What does “FDA Approved” actually mean?

We hear “FDA Approved” verbiage in marketing materials for anything from the newest dietary supplement to hit the market to the heartworm medicine you just picked up for the dog. But what does the FDA approve and regulate, and what does “FDA Approved” really mean?

About THE FDA

The Food and Drug Administration (FDA) has been around for over 100 years. Due to their exposure and regulation over the years, the FDA logo typically gives consumers a level of comfort. However, while certain products require premarket approval by the FDA before they go to market, it’s probably less than you think. It’s also critical to note that there are a lot of things the FDA does NOT approve.

  • The FDA does not “approve” companies. However, they do have the authority to inspect a regulated facility to verify they comply with manufacturing practice regulations. For example, certain facilities (like mammography facilities) must be FDA certified which indicate they have met stringent standards for providing a quality service.
  • The FDA does not approve cosmetics. This means your shampoos, perfumes, makeup, etc. is not FDA approved. Therefore, cosmetic products and ingredients, and their labeling do not require FDA approval before they go on the market. The one exception is color additives, which are subject by law to approval by the agency, and must be used only in compliance with its approved uses, specifications, and restrictions.
  • The FDA does not approve infant formula. However, these manufacturers are subject to FDA’s regulatory oversight.
  •  The FDA does not approve tobacco products. No surprise here, but they do regulate it heavily. To legally sell or distribute a new tobacco product in the United States, manufacturers must receive a written order from the FDA. A marketing order does not indicate that the tobacco product is either safe or “approved.” It simply means that the manufacturer has complied with the requirements under the law to bring its product to market. (source)

So, FDA approval is not always required before a product is sold and, in many cases, doesn’t approve certain products at all. However, their regulation categories are quite broad ranging from electronic products that give off radiation (like microwaves or x-ray equipment) to tobacco products.

What does FDA approved really mean?

To become FDA approved, FDA experts review the results of clinical testing done by the manufacturers (they do not test). If approval is granted by the FDA, it means they have determined that the benefits of the products outweigh the known risks. Manufacturers must submit a premarket approval application and the results of clinical testing in order to get approval.

The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant — like an artificial heart valve that can save someone’s life. (source)

What does it mean if something is FDA Cleared but not FDA Approved?

Products that are considered lower-risk like condoms, motorized wheelchairs and bandages fall into Class II and Class I. These classes are usually “cleared” by the FDA, which means the manufacturer can show that their product is substantially equivalent to another product that has already been FDA approved or cleared. Let’s say Samsung wanted to create an app that can record a single channel electrocardiogram (ECG, aka EKG), which is what Apple’s ECG app does. It could get FDA clearance if it can compare its product to Apple’s and demonstrate that it is safe, effective, and equivalent in how it works. (source)

Pretty crazy right? Like many things in this category, there is a lot of gray. We didn’t realize how many categories the FDA does not approve as well as many other areas they regulate instead.

 

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