FDA Laws
The U.S. Food and Drug Administration has been the subject of nearly 200 pieces of legislation regulating consumer products affecting public health and safety in America.
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History
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The first legislative effort to regulate public and consumer health information was The Food and Drugs Act of 1906. Since then, many other laws, like the Food and Drug Administration Modernization Act of 1997 and the Kefauver-Harris Amendments of 1962, have been established as a result of or in association with this legislation.
Coverage
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The laws surrounding the Food and Drug Administration pertain mostly to pharmaceutical products, medical devices and food safety information. Laws like the recent the Food and Drug Administration Amendments of 2007 are put into place to advance reviews of proposed new drugs and medical devices.
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Enforcement
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The Office of Regulatory Affairs under the Food and Drug Administration is responsible for developing the policies implemented today, while the Office of Criminal Investigations is solely responsible for the enforcement of such policies.
Impact
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As a result of the FDA laws, the administration is able to regulate approximately $1 trillion dollars worth of proposed products per year.
Consumers
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The FDA operates its own docket management system to archive all administrative proceedings and regulatory documents pertaining to the Administration. The system is administered through the Federal Dockets Management System (FDMS) and can be accessed by all consumers.
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