The FDA has issued over 100 warning letters and cease-and-desist orders to companies like Hims & Hers, targeting false advertising and misleading claims about weight-loss medications and compounded drugs.

This crackdown marks a more assertive approach, with the FDA sending clear cease-and-desist orders, emphasizing the seriousness of violations and moving away from traditional bureaucratic language.

Hims & Hers received a cease-and-desist order following allegations of falsely claiming its compounded weight-loss medications contain the same active ingredients as FDA-approved drugs like Wegovy and Ozempic.

The FDA's recent notices have adopted a more direct tone, signaling a shift in regulatory communication.

FDA Commissioner Marty Makary highlighted the importance of companies providing balanced drug information, including side effects, and announced plans for further enforcement actions.

Shares of Hims & Hers fell over 6% after the warning letters were issued, reflecting investor concerns about regulatory scrutiny.

This marks the first direct FDA effort to regulate online telehealth platforms and their advertising practices, part of a broader government push to ensure truthful pharmaceutical advertising.

The FDA has also criticized misleading vaccine advertisements, such as AstraZeneca’s FluMist, for distracting visuals that undermine important safety information.

Critics and researchers have long argued that drug ads overemphasize benefits and minimize risks, influencing patient requests and increasing demand for expensive medications.

Health Secretary Robert F. Kennedy Jr. has previously criticized the pharmaceutical industry and suggested that obesity could be addressed through diet and exercise alone.

The FDA's actions are part of an effort initiated by President Trump to crack down on deceptive drug advertising, with a response deadline of 15 days for companies to address violations.

Hims has faced scrutiny for months, especially after a Super Bowl ad promoting weight-loss drugs without listing side effects, violating FDA rules for balanced risk-benefit information.