WASHINGTON (AP) — 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.”
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.
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
WASHINGTON (AP) — The U.S. Supreme Court is hearing arguments at 10 a.m. ET over the constitutionality of President Donald Trump’s order to end birthright citizenship for children born in the United States to someone in the country illegally or temporarily.
The birthright citizenship order, which Trump signed on Jan. 20, 2025, the first day of his second term, is part of his Republican administration’s broad immigration crackdown.
Trump plans to be in attendance. He will be the first sitting president to attend oral arguments at the nation’s highest court.
Every lower court to have considered the issue has found the order illegal and prevented it from taking effect. A definitive ruling by the nation’s highest court is expected by early summer.
Here’s the latest:
Way back in 1841, former President John Quincy Adams represented a shipload of African men and women who had been sold into slavery in the famous Amistad case.
Former President William Howard Taft became chief justice nearly eight years after leaving the White House in 1913. Charles Evans Hughes left the Supreme Court for a presidential run in 1912, which he nearly won, then returned to the court in 1930 as chief justice.
In 1966, Richard Nixon argued his only Supreme Court case, which he lost.
Twenty-four Democratic state attorneys general put out a statement Wednesday morning saying they’re “proud to lead the fight against this unlawful order.”
While Democratic attorneys general have sued the Trump administration scores of times, the plaintiffs in this case are represented by the American Civil Liberties Union and other civil rights groups.
The Democratic attorneys filed court papers supporting their position. Twenty-five of their Republican counterparts filed a friend-of-the-court brief backing the Trump administration.
The only state sitting this one out is New Hampshire.
More than 250,000 babies born in the U.S. each year would not be citizens, according to research from the Migration Policy Institute and Pennsylvania State University’s Population Research Institute.
The order would only apply going forward, the administration has said. But opponents have said a court ruling in Trump’s favor could pave the way for a later effort to take away citizenship from people who were born to parents who were not themselves U.S. citizens.
The president and first lady Melania Trump showed up for the court ritual marking the arrival of a new justice following the confirmations of Justice Neil Gorsuch in 2017 and Justice Brett Kavanaugh a year later.
The ceremony for Trump’s third appointee, Justice Amy Coney Barrett, was delayed a year because of the COVID-19 pandemic and Trump, who was no longer in office, did not attend.
Traditionally the president has avoided attending arguments to maintain distance between the government branches — since the executive officer’s presence is seen by many as a way to pressure the independent court to rule in their favor.
Given the unusual nature of it all — Trump’s presence in the courtroom spotlights how high the stakes are for him, as the court’s decision will have massive consequences on his longstanding promise to crack down on immigration.
Last year, Trump said that he badly wanted to attend a hearing on whether he overstepped federal law with his sweeping tariffs, but he decided against it, saying it would have been a distraction.
Adam Winkler, a constitutional law professor at UCLA, told the The Associated Press that Trump’s attending SCOTUS oral arguments signals how important the president views this case.
However, Trump’s presence “is unlikely to sway the justices,” Winkler said, adding that the SCOTUS justices “pride themselves in their independence, even if some agree with much of Trump’s agenda.”
The fanfare of Trump being in the courtroom will make for a different experience for the justices themselves, however, as “Trump’s presence will make the atmosphere a little bit more circus-like,” Winkler said.
Solicitor General D. John Sauer is making his ninth Supreme Court argument and second in as many weeks. Sauer’s biggest win to date was the presidential immunity decision that spared Trump from being tried for his effort to overturn the 2020 election.
Sauer was a Supreme Court law clerk to Justice Antonin Scalia early in his legal career.
ACLU legal director Cecillia Wang, the child of Chinese immigrants, is presenting her second argument to the Supreme Court. In the first Trump administration, a 5-4 conservative majority ruled against Wang’s clients in another immigration case.
It’s not an April Fool’s joke. Alito was born this day in 1950. Only Thomas, who turns 78 in June, is older than Alito among the nine justices.
In the post-pandemic era, the other justices allow the 77-year-old Thomas, the longest-serving member of the court, to pose a question or two before the free-for-all begins.
In a second round of questioning, the justices ask questions in order of seniority. Chief Justice John Roberts, whose center chair makes him the most senior, gets the first crack.
The justices have routinely gone beyond the allotted time since returning to the courtroom following the Covid-19 pandemic.
A buzzer and the court marshal’s cry, “All rise,” signal the justices’ entrance from behind red curtains. The livestream won’t kick in for several minutes, until after the ceremonial swearing-in of lawyers to the Supreme Court bar.
FILE - The U.S. Supreme Court is seen in Washington on Feb. 24, 2026. (AP Photo/Matt Rourke, File)
People arrive to walk inside the U.S. Supreme Court, on Capitol Hill in Washington, Wednesday, April 1, 2026. The Supreme Court justices will hear oral arguments today on whether President Donald Trump can deny citizenship to children born to parents who are in the United States illegally or temporarily. (AP Photo/J. Scott Applewhite)
