What is an FDA-Approved Product?

What is an FDA-Approved Product?

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.

How can you know for sure that a product is FDA-approved?

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: 

• Compounded drugs
  Compounding is in general a practice in which a pharmacist or a doctor combines ingredients to create medications for individual patients.
• Tobacco products
  The FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population, including users and nonusers of tobacco products. A marketing authorization does not indicate that the tobacco product is either safe or approved.
• Cosmetics
  Cosmetic products and ingredients (except from color additives) do not require FDA approval.  
• Infant formula
  The FDA does not approve infant formulas before they can be marketed. However, manufacturers are subject to the FDA’s regulatory oversight and must ensure that their infant formula complies with federal nutrient requirements and other regulations.
• 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 approves:

• 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. 
• 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.

Read more in the FDA post entitled Is It Really ‘FDA Approved’? on the U.S. FDA website.