On Oct. 14, a temporary “” appeared on a White House docket, proposing to allow licensed pharmacies to make and sell certain unapproved peptides to people. Scientists at the FDA had advised against the measure at a , warning that the drugs hadn’t been adequately vetted in clinical trials.

A panel that advises the FDA disagreed, however, voting to loosen restrictions. Many of the panel members are new appointees with in the peptide industry. In an email, Department of Health and Human Services spokesperson Emily Hilliard said that every committee member satisfies the FDA’s ethics requirements.

“I voted ‘yes’ for patient safety, the greater good, and medical freedom,” Haleem Mohammed, one of the new committee members, said at the . He’s the chief medical officer of a men’s clinic that sells peptides, Gameday Men’s Health.

To make good decisions, consumers need to rely on accurate information, but much of the hype around peptides is misleading. 吃瓜不打烊 flags four misleading phrases commonly used by those promoting peptides — and one truth.

Red Flag: Peptides aren’t drugs.

Gary Brecka, a co-chair of the MAHA Action committee, says peptides aren’t drugs of his podcast. He talks about using them to “help regulate cortisol, improve circulation, all kinds of things.” When peptides are used to treat, prevent, or cure conditions, or to affect the body’s function, they are, , drugs.

“Peptide” is a general term for substances that are smaller than proteins but made of the same building blocks. Humans make many peptides, including insulin. Insulin is a drug when people inject it to regulate blood sugar.

“Most of the drugs we have had some antecedent in nature,” said Jacob Sherkow, a professor of law specializing in biotechnology at the University of Illinois Urbana-Champaign. “Heroin is natural. No one in their right mind would call it not a drug.”

Brecka did not respond to requests for comment, but Chris Woodward, a public relations representative for him, said in an email that the health issues discussed on Brecka’s podcast do not constitute medical advice.

Red Flag: Peptides are safe because they’re natural.

Peptide promoters that peptides are safe because they’re natural. This clip of Brecka’s discussion with Brigham Buhler, a co-author of The Peptide Revolution and owner of a that sells peptides, is an example. Some influencers go further, saying that peptides are safe because they’re made by the human body. Buhler did not respond to requests for comment.

It’s murky territory. One of the most popular experimental peptides, BPC-157, was developed by Croatian scientists who isolated what they called “body protective compound” from gastric juices in the stomach lining. However, researchers have been unable to find a trace of BPC in the human genome, meaning it’s not made by humans, said Katrin Svensson, a peptide scientist at Stanford University. Researchers in Taiwan suggest the peptide is produced by stomach microbes, according to .

Even if BPC-157 and other peptides exist in nature, Svensson said, “natural things can be toxic.” People have died from taking , for example. And drugs considered safe can still make people feel ill. To learn about safety, and whether the benefits of a drug offset the side effects, researchers conduct placebo-controlled trials. These reveal problems that might not be obvious in the short term, such as liver damage, as well as underlying conditions that could turn minor issues into something serious.

The FDA is considering lowering restrictions on BPC-157 and five other experimental peptides that have not undergone high-quality clinical trials and are not FDA-approved. “I am excited about peptides too,” said Svensson, whose lab studies several peptides that she hopes to develop into drugs. “But,” she added, “you need to show they’re not harmful.”

Red Flag: These peptides treat illnesses and heal injuries.

Kris Wusterhausen, one of the new appointees to the FDA advisory panel, that the experimental peptide BPC-157 “can reduce [acid] reflux disease” and treat “neurologic disorders.” He’s the founder of an antiaging company that sells “clinically guided peptide treatments.” He did not respond to requests for comment.

Such claims are common among peptide promoters who say that various experimental peptides treat muscle injuries, covid, inflammatory bowel disease, and more. But vanishingly few clinical trials have been conducted.

A summary of a small clinical trial testing BPC-157 as a treatment for inflammatory bowel disease was published in 2005, but it lacked critical details about how the study was conducted. FDA scientists who called it “inadequate.”

Another concluded that BPC-157 relieved knee pain for 14 of the 16 patients involved, but it lacked a control group, meaning the participants might have felt better because of other factors, or their pain simply resolved over time.

In a 2025 on BPC-157 as a treatment for musculoskeletal injuries, researchers warned that it should be “approached with caution” because of a lack of evidence. Flynn McGuire, a physical rehabilitation doctor at the University of Utah and an author of the review, said anecdotes about people having miraculous recoveries are even less reliable.

He has told patients he won’t prescribe BPC-157 until quality studies are conducted. “People want new things quickly,” he said, “but medicine and science just don’t work fast.”

Peptide enthusiasts also tout laboratory studies, such as a particular peptide stimulating blood vessel growth. Such research is critical, but it doesn’t speak to safety, efficacy, or off-target effects in people, like fueling cancerous growths. Human biology is complicated, which is why most substances that show promise in early experiments fail in clinical trials.

Red Flag: Peptides can’t be patented.

A few months before Kennedy took charge at HHS, on the social media platform X that the FDA hindered access to peptides and other alternative therapies because they couldn’t be patented. It’s a common misconception about peptides: In an about the drugs, researchers found many posts suggesting that mainstream medicine has sidelined peptides because pharmaceutical companies cannot patent the substances and therefore can’t turn a profit.

Yet hundreds of peptide patents are listed in the U.S. Patent and Trademark Office database. A patent on an early formulation of BPC-157 is .

“One cannot obtain a patent on the natural thing itself,” Sherkow said, “but if you slightly modify it, link it to something that allows me to inject it, formulate it to be more stable, all of that stuff is patentable and is being patented.”

Peptide patents can be lucrative. Pharmaceutical companies are suing one another over patents surrounding GLP-1 peptides, the basis of Ozempic and other such weight loss drugs. The market for those medicines is projected to within the next decade, according to the investment bank Morgan Stanley.

So why haven’t pharmaceutical companies invested in clinical trials on popular peptides? Clinical trials cost millions of dollars, so companies first must be convinced the drugs look promising enough for FDA approval, as well as have an edge over current medications.

Companies conduct experiments before investing big bucks. They may have done so for certain peptides and been discouraged by the results, Svensson said.

Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors backed out of funding trials on a peptide he helped discover, MOTS-c, because they worried its use overlapped with GLP-1 medications. “Investors felt we couldn’t compete with that,” he said.

Kennedy’s push to make experimental peptides more accessible might make clinical trials even more unlikely, researchers say, because compounding pharmacies wouldn’t need FDA approval to sell the drugs for human use.

In a letter to the FDA, the pharmaceutical trade organization PhRMA advised against easing restrictions on unapproved peptides, saying it would “erode incentives for manufacturers to undertake the substantial time and cost required for FDA approval.”

True: Americans aren’t as healthy as they could be.

Kennedy and other leaders of the MAHA movement are right when the U.S. spends per person than any other nation and ranks below all other wealthy nations in . They also rightly note the high cost of treatment. Six in 10 U.S. adults said they worried about affording prescription drugs in a , with 4 in 10 saying they’ve skipped doses or taken other measures because of the price.

Researchers have outlined policies to lower healthcare costs and improve public health, such as limiting and improving access to . What’s not on the list: skipping clinical trials to sell unproven treatments that could harm people.

This article first appeared on 吃瓜不打烊 and is republished here under a .

The administration of President Donald Trump has used claims of widespread wrongdoing to justify investigations, suspensions of billions of dollars in payments to states, and the cancellation of Affordable Care Act health coverage for hundreds of thousands of people.

has opened a broader political fight over the extent of fraud and the administration’s response to it. Republicans say they’re safeguarding taxpayer dollars by going after bad actors. Democrats contend the administration has relied on insufficient evidence to target blue states and cut programs Republicans have long tried to shrink. Meanwhile, Trump’s pardons of executives convicted of healthcare fraud, administration moves to weaken some protections against abuses, and a high-profile error by Trump regulators stand in contrast with the administration’s proclaimed fraud-fighting goals.

The dispute is becoming a talking point for both parties leading up to the November election.

Republican candidates are trying to win voters’ confidence by emphasizing their efforts to halt what they say is the misuse of taxpayer dollars in federal health programs.

“Going after fraud gives Republicans a healthcare message when they would otherwise just be defending cuts to Medicaid and the Affordable Care Act,” said Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes 吃瓜不打烊. The approach, he said, helps “blunt” those attacks.

Democrats, however, traditionally have an advantage on healthcare in general, with are with such issues. Now Democrats are portraying Republicans’ fraud crackdown as a cover for the GOP’s weakening of safety net programs. But the GOP messaging could resonate at the ballot box.

About 44% of voters 鈥� and 54% of Republican voters 鈥� say fraud in government programs is “extremely important” for candidates to talk about, conducted in mid-September, suggesting the fraud focus might be connecting with the GOP base. Such fraud is also the top issue rural Republican voters want candidates to talk about, based on a by KFF and the Associated Press.

It’s an issue that is hardly new, and government watchdogs have repeatedly documented fraud by health providers and brokers, as well as improper enrollment in government health programs. A report by the in March warned that the “sheer amount of payments in the Medicare program creates significant fraud risks.” And in a , GAO investigators were able to get subsidized insurance for fake ACA enrollees.

What has changed is the prominence the issue now occupies in national politics.

Administration’s Fraud Targets

Trump administration authorities have this year charged hundreds of people, , in alleged billing schemes. It has announced and increased scrutiny of enrollment in federal programs, withholding in federal Medicaid payments over claims of lax oversight 鈥� with what Democrats say is a laser focus on blue states despite a lack of evidence.

The administration’s more expansive claims about fraud 鈥� and the actions it has taken in response 鈥� have generated fierce political clashes.

Most recently, the Centers for Medicare & Medicaid Services canceled ACA enrollments covering 760,000 people. While Democrats have questioned the methods that found them to be fraudulent, federal officials said they included nonexistent consumers whose applications were submitted by brokers or agents who can earn commissions from insurers.

CMS Administrator Mehmet Oz that the cancellations included people who had coverage through the ACA but hadn’t used it. He also said some had no Social Security numbers, calling that evidence of problems.

“About 35% of current people on the Obamacare system 鈥� 35%, more than a third 鈥� had never used the program. They haven’t bought a prescription medication. They haven’t seen a doctor. That just is not possible,” Oz said. “So we know there is fraud.”

Democrats and some health policy analysts challenge that conclusion. They say that younger and healthier people are much less likely to use their insurance and that not using their coverage doesn’t mean they were improperly enrolled. Critics also say the absence of Social Security numbers doesn’t necessarily establish fraud; for example, newborns can be added to their parents’ plans before receiving a number.

“This is yet another attempt by the Trump administration to kick hundreds of thousands of vulnerable Americans off their healthcare,” on the social media site X. “Millions are already struggling to access healthcare鈥攁nd this is their plan?”

There are political risks for the GOP as well. The disenrollment of alleged phantom accounts is likely to ensnare legitimate consumers, say health analysts and ACA advocates, leading to a potential backlash against Republicans if scores of people lose coverage just before the midterm elections.

States that tend to deliver for GOP candidates will be hit especially hard, they say, because ACA enrollees are concentrated in those states. The 4.5 million people in Florida and 4.1 million in Texas who have marketplace coverage account for nearly 40% of the country’s ACA enrollment, according to .

Conservative health policy advisers say the administration took multiple steps to avoid canceling legitimate coverage, including attempts to contact consumers and requirements that additional criteria be met before coverage was terminated.

“Those criticizing the action either don’t understand it or see some political advantage in mischaracterizing it,” said Brian Blase, president of Paragon Health Institute and a former Trump health policy adviser.

Democrats, meanwhile, highlight inconsistencies in the administration’s broader anti-fraud campaign.

They note that the Department of Health and Human Services last year of insurance brokers and agents who had been suspended in 2024 by the Biden administration for suspected fraud or abuse. The Trump administration also laid off from involved in regional oversight of the ACA marketplace.

On Oct. 3, to pass legislation with mandatory prison terms for defrauding Medicare and Medicaid, eliminating probation as an option.

But Trump has also pardoned health industry executives convicted of major fraud schemes, including people who are connected to his political allies or who spent heavily on lobbying on their behalf. The pardons included a sentenced to three years in prison for a nearly $40 million tax scheme and, in Trump’s first term, convicted for Medicaid fraud.

Trump’s pardons in 2021 of executives who profited from massive public healthcare fraud spurred criticism from the National Health Care Anti-Fraud Association. Critics now say the administration is portraying cuts to Medicare and Medicaid as necessary for weeding out waste, fraud, and abuse while exonerating criminals who have engaged in some of the biggest schemes in federal health programs.

Blue State Allegations

HHS has raised concerns about Medicaid fraud and program integrity in several states, and the administration has deferred or threatened to cut federal Medicaid funding while disputes are investigated.

Democrats say the administration is itself engaging in fraud by using unsubstantiated allegations of abuse to politically target blue states.

One of the most striking clashes occurred in New York.

Federal officials launched an investigation of the state’s Medicaid program after claiming that personal care services 鈥� including help with bathing, dressing, and meal preparation 鈥� had been provided to more than 5 million people, which would have amounted to roughly three-quarters of the state’s Medicaid population 鈥� an almost impossibly large proportion.

“It is time for New York to come clean about its Medicaid program,” CMS’ Oz .

CMS its calculations were wrong. The agency said that it had misunderstood the state’s billing codes and that the actual number of beneficiaries who received the services was closer to 450,000. The administration continued its scrutiny of the New York program, however, and later suspended millions of dollars in federal funding for the state’s Medicaid fraud unit, wasn’t producing enough indictments.

The administration also withheld about from California, citing concerns about program integrity and oversight of some home medical services. State officials deny the allegations, saying has grown because of factors such as higher wages for home health aides and an increase the number of older people receiving care.

The White House announced plans to in federal funds from Minnesota, claiming the state had failed to protect its Medicaid program from abuse. State officials have and gone to court to challenge the decision.

Vice President JD Vance, who chairs Trump’s Task Force to Eliminate Fraud, and other administration officials announced the state deferrals at the White House, giving what traditionally would have been technical disputes between state and federal health officials a much higher political profile. Vance’s office did not respond to 吃瓜不打烊 questions about the administration’s anti-fraud activities related to healthcare.

“I’ve never seen anything like this,” said , a Georgetown University research professor and a senior adviser at CMS during the Obama administration. “It’s a deferral, not a finding of fraud. This is being elevated by political decision-makers.”

Republican candidates have pounced on the investigations and allegations. In Minnesota, Republican gubernatorial candidate , who is speaker of the Minnesota House, released claiming that her Democratic opponent, U.S. Sen. Amy Klobuchar, “has never done anything to stop the fraud here in Minnesota.” Klobuchar has said that as governor she would “launch a top-to-bottom audit of state government to root out fraud.”

In New York, , a Democrat whose office runs the Medicaid fraud unit, criticized the decision to withhold funds and said weakening the operation would benefit criminals. Her Republican challenger in the November election, , has cited the Trump administration’s claims , telling Fox News Digital that James is “totally failing to prosecute Medicaid fraud.”

The administration says its actions are necessary because fraud diverts taxpayer money from people who legitimately qualify for government programs.

“The fraud doesn’t just steal money 鈥� it steals our trust,” Oz said in August on .

Democrats and healthcare advocates say the White House’s anti-fraud crusade is being used by Republicans to distract from criticisms over its to Medicaid, the ACA, and other federal health programs.

Republican-backed legislation enacted last year is projected to reduce federal Medicaid spending by hundreds of billions of dollars over a decade.

Congressional Republicans also declined to extend enhanced ACA premium subsidies that expired , increasing premium costs for many people who buy insurance through the marketplaces. Enrollment has since declined by millions.

Overall, the combined effect of GOP-led changes will result in more uninsured people by 2034, according to an analysis by the Congressional Budget Office.

Those changes have given Democrats an opening to campaign on protecting healthcare coverage and affordability while Republicans seek to shift some of the debate toward fraud and government spending.

“It’s really a way to distract and reframe the cuts in a different way, to say it’s part of an anti-fraud effort,” said Anthony Wright, executive director of Families USA, an advocacy group focused on expanding health coverage. “Fighting fraud shouldn’t result in people losing coverage.”

This article first appeared on 吃瓜不打烊 and is republished here under a .

Not all of those kicked off were fraudulently enrolled, 吃瓜不打烊 has learned. Insurance industry sources said the Centers for Medicare & Medicaid Services has reinstated a small number of people whose coverage should not have been canceled. More could follow in the coming weeks if enrollees discover they are uninsured when they go to use their coverage.

Still, the sweep was long overdue, say supporters such as Brian Blase, whose Paragon Health Institute has of the cited by those who allege in the ACA. But other policy experts question how many legitimate consumers were caught in the dragnet, perhaps because they failed to open a letter from their insurer or answer a phone call.

Questions continue to swirl, even as a second phase of the anti-fraud effort is underway. An additional 419,000 sign-ups are being scrutinized. Insurers must let CMS know how many of those enrollees don’t respond to outreach efforts by “around mid-to-late November, after the midterm elections,” said David Merritt, senior vice president of external affairs at the Blue Cross Blue Shield Association.

He confirmed that some BCBS members are among those who have been reinstated. He also said that CMS has an expedited review process for those who discover they have been improperly disenrolled.

Overall, however, the administration is providing few details about the cancellations, such as how robust the outreach was to those it targeted, how long it takes for people to get reinstated after discovering their coverage was wrongly canceled, and how many such cancellations have been reversed.

“It may be true that some of those enrollments were not authorized, but it can be equally true that people got lost in the shuffle and have a valid enrollment. Without more information, it’s almost impossible to tell,” said , a director of the Center for Health Policy and the Law at Georgetown Law. “That they are not being very transparent is telling too,” she said of the administration.

The enrollment cut comes as part of a larger Republican strategy to focus on fraud in government programs, including and , which resonates with GOP voters.

At an Oct. 14 press conference, Health and Human Services Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz touted the removal this year of subsidies for with duplicate Medicare, Medicaid, or Children’s Health Insurance Program coverage, citing not fraud but a failure to look for concurrent enrollments or continued coverage for dead people. They credited an by the Trump administration to restore more frequent data matching checks than were done under the prior administration.

Unauthorized sign-ups by rogue insurance agents seeking commissions and other potential impropriety in the ACA marketplace 鈥� applicants’ providing incorrect income estimates, for example 鈥� has been a concern for several years, with much debate over the magnitude of the problem.

Even so, how the recent move to cancel the 760,000 enrollments will play out politically is uncertain. with gas prices as a top concern for voters. It is likely that many removed from the ACA are in red states, such as Texas, Florida, Louisiana, and Mississippi. Those areas in ACA enrollment from 2020 to 2025, driven in part by now-expired enhanced subsidies put in place during Joe Biden’s presidency. Additionally, the cancellations target only enrollees in states that use , the federal ACA marketplace. The fully running their own marketplaces generally have programs, such as multifactor authentication, and have reported few or none of the kinds of unauthorized sign-ups plaguing the federal marketplace.

“To the extent there is a reaction depends on whether the government got it wrong, whether people try to get care and then find out their coverage is no longer active,” said Adrianna McIntyre, assistant professor of health policy and politics at the Harvard T.H. Chan School of Public Health.

How It Played Out

According to information the agency provided to 吃瓜不打烊, CMS in June selected for further review nearly 1.2 million enrollments that had all of what it deemed four warning signs for fraud:

• The application included no Social Security number or immigration document number.
• A broker was involved in the sign-up process.
• The plan had no monthly premium payment.
• The enrollee had had no contact with their insurer and no claims filed.

Then, as first reported by 吃瓜不打烊, CMS sent lists of those ACA accounts to specific insurers, instructing the carriers to review them and use at least two methods of contact 鈥� such as a phone call and a letter 鈥� to try to reach the enrollees. Policyholders were given 30 days to respond to the insurers’ outreach and provide the missing information. CMS disenrolled those who didn’t respond.

Johnny Wallin, chief operating officer of Texas-based Marketplace Insurance Exchange, which helps clients in about 35 states enroll in coverage, said insurers reached out to his organization for help contacting people on the CMS lists, prompting “an all-hands-on-deck” effort by agents to reach clients, some of whom were vacationing overseas.

“Getting them to answer the phone isn’t easy,” he noted, although he suspects his agents had a better chance of getting a reply than an insurer because their clients are familiar with their phone numbers. Still, they could not reach about 60 of them.

Additionally, his team has been asked by insurers to help contact those targeted in the second phase of CMS’ review. A recent case involved a client who needed to upload his new green card after his previous one expired, but language barriers meant that he had to take time off work to come in for agents to help with the process.

CMS would not provide a list of the insurers it contacted, but publicly available documents show that New York-based Oscar Health was one.

In an August earnings call with analysts and investors, CEO Mark Bertolini said the company was reviewing the files and that “there are a number of cases ” with people on the list. In other words, the company reached enrollees CMS had targeted over fraud concerns.

He did not specify how many it had reached. The company declined to comment for this article because it is in a voluntary “quiet period,” when publicly traded companies limit disclosing information before the release of an earnings report.

Still, in with the Securities and Exchange Commission, Oscar Health estimated that 250,000 to 300,000 of its members might be disenrolled because of the CMS effort. Nationally, the company had about 3 million members in the second quarter and reported strong profits.

A Smaller Patient Pool

Overall ACA enrollment has , falling by nearly 3 million in the first few months of the year, due in large part to the expiration at the end of last year of the enhanced subsidies. The Trump administration has also taken some credit, saying its focus on weeding out improper enrollments and other changes, such as eliminating a special year-round low-income enrollment period, led to the decline.

CMS has also suspended some brokers for improper activity and barred new brokers from enrolling clients in ACA insurance on the federal exchange during the upcoming open enrollment period.

CMS did not respond to requests for data on the reasons it canceled enrollments. What percentage of enrollees were deemed ineligible due to incorrect income reporting or because they had other health coverage, such as through their jobs? How many because their ACA applications lacked immigration documents or Social Security numbers?

“Currently, there is no additional data to share,” the agency’s press office said.

But people outside the administration have been vocal.

“This was clearly phantom enrollees,” said Paragon’s Blase. He thinks more than 99% of the cancellations are of zero-premium coverage that people were signed up for by rogue call centers without their knowledge, or for people who don’t exist at all.

Blase said the carriers had a big incentive to get hold of the enrollees because they would lose the subsidies they were being paid if the plans were canceled.

And for any people unfairly caught up, Blase and Trump administration officials say all they have to do to be reinstated is call the marketplace and provide their Social Security number or other missing information.

“Everyone has the political incentive for that process to be that easy,” Blase said. “We’re a month before the election.”

But, as prior reporting has shown, it isn’t always a quick process to get an ACA plan canceled or reinstated following an unauthorized sign-up or switch, even when a consumer discovers it themselves and reaches out to the marketplace.

Brokers and policy analysts note that some of the factors used to question enrollments 鈥� such as a plan’s having no claims filed in a year 鈥� are not that unusual because many people don’t visit a doctor or hospital in a given year.

Insurers “want those healthy people in the insurance pool to help bring down the rates,” said Ronnell Nolan, president and CEO of Health Agents for America, a trade group for health insurance agents. “We’re against fraud, and CMS has allowed a lot of fraud to happen. But we don’t want people who just didn’t go to the doctor to be canceled.”

And even with the outreach required by CMS, not everyone answers phone calls from unknown numbers or opens their mail or emails.

A found an average “open rate” on emails of 28.6%.

Policy experts also note that, while lack of a Social Security number on an ACA application could indicate a fake enrollee, it might also be an oversight, or the number might not be required, like for a child if the who is not seeking coverage for the child.

“There will be legitimate people who don’t have a claim or don’t respond to an inquiry from an insurer,” said , a senior fellow at the Brookings Institution. “If the goal is to target fraudulent enrollment, what CMS did is better than tossing people at random, but is likely to miss the mark.”

This article first appeared on 吃瓜不打烊 and is republished here under a .

“It was like I was underwater, like it took the most to do anything,” he said.

Meetze stopped taking the drug but endured fatigue and anxiety for months afterward, and his eyes and muscles twitched, he said.

He had taken BPC-157, a peptide drug popularized by podcasts about wellness, longevity, and what’s called “body optimization.” “Peptide” is a general term for substances that are smaller than proteins but composed of the same building blocks. Dozens of , including insulin and GLP-1 weight loss medicines, have garnered approval by the Food and Drug Administration. But BPC-157 and many others have not because they haven’t undergone clinical trials.

This fact hasn’t stopped online influencers from promoting them as remedies for muscle injuries, gut issues, covid, and more. Use of BPC-157 is growing in the U.S., particularly among white males, according to a of millions of de-identified electronic health records. Since 2020, the analysis, which hasn’t yet been published in a peer-reviewed journal, found that more than 1,000 people told doctors they had used the drug.

Meetze said he decided to take BPC-157 after listening to Andrew Huberman, a Stanford neuroscientist with more than 16 million followers on YouTube, Instagram, and TikTok, who talks up peptides frequently . Studies in mice suggest that BPC-157 helps muscles heal and has “very high safety profiles,” Huberman , “at least, with respect to the lethal dosing.” His guest on , Craig Koniver, a doctor who sells peptides through his wellness clinic, called BPC-157 “super safe” and recommended it for “anyone who’s working out on a regular basis.” Koniver did not respond to requests for comment.

Huberman didn’t respond to multiple queries from 吃瓜不打烊, but an automatic reply on his Huberman Lab website that says the podcast doesn’t constitute medical advice: “Any reliance on information provided through the podcast is solely at the user’s own risk.”

Hoping BPC-157 might help him advance as a weightlifter, Meetze said he bought the drug last year from an online vendor, Researchem. A chemical supply company with that name sells experimental peptides , warning that the substances are “solely for laboratory research” and are “not intended for human consumption.” (It lists an address in Hillsboro, Oregon, that corresponds to a shared office space. A receptionist at the space said Researchem wasn’t registered there, and multiple queries from 吃瓜不打烊 to the email address listed on the website went unanswered.)

Companies are required to warn that experimental peptides, which haven’t been approved by the FDA, are for research use only. But many companies may soon be permitted to drop the warning because of a push by health secretary Robert F. Kennedy Jr. to lower barriers to their use. He and other leaders of the Make America Healthy Again movement have promoted peptides as a way to improve the country’s health.

On the social media platform X, before he took the helm at the Department of Health and Human Services, Kennedy the “aggressive suppression” of “peptides, stem cells, raw milk” and “anything else that advances human health and can’t be patented by Pharma.” (In fact, peptides are heavily patented.)

He has repeated the pledge since taking office. On early this year, Kennedy said he was a “big fan” of peptides and wanted to make many of them “more accessible.” On a podcast with the co-chair of the MAHA Action committee, Gary Brecka, the FDA’s role should be to assess science, “but not tell people and not tell physicians what they can and cannot prescribe.”

“If you want to take an experimental drug,” he added, “you ought to be able to do that.”

This summer, Kennedy’s health department with financial stakes in the peptide industry to a panel that advises the FDA. At an in July, the new appointees voted to ease restrictions on six experimental peptides, including the trendy compounds BPC-157, TB-500, and MOTS-c. Specifically, they advised adding these peptides to a list, called 503A, that would allow specialized pharmacies to make the drugs for human use, even though the FDA hasn’t approved them.

In an email, HHS spokesperson Emily Hilliard wrote that every committee member satisfies the FDA’s ethics requirements. “FDA — not podcasts or politics — determines which substances qualify for inclusion on the 503A Bulks List,” she wrote. The FDA has yet to issue a final decision.

The vote went against FDA scientists who on the six peptides, concluding there wasn’t enough evidence to show they improved any condition. Furthermore, the scientists highlighted a potential for liver damage, allergic reactions, or other serious consequences.

“People are saying this is about medical freedom — putting decisions back in the hands of patients,” said Reshma Ramachandran, a regulatory science researcher at Yale School of Medicine. “But what we see in practice is that incentives aren’t actually centered around patients. They’re centered around selling products.”

Scientists also warned that drugmakers would be reluctant to invest millions of dollars into clinical trials on peptides if they could be sold without FDA approval.

“The chances of clinical trials getting done now are diminished,” said Eric Topol, executive vice president of Scripps Research, a biomedical science institute in San Diego. “We will have more people who are prey to predators that will sell, sell, sell.”

A lack of data leaves consumers in the dark.

Meetze sought help on Reddit, where people post about pain, headaches, vision problems, and a lack of motivation after taking experimental peptides. Peptide enthusiasts often comment on these posts with skepticism, attributing a person’s problems to contaminated products, preexisting conditions, or misuse of the drugs. The online vitriol in the Reddit conversations can be intense, so Meetze welcomed an invitation to join a private group on the social platform Discord in which people with BPC-157 side effects tried to figure out what happened to them and how to fix it.

“There are millions of success stories with these peptides,” Meetze said, “but no one wants to believe that this wrecks some of our lives.”

Wolverines and Migraines

One member of the private side-effects group, a 46-year-old software engineer named Dominik E., said he got an excruciating migraine within days of taking BPC-157 with TB-4, another unapproved peptide — a combination called the “Wolverine Stack” because of its purported ability to heal wounds rapidly, like its namesake Marvel superhero.

“My left eye started throbbing really badly, and the left side of my face became numb,” he told 吃瓜不打烊, which agreed to only partially identify him and others interviewed for this article who were concerned about divulging sensitive health information.

After two months of migraines, Dominik said, the pain eased, but his face felt inflamed. “It is a total nightmare,” he said.

“I’m afraid how people will judge me,” said Lois S., a woman who works at a Michigan elementary school. She hoped BPC-157 and another unapproved peptide, retatrutide, would help with weight loss, but she stopped taking the treatment when she felt pain.

“I sought out this substance from a lab that clearly labeled it not for human use, purchased a syringe, and injected this in my kitchen,” she said. “That belies all logic about what a normal person would do.”

Peptide proponents argue that shoddy manufacturing — not the peptides — causes harm. Therefore, they say, the FDA must protect the public by allowing doctors to prescribe peptides made for human use by pharmacies that specialize in . Typically, compounding pharmacies manufacture alternatives to FDA-approved drugs so a patient can, say, get a liquid version of a drug that the original manufacturer makes only as pills.

Adding unapproved peptides to the FDA’s list of compoundable drugs would mark a departure from the list’s purpose, said Peter Lurie, a former FDA official who now directs the advocacy group Center for Science in the Public Interest. He noted that federal and state oversight for compounding pharmacies is often lax, and they’ve been .

Furthermore, he added, the move would mislead consumers into thinking they’re buying drugs backed by clinical trials. People promoting peptides often point to promising laboratory research as evidence. Rats with spinal injuries after BPC-157 injections, for example, and old mice given the experimental could run longer. On average, however, fewer than 10% of substances that show promise in animal studies prove effective in clinical trials.

“A lot of this pseudoscience stuff sounds deeply impressive — inflammation this and telomere that — but at the end of the day, none of it really matters,” Lurie said. “You’ve got to show clinical benefit in humans: Does it work?”

Peptide promoters lean on anecdotes, often without verifiable numbers. In a at the White House, the MAHA influencer Brecka said: “Twenty million people have been prescribed these things without adverse events.” His guest on the episode, Brigham Buhler — who is the co-author of The Peptide Revolution and owner of a compounding pharmacy that sells peptides and a clinic, Ways2Well, that prescribes them — told Brecka that none of its 75,000-plus patients had reported adverse events from peptides.

Buhler cited even higher numbers in the movie , a documentary featuring Kennedy and other leaders of the MAHA movement and that bears the MAHA trademark. In the segment on peptides, Buhler said: “Having treated literally hundreds of thousands of people through our compounding pharmacy, we’ve never had a major adverse event.”

Topol asks why those boasting success haven’t conducted clinical studies. “If influencers and companies really believe these peptides are helping people,” Topol said, “then they should put their profits back into rigorous research.”

Chris Woodward, a spokesperson for Brecka and his company, the Ultimate Human, said in an email that the health and wellness issues discussed on Brecka’s podcast do not constitute medical advice. “Mr. Brecka consistently advises his audience to consult a licensed physician,” Woodward wrote. Buhler did not respond to requests for comment.

Not all anecdotes are rosy. At an antiaging conference last summer in Las Vegas, two women were rushed to the hospital and intubated after being injected with experimental peptides and vitamins, according to citations that Nevada’s state pharmacy board issued against the doctor running the booth and his colleagues for prescribing and administering drugs without a state medical license.

An for adverse events contains concerning reports. Although the database can’t prove that a drug, vaccine, or medical device caused harm — the reports are brief, unverified, and voluntary — it signals issues worth exploring. A 36-year-old woman was hospitalized in December after taking the experimental peptide BPC-157 for weight control and a skin disorder, for example, and a 48-year-old man was hospitalized with a “life-threatening” condition after taking the peptide.

FDA scientists presented some of these reports at the July meeting and flagged worrisome outcomes in animal experiments, such as a revealing signs of liver toxicity in rats and dogs injected with BPC-157.

Brian Lee, a liver disease specialist at the University of Southern California, was among the panel’s minority who voted against easing restrictions. Without clinical studies, he said, afflictions that take time to develop, like liver damage and cancer, might not be spotted for years: “I think this endorsement can be potentially harmful, and I cannot in good conscience vote ‘yes.’”

The panel’s newcomers disagreed. “I do not believe the FDA made a good case on issues with safety with BPC,” said Kris Wusterhausen, founder of an antiaging company in Texas, the Resurge Clinic, which sells a BPC-157 product for $149.

“Once you’ve seen the effects of BPC,” he said, “you can’t unsee it.”

Awaiting Trial

Deepak Srivastava, president of the Gladstone Institutes in San Francisco, designed a clinical trial two decades ago to see if a peptide he studies, TB-4, could repair tissue after a heart attack. Before enrollment, people volunteering for the study would be screened for early signs of cancer because TB-4 triggers vessel growth and cell migration, which might exacerbate malignant growths. He worries about the FDA panel’s vote to ease restrictions on a derivative of TB-4, before such trials have been completed, saying, “You need to have a healthy respect for the fact that drugs can be harmful.”

Pinchas Cohen, a peptide researcher at the University of Southern California, was less cautious, saying the FDA buzz might drive investors to fund trials. He’s seeking support to bring a peptide his lab identified, MOTS-c, to market. It’s “un-ideal” for people to take unproven drugs, Cohen said, but that’s what’s happening: “The world is changing and people like me need to accept that this is the new reality and find ways to make it as safe as possible.”

In the meantime, people like Meetze resort to podcasts and online forums for advice. His symptoms faded after a year, but he still had spells of feeling “zero emotions.”

Peptide users describe this condition as anhedonia. It’s come up on .

Huberman occasionally mentions other potential peptide risks, like cancer, sprinkling them into advice on how to take them. Take a with 1.2 million views: “I do not think that BPC-157 is not without its quote-unquote ‘side effects,’” Huberman says. “If you’re going to go down this path of taking BPC-157, I would encourage you to take the minimal effective dose, to not simply do it every day, and certainly to not do it continuously, and of course to monitor your other health metrics for anything that could potentially resemble cancer or tumor growth, because obviously stimulating angiogenesis for wound repair sounds like a great thing, recovering and being able to do your workouts or play your sport, or move about more comfortably, of course, a wonderfully attractive thing to do.”

“Isn’t that what we all want? But obviously not with the trade-off of growing a tumor,” he said, before interrupting the discussion to advertise a supplement company sponsoring the show.

This article first appeared on 吃瓜不打烊 and is republished here under a .

As that campaign has unfolded, administration officials have granted tech companies an unusual opportunity to nudge the nation’s health department toward a loosely regulated future for AI health apps in which the government reimburses them for services as it does medical professionals.

In February, federal health officials invited those businesses — including tech giants Microsoft, Anthropic, OpenAI, Apple, and Google — to a listening session on conversational AI products for patients, such as chatbots. Representatives from at least 35 industry organizations attended the meeting held by the Food and Drug Administration, which is responsible for regulating health apps as medical devices. Companies were prompted in advance to explain their AI products and how they access patients’ sensitive medical information.

But the meeting did not appear on the FDA’s public calendar or regulatory notices, nor was the public invited. Rather, the invitation for a select group to help shape federal policy governing AI in healthcare was extended in a chat room on the messaging service Slack.

“This is a great opportunity to support HHS’ goals and share your state-of-the-art understanding of safe Conversational AI development and monitoring to help FDA shape future guidance,” CMS senior policy adviser Morgan Taylor wrote in the Slack workspace.

The Centers for Medicare & Medicaid Services has not formally announced the chat room through federal regulatory channels, though CMS officials have talked about it at industry conferences. Legal experts said the chat room resembles a federal advisory panel, which would be required to operate in public view.

吃瓜不打烊 reviewed thousands of Slack messages, meeting transcripts, and video recordings that reveal how the Trump administration has granted the industry a direct line to top government officials — including former head of the Department of Government Efficiency .

The conversation took place behind the scenes as federal health officials publicly worked to integrate AI and other technology into nearly every aspect of healthcare, a plan they’ve branded the “.”

“We wanted to give industry a chance to play in the sandbox of government-supported healthcare,” CMS Administrator Mehmet Oz at the public launch of an initiative that allows health apps to bill Medicare for AI services such as wearable device tracking. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. delivered an enthusiastic endorsement of AI in healthcare, claiming it is “much better informed than any doctor in the country.”

Meanwhile, HHS staff even promised that a recently launched would serve as a lucrative pipeline for those businesses to get new users. The library’s webpage currently promotes only two dozen commercial apps to millions of American seniors and those with disabilities.

, Americans will get easier access to their medical records so apps can swiftly provide health or wellness advice. In practice, however, so will the tech companies.

Doctors, meanwhile, are increasingly worried about how patients use and share their medical records with the nascent technology.

“Some of these tools just aren’t ready for primetime,” said John Whyte, CEO of the American Medical Association. “We don’t have enough data about them. We don’t understand how they work, how they’re using the information. There’s no liability if these tools get things wrong.”

CMS officials declined to answer several questions about the Slack workspace, including about its legality.

“CMS is focused on giving Medicare beneficiaries greater access to their health information and useful digital tools while promoting an open, interoperable healthcare system,” Gleason, now chief product officer for the newly created Office of Health Technology and Products at CMS, wrote in an emailed statement. “The Health Technology Ecosystem is an open, voluntary technical collaboration. CMS will continue working with patients, providers, payers, technology organizations, and other stakeholders to make health information more accessible and useful to the Americans it serves.”

The FDA did not respond to a request for comment.

The Conversation Begins

The behind-the-scenes effort to funnel more Americans to AI-powered health apps began in August 2025 in the Slack workspace.

“Welcome all!” Gleason wrote. “Please be sure to read the Code of Conduct and see the Channel list as well to help you find channels that are relevant to you.”

Gleason is best known as the acting administrator of Elon Musk’s Department of Government Efficiency, as it to millions of Americans’ sensitive personal and financial data, including at the Social Security Administration.

As her work with DOGE wound down last year, Gleason welcomed a variety of tech leaders, investors, and entrepreneurs to the chat room.

The Slack workspace’s participants include representatives from major digital wellness companies like Oura Health, AI companies like Palantir, and investment outfits like 8VC, associated with Kennedy’s . While the Slack’s member count has ballooned to 1,700 over the past year, only a handful of patient advocates, doctors, and hospital representatives are in it.

The code of conduct Gleason shared on Slack in August 2025 documented that CMS had quietly established a technology working group.

The document also set ground rules for the Slack workspace, noting that the group does not constitute an “advisory committee,” nor would it be used “to obtain advice or recommendations for HHS, CMS, or any HHS/CMS officials.” The code also advises that federal employees “are prohibited from endorsing any product, service, or enterprise.”

Joseph Daval, a former FDA lawyer who is now a research specialist at Harvard Medical School, reviewed messages from the Slack workspace at the request of 吃瓜不打烊. He said the chat room in some ways resembles a federal advisory committee — an independent panel that can be formally stood up by an agency head, Congress, or the president to ensure agencies act in the best interest of the public rather than industry.

The law on advisory committees “was passed in part out of a concern about interest group capture, about anticompetitive capture of agency policymaking, about corruption,” he said.

Daval said the chat group looks like a committee, with members interacting with one another and building consensus on preferred courses of action.

If it were a formal advisory committee, though, Daval said, it would be subject to certain “membership requirements having to do with independence and fair balance.”

A ‘Sales Engine’

Over a series of video calls, CMS officials promised tech leaders participating in the Slack workspace that the agency would promote their health apps.

Jacob Shiff, the chief AI and technology officer at CMS’ Innovation Center, told industry representatives in a Zoom meeting in February that he hoped the agency’s work would be a “sales engine” for the health apps.

“We’re going to have a directory of all the organizations,” Shiff said in a video recording reviewed by 吃瓜不打烊. “The people on this call who hopefully will have amazing solutions that work will be the winners, and you have every incentive to obviously drive down your costs so you can be extremely profitable and scale. So hopefully we’re selling — or enabling you guys to thrive.”

A recording of the call had been publicly available through a Google Drive link but was made private the day after 吃瓜不打烊 asked about comments made during the meeting.

CMS did not respond to queries about how the agency has decided which AI-powered health apps appear in the Medicare App Library or why federal employees have promised to promote the products.

Days before publicly launching the Medicare App Library, CMS officials promised AI tech leaders during an informal meeting that the new webpage would become an important distribution channel for health apps because Medicare enrollees would place trust in products listed on the CMS website.

“If medicare.gov is promoting it, for lack of a better word, then yeah, it would be an app that I would trust and explore,” CMS’ Taylor said during the April 7 meeting, channeling enrollees, according to a transcript of the call.

The Medicare App Library’s webpage encourages older and disabled Americans to manage health conditions such as obesity, cancer, or diabetes using two dozen AI-driven apps developed by some of the world’s largest corporations, including Microsoft and Google. Many of the apps promise in their product descriptions to give insight, perform analyses, or develop plans that will help patients lose weight or manage diabetes.

CMS officials have suggested to tech representatives during at least two meetings this year that those apps will be prioritized for a new agency program that reimburses companies for AI chatbot advice or wearable device tracking, according to video recordings.

CMS has not publicly divulged all the criteria it uses to decide which apps are listed in its library, but the webpage promotes apps still in their infancy.

Among them is Slothwise, a health app launched this year from a San Francisco apartment by a young, biotech entrepreneur and triple citizen of Russia, Israel, and the U.S. says it “knows your whole health” by analyzing medical records and tracking health data, offering users a free option with limited functionality or its full features for $9.99 a month. It has been reviewed on the Apple and Google app stores only a handful of times.

“I trusted slothwise with my health info because it was endorsed by medicare,” one reviewer wrote in a in August. “Connecting info was smooth and I learned a lot about my health.”

In a statement, Slothwise CEO Sofia Sigal-Passeck did not answer questions about the size and medical expertise of her current team, nor about the availability of a doctor to consult with patients who use the app. The app, she said, is only “informational” at this time.

“I’ve spent years building at the intersection of AI and complex biological data,” Sigal-Passeck wrote in an email. “A small team is not the same thing as an inexperienced team. Slothwise is built by physicians, PhD researchers and engineers.”

‘No Regulation, No Rulemaking’

What’s often less clear — and buried deep in lengthy privacy policies — is that these apps are tapping into the intimate details of patients’ medical records to fuel their AI-driven analyses.

Tech vendors have to treat these apps, once they are vetted and authorized by a third-party organization, like a patient requesting records. That position gives apps sweeping access to pull sensitive health data from the national network through which providers electronically exchange medical records, called the , or TEFCA.

A small but influential group of those tech company executives directly made the case to federal health officials during a in May, arguing that when health apps request medical records they should be treated as if they are standing “in the shoes” of a patient.

On Slack, tech vendors have lobbied for a “frictionless pathway” for verified users, after they’ve consented once, that allows the app to gain limitless access to patients’ medical records from the TEFCA network.

Ryan Howells, a healthcare management consultant who lobbies for a Washington, D.C.-based digital health tech organization called the CARIN Alliance, has spearheaded an effort for patients — vis-à-vis apps — to more easily access medical records. He has regularly noted in Slack that health apps accessing TEFCA must be vetted by a third-party organization — one of which he sits on the board of — and agree to a code of conduct, developed by the alliance he lobbies for.

“What more can you do to have trust in these apps?” he wrote in a March Slack message, responding to concerns about how much patient consent is needed for apps to access medical records on the network.

Kristen Valdes, the CEO of b.well, a company that also connects apps to the TEFCA network, made a similar argument.

“My opinion is that we need to stop protecting patients from themselves,” she wrote in the same message thread. “Full stop.”

Howells did not respond to an emailed list of questions from 吃瓜不打烊. In an interview, Valdes told 吃瓜不打烊 that her comment reflected her frustration at the “paternalism” of the healthcare system, which she said has historically made it difficult for patients to access their records. Although, she said, “there are going to be good and bad apps.”

Other tech leaders worried in Slack about the approach.

One startup founder cautioned the group to think about the pitfalls of giving health apps broad leeway to pull medical records.

“We might all be good, honest actors here but security & privacy systems have to be designed around the presence of malicious actors – especially if we want this system to scale up to thousands of apps,” wrote Jason Kulatunga, who runs Fasten Health, a medical records management platform.

Gleason, the CMS official, has publicly championed the vision shared by Howells and Valdes. In her speeches, she frequently urges doctors to accept patient medical records directly from apps and calls on them to “,” also the title of a 2025 co-authored by Howells that urges doctors’ offices to abandon paper records.

Last month, Gleason spoke to a crowd gathered at a swanky hotel in Washington for an event hosted by the MAHA Institute, a think tank that supports Secretary Kennedy’s agenda. She laid out her work with tech companies over the past year as she discussed the Trump administration’s efforts to make medical records more digitally accessible.

As she told it, more Americans can now download an app and access their medical records.

“Once you’ve verified your identity you can just click a simple button and say, I’d like my medical records into whatever app I choose,” Gleason said.

She continued: “That was all done just — no regulation, no rulemaking — just by challenging industry to work together.”

This article first appeared on 吃瓜不打烊 and is republished here under a .

吃瓜不打烊 chief rural correspondent Sarah Jane Tribble discussed the findings of a KFF-Associated Press poll about rural support for the Make America Healthy Again movement on NPR’s Morning Edition on Sept. 30.

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• Read Tribble’s “Rural MAHA Followers Say Trump Health Policies Haven’t Reached Their Communities,” co-reported with Ali Swenson and Linley Sanders of the AP.

Céline Gounder, 吃瓜不打烊’ editor-at-large for public health, discussed a new GLP-1 weight loss drug on CBS News’ CBS Mornings and health secretary Robert F. Kennedy Jr.’s comments at a MAHA summit this week on CBS News 24/7’s Mornings, both on Sept. 30.

Gounder also discussed how Anthropic’s Claude agents might help develop new gene-editing technology on CBS News 24/7’s The Daily Report on Sept. 24.

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吃瓜不打烊 senior correspondent Renuka Rayasam discussed聽the Rural Health Transformation Program on WUGA’s The Georgia Health Report on Sept. 25.

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• Read 吃瓜不打烊’ ongoing coverage: Rural Health Payout.

This article first appeared on 吃瓜不打烊 and is republished here under a .

The summer was marred by a massive foodborne outbreak that and the recall of of imported meat, turning the safety of the U.S. food supply into a topic of national conversation and a political cause.

Late-night talk show hosts that included explosive diarrhea. As a precaution, such as Chipotle and Taco Bell , jalapeños, and other suspected products from menus. Some food safety scientists blamed the outbreaks on federal cuts to public health.

These dynamics collectively have raised questions about whether it’s safe to order a salad or burger.

Democrats have come out on the offensive, saying voters worried about the safety of the U.S. food supply should oust Republicans in the midterm elections. The Trump administration has countered by accusing Democrats of scaremongering over food safety to score political points.

The political fracas reflects the toll that large-scale outbreaks have had on the public psyche. Midterm voters have long cared about pocketbook issues such as grocery prices, but the spate of recalls has them worried about whether the food they’re buying is safe to eat 鈥� and political leaders are paying attention.

The outbreak linked to cyclospora in lettuce led to almost 20,000 laboratory-confirmed cases of illness from May through August, compared with 1,180 cases during the same span in 2025, according to the Centers for Disease Control and Prevention. That makes it the largest recorded outbreak of the parasite.

“One of the reasons food safety is in the news this year, and people have been rightfully concerned, is the combination of high-profile restaurant names and the absolute colossal number of illnesses,” said , consumer watchdog director with the U.S. Public Interest Research Group, or PIRG, an advocacy group, referring to a recent cyclosporiasis outbreak. “It’s thousands of people. It makes it more real.”

there have been about , which is about on par at this time last year, according to PIRG data.

Following the Numbers

A majority of registered voters have little or no confidence in government oversight of food safety, with Democrats far more likely than Republicans to doubt the protections in place, by Quinnipiac University. of U.S. adults indicated they were concerned about the frequency of food recalls in a poll by GS1 US, a data standards organization.

The share of consumers who strongly agree that the U.S. food system produces food that’s safe to eat declined to about 30% in August, from 40% in November, released in September by the University of Illinois and Purdue University.

Democrats have jumped at the chance to repeat criticisms of President Donald Trump’s budget cuts and priorities.

The Democratic National Committee on social media while calling Health and Human Services Secretary Robert F. Kennedy Jr. a “complete disaster” who must resign.

“Trump is dismantling our government 鈥� and it’s harming people,” Sen. Elizabeth Warren (D-Mass.) posted , adding: “Slashed food safety agencies 鈫� cyclospora outbreak.” Just weeks earlier, she had written to Kennedy demanding answers for what she described as the administration’s “” and its connection to political contributions.

Rep. Gabe Amo (D-R.I.) : “I’m calling on Trump to stop gutting the FDA & restore its inspectors. We deserve safe food.”

The campaign for Rep. Judy Chu (D-Calif.) : “Trump is cutting our food safety funding and workforce, and we have seen far too many food recalls this summer.”

But the number of recalls doesn’t tell the whole story.

While recalls aren’t markedly up this year compared with 2025, they are up over a broader time span. The country saw 320 food recalls by the Food and Drug Administration and the U.S. Department of Agriculture in 2025, up from 296 in 2024, .

The total number of recalls grew 21% from 2021 to 2025, based on an , a provider of regulatory guidance software. A rise in Class I recalls, which are the highest priority because the products could cause serious illness or death, drove much of the increase.

But recall numbers can be misleading. For starters, federal agencies do not publicize all recalls, especially if products are no longer on the market. Recall data itself is suspect because a single contaminated food can result in multiple recalls if the item is incorporated into processed food or other products.

A far better measure is the number of people sickened, epidemiologists say. And this summer’s specific multistate outbreak from cyclospora was exceptional, affecting people in 21 states.

When it comes to bacterial contamination of food 鈥� which is more common and includes E. coli, listeria, and salmonella 鈥� the overall trend points to outbreaks in which fewer people are falling ill. That’s a promising sign, some food safety leaders say, although the CDC says an estimated each year in the U.S. experience foodborne illness.

“That’s an indication we’re finding more outbreaks and finding more when they are smaller and limiting the extent to which they can get bigger,” said , a public health professor at the University of Minnesota and leader in food safety surveillance.

Still, the perception that the food supply is riskier has been enough to ignite political rancor.

The FDA recently that recalls for fiscal year 2026 are among the lowest levels recorded in over a decade, stating, “Don’t believe the fake news.” It included a chart that showed recalls dropping to 1,836 in fiscal 2026 from almost 4,000 in fiscal year 2013.

On the same day, doubled down on the claim, that Kennedy is doing so well that Democratic operatives are slamming the FDA for doing its job by conducting food recalls.

“It makes sense that these craven, disingenuous attacks are all these influencers have,” he wrote.

But some food safety experts question the numbers, noting that the agency’s recall totals cover a range of products. The tally also includes drugs and medical devices, based on an by , who was director of the FDA’s Center for Food Safety and Applied Nutrition from 2015 to 2023. Some food safety leaders say it’s misleading to imply that food safety recalls have declined if the data the claim is based on includes recalls not related to food.

“This HHS assertion appears to be based on incorrect data,” Mayne said on LinkedIn, a job-oriented social networking site.

It’s About More Than Recalls

Food safety has occasionally taken center stage in politics. In 1993, for example, an E. coli outbreak traced to Jack in the Box fast-food outlets pressured newly inaugurated President Bill Clinton to make it an at his first Cabinet meeting. His administration wound up adopting a new approach focused on preventing foodborne illness and credited with drastically reducing E. coli infections.

Concern about food safety has especially taken hold now, public health leaders say, because the administration is portraying itself as a safety crusader while cutting staffing and funding for federal agencies responsible for surveillance and inspection.

“There’s a level of hypocrisy from the administration when they promise to make our food safer and then eviscerate the agencies and programs that detect and prevent outbreaks,” said , regulatory affairs director at the Center for Science in the Public Interest.

The FDA continues to have the staff required for outbreak investigations, and no FDA investigators were affected by staffing changes or reductions in force, HHS spokesperson Grace Davis Jamison said in an email.

The CDC lab supporting foodborne outbreak investigations also was not impacted by reductions in force, she said, and the agency maintains a dedicated team investigating foodborne outbreaks and working closely with state and local health departments.

“The Trump Administration has mounted a robust response to each outbreak, working closely with health departments in all 50 states and leading the public health response by promptly identifying known sources and providing Americans with the information they need to protect themselves,” she said.

The administration’s initiatives risk weakening food safety protections. Trump in late August said he would take action to make it easier for small livestock operations to , raising concerns among food safety leaders that the change could allow inadequately inspected beef to enter the food system.

Trump also announced the U.S. would , despite concerns about inspections and safety. The European Union has on Brazilian beef imports because of noncompliance with food safety and antibiotic use.

The administration that would have stopped the sale of raw turkey and chicken containing high levels of salmonella. And it said it would delay requiring grocery stores and companies to trace food in their supply chains, allowing for quick removal in cases of contamination. Implementation, originally set for Jan. 20 of this year, would instead occur in July 2028.

The actions came after hearing concerns from stakeholders about the time needed to comply, Davis Jamison said.

Some food safety leaders say the administration should do more to prevent foodborne illnesses, saying that failing to direct more resources into preventing problems makes it harder for Kennedy’s campaign to encourage people to eat more fresh foods.

In fact, almost half of consumers changed their habits regarding which groceries they bought and 40% modified purchases at restaurants in the past month due to foodborne illness concerns, according to the survey by the University of Illinois and Purdue University. Concerns about foodborne illness exposure via fresh vegetables increased in August compared with feedback from the previous two years.

“If you want people to eat real food, fresh fruits and vegetables, they have to be safe,” said Sandra Eskin, chief executive at , a nonprofit public health organization. “Instead, we have had farmers plowing under fields because people aren’t buying lettuce.”

This article first appeared on 吃瓜不打烊 and is republished here under a .

吃瓜不打烊 contributor Erin Rode discussed California prison heat protections on KVPR’s Central Valley Daily on Sept. 24.

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• Read Rode’s “California Eyes Prison Heat Protections That Fall Short of Workplace Standards.”

吃瓜不打烊 chief Washington correspondent Julie Rovner discussed the removal of more than 750,000 people from Affordable Care Act coverage over fraud claims on WBUR’s Here & Now on Sept. 23. Rovner also discussed “Medicare for All” on WNYC’s The Brian Lehrer Show on Sept. 22.

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吃瓜不打烊 senior correspondent Stephanie Armour discussed health secretary Robert F. Kennedy Jr.’s comments to an anti-vaccine group that he founded and the surgeon general nominee’s contradictory comments in her confirmation hearing on WBUR’s Here & Now on Sept. 18.

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Céline Gounder, 吃瓜不打烊’ editor-at-large for public health, discussed聽Kennedy’s comments on CBS News 24/7 on Sept. 17.

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This article first appeared on 吃瓜不打烊 and is republished here under a .

One problem cited: The manufacturer had provided only

As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market.

Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a . As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an and .

Meanwhile, the FDA has dozens of cases of “possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.

Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices 鈥� and the frequent lapses in follow-through.

A 吃瓜不打烊 analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.

As a result of delays, patients, doctors, and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health, or their lives on the products.

Postmarket study requirements “have often proven toothless,” said cardiologist , an associate professor of medicine at the University of California-San Francisco who has published .

The FDA’s reliance on postmarket studies reflects a balancing act.

Making new treatments available faster can save or improve lives, especially when patients with grim prognoses and no good options have little to lose. The full risks and benefits may be revealed only over the long term, and when therapies are used by far more people than even large clinical trials enroll.

But relying on post-approval studies to resolve questions risks exposing patients to products that do more harm than good. Whoever is paying the bills 鈥� patients, insurance companies, employers, or government health programs such as Medicare and Medicaid 鈥� can end up wasting money and rewarding manufacturers for useless or risky products.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty,” Dhruva said.

Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.

For example, in February, that “the default requirement” for agency approvals will be one clinical trial instead of two.

Reducing pre-approval testing “will inevitably put a lot of pressure on the post-approval system,” said , a professor at Harvard Medical School who postmarket studies.

FDA officials said the new policy would “substantially reduce costs” for manufacturers and “speed drugs to market.” Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that “erroneous conclusions may be reached even with two, three, or four studies.”

In response to questions for this article, a spokesperson for the Department of Health and Human Services, which includes the FDA, said postmarket studies can experience delays for legitimate reasons. “Assessing the significance of any delay requires a case-specific review,” said the spokesperson, Emily Hilliard.

The fact that a study is delayed “should not be treated as evidence that a product has an unresolved safety or effectiveness issue,” Hilliard said.

Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, “We remain committed to completing this important study.”

Behind Schedule

An FDA database downloaded by 吃瓜不打烊 in August tracks the progress of postmarket studies that makers of 鈥� such as vaccines and gene therapies 鈥� were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

Of those, more than 250 originally had final reports due before July 31, 2026 鈥� the date that, according to an FDA webpage, the database last had been updated.

About a third of ongoing studies were listed as delayed.

In some cases, the FDA has granted extensions. In others, it has denied them. And in rare instances, the products were discontinued before the studies ran their course.

Postmarket studies can involve clinical trials or other analyses of patient data. They can look at safety or efficacy. A product can be the subject of more than one postmarket study.

The nearly 600 delayed studies involved almost 350 products, 吃瓜不打烊 found.

The FDA has defined delayed as . That can mean off track or overdue.

As of August, other FDA databases tracking listed dozens of postmarket studies as behind schedule.

Products included:

The CustomFlex Artificial Iris, a prosthesis implanted in the eye in place of damaged, defective, or congenitally missing irises. The protocol for a study in children was accepted in 2019, the database said. The study was meant to follow patients for five years. According to an FDA page downloaded in August, zero patients were enrolled.

Barbara Fant of Clinical Research Consultants, to whom the FDA’s 2018 letter approving the product was addressed, said the rarity of an eye disease called aniridia poses challenges for post-approval studies. The German manufacturer, the U.S. distributor, and Clinical Research Consultants are working with the FDA to identify alternative ways to fulfill the postmarket requirements, Fant said.

“Confirming the long-term safety of the device remains a top priority for both the study team and FDA,” Fant said.

Paxlovid, a treatment for covid. A study to assess its safety in pregnant women was originally to be completed by the end of 2024, the FDA database said. “The trial completion and final report milestones were missed,” the database said.

Pfizer, the manufacturer, is working with the FDA and remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts said.

The Scandinavian Total Ankle Replacement system. The device and the original protocol for the clinical trial were approved in 2009. The study was meant to include a minimum of 500 subjects, the database said, but the actual number enrolled was 142. Almost half those patients had one or more adverse events, with dozens of “reoperations,” “revisions,” or “removals,” the database said.

Rachel Colloff and Cristina Pasquino 鈥� spokespeople for Enovis, which markets STAR Ankle 鈥� did not respond to multiple inquiries. Jenny Braga, a spokesperson for Stryker, which previously sold the product, did not answer questions about the postmarket study.

Oxaydo (originally named Oxecta), a form of the potentially addictive opioid painkiller oxycodone . When the FDA approved it in 2011, it required the manufacturer, , to conduct a postmarket study to assess whether it reduces “misuse and abuse, and their consequences: overdose, death and addiction.” The final report was originally scheduled to be submitted in 2016.

The FDA database listing the study as delayed said the agency “issued a failure to respond letter” in 2022.

Today the issue may be all but moot.  

Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a that patents on Oxaydo would begin expiring that year and it didn’t intend to continue marketing the drug.

According to another FDA database, Oxaydo .

The FDA has enforcement powers and uses them “where appropriate,” HHS’ Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.

Delay Can Pay

For manufacturers, delay can pay, Harvard’s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.

“Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory trials past their original planned completion dates,” the HHS Office of Inspector General .

The FDA can demand postmarket studies for a variety of reasons, including to address concerns that arise after a product has been approved. Some look at uses not covered by the original approval, and some are meant to shed light on that are already known.

In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct additional research to assess a variety of concerns, including “retained gastric contents,” “major adverse cardiovascular events,” and “drug-induced liver injury,” as well as effects of exposure during pregnancy, such as “major congenital malformations,” “spontaneous abortions,” and “stillbirths.”

The FDA said it approved the drug under the new Commissioner’s National Priority Voucher program, intended for products that “.” The program strives for an “” review, the FDA has said 鈥� one to two months, instead of six months or more with other expedited pathways.

“Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA’s approach to evaluating newly approved medicines,” Eli Lilly spokesperson Kristiane Silva Bello said, “including ongoing monitoring in areas identified during clinical development.”

鈥楩alse Hope’

The FDA waded into a world of uncertainty in 2016 when it granted accelerated approval to a drug for Duchenne muscular dystrophy, a degenerative disease that primarily affects boys, disabling them at a young age and ultimately killing them.

Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.

Ellis Unger, then a senior drug evaluation official at the FDA, that “thousands of patients and their families would be given false hope in exchange for hardship and risk.”

The manufacturer, Sarepta Therapeutics, . “A clinical benefit of EXONDYS 51 has not been established,” it said when the drug, also known by the generic name eteplirsen, was approved.

The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.

The FDA required Sarepta to conduct further studies and it could withdraw approval if postmarket trials failed to verify a clinical benefit or were “not conducted with due diligence.”

Unger issued a warning of his own: “FDA has not succeeded in withdrawing the marketing of a single drug for lack of verification of clinical benefit following accelerated approval. The reality is that if eteplirsen is given accelerated approval, it is highly likely to remain on the market indefinitely, irrespective of whether or not efficacy is verified.”

Sarepta was originally required to submit a final report on a postmarket study by a May 2021 deadline, according to an FDA database and a 2016 FDA letter to the company.

Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database as delayed.

“The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,”  the database said.

Meanwhile, in 2022 the website ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.

Last year, the drug generated for Sarepta, according to a company presentation to investors.

Sarepta found it difficult to recruit patients for the postmarket clinical trial, company spokesperson Tracy Sorrentino said. The target population is small, patients were hesitant to enroll, and Sarepta was competing with other clinical trials for participants, Sorrentino said.

The study has been fully enrolled since 2023, Sorrentino said, and the company plans to provide an initial look at the data late this year.

鈥楳补苍颈辫耻濒补迟别诲’

Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.

When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen’s Chartan said.

The clinical trial supposed to be done . As of July 24, just 49 patients had been enrolled, Chartan said.

The FDA has said the study was to include , and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.

Tavneos was approved to treat severe cases of a group of diseases 鈥� known by the shorthand ANCA-associated vasculitis 鈥� in which, as the explains, the immune system inflicts potentially fatal damage on blood vessels and organs. 

“As of January 2026, estimated real-world exposure” to Tavneos “exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,” Amgen has said. (For context, one patient taking a drug for five years would amount to five “patient-years.”)

A clinical trial sponsored by ChemoCentryx to secure approval of Tavneos failed to prove it was effective, the FDA now alleges. Instead of disclosing that outcome to the FDA, company personnel “” the , the FDA alleged in an to Amgen.

Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data “.”

Nonetheless, the recently of Tavneos.

The FDA is trying to , and Amgen is fighting that effort.

The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the , and when Amgen in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.

In a June , Amgen said the benefits of Tavneos outweigh the risks.

The FDA disagrees.

The FDA “can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,” .

Citing 76 cases of DILI 鈥� 鈥� the agency said it was “increasingly concerned about the safety profile of TAVNEOS.” Without proof of effectiveness, at least for its approved use, “the drug’s benefits its known risks,” the FDA wrote.

Data reporter Maia Rosenfeld contributed to this report.

This article first appeared on 吃瓜不打烊 and is republished here under a .

On a weekday morning in a quiet Boston neighborhood, a kitchen bustled with activity. Volunteers sliced chicken breasts, stuffed bell peppers, filled trays, and carefully labeled each item. It was part of an experiment to offer nutritious and medically tailored meals to Medicaid patients who are unable to shop for groceries and cook for themselves.

“Once I started to eat these meals that were geared toward my illness, I built up my muscle mass again, built up my strength, built up my confidence in myself,” said Vanessa Georges, who is in remission from throat cancer and said she would struggle to consume enough calories without the deliveries. “These meals have given me a second chance.”

Georges said she noticed another benefit from the meals: She spends less time at the doctor’s office.

Researchers have found evidence backing her observation. About 1,900 Massachusetts residents who, like Georges, received medically tailored meals for at least three months needed less medical care, according to published in the journal Nature Medicine. They had 20% fewer emergency department visits and 31% fewer hospitalizations than similar patients who did not receive meals.

“It actually saves the healthcare system money,” said , a cardiologist and professor at Tufts University who led the study. “That’s a really big deal, because most things in healthcare don’t.”

The research from Massachusetts that medically tailored meals could save states money 鈥� in addition to improving health. Yet such programs could land on the chopping block as states look to tighten spending under Trump administration budget cuts, even as federal officials argue that food is a critical component of health.

Medicaid Budget Cuts Loom

The 2025 law known as the One Big Beautiful Bill Act slashed projected Medicaid funding by more than $900 billion. Many Republicans who backed the bill believe federal health spending is too high and riddled with fraud. Sen. John Kennedy, a Louisiana Republican, for example, has accused California of “outrageous fraud” for using Medicaid dollars to fund housing and nutrition programs.

, a policy analyst at KFF, said states will have to make tough choices in the next few years as they figure out how to fill funding gaps. “If states are not able to offset the loss of federal funds with new taxes or reductions in other state spending, they may have to make program cuts,” she said. (KFF is a health information nonprofit that includes 吃瓜不打烊.)

Thirteen states have received federal waivers to use Medicaid dollars to pay for meals 鈥� part of an approach known as “food is medicine.” Three other programs are awaiting federal approval.

President Donald Trump’s support for social services has wavered. While the first Trump administration allowed states to pursue medically tailored meals and other social supports, the second Trump administration for Medicaid initiatives that address social needs. It hasn’t detailed a new policy. Administration officials have warned that they will be more focused on the budget impacts of such initiatives.

“They signaled they’re going to be a lot more skeptical,” said , an assistant professor at the University of Massachusetts Chan Medical School who studies nutrition programs and helped lead the Massachusetts study. “Instead of using a broad-based approach nationwide, they’re going to make decisions on a state-by-state basis.”

At the same time, health leaders in Trump’s administration have made nutrition a major focus, including by promoting . Robert F. Kennedy Jr., who leads the Department of Health and Human Services, and Mehmet Oz, administrator of the Centers for Medicare & Medicaid Services, have to serve healthier foods to boost patient outcomes.

The healthcare system is often willing to pay for surgeries, Oz said in a social media video in June, “but not always willing to pay for the nutrition that might help prevent those outcomes in the first place. That’s bothered me my whole career.” He added that the agency is , including medically tailored meals, to prevent illness and hospitalization. CMS officials did not respond to several emailed requests for comment for this article.

, who studies social determinants of health at Harvard Law School’s Center for Health Law and Policy Innovation, said the lack of federal guidance is stirring uncertainty for states that want to pursue nutrition programs in Medicaid. “We’re still waiting to see that big step forward around 鈥榝ood is medicine’ interventions,” she said. “We need to see that step forward to resolve some of the uncertainty.”

Lawmakers have had a hard time engaging administration officials on medically tailored meals, said U.S. Rep. Jim McGovern, a Massachusetts Democrat who sponsored a bill that would pilot meal deliveries for some . The legislation has yet to come up for a vote.

“I had thought, based on some of his rhetoric before he entered the Trump administration, that RFK Jr. would be a natural ally on this,” McGovern said. “But we can’t seem to get his attention.”

The Costs of Poor Nutrition

Some companies have been accused of for meals that were neither healthy nor nutritious, raising concerns about lax regulation of these programs.

But at in Boston, the food is prepared with specific attention to sugar, salt, fat, vitamins, and minerals and is based on a person’s health needs, said , chief executive of the nonprofit. Many recipients require food that is mild or low in fiber, for example.

“What we’re able to do is to work with your healthcare provider to understand your health realities 鈥� what your diagnoses are, what your medications are, side effects, food allergies, cultural norms 鈥� and then prescribe a diet for you that is scratch-made,” Waters said.

The Massachusetts researchers found that the meals 鈥� at a cost of $125 per person per week 鈥� essentially paid for themselves. Patients with heart disease used about $10,000 less in healthcare services over six months, and patients with kidney disease used $12,000 less in healthcare. There were also savings for people with diabetes, depression, and anxiety.

“Those are pretty big numbers when you think of how expensive those diseases can be and the prevalence in the population,” Waters said.

Nationally, , 10 million Americans would benefit from medically tailored meals, though only a small fraction are enrolled.

“Poor nutrition is the top cause of poor health in this country. It’s the top cause of preventable healthcare spending,” said Mozaffarian, director of the Food is Medicine Institute at Tufts. He has estimated that medically tailored meals could help patients avoid 1.6 million hospitalizations and in healthcare costs each year.

A Weekly Delivery That Makes a Difference

Steve Honyotski receives 10 meals at his Boston home each week, cooked fresh and delivered cold or flash-frozen. They’re ready to eat after just a couple of minutes in the microwave.

“The carrot ginger soup is my favorite,” Honyotski said.

Honyotski, 71, lives with several chronic conditions, including diabetes, obesity, and high blood pressure. He said he’s noticed improvements in his health since he started eating medically tailored meals. He needs less insulin to control his diabetes, and he’s lost enough weight to delay a knee replacement surgery.

For now, those meals will keep coming. And Massachusetts’ Medicaid director, Ryan Schwarz, said the state will seek federal approval to continue medically tailored meals in the coming years. “We feel very strongly committed to continuing these services,” he said.

In North Carolina, researchers found that food and housing supports lowered Medicaid spending over time. Yet even with federal approval for medically tailored meals, and evidence that the meals 鈥� along with housing and transportation support 鈥� were helping people, North Carolina state lawmakers suspended the services in 2025 over budget worries. After budget deliberations this summer, state legislators changed course and decided to the program.

“To me, that’s a signal of what might occur in other states as these Medicaid cuts hit,” said Hager, the UMass researcher. “Even though they have the authority to run these programs, it might be a lot harder for the states to actually implement them.”

This article is from a partnership that includes , , and 吃瓜不打烊.

This article first appeared on 吃瓜不打烊 and is republished here under a .