EXCLUSIVE: FDA Lifts Restrictions on Testosterone Replacement Therapy

FIRST ON THE DAILY SIGNAL — The Food and Drug Administration has loosened its label on testosterone replacement therapy, or TRT, for short, in an attempt by President Donald Trump’s administration to reverse the historic testosterone decline among young men.

TRT was recently considered to be harmful to men over potential risks of developing prostate cancer and/or heart complications. However, an FDA panel in December 2025 determined, through science-based evidence, that this is not the case, and the supplement helps more than it harms young men.

The FDA hopes the new label on TRT will encourage men who are testosterone deficient to seek the treatment and reverse the country’s epidemic of obesity, substance abuse, suicide, and mental health challenges caused, in part, by a lack of testosterone.

“20–25% of young men have testosterone deficiency,” HHS Assistant Secretary for Health Admiral Brian Christine, MD, told The Daily Signal. “This could be a product of environmental factors. It affects our libido, our vitality, our desire for intimacy. [Testosterone] is an important way to improve the health span and the quality of life for men.”

“Low energy, low libido, low vitality, difficulty maintaining a lean muscle mass, and we know that replacing their testosterone, and getting their levels back up is extremely healthy,” Christine added.

Christine says that lowering the barrier of entry for men who need the substance could be instrumental in reversing the epidemic of idiopathic hypogonadism, low testosterone levels without identifiable cause, or testosterone levels that simply drop over time without an identifiable driving cause.

“We convened an expert panel on testosterone replacement in men,” Christine added. “That was kind of the genesis for this labeling change. If you had to look at one value in blood test for men, in my opinion, look at one value that would predict the longevity, the vitality, the lifespan, and the healthy life span of men, testosterone would probably be that number.”

Now Christine did note that not all substances are perfect, and the harmful side effects for TRT users, especially for those who do not need it, are still prevalent. Therefore, the government agency continues to issue maximum caution to users who are at risk of experiencing acne, reduced sperm count, testicular shrinkage, breast growth, fluid retention, and increased red blood counts.

“Testosterone is the medication that should be used like any medication with proper oversight,” Christine said. “It should be used while understanding that there can be side effects from testosterone. It has to be used under proper supervision.”

Christine used his experience as a urologist to say that practitioners are “going to do what’s right for the patient, give the patient the information, always try to guide them in a way that’s healthy. We must advocate for the wellness of patients, not simply to say, oh, now we have some change labeling.”

“We absolutely want to make sure as practitioners and as health care professionals and as a health administration, helping men understand that if they’re going to use testosterone, it absolutely must be done under the supervision of a qualified practitioner or qualified physician who understands this, it must be done with appropriate monitoring, periodic blood testing,” the admiral continued.

While the admiral could not give an explanation as to why the previous administration refused to conduct in-depth studies on TRT, or how to end the low testosterone epidemic, Christine told The Daily Signal that it’s “all for the better” that the current administration is fighting this epidemic now.

“I’m glad that the day has come when people realize the testosterone is an important way to improve the health span to improve the quality of life for men in this country,” the admiral continued. “I’m glad it’s happening under our administration. I’m glad that I’ve been a part of that, and I’m really glad that the FDA has taken steps to change that labeling.”

Christine took a moment to acknowledge the importance of healthy men in this country, reiterating the point of reversing the universal decline in testosterone levels, before wishing America’s dads a happy Father’s Day.

“We want to make a positive impact on men’s health during this administration. In this administration, men matter,” Christine said. “I wish a really happy Father’s Day to all the fathers out there. Fathers have such an incredible impact on making the country great and strong again.”

“A strong, loving, committed, engaged father can do so much, obviously, for their children, for their wives. You know, we want strong fathers,” he added. “We realize that the vocation of fatherhood, it demands a lot. It requires a lot, but it most certainly gives so much to the men who choose that path in their life to be father. So we want to say happy Father’s Day.”