The FDA Guidelines for Approved and Not Approved Products

The Food and Drug Administration (FDA) is the regulatory body responsible for protecting consumer health. The organisation works by regulating food and beverage products, medical devices, human drugs, biological products, cosmetics and electronic products that emit radiation.

However, not all of those products go through premarket approval, which is a study of safety, quality, and effectiveness by FDA experts, followed by agency clearance before a product is made available to consumers. Here is a list of products that undergo approval and some that don’t:

Products that undergo approval Process

1. Human Drugs and Biological Products: After rigorous safety and efficacy assessments, they are FDA-approved.
2. Medical Devices: Medical Devices are classified based on risk. While high-risk devices require FDA approval, lower-risk ones follow different clearance paths.
3. Human cells and Tissues: These products are regulated to prevent the transmission of diseases, with some necessitating FDA approval due to increased risk.
4. Food Additives: Some additives must be approved by the FDA to ensure their safety, although others that are “generally recognised as safe” (GRAS) do not require premarket approval.
5. Colour Additives: Colour additives are subject to FDA approval before they can be added to various food products.

Products that do not undergo the approval process

1. Facilities: Although facilities are inspected for compliance with manufacturing practices, they do not undergo the approval process.
2. Laboratories and healthcare providers: Like facilities, they are subject to FDA inspections.
3. Compounded Drugs: Compounded drugs are not FDA-approved and do not undergo premarket review for quality, safety and effectiveness.
4. Cosmetics: Cosmetics and their ingredients do not require FDA-approval, although some colour additives must be approved.
5. Dietary Supplements, Infant Formula, medical foods: These products are not subject to FDA premarket approval, although compliance with regulations and quality standards are required.
6. Tobacco products: Tobacco products are not subjected to FDA ‘approval’ but require authorisation for sale through specific means.
7. Labelling and product claims: Food product labels, structure-function claims on dietary supplements and health-related claims must be accurate and not misleading, but they do not require FDA approval [1].