FDA says it will take “decisive steps” against GLP-1 compounders, HHS refers Hims to DOJ for investigation
The Food and Drug Administration said it would take “decisive steps” to restrict GLP-1 compounding, a day after Hims & Hers announced that it would sell copies of Novo Nordisk’s Wegovy pill.
The FDA specifically called out Hims in the announcement. Additionally, Department of Health and Human Services General Counsel Mike Stuart said in a post on X on Friday that he has referred Hims to the Department of Justice “for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.”
In a statement, Hims said the company “has always operated with a deep commitment to the safety and best interests of consumers and in compliance with applicable law.”
“We have a long history of successfully working with regulators, and look forward to continuing to engage with the FDA to ensure safe access to affordable healthcare,” they said.
Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. (“Hims”) to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
— HHS General Counsel Mike Stuart (@HHSGCMikeStuart) February 6, 2026
This marks a significant shift in tone from the FDA, which has done little to prevent companies like Hims from marketing copies of Novo’s lucrative weight-loss drugs.
Shares of Hims fell 14% after-hours. The stock had already taken a hit after FDA Commissioner Marty Makary said in an X post on Thursday that the agency would “take swift action against companies mass-marketing illegal copycat drugs.”
Hims received a warning letter from the FDA in September that took issue with it saying its product has the “same active ingredient” as branded drugs made by Novo. The company has continued to use this language, including for its new oral product.
In its statement, the FDA said it is “also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025.”
The FDA specifically called out Hims in the announcement. Additionally, Department of Health and Human Services General Counsel Mike Stuart said in a post on X on Friday that he has referred Hims to the Department of Justice “for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.”
In a statement, Hims said the company “has always operated with a deep commitment to the safety and best interests of consumers and in compliance with applicable law.”
“We have a long history of successfully working with regulators, and look forward to continuing to engage with the FDA to ensure safe access to affordable healthcare,” they said.
Based on a review of the applicable facts, earlier today @HHSOGC referred Hims & Hers Health, Inc. (“Hims”) to the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
— HHS General Counsel Mike Stuart (@HHSGCMikeStuart) February 6, 2026
This marks a significant shift in tone from the FDA, which has done little to prevent companies like Hims from marketing copies of Novo’s lucrative weight-loss drugs.
Shares of Hims fell 14% after-hours. The stock had already taken a hit after FDA Commissioner Marty Makary said in an X post on Thursday that the agency would “take swift action against companies mass-marketing illegal copycat drugs.”
Hims received a warning letter from the FDA in September that took issue with it saying its product has the “same active ingredient” as branded drugs made by Novo. The company has continued to use this language, including for its new oral product.
In its statement, the FDA said it is “also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025.”
