TRT Is Becoming a Direct-to-Consumer Business, but Is That Wise?

• Growing interest in testosterone extends beyond men with diagnosed deficiency — Men's Fitness points to fitness and "optimization" culture as an important force behind demand. Testosterone has become a mainstream topic online, while greater acceptance of conversations about male hormonal health has reduced some of the stigma that once surrounded treatment.

At-home testing removes another barrier. Instead of arranging multiple office visits, you're able to begin the process from home. The concern is that easier access also attracts men who aren't trying to correct a medically established deficiency but instead want higher testosterone for performance or optimization.

• One low testosterone result doesn't provide a complete diagnosis — Testosterone levels fluctuate, so a single measurement doesn't necessarily tell you whether you have a persistent deficiency. Men's Fitness also emphasizes that symptoms commonly associated with low testosterone, including fatigue and low libido, have numerous causes.

That's why a careful evaluation looks beyond a questionnaire and one laboratory result. The report describes responsible treatment as a process that confirms deficiency with repeated testing and reviews your medical history before therapy begins. As the article puts it, "A real evaluation is more than one low reading and a checklist."

• Fertility deserves attention before treatment starts — Testosterone supplied from outside your body suppresses your natural testosterone production, and the report specifically warns that TRT can impair fertility. That issue becomes particularly important if you're younger and plan to have children.

A responsible provider discusses fertility before prescribing testosterone rather than waiting until after treatment has begun. Men's Fitness describes TRT as a "serious, usually lifelong commitment," which is an important distinction when online marketing makes treatment feel as simple as signing up for another monthly service.

• Proper TRT care continues after your first prescription — Getting testosterone delivered isn't the end of medical care. TRT requires ongoing monitoring of red blood cells, prostate health and heart-related markers. Simply issuing automatic refills without checking how your body responds misses an important part of treatment.

The central risk isn't telehealth itself. Online care removes barriers and expands access, which benefits men who genuinely need treatment. The problem arises when convenience makes it easier to prescribe testosterone to men whose levels are normal, but who want an additional physical or performance edge.

• Age-related low testosterone could receive different treatment under the proposed labeling — Current FDA approval covers men whose testosterone deficiency stems from a known medical cause rather than low testosterone without a diagnosed underlying condition.

The June 2026 proposal requested removal of language stating that the safety and effectiveness of TRT for age-related hypogonadism — clinically low testosterone that develops as men get older rather than from a specific medical condition — hadn't been established.

The proposed change doesn't mean every older man with a lower testosterone level needs treatment. Instead, it changes how federal prescribing information addresses this group and reflects the government's reassessment of evidence that has accumulated since the earlier restrictions were adopted.

• Newer evidence changed the FDA's position on major cardiovascular events — The report points to the TRAVERSE trial, which is a randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5,246 men ages 45 to 80 years old with two fasting testosterone readings below 300 ng/dL who already had cardiovascular disease or were at elevated risk for it, as an important part of this shift.⁵

Over an average of 21.7 months on daily 1.62% transdermal testosterone gel, testosterone proved noninferior to the placebo for a composite of cardiovascular death, nonfatal heart attack, and nonfatal stroke. Specifically, 182 patients (7%) in the testosterone group and 190 patients (7.3%) in the placebo group experienced primary cardiovascular endpoint events. Note that the trial was funded by a consortium of testosterone manufacturers led by AbbVie.

• The same trial reported higher rates of other adverse events — Noninferiority for heart attacks and strokes is not a clean bill of health. TRAVERSE also found a higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism among the men receiving testosterone than among those receiving placebo. Those findings belong in the same conversation as the cardiovascular result.*

Those findings contributed to an earlier regulatory change. In February 2025, the FDA notified testosterone product manufacturers that boxed warning language concerning cardiovascular risk would be removed and that information from TRAVERSE would be added to testosterone product labeling.⁶

• Blood pressure remains an important safety issue — A less restrictive cardiovascular warning doesn't mean testosterone has no cardiovascular effects. Separate ambulatory blood pressure monitoring studies found that testosterone products as a class are associated with an increase in blood pressure.

Ambulatory monitoring measures your blood pressure repeatedly as you go about your normal day, rather than relying on a single reading in a medical office. As a result, the FDA required product-specific warnings about increased blood pressure.

• Prostate cancer warnings are also under review — The 2026 proposal would revise how testosterone labeling addresses prostate cancer. The FDA said evidence from clinical trials and population studies generally hasn't shown that testosterone therapy increases prostate cancer risk, although uncertainty remains because prostate cancer often develops slowly over many years.

Under the proposed labeling described in the report, TRT would be formally contraindicated only in men with metastatic prostate cancer. "Contraindicated" means the treatment isn't appropriate because the risk is considered too great, while metastatic prostate cancer means the cancer has spread beyond the prostate to other parts of the body.

• Enlarged prostate requires a more individualized assessment — The FDA also reviewed whether testosterone worsens symptoms associated with BPH. Clinical trial data cited in the Miami Herald report didn't show worsening symptoms among men with mild to moderate cases. Evidence was more limited for men with severe symptoms, so continued monitoring remained part of the proposed guidance for that group.

These distinctions show why updated federal guidance isn't the same thing as a blanket declaration that TRT is safe for everyone. As Michael Davis, M.D., Ph.D., acting director of the FDA's Center for Drug Evaluation and Research, explained, the changes are intended to provide "clearer information about the benefits and risks" of TRT.

That means newer evidence provides a more refined picture of risk, but your individual health history and response to treatment still determine what those findings mean in practice.

• Many men equate higher testosterone with masculinity, appearance, and longevity — A Men's Health survey of about 2,200 men found that 49% agreed their testosterone level was a measure of their masculinity, while 37% agreed that having more testosterone made them better looking.⁷ Even more striking, 54% believed a high testosterone level would help them live longer.

Those beliefs matter in a marketplace where testosterone is increasingly sold around ideas of performance and self-improvement. Half of Gen Z men believed that more testosterone made you better looking, significantly more than older generations. The survey also found that 70% of men considered their testosterone level important, and 40% said it mattered more to them than it had one year earlier.

• Nonmedical information sources were linked to more testosterone misconceptions — Only 34% of surveyed men named medical professionals as their main source of testosterone information.⁸ Another 27% said they didn't get testosterone information from any source, while the remainder reported sources that included online communities, friends and family, podcasts or social media influencers, traditional media, and artificial intelligence (AI).

Men who relied on online communities, podcasters, or social media influencers were more likely to associate testosterone with masculinity and longer life. Knowledge of high-testosterone risks was also limited: 59% didn't know high testosterone was associated with heart or liver problems, 62% didn't know about infertility, 53% didn't know about acne and 57% didn't know about hair loss.

That information gap gives you another reason to treat testosterone as a medical issue rather than a number to maximize.

• Current prescribing has surpassed the earlier testosterone boom — The comparison with 2013 is especially revealing because testosterone prescribing had already risen substantially during the 2000s and early 2010s. That earlier expansion coincided with direct-to-consumer "low T" awareness campaigns and the arrival of convenient topical testosterone products.

Yet the current prescribing rate is even higher. The 0.93% recorded in 2025 exceeded the previous 2013 peak of 0.83%, and the partial 2026 figure climbed higher still.

• Men ages 50 to 64 years old have the highest testosterone prescription rate — The resurgence wasn't concentrated in one narrow group. Men who belonged to this age group consistently had the highest prescribing prevalence, reaching 1.57% in 2025. Their previous peak was 1.30% in 2013.

Other age groups also exceeded their earlier peaks. In 2025, testosterone prescription prevalence reached 0.57% among men ages 30 to 39, 1.35% among those ages 40 to 49, 1.06% among those ages 65 to 74, and 0.57% among men age 75 and older. This broad rise shows that the renewed interest in testosterone isn't limited to older men.

• Younger men still have much lower prescribing rates — Men ages 18 to 29 stood apart from the older groups. Their testosterone prescription prevalence remained between 0.10% and 0.15% throughout the study period, although their prescribing pattern generally rose and fell in the same direction as rates among older men. By 2025, every age group age 30 and older had surpassed its own early-2010s peak, while men under 30 continued to have the lowest prevalence by a wide margin.

• Prescribing fell after earlier safety concerns and later began climbing again — The timing provides important context. In March 2015,¹⁰ the FDA required testosterone labeling changes that warned about a possible increased risk of heart attack and stroke and emphasized that testosterone products weren't approved for age-related low testosterone. Testosterone prescribing subsequently declined.

The regulatory environment changed again years later. After the 2023 TRAVERSE trial found testosterone therapy noninferior to placebo for major adverse cardiac events among the men studied, the FDA removed its boxed cardiovascular warning from testosterone products in February 2025.¹¹ The prescribing rebound, however, had already begun around 2022, several years before that FDA action.

• The study doesn't prove what caused the renewed rise — Telehealth and direct-to-consumer men's health services expanded during the same general period that testosterone prescribing rebounded, making the overlap particularly relevant to today's TRT marketplace. But the analysis tracked prescribing trends; it didn't establish that online clinics, changing FDA guidance or any other single factor caused the increase.

That's an important limitation, and it isn't the only one. The number of patients in the database grew as more health systems began contributing data, so the earliest years rest on thinner numbers, and a prescription on record doesn't confirm that a man filled it or kept taking it.

What the data do show is striking enough on its own: After falling for years, testosterone prescribing reversed course and surpassed its previous peak across every age group age 30 and older by 2025. Against the backdrop of easier online access, those numbers make careful diagnosis more important as testosterone treatment becomes increasingly common.

1. Confirm that your testosterone is actually low — Avoid making a long-term treatment decision based on an online symptom quiz or one blood test. Testosterone fluctuates throughout the day, so timing matters. Ideally, have your blood drawn between 7 a.m. and 11 a.m., when testosterone levels are typically highest.

Repeated testing gives you a much clearer picture of whether you're dealing with persistent testosterone deficiency. That said, talk to your health care provider about whether this testing is appropriate for you.

2. Eat enough healthy carbohydrates to support testosterone — Carbohydrate intake is one of the first dietary factors to address. Your body needs adequate fuel to support normal metabolic and hormonal function, so severely restricting carbohydrates works against the environment you're trying to restore.

Most people need about 250 grams of healthy carbohydrates per day, and highly active people need considerably more. Choose carbohydrate sources that agree with your digestion, such as whole fruit, white rice and root vegetables.

3. Use exercise and sunlight to stimulate your own testosterone production — Regular physical activity supports natural testosterone production, and KAATSU, also known as blood flow restriction training, is one option. Specialized bands partially restrict blood flow to your arms or legs while you exercise with relatively light loads. This creates a strong training stimulus without requiring the heavy weights used in conventional strength training.

Regular sunlight exposure belongs in this strategy as well. It can support cellular energy production, and researchers have examined its relationship with hormone levels, including testosterone. Build your sun exposure gradually, and avoid harsh midday sunlight until you've been off seed oils for four to six months.

4. Reserve TRT for situations where restoring natural production isn't enough — After you've addressed diet, activity, sunlight, environmental exposures and hormone balance, reassess your testosterone rather than assuming replacement is inevitable. If you're considering TRT, remember that testosterone supplied from outside your body suppresses your natural production and affects fertility, so those consequences belong in the decision from the start.

If TRT is necessary, treat it as ongoing medical care rather than a subscription you automatically renew. Your bloodwork, red blood cells, prostate health and cardiovascular markers require monitoring. Blood pressure deserves particular attention because studies reviewed by the FDA found that testosterone products as a class are associated with an increase in blood pressure.

Your goal isn't to push testosterone as high as possible. It's to create the metabolic and hormonal conditions that allow your body to maintain a healthy level naturally whenever possible.

5. Reduce endocrine disruptors and address excess estrogen — Your environment affects your hormones. Reduce your exposure to endocrine-disrupting chemicals such as phthalates, bisphenol A, and PFOAs, which research indicates can interfere with normal hormone signaling. These chemicals occur in plastics and numerous consumer products, so reducing your contact with them removes another obstacle to healthy testosterone regulation.

Excess estrogen also interferes with testosterone levels and function. Progesterone is one of a small number of supplemental hormones I believe many adults may benefit from, along with thyroid hormone T3 and DHEA. Progesterone acts as a natural counterbalance to estrogen and may also help offset estrogen-like signaling from environmental chemicals that activate estrogen receptors.

If you and your physician decide progesterone is appropriate, use pharmaceutical-grade bioidentical progesterone delivered transmucosally in natural vitamin E rather than a transdermal cream, and use it under medical supervision. For additional information on how progesterone is used, continue reading below.