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Who or What is the FDA?

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Weldon Stanford

- Author, Drug Guardians

The FDA or Food and Drug Administration is a federal agency of the United States Department of Health and Human Sciences, and is one of the federal executive departments of the United States. The function of the FDA in short is to protect the consumer and promote public health by controlling and supervising all food and drug related products manufactured, marketed and imported by the United States. Their mandate is to oversee all products, ensuring all products are not only fit for human consumption, but also ensuring the contents of the products to be as advertised. The FDA also regulates animal feeds and veterinary products, ensuring no mistreatment of animals through products, as well as within the food production chain. Formed as we now know it, on the 30th June 1906, the FDA has been doing very important work for over 110 years.

Areas overseen by the FDA include food safety, tobacco products, dietary supplements, prescription and over the counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and feeds and veterinary products.

The FDA’s organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical products and Tobacco, Foods, Global Regulatory Operations and policy, and Operations.

The FDA is led by the Commissioner of Food and Drugs who is appointed directly by the President with consent of the senate. The Commissioner as of February 2016 is Dr. Robert M. Califf MD having taken over from Dr. Stephen Ostroff who was the acting head.

Based in White Oak, Maryland, the agency has 223 field offices and 13 laboratories throughout the United States, the United States Virgin Islands and Puerto Rico. This allows the FDA the ability to successful achieve their objectives throughout the United States. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium and the United Kingdom.

One of the FDA’s best-known functions is to test and approve different drugs being sold within the United States, a task undertaken by the FDA’s Center for Drug Evaluation and Research (CDER). Before a drug company is able to sell a drug in the United States, it must first be stringently tested. The company first does in-house or independent testing, after which it sends the evidence from these tests to the CDER. The CDER has a team of physicians, statisticians, chemists, pharmacologists and other scientists review the company’s data as well as the proposed labelling. If this review establishes that a drug’s health benefits outweigh their known risks, the drug is approved for sale. The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety and effective standards.

It is important to note that before a drug even reaches approval by the FDA, it would first have undergone rigorous testing in a laboratory environment as well as in animals, to establish its safety and efficacy in human trials. Human trials then begin to determine the actual safety of the drug, as well as to measure whether it provides actual health benefits.

Similar approval processes exist in each area of the FDA’s mandate, ensuring no banned substances are used, labelling is always correct, and above all, that no harm is done to consumers.

If you have any questions, comments or suggestions for the FDA, they encourage dialogue with consumers through:

Email – webmail@oc.fda.gov

Mail – Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002

Telephone – 1-888-INFO-FDA (1-888-463-6332)

Sources:

http://www.fda.gov/

http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm

http://www.fda.gov/AboutFDA/WhatWeDo/

https://en.wikipedia.org/wiki/Food_and_Drug_Administration

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