Overview
- FDA says it has sent thousands of letters ordering the removal of misleading promotions and about 100 cease‑and‑desist notices to companies with deceptive ads.
- The agency has begun rulemaking to end the 1997 ‘adequate provision’ approach that let advertisers refer viewers elsewhere for full safety details.
- Officials cite failures to present a fair balance of risks and benefits and extend enforcement to social media, paid influencers, telehealth advertising and online pharmacies.
- Regulators report the use of artificial intelligence and other tools to review current ads as they ramp up compliance checks.
- The shift follows years of sparse enforcement — one warning letter in 2023 and none in 2024 — and it may trigger legal challenges and commercial fallout in a $10.8 billion DTC market.