The Food and Drug Administration By Joseph Devine

The Food and Drug Administration (FDA) is a federal agency in the United States Department of Health and Health Services. It is responsible for the regulation of most types of food, drugs, medical devices, veterinary equipment, and cosmetics. Additionally, the FDA regulates sanitation on interstate highways as well as disease control regulations on specific situations, from pets like turtles that carry salmonella to semen and egg donations. In 2008, the agency received a $2.1 billion budget to perform its duties, which is a $105.8 million dollar increase from 2007.

Most of the regulations enforced by the FDA are codified into law by the Food, Drug, and Cosmetic Act. Safety specifications vary according to each product, especially in regards to its potential risks. The Food and Drug Administration Act heavily regulates all prescription medication, including all steps of production, from testing, manufacturing, marketing, and labeling to efficacy, safety, and distribution, because of its large set of inherent risks. The FDA's Center for Drug Evaluation and Research is responsible for the monitoring of medication, with different requirements for new drugs, generic drugs, and over-the-counter medicine.

New medications must undergo extensive investigation in a process called the New Drug Application (NDA). Generic drugs are prescription medications whose patents have expired, and are therefore available for other companies to manufacture and market. The non-patented versions must be interchangeable or equivalent to the original substance. Over-the-counter medications must be deemed safe without a doctor's prescription.

Interestingly enough, diet drugs and supplements are not subject to the strict requirements of all prescription medication, as they fall under the jurisdiction of Center for Food Safety and Applied Nutrition. This department monitors all food products, with the exception of meat and alcoholic beverages containing more than 7% alcohol. The Dietary Supplement Health and Education Act of 1994 officially evaluated weight loss supplements as food rather than drugs, thereby removing them from the extensive safety and efficacy testing of the New Drug Application. The FDA can only pursue action against a supplement after it proves to be harmful to a person's health. This unfortunate situation has allowed several drugs, such as Fen-phen and Redux, to inflict large amounts of physical pain on users. Both supplements were responsible for heart valve damage and primary pulmonary hypertension cases in the mid 1990's.

If you are interested in learning more, this website contains helpful FDA information and this site showcases the dangers of diet drugs.

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