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What Does FDA Approval Mean?

“FDA approved!”

Maybe you saw those words on a company’s website or in a commercial promoting a product or treatment.

FDA approval means a drug product approved by FDA through extensive review by center for drug evaluation and research (CDER).

How can you know for sure what the U.S. Food and Drug Administration has approved?

The FDA is responsible for protecting public health by regulating human drugs and biological products, 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!

In some cases, the FDA’s enforcement efforts focus on products after they are already for sale.

Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.

The FDA doesn’t approve facilities!

The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices and other requirements, including an adequately designed and controlled production process.

Unless an exemption applies, owners and operators of domestic or foreign food, drug, and most device facilities must register with the FDA before exporting products to the U.S.

Owners and operators of establishments that manufacture blood products or cells, tissues, and cellular and tissue-based products must also register with the agency.

Cosmetic companies are not required to register their products or facilities with the FDA but may do so voluntarily.

The FDA approves new human drugs and biological products.

The FDA doesn’t approve compounded drugs.

The FDA uses a risk based, tiered approach for regulating medical devices for people. The FDA classifies devices according to risk and the level of regulatory controls needed to provide a reasonable assurance of the safety and effectiveness of the devices.

The FDA uses a risk-based approach for human cells and tissues.

The FDA doesn’t approve tobacco products.

There are three pathways available to bring a new tobacco product to market:

1. premarket tobacco product applications

2. substantial equivalence applications

3. exemption from substantial equivalence requests.

The FDA approves food additives in food for people.

The FDA has the authority to approve certain ingredients before they are used in food or intended to contact food.

Those include food additives and color additives.

The FDA doesn’t approve medical foods.

The FDA doesn’t approve infant formula.

The FDA doesn’t approve dietary supplements.

The FDA doesn’t approve the food label, including the Nutrition Facts label.

The FDA doesn’t approve structur function claims on dietary supplements and other foods.


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