine prescribing to the White House Office of Management and Budget for review, a sign a permanent framework may arrive before the deadline.
What it means for youIf you get TRT through a telehealth-only provider, nothing changes yet. But the rules for 2027 aren't final, and they could add registration, in-person visit, or other requirements for prescribers. Ask your provider how they're preparing. We'll cover the final rule when it's published.
Sources: DEA press release · Federal Register · NASCSA on the final rule
FTCJuly 29, 2026
FTC and two states sue Hims & Hers
The FTC, joined by Utah and California, sued telehealth company Hims & Hers in federal court in Northern California. The complaint alleges that the company shared customers' health information with advertising platforms despite privacy promises, that its advertised "free consult" often didn't include an actual consultation with a provider, that customers were billed without clear consent, and that subscriptions were hard to cancel. These are allegations, and they have not been proven in court.
What it means for youIf you use any subscription telehealth service, check how to cancel before you sign up, and review what data it shares. Hims is one of the providers in our directory.
Read our Hims review →
Sources: Frier Levitt summary of the complaint · FTC health news
FDAMarch & June 2026
Dozens of FDA warning letters to telehealth GLP-1 sellers
The FDA sent 30 warning letters in March and 25 more in June to telehealth companies marketing compounded semaglutide and tirzepatide. The agency cited marketing that implied compounded products were the same as FDA-approved Wegovy, Ozempic, Zepbound, or Mounjaro, and branding that obscured who actually made the drug.
What it means for you"Same active ingredient as Ozempic" is not the same as FDA-approved. If you're considering a GLP-1, the approved versions are the ones with proven safety and effectiveness data. If you choose compounded, know which pharmacy makes it.
Sources: Pharmaceutical Technology · Venable LLP
TelehealthFebruary 3, 2026
Medicare telehealth coverage extended through 2027
The Consolidated Appropriations Act, 2026 extended Medicare's telehealth flexibilities, including telehealth from home and audio-only visits, through December 31, 2027. Medicare patients can also keep receiving mental health care by telehealth without a prior in-person visit through January 1, 2028.
What it means for youIf you're on Medicare, you can keep seeing doctors and therapists by video or phone from home through at least the end of 2027. This is separate from the DEA rules for prescribing controlled substances, including testosterone.
Source: Center for Medicare Advocacy
This briefing summarizes publicly reported news and government actions for general education. It is not medical or legal advice. Legal allegations described here have not been proven unless stated. Always confirm details with the original sources and talk to a licensed physician before changing any treatment.