(21) Quit Smoking
What is the mission of the FDA, especially in regard to tobacco?
The overall mission of the Federal Drug Administration (0FDA) is to protect the public’s health. President Roosevelt enacted a law in 1938 that established the FDA. As a government regulatory agency, the FDA is responsible for testing drugs and medical devices for quality and safety.
It is responsible for the manufacturing, labeling, advertising, and marketing of drugs and other products, to ensure their efficacy and safety. It is responsible for three types of drugs: prescription drugs, generic drugs, and over-the-counter drugs.
The FDA provides approval for advertising and marketing new drugs. It also regulates food and cosmetics, animal food, dietary supplements, biological goods, and blood products according to a set of published standards, which are enforced by inspections of laboratories, factories, and other facilities. The law establishing the FDA brought products that affect the public’s health under federal regulatory authority and public scrutiny.
Until Congress passed a law in 2008, the FDA had no jurisdiction over tobacco. While Congress has passed tobacco regulations six times in its history, it had never explicitly given the FDA any direct authority over tobacco. In 1996, the FDA attempted to assert authority to regulate tobacco advertising to minors, and to oversee the warning labels on tobacco products by declaring that nicotine was a drug and cigarettes were drug delivery devices.
However, in 2000, the Supreme Court denied the FDA’s authority. The arguments pro and con centered on the fact that Congress had never explicitly stated that the FDA had authority over tobacco. Did the FDA need Congress to pass a law granting it special authority over tobacco, or had that authority always been with the FDA, even though it had never acted on it? Given the fact that for fifty years preceding the 1996 FDA assertion, it itself had explicitly denied that Congress had ever granted it authority over tobacco; the FDA could not now suddenly claim the opposite.
In 2007, the Surgeon General, in an interview, endorsed the idea that the FDA not involves itself in the regulation of tobacco because the FDA was involved in the business of health promotion. Bringing it under the control of the FDA could give a false impression to the public that tobacco could be made into a safer product. In 2008 Congress finally passed a law granting this authority to the FDA.
Term:
Federal Drug Administration (FDA) - The Federal Agency devoted to ensuring the safety and effectiveness of all medications released in the United States.
