FOR LAWYERS

Food and Drug Administration (FDA)

By
Lia Kopin-Green
/
June 1, 2023

What is the FDA (Food and Drug Administration)?

The United States Food and Drug Administration, or FDA, is a regulatory agency of the US government that is responsible for protecting and promoting public health. The FDA, which operates under the Department of Health and Human Services, ensures the safety, efficacy and security of a wide range of products including pharmaceuticals, food and beverages, cosmetics and medical devices. It plays a crucial role in approving and regulating the use of certain drugs before they are released to the general market. Moreover, the FDA monitors various products' manufacturing, labeling and distribution.

Key Takeaways 

  • The United States Food and Drug Administration, or FDA, is a regulatory agency of the US government under the Department of Health and Human Services
  • The FDA is responsible for ensuring the safety of a wide range of products such as drugs, food, cosmetics and medical devices.
  • The FDA often plays a crucial role in determining liability and providing evidence in tort law cases involving harm or injury caused by FDA-regulated products.

Understanding the FDA (Food and Drug Administration)

The FDA has a number of essential responsibilities that protect public health and ensure the safety of important products and devices. Some of the main roles performed by the FDA include:

  • Product Regulation: The FDA is responsible for regulating various products such as drugs, medical devices, vaccines, biological products, food, beverages and cosmetics.
  • Labeling: The FDA ensures that products are appropriately labeled with accurate information about their use, risk and benefits. 
  • Pre-Market Approval: The FDA applies strict standards and processes for manufacturers to follow in order to obtain approval before introducing certain regulated products to the market.
  • Research: The FDA conducts critical scientific research, studies and experiments regarding regulatory science and medicine.
    Safety and Quality Control: The FDA sets rigorous quality control standards to make sure particular products are manufactured, stored and distributed safely.

The FDA (Food and Drug Administration) and Tort Cases

Both the tort system and the FDA share the common goal of safeguarding consumers of medical products. The FDA's rules and guidelines are used as a reference point in product liability lawsuits to assess whether a producer met its duty of care by creating a reliable product. Manufacturers must adhere to strict pre-market approval procedures and conditions set forth by the FDA before their products can be sold. A manufacturer may be held to have violated its duty of care if it is discovered that it did not uphold these standards, such as by releasing a defective product or failing to sufficiently warn about known dangers. Liability in tort suits may be based on this breach.

Bottom Line

Examining key tort-related issues requires having a thorough understanding of the Food and Drug Administration's (FDA) powers and responsibilities. The FDA and tort law both aim to make products safer, hold those responsible accountable, and protect public health and consumer well-being. If you need assistance navigating the complexities of FDA regulations and their intersection with tort law, Attorney at Law is here to provide unmatched guidance and legal support.

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