Just What is FDA Approved?

Chances are you’ve stumbled on a product that shows approval from the U.S. Food and Drug Administration. This is the agency responsible for protecting the public health by regulating the production and labeling of certain products and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics and electronic products that emit radiation.

While many are familiar with the FDA, it is less commonly known that not all of the products the agency handles undergo premarket approval. That means a review of the product’s safety and effectiveness by FDA experts and agency approval may not necessarily occur before it is marketed.

In some cases, enforcement efforts by the FDA focus on products after they are already for sale. Congress is responsible for establishing FDA’s authorities related to those matters. However, even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

Curious about how the FDA regulates products and what the agency approves and doesn’t approve? Here’s the breakdown.

What the FDA does:

1. Approves new drugs and biologics
2. Uses a risk-based, tiered approach for regulating medical devices
3. Uses a risk-based approach for human cells and tissues
4. Approves food additives in food for people
5. Approves color additives used in FDA-regulated products
6. Approves animal drugs and approves food additives for use in food for animals

What the FDA does not do:

1. Does not approve companies
2. Does not approve compounded drugs
3. Does not approve tobacco products
4. Does not approve cosmetics
5. Does not approve medical foods
6. Does not approve infant formula
7. Does not approve dietary supplements
8. Does not approve the food label including the Nutrition Facts panel
9. Does not approve structure-function claims on dietary supplements and other foods

For more detailed information about the responsibilities of the FDA and what products the agency does and does not regulate, visit www.fda.gov.

Source: FDA Consumer Health Information


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