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What is the FDA?: A Brief Introduction of the FDA



What is FDA?

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.


What is FDA responsible for?

-Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled.

-Human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective

-Protecting the public from electronic product radiation

-Assuring cosmetics and dietary supplements are safe

and properly labeled

-Regulating tobacco products

-Advancing the public health by helping to speed product innovations

-Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health


Importing issues

-U.S. Customs or the FDA Import Office may place a hold on the products you are trying to have imported into the U.S. This may be due to problems with your company registration, product listing or some other issue.

-Provision Consulting Group effectively resolves such problems for our clients. We will work with U.S. Customs or the FDA Import Office to resolve the outstanding issue and release your company’s products from hold in as timely a manner as possible.

-Provision Consulting Group has registered many importers with the FDA and can register your company, list your devices with the FDA, and act as your company’s U.S. Agent.


The truth about FDA approval

Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?

FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

Here is a guide to how FDA regulates products — and what the agency does (and doesn’t) approve.

 

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