Is “Low T” a Real Condition? FDA Weighs In

Over the past several years, the number of testosterone replacement therapy products prescribed to men approaching senior citizen status has literally soared – reaching sales topping $9 billion. The culprit? The apparent onset of the condition known as “low-t,” or low testosterone – a condition believed by some in the medical field to be a made up condition calculated to sell an unnecessary and potentially dangerous prescriptions for hormone replacement therapy.

However, the Food and Drug Administration (FDA) has begun to take a keen interest in this burgeoning industry, which is presumably aimed at the growing number of male baby boomers experiencing the onset of symptoms like lethargy, weight gain, and low libido. However, despite receiving several complaints from consumers about the unexpected side effects of low-t treatment, the FDA asserts that it cannot actually dismantle a marketing campaign unless a specific product is mentioned or promoted.

In the widespread low-t movement, drug companies engaged in touting general testosterone – and not a specific product or device, making the campaigns outside the reach of the FDA’s regulations. However, the agency has considered other avenues.

Low-t treatment as a consumer protection issue

Opponents of low-t testosterone replacement treatment have not only questioned its safety and efficacy against certain vague symptoms, but have asserted that the male-centric advertising aimed at issues like weight gain, aging, and low sex-drive could be bordering on deceptive trade practice. For many in the medical – and specifically, endocrinology – field, the so-called symptoms of low-testosterone are generally considered common as men get older. Moreover, many have questioned whether the symptoms described by low-t advertisements are actually related to a reduced level of testosterone or possibly caused by one or more other underlying conditions.

As the low-t movement continues, many have inquired as to whether the FDA has referred the issue to the Federal Trade Commission, which investigates and addresses issues negatively impacting consumers – including deceptive trade practices. Because, in the words of famed comedian Stephen Colbert, low-t can be described as “a pharmaceutical company-recognized condition affecting millions of men with low testosterone, previously known as getting older.”

Testosterone drug risks

Deceptive trade practices aside, problems associated with low-t treatment can include life-threatening unexpected side effects. In a March, 2015 Safety Communication from the FDA, experts warned about the possible increased risk of heart attack or stroke in men taking testosterone therapy. Further, the FDA implemented a mandatory warning label on low-t treatments indicating these risks, and urged physicians and endocrinologists to ensure patients understand the potential for serious side effects.

Testosterone therapy, while dangerous, can be helpful in certain males experiencing decreased or imbalanced hormone levels due to identifiable underlying conditions. For instance, men enduring chemotherapy or a genetic abnormality may safely benefit from the introduction of testosterone, while children and adolescents with undescended testes may similarly experience the advantages of replacement therapy. However, millions of men are being prescribed this medication for symptoms unrelated to any actual underlying medical issue, prompting many to conclude the low-t movement is an invention advanced solely for profit and financial gain.

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