Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is responsible for regulating the labeling of drugs, medical devices, and other products. This includes overseeing advertising practices for prescription-only products to prevent misleading information and potential off-label violations.

Labeling and advertising for FDA-regulated products must be truthful and, in many cases, must be vetted or approved by the FDA before public dissemination. Required labeling information includes the product’s established name, quantitative composition, and a brief summary of side effects, contraindications, and effectiveness. For direct-to-consumer advertisements, a statement encouraging consumers to report negative side effects to the FDA is also required.

Interestingly, the FDA does not oversee the advertising of over-the-counter (OTC) drugs; instead, the Federal Trade Commission (FTC) regulates OTC advertising.

 

Services offered by Prologos Law:

• FDA and FTC Administrative Proceedings

• Form 483, Warning Letters and Consent Decree

• Action Indicated Notices

• Prescription labeling

• Over-the-counter labeling

• Promotion and advertisement

• TV and media advertisement

• Testimonials review