What is the Food, Drug, and Cosmetic Act?

The Food, Drug, and Cosmetic Act is a federal law that gives the Food and Drug Administration (FDA) authority to oversee the safety of food, drugs, cosmetics, and medical devices. It establishes regulatory frameworks for approval, manufacturing standards, labeling requirements, and monitoring of these products to protect public health.

Why is the Food, Drug, and Cosmetic Act important?

• Consumer protection: Ensures products are safe for their intended use.
• Quality standards: Establishes manufacturing and testing requirements.
• Information access: Mandates accurate labeling and disclosure of risks.

Key provisions of the Food, Drug, and Cosmetic Act

• Premarket approval requirements for new drugs and devices.
• Labeling and advertising regulations to prevent misrepresentation.
• Post-market surveillance systems for adverse events and safety concerns.

How Solace can help

A Solace advocate can help you navigate FDA-regulated products, understand drug and device safety information, and report adverse events to appropriate authorities. They can assist with researching approved uses of medications and devices, help you understand clinical trial options for experimental treatments, and support informed decision-making about FDA-regulated products recommended for your care.