The FDA changed its mind on testosterone. The law around it didn’t.
For a decade, every testosterone product carried a boxed warning about heart attack, stroke and death. In February 2025, the FDA removed that cardiovascular language. In June 2026, it went further and asked manufacturers to drop the label’s limitation on treating age-related low testosterone.
That is a real shift, and the TRT market is treating it like a green light. It isn’t one. Testosterone is still a federally controlled substance, age-related low T is still not an approved indication, and the marketing rules for TRT clinics haven’t moved an inch.
Quick answer: Testosterone therapy is legal with a valid prescription from a DEA-registered provider. The FDA’s 2025 and 2026 label changes reduce the stigma around TRT, but they do not change DEA Schedule III rules, telehealth prescribing requirements, advertising law, or compounding restrictions. Clinics and telehealth brands still carry the same compliance obligations.
Below: what the FDA actually changed, the study behind it, and the legal issues every TRT clinic, telehealth platform and founder needs to get right.
What the FDA changed on testosterone labels
The FDA has made two rounds of changes, and they do different things.
|
Date |
FDA action |
What it means |
|---|---|---|
|
June 18, 2026 |
Requested new label updates (HHS/FDA) |
Remove the age-related hypogonadism limitation; narrow the prostate cancer contraindication to metastatic disease; soften enlarged-prostate warnings |
|
April 16, 2026 |
Announced a possible pathway for a new indication (Urology Times) |
Low libido in men with idiopathic hypogonadism could become an approved use, if sponsors submit data |
|
Dec 10, 2025 |
FDA expert panel on TRT (NBC News) |
Panelists urged broader indications and removing testosterone from Schedule III; recommendations only |
|
Feb 28, 2025 |
Class-wide labeling change (FDA) |
Cardiovascular language removed from the Boxed Warning; TRAVERSE results added; new blood pressure warning required; age-related limitation kept |
|
March 2015 |
Label change after a 2014 advisory committee |
Cardiovascular risk language added; age-related low T flagged as unproven |
Two details matter for anyone selling or prescribing TRT:
- The June 2026 changes are requested, not final. Manufacturers must submit labeling supplements. No deadline was set, and the 2025 round took roughly 19 months to complete.
- “Black box gone” is an overstatement. The cardiovascular language is gone. Other boxed warnings, such as the secondary-exposure warning on topical gels, remain on some products.
The TRAVERSE trial: the study behind the change
TRAVERSE found no increase in heart attacks, strokes or cardiovascular deaths in men on testosterone versus placebo. It exists because the FDA required testosterone manufacturers to run a cardiovascular safety trial in 2015.
- Who: 5,246 men aged 45 to 80 at 316 U.S. sites, all with existing heart disease or high cardiovascular risk.
- Entry criteria: Symptoms of hypogonadism plus two fasting morning testosterone levels below 300 ng/dL.
- Design: Randomized, double-blind, placebo-controlled. Daily 1.62% testosterone gel or placebo gel.
- Result: Major cardiovascular events occurred in about 7.0% of the testosterone group and 7.3% of the placebo group over a mean of 22 months.
- Published: New England Journal of Medicine, June 2023.
What TRAVERSE does not prove
The limits of the study are where much of the legal risk sits.
- It studied confirmed low T, not optimization. The lead investigator said the results should not justify treating populations outside the trial. Men with normal levels, younger men and bodybuilders were not studied.
- It studied gel, not injections or pellets. Most cash-pay clinics prescribe injectable testosterone cypionate or compounded products.
- Patients were closely monitored. Levels were checked and doses adjusted. Investigators noted that this level of monitoring may not happen in everyday practice.
- Other risks showed up. Rates of atrial fibrillation, acute kidney injury and pulmonary embolism were higher on testosterone, and a substudy found more fractures.
- It was industry-funded. A consortium of five testosterone manufacturers, led by AbbVie, sponsored the trial. Consumer advocates such as Public Citizen called the label change premature.
The practical takeaway: TRAVERSE supports monitored therapy for men with diagnosed low testosterone. It is not evidence for high-dose protocols, and claims built on it should say so.
The legal issues that didn’t change
1. Testosterone is still a Schedule III controlled substance
Testosterone has been a Schedule III anabolic steroid under the federal Controlled Substances Act since the Anabolic Steroid Control Act of 1990. The December 2025 FDA panel urged the DEA to deschedule it, but that was a recommendation. As of this writing, testosterone remains Schedule III.
That means:
- Every prescriber needs an active DEA registration in each state where patients are located.
- Prescriptions can’t be filled more than six months after issue or refilled more than five times.
- Most states schedule testosterone too and require reporting to their prescription drug monitoring program.
- Dispensing, storage and record-keeping rules apply to any clinic that keeps testosterone on site.
The FDA controls the label. The DEA controls the schedule. A label change does nothing to the second.
2. Telehealth TRT faces a December 31, 2026 deadline
The Ryan Haight Act generally requires an in-person exam before prescribing controlled substances online. Since 2020, DEA has extended pandemic-era flexibilities that allow telehealth prescribing without one. The current extension runs through December 31, 2026, and requires a real-time encounter, not an asynchronous questionnaire.
If DEA finalizes a permanent rule with in-person or special-registration requirements, telehealth TRT models will need to change fast. Platforms should be building that contingency now.
3. Age-related low T is still off-label
Approved testosterone products are indicated for hypogonadism with a known structural or genetic cause. The June 2026 request removes a warning; it does not yet add age-related hypogonadism as an approved use.
- Physicians may prescribe off-label under the practice of medicine, with proper diagnosis, informed consent and documentation.
- Manufacturers, distributors and the brands promoting them may not market a drug for an unapproved use. Off-label promotion can make a product misbranded under the Food, Drug, and Cosmetic Act.
The same is true for women. No testosterone product is FDA-approved for women, despite growing off-label use and a September 2026 FDA workshop on menopausal testosterone.
4. Advertising: “FDA says TRT is safe” is a liability
The FTC requires health claims to be backed by competent and reliable scientific evidence. TRAVERSE supports cardiovascular safety in monitored men with confirmed low T. It does not support claims about safety for everyone, anti-aging, muscle gain or longevity.
Watch for these red flags in TRT marketing:
- “FDA-approved for low T” or “FDA cleared TRT” without the actual indication.
- “Heart-safe” or “no risks” claims. The label now carries a blood pressure warning.
- Before-and-after physique content implying results the drug isn’t approved for.
- Influencer posts without clear disclosure of payment or free product, which the FTC Endorsement Guides require.
State medical boards also discipline physicians for misleading advertising, and state attorneys general enforce consumer protection laws.
5. Compounded testosterone doesn’t benefit from the label change
The FDA’s label changes apply to FDA-approved products. Compounded testosterone, including many pellets and custom-strength injectables, is not FDA-approved and has no label to change.
Pharmacies compounding under Section 503A need a patient-specific prescription. They also generally can’t regularly compound drugs that are essentially copies of commercially available products. Clinics that rely on compounded testosterone should confirm their pharmacy partner’s licensing and the clinical justification on each prescription.
6. Business structure and patient brokering
Many states restrict lay ownership of medical practices under the corporate practice of medicine doctrine. Founder-led TRT brands typically use a management services organization (MSO) paired with a physician-owned professional entity. The structure has to give physicians real clinical control, not just a signature.
Payment arrangements matter too. Federal anti-kickback rules mainly reach federally funded care, but some state laws apply regardless of payer. Florida’s Patient Brokering Act, for example, prohibits paying or receiving anything of value for patient referrals, including in cash-pay models. Per-patient fees to marketers or influencers deserve a hard look.
7. Liability didn’t disappear with the warning
In the 2010s, thousands of lawsuits claimed testosterone makers failed to warn of heart risks. Most were consolidated in a federal MDL in Illinois and resolved through settlements. The new label weakens future cardiovascular failure-to-warn claims against manufacturers.
Clinics are a different story. Malpractice exposure comes from how therapy is delivered: skipping baseline labs, ignoring hematocrit or blood pressure, failing to discuss fertility suppression, or prescribing to men with normal levels. TRAVERSE’s monitored conditions are now the de facto benchmark.
TRT clinic and telehealth compliance checklist
Use this as a starting audit. Each item maps to one of the issues above.
- Every prescriber holds a DEA registration and a medical license in each patient’s state.
- Intake requires symptoms plus two confirmed low morning testosterone levels before prescribing.
- Telehealth visits are real-time, and you have a plan for when DEA flexibilities expire after December 31, 2026.
- Refill limits and state PDMP reporting are built into the prescribing workflow.
- Informed consent covers off-label use, blood pressure, hematocrit, fertility suppression and cardiovascular uncertainty outside TRAVERSE’s population.
- Follow-up labs (testosterone, hematocrit, PSA where indicated, blood pressure) are scheduled and tracked.
- Marketing and influencer content is reviewed for unsupported claims and proper disclosures.
- Compounding pharmacy partners are licensed in each patient’s state, and each compounded prescription has a documented clinical reason.
- Your MSO and professional entity structure gives physicians real clinical control and complies with state corporate practice rules.
- Marketing and referral payments are reviewed under state patient brokering and fee-splitting laws.
Frequently asked questions
Did the FDA remove the black box warning on testosterone?
The FDA removed the cardiovascular language from the Boxed Warning on all testosterone products in February 2025, based on the TRAVERSE trial. Some products still carry other boxed warnings, such as the secondary-exposure warning on topical gels.
Is testosterone still a controlled substance?
Yes. Testosterone is a Schedule III controlled substance under federal law. An FDA panel recommended descheduling it in December 2025, but the DEA has not acted.
Is TRT now FDA-approved for age-related low testosterone?
Not yet. In June 2026 the FDA asked manufacturers to remove the label language saying benefit in age-related low T was unestablished. Treating age-related low T remains off-label until updated labels are approved.
Can testosterone be prescribed through telehealth?
Yes, through December 31, 2026, under DEA’s temporary telehealth flexibilities. The prescriber needs a DEA registration and a real-time visit. Rules after 2026 depend on DEA’s permanent rule.
Do the FDA label changes apply to compounded testosterone?
No. The changes apply to FDA-approved products. Compounded testosterone is not FDA-approved and remains subject to separate compounding rules.
Can a TRT clinic advertise that testosterone is safe for the heart?
Only carefully. TRAVERSE supports cardiovascular safety in monitored men with confirmed low testosterone. Broader claims, such as safety for anyone or anti-aging benefits, risk FTC and state enforcement.
Building or scaling a TRT brand?
The label changes will bring a wave of new TRT clinics, telehealth platforms and creator-led brands. The ones that last will be built on compliant prescribing, structure and marketing from day one.
LumaLex Law advises founders in heavily regulated health markets, including telehealth, compounding and peptides. Schedule a consultation to review your TRT model before regulators do.
This article is for general information and is not legal advice. Reading it does not create an attorney-client relationship. Laws change quickly; consult counsel about your specific situation.
