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.
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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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A specific gut microbe could help with long-term weight-loss goals.
New research published in the journal Nature Medicine tested whether a pasteurized (not live) gut bacterium, called Akkermansia muciniphila MucT, could help people keep weight off after losing it.
The study enrolled 90 overweight and obese adults from the Netherlands in an eight-week, low-energy diet where they were instructed to lose 8% of their body weight, according to a press release.
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The participants then started a 24-week weight-maintenance phase and were randomly assigned to take either the gut bacterium or a placebo.
People taking Akkermansia regained significantly less weight than those taking the placebo, the study found. (iStock)
People taking Akkermansia regained less weight than those taking the placebo, at an average of 2.6 pounds versus 7.1 pounds — a statistically significant difference, according to the study results.
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The researchers noted that the efficacy of the treatment depends on a person’s existing gut microbiome. There were no serious adverse events reported.
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The study’s short duration and small sample size may not be enough to prove long-term benefits, the team noted. Another limitation is that participants ate whatever they wanted instead of following a standardized diet.
The study enrolled 90 overweight and obese adults from the Netherlands in an eight-week, low-energy diet where they were instructed to lose 8% of their body weight. (iStock)
Dr. Peter Balazs, MD, a hormone and weight loss specialist practicing in New York and New Jersey, called this a “well-designed” trial.
“The finding that a single gut microbe, pasteurized Akkermansia, significantly reduced weight regain is particularly compelling,” the expert, who was not involved in the research, told Fox News Digital. “Most probiotics have demonstrated far less efficacy, making these results especially noteworthy.”
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Balazs pointed out that pasteurized Akkermansia isn’t a live probiotic, but works through “components of the bacteria, particularly a protein called Amuc_1100.”
Akkermansia is “not a miracle pill,” an expert noted, although the study results are promising. (iStock)
“This protein helps strengthen the gut barrier, reduce low-grade inflammation and support healthy metabolic function,” he said. “After weight loss, the body naturally tries to regain fat, but Akkermansia appears to help quiet some of those biological signals, making it easier to maintain results over time.”
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While the study results are promising, the doctor cautioned that Akkermansia is not a miracle pill.
“It helps with maintenance, not initial loss,” he said. “Long-term use is plausible; however, it hasn’t been proven beyond 24 weeks. This does not replace diet, exercise or medical advice.”
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The latest beverage trend is far from clean – and it’s raising red flags with doctors.
Known as a “dirty soda,” it’s a soft drink that also includes a combination of added ingredients, such as flavored syrups, creamers, fruit juices and other garnishes. The result is a sweet beverage that’s a combination of a soda, mocktail and dessert.
Dirty sodas can easily deliver 250-400 calories and 55-70 grams of sugar in a single drink – which is often more than double the American Heart Association’s daily added sugar limit, according to Erin Palinski-Wade, a New Jersey-based registered dietitian.
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“It’s more like a dessert beverage than a soft drink, even if people use diet soda as the base,” she told Fox News Digital.
The drinks are most dangerous for those with insulin resistance, prediabetes or diabetes, Palinski-Wade warned.
A dirty soda is a soft drink that also includes a combination of added ingredients, such as flavored syrups, creamers, fruit juices and other garnishes. (iStock)
“The combination of rapidly absorbed sugar plus cream can cause sharp blood sugar spikes and crashes, driving hunger, fatigue and higher insulin demands,” she cautioned.
The trend is said to have originated in Utah years ago at a specialty soda shop, Swig, reportedly due to people in the Mormon faith seeking an alternative to coffee. The drink was then popularized by social media and TV shows, such as “The Secret Lives of Mormon Wives,” according to Eater.com.
The dirty soda trend is widely credited to Swig, a Utah-based soda shop founded in 2010. The concept reportedly gained popularity in Utah, where many members of The Church of Jesus Christ of Latter-day Saints abstain from coffee and alcohol, helping create demand for customizable, non-alcoholic drinks.
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“There are multiple soda shops in most suburbs here,” one Utah resident wrote on Reddit. “I have many coworkers who stop at one daily on their way to work [because] they don’t drink coffee, but will drink dirty sodas.”
Trend goes mainstream
Dirty sodas have recently grown in popularity, appearing on many restaurant menus and grocery store shelves. Coca-Cola has launched its Coca-Cola Cherry Float, which is designed to mimic the soda-and-cream experience, while PepsiCo offers a Dirty Mountain Dew Cream Soda.
McDonald’s, Taco Bell, Sonic and Dunkin are among the fast-food brands that include dirty soda options in their beverage line-ups.
Crumbl recently launched a dirty soda that includes multiple sweet ingredients on top of an already sugary soda base. (USA TODAY Network via Reuters Connect)
Perhaps taking the cake is Crumbl, which recently launched a dirty soda that includes multiple sweet ingredients on top of an already sugary soda base.
“Crumbl needs to be stopped,” Dr. Mark Hyman wrote in a recent social media post. “Their new ‘dirty soda’ contains 186 grams of sugar, the equivalent of eating 19 Krispy Kreme donuts. This is a metabolic disaster and should be illegal.”
Experts warn of health risks
Dr. Marc Siegel, Fox News senior medical analyst, echoed the warnings about dirty sodas being “very unhealthy.”
“They are loaded with processed sugar, empty calories and saturated fats,” he told Fox News Digital. “They are also highly addictive, especially because of the high sugar content, and are about 400 calories per serving.”
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Over time, regular consumption of these types of sugary beverages can train the brain to seek repeated dopamine and endorphin releases, Siegel warned. This can increase the risk of obesity, diabetes, heart disease, dementia and other chronic illnesses.
An employee prepares a dirty soda at Floso, a drink shop in Salem, Oregon, in July 2024. (Abigail Dollins/Statesman Journal)
Tanya Freirich, a registered dietitian nutritionist in Charlotte, North Carolina, echoed that daily added sugars increase the risk of obesity, non-alcoholic fatty liver disease, cardiovascular disease and diabetes.
“Additionally, the creamy mix-ins featured in dirty sodas are generally high in saturated fat, another nutrient that should be consumed in limited amounts,” Freirich told Fox News Digital.
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“If you’re looking for a mocktail or fun non-alcoholic beverage, consider using a base of plain seltzer water for a bubbly drink,” she recommended. “Even with the same add-ins, your end result will contain considerably less sugar, but still taste sweet.”
An orange dirty soda is displayed at the Ross County Fair in Ross County, Ohio. (USA TODAY Network via Reuters Connect)
Kenneth J. Perry, M.D., an emergency physician in Charleston, South Carolina, also noted that dirty sodas represent a continuation of the trend toward highly sugary beverages.
“Their effects are short-lived, prompting individuals to consume excessive amounts,” he warned. “This combination of low nutritional value, high sugar content and poor satiety can have significant health implications.”
Each additional highly sugary beverage consumed daily increases the risk of developing diabetes, high blood pressure or heart disease, Perry cautioned.
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The World Health Organization recommends limiting free sugars – such as those found in beverages with added sugar – to less than 10% of total daily energy consumption, the doctor noted.
“Beverages with added sugar are one of the most easily modifiable risk factors for various downstream health issues,” Perry added.
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For those who do decide to try the dirty soda trend, Palinski-Wade recommends choosing a small size, using a diet soda base and limiting it to a rare treat.
“It really belongs in the same category as a cake or a milkshake – occasionally, and in smaller portions.”
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