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yesterday

FDA Posts More Than 100 Warning Letters in Drug-Ad Crackdown Targeting Hims’ Compounded Semaglutide

The move follows a presidential directive to tighten oversight of pharmaceutical advertising.

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)
The New York Stock Exchange with a Hims & Hers Health, Inc banner is pictured as a person runs past in the Manhattan borough of New York City, New York, U.S., January 21, 2021. REUTERS/Carlo Allegri/ File Photo
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WASHINGTON, DC - SEPTEMBER 04: Health and Human Services Secretary Robert Kennedy Jr. appears before the Senate Finance Committee at the Dirksen Senate Office Building on September 04, 2025 in Washington, DC. The committee met to hear testimony on President Trump's 2026 health care agenda. (Photo by Andrew Harnik/Getty Images)

Overview

  • Federal regulators publicly posted over 100 letters in a campaign against misleading drug promotions, marking the agency’s first direct policing of telehealth platforms selling compounded versions of prescription medicines.
  • A warning to Hims & Hers orders removal of claims implying its compounded semaglutide is the same as FDA‑approved Wegovy and Ozempic, emphasizing that compounded products are not reviewed or approved by the FDA.
  • The new letters deploy "cease and desist" language and caution that continued violations could lead to seizures or court injunctions.
  • Separate letters fault Eli Lilly and Novo Nordisk over an Oprah Winfrey TV special and promotional videos that regulators say gave a misleading impression of GLP‑1 drug safety and effectiveness.
  • Hims must respond within 15 working days detailing corrective steps, and its shares fell roughly 6% to 7% in Tuesday trading.