Connect with us

Business

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

Published

on



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.”

___

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.

Fortune Global Forum returns Oct. 26–27, 2025 in Riyadh. CEOs and global leaders will gather for a dynamic, invitation-only event shaping the future of business. Apply for an invitation.



Source link

Continue Reading

Business

Morgan Stanley strategist Michael Wilson says lackluster job numbers could actually be good news

Published

on



Ahead of the highly anticipated November jobs data to be released this week, even lackluster numbers may be greeted with relief by Wall Street.

A moderately cooling labor market could increase the likelihood of more rate cuts by the Federal Reserve—a tantalizing prospect for many investors eying future earnings growth—fueling bullish behaviors in the stock market, according to Morgan Stanley analysts.

“We are now firmly back in a good is bad/bad is good regime,” Michael Wilson, chief U.S. equity strategist and chief investment officer for Morgan Stanley, wrote in a note to investors on Monday.

Fed Chair Jerome Powell’s divisivecut last week, the Fed’s third cut in as many meetings, was based on consistent data showing a softening job market, including unemployment rising three months in a row through September, and the private sector shedding 32,000 jobs last month, per ADP’s November report

According to Powell, the quarter-point cut was defensive and a way to prevent the labor market from tumbling, adding that while inflation sits at about 2.8%, which is higher than the Fed’s preferred 2%, he said he expects inflation to peak early next year, barring no additional tariffs.

He added that monthly jobs data may have been overcounted by about 60,000 as a result of data collection errors, and that payroll gains may actually be stagnant or even negative.

“I think a world where job creation is negative…we need to watch that very carefully,” Powell said at the press conference directly following the announcement of the rate cut. 

Wilson suggested that Powell’s emphasis on the jobs data, as well as his de-emphasis on tariff-caused inflation, makes the labor market a crucial factor in monetary policy going into 2026. 

As a result of the government shutdown, the Labor Department’s job market report will be released on Tuesday, which will contain data from both October and November, and is expected to show a modest 50,000 payroll gain in November, with the unemployment rate ticking up from 4.4% to about 4.5%, consistent with the trend of a labor market that is slowing, but not suddenly bottoming out. 

‘Rolling recovery’ versus plain bad news

The Morgan Stanley strategist has previously argued that weak payroll numbers are actually a sign of a “rolling recovery,” with the economy in the early stages of an upswing slowly making its way through each sector. It follows three years of a “rolling recession” that Wilson said had kept the economy weaker than what employment and GDP figures suggested.

In Wilson’s eyes, because jobs data is a lagging metric, the trough of the labor cycle was actually back in the spring, coinciding with mass DOGE firings and “Liberation Day” tariffs. For a more accurate representation of the health of the economy, Wilson argued to look instead at the markets. The S&P 500, for example, is up nearly 13% over the last six months.

However, with Powell basing his policy decisions on data such as jobs, Wilson noted, the Fed could still see more room to cut, even as Morgan Stanley sees a labor market that is not in jeopardy.

“In real time, the data has not been weak enough to justify cutting more,” Wilson told CNBC last week prior to the Fed meeting. “But when they actually look at the revisions now…it’s very clear that we had a significant labor cycle, and we’ve come out of it, which is very good.”

But just as economists weren’t in consensus for the FOMC’s most recent rate cut, the possibility of more meager jobs numbers is not universally favored.

Claudia Sahm, chief economist at New Century Advisors and a former Fed economist, agreed the job data is a lagging economic indicator, but warned it could indicate a recession is underway, not that we’re already in the clear. What was particularly concerning to her was that lagging labor data could bear worse job news, as layoffs have yet to surge following shrinking job openings. 

She told Fortune ahead of the Fed’s decision last week that additional rate cuts would not be welcome news, but rather a sign the Fed had acted too late in trying to correct a battered labor market.

“If the Powell Fed ends up doing a lot more cuts, then we probably don’t have a good economy,” she said. “Be careful what you wish for.”



Source link

Continue Reading

Business

Actor Joseph Gordon-Levitt wonders why AI companies don’t have to ‘follow any laws’

Published

on



In a sharp critique of the current artificial intelligence landscape, actor-turned-filmmaker-turned- (increasingly) AI activist Joseph Gordon-Levitt challenged the tech industry’s resistance to regulation, posing a provocative rhetorical question to illustrate the dangers of unchecked development: “Are you in favor of erotic content for eight-year-olds?”

Speaking at the Fortune Brainstorm AI conference this week with editorial director Andrew Nusca, Gordon-Levitt used “The Artist and the Algorithm” session to pose another, deeper question: “Why should the companies building this technology not have to follow any laws? It doesn’t make any sense.”

In a broad-ranging conversation covering specific failures in self-regulation, including instances in which “AI companions” on major platforms reportedly verged into inappropriate territory for children, Gordon-Levitt argued relying on internal company policies rather than external law is insufficient, noting such features were approved by corporate ethicists.

Gordon-Levitt’s criticisms were aimed, in part, at Meta, following the actor’s appearance in a New York Times Opinion video series airing similar claims. Meta spokesperson Andy Stone pushed back hard on X.com at the time, noting Gordon-Levitt’s wife was formerly on the board of Meta rival OpenAI.

Gordon-Levitt argued without government “guardrails,” ethical dilemmas become competitive disadvantages. He explained that if a company attempts to “prioritize the public good” and take the “high road,” they risk being “beat by a competitor who’s taking the low road.” Consequently, he said he believes business incentives alone will inevitably drive companies toward “dark outcomes” unless there is an interplay between the private sector and public law.

‘Synthetic intimacy’ and children

Beyond the lack of regulation, Gordon-Levitt expressed deep concern regarding the psychological impact of AI on children. He compared the algorithms used in AI toys to “slot machines,” saying they use psychological techniques designed to be addictive.

Drawing on conversations with NYU psychologist Jonathan Haidt, Gordon-Levitt warned against “synthetic intimacy.” He argued that while human interaction helps develop neural pathways in young brains, AI chatbots provide a “fake” interaction designed to serve ads rather than foster development.

“To me it’s pretty obvious that you’re going down a very bad path if you’re subjecting them to this synthetic intimacy that these companies are selling,” he said.

Haidt, whose New York Times bestseller The Anxious Generation came recommended from Gordon-Levitt onstage, recently appeared at a Dartmouth-United Nations Development Program symposium on mental health among young people and used the metaphor of tree roots for neurons. Explaining tree-root growth is structured by environments, he brought up a picture of a tree growing around a Civil War–era tombstone. With Gen Z and technology, specifically the smartphone, he said: “Their brains have been growing around their phones very much in the way that this tree grew around this tombstone.” He also discussed the physical manifestations of this adaptation, with children “growing hunched around their phone,” as screen addiction is literally “warping eyeballs,” leading to a global rise in myopia shortsightedness.

The ‘arms race’ narrative

When addressing why regulations have been slow to materialize, Gordon-Levitt pointed to a powerful narrative employed by tech companies: the geopolitical race against China. He described this framing as “storytelling” and “handwaving” designed to bypass safety checks,. Companies often compare the development of AI to the Manhattan Project, arguing slowing down for safety means losing a war for dominance. In fact, The Trump administration’s “Genesis Mission” to encourage AI innovation was unveiled with similar fanfare just weeks ago, in late November.

However, this stance met with pushback from the audience. Stephen Messer of Collectiv[i] argued Gordon-Levitt’s arguments were falling apart quickly in a “room full of AI people.” Privacy previously decimated the U.S. facial recognition industry, he said as an example, allowing China to take a dominant lead within just six months. Gordon-Levitt acknowledged the complexity, admitting “anti-regulation arguments often cherrypick” bad laws to argue against all laws. He maintained that while the U.S. shouldn’t cede ground, “we have to find a good middle ground” rather than having no rules at all.

Gordon-Levitt also criticized the economic model of generative AI, accusing companies of building models on “stolen content and data” while claiming “fair use” to avoid paying creators. He warned a system in which “100% of the economic upside” goes to tech companies and “0%” goes to the humans who created the training data is unsustainable.

Despite his criticisms, Gordon-Levitt clarified he is not a tech pessimist. He said he would absolutely use AI tools if they were “set up ethically” and creators were compensated. However, he concluded without establishing the principle that a person’s digital work belongs to them, the industry is heading down a “pretty dystopian road.”



Source link

Continue Reading

Business

Fed chair race: Warsh overtakes Hassett as favorite to be nominated by Trump

Published

on



Wall Street’s top parlor game took a sudden turn on Monday, when the prediction market Kalshi showed Kevin Warsh is now the frontrunner to be nominated as the next Federal Reserve chairman, overtaking Kevin Hassett.

Warsh, a former Fed governor, now has a 47% probability, up from 39% on Sunday and just 11% on Dec. 3. Hassett, director of the National Economic Council, has fallen to 41%, down from 51% on Sunday and 81% on Dec. 3.

A report from CNBC saying Hassett’s candidacy was running into pushback from people close to President Donald Trump seemed to put Warsh on top. The resistance stems from concerns Hassett is too close to Trump.

That followed Trump’s comment late Friday, when he told The Wall Street Journal Warsh was at the top of his list, though he added “the two Kevins are great.”

According to the Journal, Trump met Warsh on Wednesday at the White House and pressed him on whether he could be trusted to back rate cuts. 

The report surprised Wall Street, which had overwhelming odds on Hassett as the favorite, lifting Warsh’s odds from the cellar.

But even prior to the Journal story, there have been rumblings in the finance world Hassett wasn’t their preferred choice to be Fed chair.

At a private conference for asset managers on Thursday, JPMorgan Chase CEO Jamie Dimon signaled support for Warsh and predicted Hassett was likelier to support Trump on more rate cuts, sources told the Financial Times.

And in a separate report earlier this month, the FT said bond investors shared their concerns about Hassett with the Treasury Department in November, saying they’re worried he would cut rates aggressively in order to please Trump.

Trump has said he will nominate a Fed chair in early 2026, with Jerome Powell’s term due to expire in May. 

For his part, Hassett appeared to put some distance between himself and Trump during an appearance on CBS’ Face the Nation on Sunday.

When asked if Trump’s voice would have equal weighting to the voting members on the rate-setting Federal Open Market Committee, Hassett replied, “no, he would have no weight.”

“His opinion matters if it’s good, if it’s based on data,” he explained. “And then if you go to the committee and you say, ‘well the president made this argument, and that’s a really sound argument, I think. What do you think?’ If they reject it, then they’ll vote in a different way.”



Source link

Continue Reading

Trending

Copyright © Miami Select.