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FDA warns Hims & Hers and other weight loss drugmakers to remove ‘false and misleading’ advertising

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For the first time, federal health officials are taking aim at telehealth companies promoting unofficial versions of prescription drugs — including popular weight loss medications — as part of the Trump administration’s crackdown on pharmaceutical advertising.

The Food and Drug Administration on Tuesday posted more than 100 letters to various drugmakers and online prescribing companies, including Hims & Hers, which has built a multibillion-dollar business centered around lower-cost versions of blockbuster obesity injections.

The FDA warned the company to remove “false and misleading” promotional statements from its website, including language claiming that its customized products contain “the same active ingredient” as FDA-approved drugs Wegovy and Ozempic. The formulations cited by regulators are produced by specialty compounding pharmacies and aren’t reviewed by the FDA.

“Your claims imply that your products are the same as an FDA-approved product when they are not,” states the warning letter, dated Sept. 9.

Hims said Tuesday that it “looks forward to engaging with the FDA.”

“Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,” the company said in a statement.

It’s the first FDA attempt to directly police online platforms like Hims, which have long argued they’re not subject to traditional drug advertising rules.

The FDA also posted separate warning letters to manufacturers of the so-called GLP-1 drugs, taking issue with a 2024 infomercial featuring Oprah Winfrey. Regulators said the 42-minute TV segment from Eli Lilly and Novo Nordisk gave a “misleading impression” about the safety of Zepbound, Wegovy and similar “drugs with multiple serious, potentially life-threatening risks.”

Washington scrutiny

Health Secretary Robert F. Kennedy Jr. has long been a critic of the pharmaceutical industry, including GLP-1 drugs, and previously suggested Americans can reverse obesity with diet and exercise alone.

A memo signed by President Donald Trump last week directed Kennedy and the FDA to ensure that pharmaceutical ads on TV, social media and other websites are “truthful and non-misleading.”

The new FDA letters each contain “cease and desist” language. That’s a different approach for the agency, which typically drafts its letters in highly bureaucratic language citing specific FDA regulations.

Hims has been under scrutiny from Washington for some time.

Earlier this year, a Super Bowl ad from the company touted the benefits of its weight-loss medications but didn’t list any of their side effects or potential harms. FDA rules require advertisements to present a balanced picture of drug risks and benefits.

Makary singled out the ad in last week’s Journal of the American Medical Association, calling it a “brazen” example of how advertising is “contributing to America’s culture of overreliance on pharmaceuticals for health.”

Hims and similar companies initially sold cheap generic versions of drugs for hair loss, erectile dysfunction and other health issues. But booming demand for obesity medications opened the door to selling cheaper copies.

The FDA permits so-called compounding, or customized production, when there is a shortage of the official versions of FDA-approved medications.

FDA recently determined that GLP-1 drugs no longer met the criteria for a shortage. That should have ended the compounding, but there is an exception: The practice is still permitted when a prescription is customized for the patient.

Hims and other companies have taken to offering “personalized” dosages and formulations for certain patients, arguing they offer extra benefits.

Shares of San Francisco-based Hims & Hers Health Inc. fell more than 6.47% in trading Tuesday.

The letters posted Tuesday come from FDA’s drug center.

A letter posted last week from FDA’s vaccine division took issue with a TV ad for AstraZeneca’s FluMist vaccine, saying the spot’s “background music and visual distractions” detract from information about side effects. The letter was signed by FDA vaccine chief Dr. Vinay Prasad, an ally of Kennedy who recently returned to his job at the agency after briefly being forced to step aside.

Researchers and consumer advocates have long complained that the upbeat TV images of patients enjoying life with family and friends often overshadow discussions of side effects.

Additionally, studies have shown that patients exposed to drug ads are more likely to ask their doctors about the medication, even if they don’t fit the prescribing criteria. The American Medical Association, the nation’s largest physician group, came out in support of a ban in 2015, citing TV advertising’s role in “inflating demand for new and more expensive drugs.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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Female libido pill gets expanded approval for menopause by FDA

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U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by postmenopausal women up to 65 years old.

The announcement Monday from the Food and Drug Administration broadens the drug’s use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive.

Addyi, marketed by Sprout Pharmaceuticals, was initially expected to become a blockbuster drug, filling an important niche in women’s health. But the drug came with unpleasant side effects including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol.

The boxed warning cautions that drinking while consuming the pill can cause dangerously low blood pressure and fainting. If patients have several drinks, the label recommends waiting a few hours before taking the drug, or skipping one dose.

Sales of Addyi, which acts on brain chemicals that affect mood and appetite, fell short of Wall Street’s initial expectations. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that acts on a different set of neurological chemicals.

Sprout CEO Cindy Eckert said in a statement the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company, based in Raleigh, North Carolina, announced the FDA update in a press release Monday.

The medical condition for a troublingly low sexual appetite, called hypoactive sexual desire disorder, has been recognized since the 1990s and is thought to affect a significant portion of American women, according to surveys. After the blockbuster success of Viagra for men in the 1990s, drugmakers began pouring money into research and potential therapies for sexual dysfunction in women.

But diagnosing the condition is complicated because of how many factors can affect libido, especially after menopause, when falling hormone levels trigger a number of biological changes and medical symptoms. Doctors are supposed to rule out a number of other issues, including relationship problems, medical conditions, depression and other mental disorders, before prescribing medication.

The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.

The FDA rejected Addyi twice prior to its 2015 approval, citing the drug’s modest effectiveness and worrisome side effects. The approval came after a lobbying campaign by the company and its supporters, Even the Score, which framed the lack of options for female libido as a women’s rights issue.

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This story has been updated to correct the age range of the FDA approval update. The agency approved the drug for postmenopausal women up to age 65, not older than 65.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.



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Gavin Newsom hires former CDC officials to work as public health consultants for state of California

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Two former senior officials from the Centers for Disease Control and Prevention, including one fired by the Trump administration, will join California as public health consultants, Gov. Gavin Newsom announced Monday.

California joined Washington and Oregon — two other states with Democratic governors — to launch an alliance in September to establish their own public health guidance and vaccine recommendations, as the Trump administration makes sweeping changes to vaccine and health policy.

Susan Monarez was fired as the CDC’s director and Dr. Debra Houry resigned as the agency’s chief medical officer and deputy director over disputes about changes at the agency. The two will work with California’s public health department to help build trust in “science-driven decision-making,” Newsom’s office said.

“By bringing on expert scientific leaders to partner in this launch,” Newsom said in a statement, “we’re strengthening collaboration and laying the groundwork for a modern public health infrastructure that will offer trust and stability in scientific data not just across California, but nationally and globally.”

California has increasingly positioned itself as a counterweight to federal health policy, and Newsom has amped up his criticisms of President Donald Trump and challenged the Republican’s policies in court. The governor’s final term ends in just over a year and he’s gearing up for a possible presidential run in 2028.

California state Sen. Tony Strickland, a Republican, said the new initiative is an example of Newsom prioritizing his national political ambitions over the state.

“California has serious problems, and we need serious solutions from a serious leader,” Strickland said in a statement.

The White House and U.S. Department of Health and Human Services did not respond to emails seeking comment on the hirings.

Trump and Health Secretary Robert F. Kennedy Jr. have repeated falsehoods about vaccines, and the administration has given health recommendations this year that experts say were not backed by science.

Trump in September urged pregnant women not to take Tylenol, saying it could pose a risk of autism to their babies, remarks medical experts said were irresponsible. The CDC website was changed last month to contradict the longtime scientific conclusion that vaccines do not cause autism. A federal vaccine advisory panel voted earlier this month to reverse decades-old guidance recommending that all U.S. babies get immunized against the liver infection hepatitis B on the day they’re born. The vaccine is credited with preventing thousands of illnesses.

Monarez, a former director of a federal biomedical research agency, was named acting director of the CDC in January. Trump later nominated her to to serve as director. She was confirmed by the Senate in July, making her the first nonphysician to serve in the role. But she was fired by the Trump administration in August after less than a month in the post.

Kennedy has said Monarez was fired after she told him she was untrustworthy. But Monarez said that was false in congressional testimony and that she was fired after refusing to endorse new vaccine recommendations that weren’t backed by science.

Houry, who spent more than a decade at the CDC, was among a handful of top officials at the agency who resigned around the time Monarez was fired. Houry said in August she was concerned about the rise of vaccine misinformation during the Trump administration, as well as planned budget cuts, reorganization and firings at the CDC.

She said she’s excited to join California’s new initiative.

“California will advance practical, scalable solutions that strengthen public health within the state and across states —showing how states can modernize data, share capacity, and work together more efficiently, while remaining focused on protecting people and communities,” Houry said in a statement.

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Associated Press writer Trân Nguyễn contributed.

This story was originally featured on Fortune.com



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Dealmakers are heading into the final weeks of 2025 on a $100 billion cliffhanger.

Paramount Skydance Corp.’s hostile bid to snatch Warner Bros. Discovery Inc. from under the nose of Netflix Inc. encapsulates the themes that have shaped a banner year for mergers and acquisitions: renewed desire for transformative tie-ups, massive checks from Wall Street, the flow of Middle East money and US President Donald Trump’s role as both disruptor and dealmaker.

Global transaction values have risen around 40% to about $4.5 trillion this year, data compiled by Bloomberg show, as companies chase ultra-ambitious combinations, emboldened by friendlier regulators. That’s the second-highest tally on record and includes the biggest haul of deals valued at $30 billion or more.

“There’s a sentiment in boardrooms and among CEOs that this is a potential multi-year window where it’s possible to dream big,” said Ben Wallace, co-head of Americas M&A at Goldman Sachs Group Inc. “We’re at the beginning of a rate-cutting cycle so there’s anticipation that there will be more liquidity.”

Beyond Netflix’s purchase of Warner Bros., this year’s blockbusters include Union Pacific Corp.’s acquisition of rival railroad operator Norfolk Southern Corp. for more than $80 billion including debt, the record leveraged buyout of video game maker Electronic Arts Inc., and Anglo American Plc’s takeover of Teck Resources Ltd. to reshape global mining. 

“When you look around and you see your peers doing these big deals and taking advantage of the tailwinds, you don’t want to be left out,” said Maggie Flores, partner at law firm Kirkland & Ellis LLP in New York. “The regulatory environment is in a position that is very conducive to dealmaking and people are taking advantage of it.”

The tally also shows a level of exuberance in certain pockets that some advisers and analysts worry is unsustainable. Global trade tensions are ongoing, and market observers are increasingly warning of a selloff in the white-hot equity markets that have underpinned the M&A resurgence.

Top executives at Goldman Sachs, JPMorgan Chase & Co. and Morgan Stanley have all flagged the risk of a correction in the months ahead, in part tied to concerns about an overheated artificial intelligence ecosystem, where huge amounts of investment have juiced technology stocks.

“These equity returns are really coming out of AI, and AI spend is not sustainable,” said Charlie Dupree, global chair of investment banking at JPMorgan. “If that pulls back, then you are going to see a broader market that isn’t really advancing.”

The AI buzz led to some the year’s standout transactions. Sam Altman’s OpenAI took in major investments from the likes of SoftBank Group Corp., Nvidia Corp. and Walt Disney Co., and a consortium led by BlackRock Inc.’s Global Infrastructure Partners agreed to pay $40 billion for Aligned Data Centers. In March, Google parent Alphabet Inc. framed its $32 billion acquisition of cybersecurity startup Wiz Inc. as a way to provide customers with new safeguards in the AI era.

“Everyone needs to be an AI banker now,” said Wally Cheng, head of global technology M&A at Morgan Stanley. “Just as software began eating the world 15years ago, AI is now eating software. You have to be conversant in AI and understand how it will affect every company.”

The technology sector more broadly has already notched a record year for deals, thanks to a series of big-ticket takeovers across public and private markets. The trend extended to the White House over the summer, when the US government took a roughly 10% stake in Intel Corp. in an unconventional move aimed at reinvigorating the company and boosting domestic chip manufacturing.

It was one of the clearest indications of Trump’s willingness to blur the lines between state and industry and insert himself into M&A situations during his second term, particularly in sectors deemed mission critical. His administration also acquired a stake in rare-earth producer MP Materials Corp. and Commerce Secretary Howard Lutnick has hinted at similar deals in the defense sector.

Trump has separately been positioning himself as kingmaker on high-profile transactions. The government secured a so-called golden share in United States Steel Corp. as a condition for approving its takeover by Japan’s Nippon Steel Corp., and the president recently signaled he’ll oppose any acquisition of Warner Bros. that doesn’t include new ownership of CNN.

“The Trump administration’s approach to merger regulation today is markedly different compared to the first time around,” said Brian Quinn, a professor at Boston College Law School. Quinn said he couldn’t think of a member of the Republican Party from 15 to 20 years ago who would now believe the US government “is involved in the business of picking winners.”

To be sure, bankers will be wondering if they could have achieved more in 2025 had it not been for the chaotic period earlier in the year, when deals were put on hold after Trump’s trade war hobbled markets. And in a sign that persistent economic challenges are still impacting some parts of M&A, the number of deals being announced globally remains flat.

Many small and mid-cap companies have lagged the broader stock market and are opting to pursue their own strategic plans instead of weighing inorganic options, according to Jake Henry, global co-leader of the M&A practice at consultancy McKinsey & Co.

“They’re thinking ‘I’m better off just operating my business and getting there.’ It has to be an explosive offer for them to come to the table,” he said.

Meanwhile, private equity firms, whose buying and selling is a key barometer for M&A, are still having a harder time offloading certain assets because of valuation gaps with buyers. This has had a knock-on effect on their ability to raise funds and spend on new acquisitions. But bankers are starting to see a recovery here too as interest rates come down and bring more potential acquirers to the table.

“What’s motivating sponsors more than anything is their need to return cash to investors,” said Saba Nazar, chair of global financial sponsors at Bank of America Corp. “We have been in bake-off frenzy for the last couple of months.”

Road to Record

Dealmakers began the year whispering of M&A records under Trump’s pro-business administration. While they will just miss out on the milestone in 2025, there is a strong sense on Wall Street that those early bumps only delayed the inevitable. 

Brian Link, co-head of North America M&A at Citigroup Inc., said that after ‘Liberation Day’ in April, he expected to spend more time figuring out the impact of tariffs on different business and how to adjust around that. 

“That has not been the case,” he said. “Unless fear creeps back into the market, there doesn’t seem to be anything in the near term that’s going to change the dynamic here.”



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