A FDA-approved product

Not all products go through FDA experts’ evaluation before they are offered for sale. In some cases, FDA experts will focus on products after they’ve been on the market.

So how do you know if a product is approved by the FDA?

The FDA approves the following types:

  • New human drugs and biological products: New drugs and biological products for people must be approved by the FDA before they can be marketed. The manufacturing company must demonstrate that its drug or biological product is safe and effective for its intended purpose and is manufactured in accordance with GMP.
  • Food additives: The FDA approves certain ingredients before they are used in foods or intended for food contact. Companies that want to use “new” food additives are responsible for providing FDA with information demonstrating that the additives are safe. Approved food additives must be used in accordance with the approved uses, specifications, and limits.
  • Coloring additives: Coloring agents used in foods, dietary supplements, drugs, cosmetics, and some medical devices must be approved by the FDA before entering the market and must be used only in compliance with the law. according to approved uses, specifications, and limits.

The FDA does not approve the following types:

  • Drug combinations: When a pharmacist or doctor combines different drugs (even though each of them has been approved by the FDA) for an individual patient, the combination is not FDA-approved.
  • Tobacco products: Marketing authorization does not indicate that tobacco products are safe or approved.
  • Cosmetics: Cosmetic products and ingredients (with the exception of color additives) do not require FDA approval to be marketed.
  • Infant formula: The FDA does not approve infant formulas before they can be marketed. However, manufacturers are subject to FDA regulatory oversight and must ensure that their infant formula complies with federal nutrient requirements and other regulations.
  • Supplements: The FDA does not approve dietary supplements for safety and effectiveness. Many supplements may be marketed without notifying the FDA. But companies are required to submit pre-sale safety notices to the FDA before marketing supplements that contain certain “new dietary ingredients.” Supplement companies must ensure that their products are safe before marketing and comply with labeling and GMP requirements.



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