FTC Rules for Health Companies
FDA regulates what a drug or device is; the Federal Trade Commission polices how health products are advertised and sold, and how health apps handle data. These are the FTC rules health companies most often run into, in full.
6 rules from Title 16 of the Code of Federal Regulations, the FTC's title, that apply to how drugs, devices, supplements, health apps and eye care are sold and marketed. Each opens the rule's full current text.
The Rules
Each opens its full text from eCFR| Rule | Citation | FTC health letters on the topic |
|---|---|---|
| Endorsement GuidesHow testimonials, influencer posts and expert endorsements must be disclosed and backed up, including claims that a product works. | 16 CFR Part 255 | — |
| Consumer Reviews and Testimonials RuleBans fake reviews, bought reviews, suppressed bad reviews and fake social-media followers; in force since October 2024. | 16 CFR Part 465 | — |
| Health Breach Notification RuleHealth apps and other services outside HIPAA must tell users, the FTC and sometimes the media when health data is breached or shared without permission. | 16 CFR Part 318 | — |
| Negative Option RuleRules for subscriptions and automatic renewals, which cover many direct-to-consumer prescription and supplement plans. | 16 CFR Part 425 | — |
| Contact Lens RulePrescribers must give patients their contact lens prescription, and sellers must verify it before selling lenses. | 16 CFR Part 315 | 4 |
| Ophthalmic Practice Rules (Eyeglass Rule)Eye doctors must hand patients their eyeglass prescription after an exam, without charging extra or requiring a purchase. | 16 CFR Part 456 | 4 |
Text comes from eCFR, the official online CFR, refreshed weekly. Letter counts are FTC warning and cease-and-desist letters from our marketing enforcement tracker on the same topic; the FTC also enforces Section 5 of the FTC Act directly, which no rule here spells out. eCFR, Title 16