How does FDA regulate?

The FDA regulates various aspects of consumer safety through several structured approaches and categories:

1. Broad Regulatory Scope: The FDA oversees a wide range of products, accounting for approximately 25% of consumer spending in the USA. This includes food (excluding meat and poultry), drugs, biologics, and veterinary products 1 2.

2. Historical Context and Evolution: Initially, regulations started with the 1906 Food and Drug Safety Act to prevent contamination and dangerous products, like mercury in syrups. Significant updates came in the 1960s following the thalidomide scandal, establishing both safety and efficacy standards for drug approvals 3.

   
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3. Approval Process for Drugs: Drugs undergo stringent scrutiny involving multiple clinical trial phases and data collection before approval. Manufacturers must demonstrate safety and efficacy before drugs can be marketed 1 3.

4. Dietary Supplements: Unlike drugs, dietary supplements are regulated under the category of food, meaning they do not require pre-market approval. Manufacturers only need to notify the FDA about new ingredients, and regulatory action can only be taken post-market if adverse events are reported 4.

5. Ecosystem Challenges: Small pharmaceutical companies often face significant challenges in navigating FDA regulations compared to larger companies with extensive drug portfolios. The FDA's cautious approach, influenced by political oversight and fear of admitting harmful drugs, can delay the availability of beneficial drugs 5.

6. Regulatory Harmonization: The US regulatory framework often gets imposed globally, creating a standardized yet restrictive environment for drug approval and regulation. This poses challenges for innovation, suggesting a need for reconsidering regulatory frameworks to foster better efficiency and adaptability 5.

Overall, the FDA aims to protect public health by ensuring the safety, efficacy, and security of drugs, while also regulating food products and supplements to varying degrees of scrutiny.