What Is FDA Compliance?

What Is FDA Compliance?
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The U.S. Food and Drug Administration (FDA) is an agency within the Department of Health and Human Services. The FDA oversees and secures the safety and effectiveness of the nation's food supply, medical devices, drugs for humans and animals, cosmetics, vaccines and medical products, as well as products that emit radiation. FDA compliance provides that any products governed by this agency have undergone specific tests and regulatory examinations and are approved to be distributed and sold with FDA approval.

FDA Regulation

The FDA regulates compliance of consumer products such as fresh fruits, vitamins, cigarettes, the H1N1 vaccine, makeup, prosthetics and X-ray machines. There are eight divisions within the FDA, each charged with securing the safety of the public sector by examining, testing and providing expectations and regulations of these products before they are released to consumers. As well, the FDA works to secure and advance the rate at which new products, medical breakthroughs, information and recalls are released to the public to improve health and well-being.

History

The FDA dates back to 1848 and is the oldest U.S. federal government agency assigned to protect consumer rights. Then known as the Department of Agriculture, the agency began its regulatory functions with the 1906 Pure Food and Drugs Act. In 1930, the Department of Agriculture became the U.S. Food and Drug Administration. The primary function of this agency is and always has been to protect and promote the health of consumers.

Food Compliance

Within the FDA, a food division is dedicated to regulating food and dietary supplementation. This includes canned and packaged food, fresh vegetables, fruit, cheese, eggs, milk, meat, seafood and supplements. The FDA warrants control over safety and hazards, ingredients, packaging, labeling and health claims. As well, this agency governs organic labeling, international exporting/importing, food defense and guidance. There are many application forms, inspections, testing and examinations and sampling that foods and dietary supplements must go through to be FDA-approved and passed to the consumer.

Recalls

All divisions within the FDA provide for the recall of any product, at any time, if it is deemed a safety or health hazard. This includes allergens, health issues, salmonella, mislabeling, undeclared ingredients and inherent risks. The website Recalls.gov is dedicated to recalls, safety alerts and market withdrawals both archived and issued within the last 60 days notifying consumers of industry and FDA press releases. You can also follow this information on Twitter.

Proposed Regulations and the Public

Because the FDA is a regulatory agency, rules are published with regards to the regulating of all products that fall within this agency. When a new regulation is being proposed or an existing regulation revised, it is announced in the "Federal Register," which is published every weekday and available at public libraries and colleges/universities. The public is encouraged to participate and comment on or about the rules that govern FDA approval of these products. By law, any consumer can comment on proposed regulatory laws and comment about product rules online or through petitions. The website is Regulations.gov.

References

Last updated on: Jan 4, 2010

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