Health
‘Wild West’ peptide craze surges beyond GLP-1s as FDA faces pressure to ease access
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As GLP-1 weight-loss medications gain traction, the peptide market is experiencing a surge in interest.
A variety of peptides — commonly marketed for weight loss, muscle building, injury recovery and other uses — have emerged as largely unregulated drugs sold through both licensed compounding pharmacies and unverified vendors.
The U.S. Food and Drug Administration is set to evaluate whether to loosen regulations on several peptides during a meeting this summer.
THINKING ABOUT PEPTIDES? DOCTORS REVEAL KEY DOS AND DON’TS AS ‘WILD WEST’ MARKET GROWS
Peptides are short chains of amino acids — the building blocks of proteins — that play key roles in biological functions, according to the National Institutes of Health. Peptide drugs are lab-made versions of natural molecules in the body that are designed to mimic or influence biological signals to treat disease, experts say.
GLP-1s are “incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health,” the expert said. (iStock)
Though the peptide market has been described as the “Wild West,” demand remains strong, potentially challenging pharmaceutical giants that dominate the GLP-1 market.
Dr. Alex Tatem, an Indiana-based board-certified urologist with expertise in men’s health and peptides, discussed how “life-changing” GLP-1s kicked off the rise of peptides.
“These were all medications that were designed to help people live well and live as healthy as possible.”
“They are incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health,” he said. “These are truly miracle compounds, and as a result we’ve seen an explosion of interest – not just on the pharmaceutical side or the doctor’s side, but from the general public.”
According to Tatem, the challenge is that nearly all commercial GLP-1 products are administered in a single-dose weekly pen, which works for the “overwhelmingly majority” of patients, but not for everyone.
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“There are patients I can prescribe tirzepatide to and they can do OK with a once-a-week [dose], but they end up developing nausea with that initial injection – and then by the end of the week, they’re hungry again.”
Because some patients respond better to smaller, more frequent doses — an option not offered by commercial drugs — compounding, or the customization of medications, has grown in popularity, Tatem said.
Several GLP-1 weight loss medications have been approved by the FDA with positive results from consumers. (iStock)
“We’ve had compounding pharmacies that have now developed compounded versions of semaglutide and tirzepatide that allow that sort of dosing flexibility,” he said.
“The reason compounders had to do this was because there was so much demand for GLP-1s that there was actually a national shortage.”
Current legislation allows compounders to step in during widespread national shortages, according to Tatem, prompting the industry to invest millions of dollars into developing and manufacturing these drugs.
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Once commercial pharmaceutical companies could catch back up, compounders continued making these medications in smaller batches for custom doses, allowing for more patient accessibility.
“That creates a huge clash between commercial pharmaceutical companies and compounders, because commercial pharmaceutical companies view that as an infringement of their property,” Tatem noted.
The expert noted a “huge clash” between pharmaceutical companies and compounding pharmacies in peptide production. (iStock)
Tatem raised concerns about the FDA’s regulation of compounding pharmacies, warning that it could limit patients’ access to customized medications.
“That is a real concern for clinicians like me who really care more about patient access, making sure we can get the right medication to the right patients at the right time,” he said.
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Some peptides have been widely administered for more than a decade without major health complications like toxicity or cancer, according to Tatem.
“These are compounds that haven’t gone through the full FDA approval process that you would normally see for a commercial drug, [yet] we didn’t see anything adverse,” he said.
The FDA plans to consider loosening restrictions on several peptides during a summer 2026 meeting. (Issam Ahmed/AFP)
In September 2023, the FDA “quietly” tightened regulation of 19 peptides, making them illegal to manufacture and cutting off patient access.
“They seemed to be working and seemed to be efficacious for patients, and all of a sudden they were banned, which inadvertently ended up contributing to this surge in interest,” Tatem said. “We kind of saw the same thing happen with peptides that we saw with prohibition.”
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While the rising popularity of GLP-1 drugs has fueled growing public and regulatory interest in peptides, most of the so-called “trendy” peptides still are not available by prescription, according to Tatem.
They may help with injury recovery, skin rejuvenation, sleep improvements and boosting of natural growth hormones, he said.
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“These were all medications that were designed to help people live well and live as healthy as possible,” the doctor told Fox News Digital. “And in reality, that was also their downfall in the American healthcare system, because if you are going to get a drug approved and to market, it has to treat a disease state.”
“These were all medications that were designed to help people live well and live as healthy as possible,” Tatem told Fox News Digital. (iStock)
Tatem confirmed that he’s seen a shift in patients confronting more than just baseline ailments, seeking advice on how to feel their best through new modes like testosterone therapy.
“The desire to function at our highest level is something that we all feel,” he said.
While nothing replaces the fundamentals — getting eight hours of sleep, eating a high-protein diet and maintaining a fitness routine that blends resistance training and cardio — Tatem said individualized treatments such as peptides may help support those healthy habits.
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“If you end up pulling a tendon or pulling a hamstring, and you’re just now starting to get some momentum in the gym, that’s really where peptides start to step in,” he added.
Experts advise consumers to avoid gray-market products, to work only with qualified physicians and reputable pharmacies, and to treat peptides as part of a broader health plan — not a shortcut or risk-free supplement.
Semaglutide (GLP-1) weight-loss drug Wegovy, made by pharmaceutical company Novo Nordisk, is designed to treat type 2 diabetes, but is widely known for its effect on weight loss. Picture date: Wednesday, October 16, 2024. (James Manning/PA Images via Getty Images)
In a statement shared with Fox News Digital, a Novo Nordisk spokesperson said the drugmaker is committed to working with regulators, law enforcement and “other key stakeholders” to ensure “affordable access to safe, effective and FDA-approved GLP-1 obesity medication like Wegovy and to protect patients from unapproved and untested knockoff drugs.”
“The desire to function at our highest level is something that we all feel.”
“Novo Nordisk supports FDA’s recent thorough scientific analysis and conclusion that there is no medical basis or clinical need for the continued mass compounding of unapproved semaglutide and liraglutide drugs,” they went on.
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“The agency’s decision reaffirms that compounding is meant to be a rare and limited exception to FDA’s gold-standard drug approval framework that ensures that medicines in the U.S. are safe and effective.”
Fox News Digital reached out to the FDA and Eli Lilly for comment.
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Potentially deadly sepsis may be more likely in certain patients due to problems in the gut.
Researchers from the Korea Research Institute of Bioscience and Biotechnology’s Infectious Disease Research Center used female mouse models to investigate why sepsis outcomes can vary so dramatically.
The study, published in the journal Nature, looked at genetically similar mice with different gut microbiomes. The mice were infected with Acinetobacter baumannii — a highly resilient bacterium that can lead to sepsis.
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The researchers compared groups of mice with higher and lower survival rates, examining differences in their gut microbiomes, the amount of bacteria in their blood and organs, and other cellular markers, according to the study press release.
Gut health could signal severe sepsis prior to infection, the study suggests. (iStock)
Measures of risk
Although some mice were genetically similar, the more vulnerable mice had a higher concentration of Muribaculaceae bacteria in the gut. In one comparison, these bacteria made up about 28% of the microbiome in poor surviving mice, but only 0.15% in better surviving mice.
Mice with worse survival showed an early and strong inflammatory response, which later led to more bacteria in the blood, lungs and spleen. This suggests that the microbiome causes the immune system to be more reactive, according to the researchers.
GUT MICROBES COULD BE KEY TO FIGHTING TOXIC, LONG-LASTING ‘FOREVER CHEMICALS,’ RESEARCH SAYS
In the microbiome of mice with worse survival, the researchers also noticed that one strain of bacteria — Sangeribacter muris KT1-3 — was most prominent. The mice that typically survived at high rates fared much worse when housed with KTI-3 mice, with their survival falling to 10%.
More vulnerable mice had a higher concentration of Muribaculaceae bacteria in the gut. (iStock)
This bacterial strain also appeared to worsen inflammation during certain infections, making sepsis more severe.
These findings suggest that the gut microbiome can signal how the immune system will react before an infection begins.
The microbiome’s surprising influence
Andrew Fleming, MD, section chief of Infectious Diseases & Immunology at NYU Langone Hospital, Brooklyn, said it has been “known for years” that gut bacteria and bacterial toxins can be released into the bloodstream during sepsis.
This worsens the inflammatory response to the initial infection, according to Fleming, who was not involved in the study.
5 GUT-BOOSTING FRUITS TO EAT MORE OF IN 2026 FOR BETTER DIGESTION, EXPERTS SAY
“This process is particularly important in septic shock, where the intestinal wall becomes more permeable to translocation (or leaking) of bacterial products,” Fleming said.
Interactions between the gut microbiome and the immune system are “complex and variable from person to person,” the doctor described.
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“But there is mounting evidence that a diverse and healthy gut microbiome – the community of bacteria that lives in a person’s gut – is protective in some ways against severe sepsis,” he went on. “And a dysregulated microbiome – for example, one severely altered by antibiotics – can impair or worsen the immune system’s response during sepsis.”
Interactions between the gut microbiome and the immune system are “complex and variable from person to person,” a doctor described. (iStock)
Scientists are starting to think of the gut microbiome “almost as a living organ,” according to Fleming, much like the heart, kidneys or liver, all serving “multiple functions” to keep the body healthy.
CLICK HERE FOR MORE HEALTH STORIES
An unhealthy microbiome can have “detrimental effects across a range of health issues,” he added – including how the body responds to infections.
“Compared to our other organs, we currently have fewer readily available tests in the doctor’s office to measure the health of our microbiome,” Fleming said. “However, this should not prevent us from thinking about our gut microbiome and how to keep it healthy.”
The role of antibiotics
The use of antibiotics has “major and long-lasting effects” on the microbiome, Fleming noted. Up to 80% of adults in the U.S. are prescribed an antibiotic every year, while 30% are estimated to be unnecessary, according to the CDC.
“Antibiotics deplete the diversity of the microbiome and create a void in the gut microbial community that can be filled by harmful bacteria from the environment,” the doctor told Fox News Digital.
Antibiotics “deplete the diversity of the microbiome and create a void in the gut microbial community that can be filled by harmful bacteria from the environment,” the doctor said. (iStock)
“We must begin to think much more critically about our antibiotic use and overuse, both to maintain our gut health and to reduce the spread of antibiotic resistance.”
The study findings are an “intriguing starting point to further research,” Fleming said, although there were some key limitations.
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“Sangeribacter muris is not typically found in humans, so the exact mechanism of this bacterial strain worsening sepsis that is demonstrated in this study cannot be directly extrapolated to people,” he said. “Well-designed clinical trials should be conducted to explore how similar gut microbiome effects may play out in sepsis in humans.”
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
Despite these limitations, the doctor said he supports the hypothesis that maintaining a healthy gut microbiome can help keep the immune system well-regulated while reducing the risk of developing severe sepsis.
NEWYou can now listen to Fox News articles!
Potentially deadly sepsis may be more likely in certain patients due to problems in the gut.
Researchers from the Korea Research Institute of Bioscience and Biotechnology’s Infectious Disease Research Center used female mouse models to investigate why sepsis outcomes can vary so dramatically.
The study, published in the journal Nature, looked at genetically similar mice with different gut microbiomes. The mice were infected with Acinetobacter baumannii — a highly resilient bacterium that can lead to sepsis.
ER DOCTOR REVEALS HOW PNEUMONIA CAN SUDDENLY TURN DEADLY AFTER KYLE BUSCH’S DEATH
The researchers compared groups of mice with higher and lower survival rates, examining differences in their gut microbiomes, the amount of bacteria in their blood and organs, and other cellular markers, according to the study press release.
Gut health could signal severe sepsis prior to infection, the study suggests. (iStock)
Measures of risk
Although some mice were genetically similar, the more vulnerable mice had a higher concentration of Muribaculaceae bacteria in the gut. In one comparison, these bacteria made up about 28% of the microbiome in poor surviving mice, but only 0.15% in better surviving mice.
Mice with worse survival showed an early and strong inflammatory response, which later led to more bacteria in the blood, lungs and spleen. This suggests that the microbiome causes the immune system to be more reactive, according to the researchers.
GUT MICROBES COULD BE KEY TO FIGHTING TOXIC, LONG-LASTING ‘FOREVER CHEMICALS,’ RESEARCH SAYS
In the microbiome of mice with worse survival, the researchers also noticed that one strain of bacteria — Sangeribacter muris KT1-3 — was most prominent. The mice that typically survived at high rates fared much worse when housed with KTI-3 mice, with their survival falling to 10%.
More vulnerable mice had a higher concentration of Muribaculaceae bacteria in the gut. (iStock)
This bacterial strain also appeared to worsen inflammation during certain infections, making sepsis more severe.
These findings suggest that the gut microbiome can signal how the immune system will react before an infection begins.
The microbiome’s surprising influence
Andrew Fleming, MD, section chief of Infectious Diseases & Immunology at NYU Langone Hospital, Brooklyn, said it has been “known for years” that gut bacteria and bacterial toxins can be released into the bloodstream during sepsis.
This worsens the inflammatory response to the initial infection, according to Fleming, who was not involved in the study.
5 GUT-BOOSTING FRUITS TO EAT MORE OF IN 2026 FOR BETTER DIGESTION, EXPERTS SAY
“This process is particularly important in septic shock, where the intestinal wall becomes more permeable to translocation (or leaking) of bacterial products,” Fleming said.
Interactions between the gut microbiome and the immune system are “complex and variable from person to person,” the doctor described.
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
“But there is mounting evidence that a diverse and healthy gut microbiome – the community of bacteria that lives in a person’s gut – is protective in some ways against severe sepsis,” he went on. “And a dysregulated microbiome – for example, one severely altered by antibiotics – can impair or worsen the immune system’s response during sepsis.”
Interactions between the gut microbiome and the immune system are “complex and variable from person to person,” a doctor described. (iStock)
Scientists are starting to think of the gut microbiome “almost as a living organ,” according to Fleming, much like the heart, kidneys or liver, all serving “multiple functions” to keep the body healthy.
CLICK HERE FOR MORE HEALTH STORIES
An unhealthy microbiome can have “detrimental effects across a range of health issues,” he added – including how the body responds to infections.
“Compared to our other organs, we currently have fewer readily available tests in the doctor’s office to measure the health of our microbiome,” Fleming said. “However, this should not prevent us from thinking about our gut microbiome and how to keep it healthy.”
The role of antibiotics
The use of antibiotics has “major and long-lasting effects” on the microbiome, Fleming noted. Up to 80% of adults in the U.S. are prescribed an antibiotic every year, while 30% are estimated to be unnecessary, according to the CDC.
“Antibiotics deplete the diversity of the microbiome and create a void in the gut microbial community that can be filled by harmful bacteria from the environment,” the doctor told Fox News Digital.
Antibiotics “deplete the diversity of the microbiome and create a void in the gut microbial community that can be filled by harmful bacteria from the environment,” the doctor said. (iStock)
“We must begin to think much more critically about our antibiotic use and overuse, both to maintain our gut health and to reduce the spread of antibiotic resistance.”
The study findings are an “intriguing starting point to further research,” Fleming said, although there were some key limitations.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
“Sangeribacter muris is not typically found in humans, so the exact mechanism of this bacterial strain worsening sepsis that is demonstrated in this study cannot be directly extrapolated to people,” he said. “Well-designed clinical trials should be conducted to explore how similar gut microbiome effects may play out in sepsis in humans.”
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
Despite these limitations, the doctor said he supports the hypothesis that maintaining a healthy gut microbiome can help keep the immune system well-regulated while reducing the risk of developing severe sepsis.
NEWYou can now listen to Fox News articles!
The old saying that laughter is the best medicine may be true, according to new research that suggests it is also a vital catalyst for children’s development.
Laughter and play are fundamental to healthy brain growth, emotional well-being and social bonding, according to Jacqueline Harding, Ph.D., an early childhood expert at Middlesex University in London.
In her book, “The Brain That Loves to Laugh,” Harding argues that joy is a complex biological phenomenon that helps children navigate stress and build more resilient, receptive minds, news agency SWNS reported.
HAPPIER AND HEALTHIER PEOPLE DO THESE 7 THINGS EVERY DAY, SAYS WELLNESS EXPERT
“When we see children laugh, we witness the brilliance of the brain in action: learning, connecting and growing,” Harding told SWNS.
“Hope and humor, it seems, are not just the seasoning of life, but foundational to a recipe for healthy development.”
Laughter alters internal chemistry by decreasing stress hormones and boosting feel-good chemicals like serotonin, experts say. (iStock)
Laughter activates broad brain networks, including motor regions and the prefrontal cortex, long before children learn to speak. By helping the brain resolve conflicting ideas, it boosts creativity and engages working memory, acting as a “mental workout,” experts say.
At a molecular level, laughter alters the internal chemistry by decreasing stress hormones like cortisol and epinephrine. It also increases “happiness chemicals” like dopamine, serotonin and endorphins.
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Additionally, laughter is known to boost oxytocin, which deepens emotional bonds between parents and children.
Prolonged stress does the exact opposite: It impairs learning, suppresses immune function and alters the developing limbic system, which governs emotion and long-term memory, according to SWNS.
Prolonged stress can negatively impact not only children’s mental well-being, but their physical state as well. (iStock)
“Stated simply, the emotional state of young children directly influences how they navigate their way through the world,” Harding said.
Parents can foster these benefits through moments of spontaneous play and joyful connection, the expert advised.
“Spontaneous, joyful play is an antidote to stress.”
These interactions do more than spark laughter — they help children develop emotional regulation, strengthen feelings of safety and connection, and support social and cognitive development, according to the American Academy of Pediatrics.
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“Spontaneous, joyful play is an antidote to stress, as it increases levels of endorphins released by the brain,” Harding said. “Creative, happy play does its most brilliant work at a molecular level, especially at a time when the human brain is at its most receptive.”
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This shared joy also establishes “co-regulation,” where a child learns to manage their own stress by drawing on a biological store of positive early experiences.
Spontaneous, joyful play is an antidote to stress, as it increases levels of endorphins released by the brain, the expert said. (iStock)
Harding advocates for integrating humor directly into classrooms to reduce cognitive load and improve how children retain key concepts.
By uplifting the nervous system, joy creates an optimal environment for information absorption, as the SWNS piece noted.
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“Safe relationships and non-stressful play environments promote learning,” she added.
“The curriculum must never be prioritized over those two fundamental factors.”
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