What Does the FDA Do

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If you have ever looked at a warning label on food or medicine, you may have noticed something that said FDA Warning, or The FDA requires. But what is the FDA, what does it do, and how does it enforce its rules?

What is the FDA?

FDA stands for Food and Drug Administration. It is also sometimes abbreviated as USFDA, for United States Food and Drug Administration. It is one of the United States federal executive departments, and is responsible for promoting public health via the regulation and supervision of food safety, tobacco products, dietary supplements, medicine, medical devices, and a myriad of other products.

The FDA is led by the Commissioner of Food and Drugs who reports to the Secretary of Health and Human Services. While the FDA is headquartered in Maryland, it has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico, as well as a number of posts abroad in countries such as China, Costa Rica, and the United Kingdom.

What Does the FDA Do?

The FDA regulates more than $1 trillion worth of consumer goods. That equates to about 25% of all consumer expenditures in the United States every year. This includes:

$466 billion in food sales,
$275 billion in drugs,
$60 billion in cosmetics, and
$18 billion in supplements.

The FDA does not just regulate domestic goods, but also goods imported into the United States. Indeed, this is a major focus of the FDAs daily operations.

Most of the FDAs regulatory authority derives from the Food, Drug and Cosmetic Act, first enacted in 1938 and heavily revised since then. Other sources of regulatory authority derive from the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, and many others. Often, responsibility for enforcing these acts may also be shared with other federal agencies.

The agencys programs for regulation of various goods differ greatly between product types, potential risks, and the authority granted to the agency by law. For example, the FDA is empowered to regulate almost every aspect of prescription drugs, including testing, manufacturing, labeling, marketing/advertising, efficacy, and safety. But, the FDAs authority over cosmetic products is primarily centered on safety and labeling.

How Does the FDA Enforce its Rules?

Enforcement is a perpetual process for the FDA. Unlike policing forces that typically respond to problems after they arise, the FDA is obligated to predict issues ahead of them causing trouble. This requires a massive labor force, perpetual testing, and requirements for manufacturers to participate in oversight programs.

Enforcement varies greatly by industry, meaning in some cases, such as with medications, extensive testing has occurred before the product ever hits the market, and constant monitoring occurs after approval to ensure that the product quality does not slip nor do new side effects develop. Other products, like food and cosmetics are more subject to inspection than to pre-approval. If pollutants or other problems are discovered, the agency has the power to issue recalls and public warnings about the use of those items.

Failure to comply with FDA rules can result in fines, seizure of non-compliant goods, civil liability, and even criminal charges in the most extreme cases. Many of the enforcement options are outlined in the enacting laws empowering the agency to regulate a particular class of products. Others are contained in the rules promulgated by the agency itself.

Those who believe they have found a dangerous product that is subject to FDA regulation may wish to report that product to the agency to ensure that it cannot harm others. Similarly, a report by the FDA identifying a particular item as dangerous may be enormously beneficial in a private lawsuit against the maker of that product for injuries suffered as a result of its use. To determine the most appropriate course of action, it may be wise to consult with an attorney. You can find an attorney in your area by using the search feature of HG.org to find a lawyer nearby who practices the appropriate area of law.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer.

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