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FDA Approved?

The U.S. Food & Drug Administration (FDA) posted an article on the ways the FDA is regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food, and cosmetics (Is it Really “FDA 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. Not all products undergo premarket approval, i.e., a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already on the market. However, 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 does not approve:

  • Facilities

The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices. Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently. The FDA does have authority to inspect regulated facilities to verify that they comply with applicable 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.

  • Compounded drugs

Compounding is in general a practice in which a pharmacist or a doctor combines ingredients to create medications for individual patients.

  • Cosmetics

Cosmetic products and ingredients (except from color additives) do not require FDA approval. 

  • Dietary supplements

The agency does not approve dietary supplements for safety and effectiveness. Many dietary supplements can be marketed without even notifying the FDA. But companies are required to submit a premarket safety notification to the FDA before marketing dietary supplements containing certain “new dietary ingredients”. Dietary supplement companies must ensure that their products are safe before marketing and that they comply with labeling and GMP requirements.

The FDA does approve:

  • New human drugs and biologics

New drugs and biologics must be FDA-approved before they are marketed. This means that a company must demonstrate that its drug or biologic is safe and effective for the intended purpose, and that it can be manufactured according to GMP.  For more information, see:

  • A directory of approved and unapproved finished drugs on the market.
  • A complete list of licensed biological products.

 

  • Medical devices

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 highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.

 

  • Food additives

The agency approves certain ingredients before they are used in food or intended to contact food (e.g. substances that can migrate to food from packaging materials). Companies that want to use new food additives are responsible for providing the FDA with information demonstrating that these additives are safe. An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.

 

  • Color additives

This includes those used in food, dietary supplements, drugs, cosmetics, and some medical devices. These color additives are subject to approval by the FDA before market entry and must be used only in compliance with its approved uses, specifications, and restrictions.