WASHINGTON (AP) \u2014 For the first time, federal health officials are taking aim at telehealth companies promoting unofficial versions of prescription drugs \u2014 including popular weight loss medications \u2014 as part of the Trump administration\u2019s crackdown on pharmaceutical advertising.<\/p>\n
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.<\/p>\n
READ MORE: In the gray world of GLP-1 supplements online, health experts urge caution<\/a><\/p>\n The FDA warned the company to remove \u201cfalse and misleading\u201d promotional statements from its website, including language claiming that its customized products contain \u201cthe same active ingredient\u201d as FDA-approved drugs Wegovy and Ozempic. The formulations cited by regulators are produced by specialty compounding pharmacies and aren\u2019t reviewed by the FDA.<\/p>\n \u201cYour claims imply that your products are the same as an FDA-approved product when they are not,\u201d states the warning letter, dated Sept. 9.<\/p>\n Hims said Tuesday that it \u201clooks forward to engaging with the FDA.\u201d<\/p>\n WATCH: Why more doctors are treating children and adolescents with weight loss drugs<\/a><\/p>\n \u201cOur website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,\u201d the company said in a statement.<\/p>\n It\u2019s the first FDA attempt to directly police online platforms like Hims, which have long argued they\u2019re not subject to traditional drug advertising rules.<\/p>\n 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 \u201cmisleading impression\u201d about the safety of Zepbound, Wegovy and similar \u201cdrugs with multiple serious, potentially life-threatening risks.\u201d<\/p>\n WATCH: The many ways new weight loss drugs could transform the economy<\/a><\/p>\n 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.<\/p>\n 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 \u201ctruthful and non-misleading.\u201d<\/p>\n The new FDA letters each contain \u201ccease and desist\u201d language. That\u2019s a different approach for the agency, which typically drafts its letters in highly bureaucratic language citing specific FDA regulations.<\/p>\n READ MORE: Can you get a COVID shot? Here\u2019s your fall vaccine guide<\/a><\/p>\n Hims has been under scrutiny from Washington for some time.<\/p>\n Earlier this year, a Super Bowl ad from the company touted the benefits of its weight-loss medications but didn\u2019t list any of their side effects or potential harms. FDA rules require advertisements to present a balanced picture of drug risks and benefits.<\/p>\n Makary singled out the ad in last week\u2019s Journal of the American Medical Association, calling it a \u201cbrazen\u201d example of how advertising is \u201ccontributing to America\u2019s culture of overreliance on pharmaceuticals for health.\u201d<\/p>\n READ MORE: Why new weight loss drugs are out of reach for millions of older Americans<\/a><\/p>\n 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.<\/p>\n The FDA permits so-called compounding, or customized production, when there is a shortage of the official versions of FDA-approved medications.<\/p>\n 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.<\/p>\n