What Does 'FDA Approved' Mean?
Last Updated on June 26, 2017
It seems like hundreds of products are labeled “FDA approved,” but what does this term actually mean?
Surprisingly, the FDA hasn’t determined whether products must meet certain criteria or standards to be labeled “FDA approved” and, as a result, the agency doesn’t actively monitor companies who use the phrase on their products.
Often, this means that companies will prey on consumers’ beliefs that “FDA approved” means the federal agency has reviewed clinical studies regarding the product in question and decided that it is safe and effective. Yet, only certain products undergo stringent approval processes by the FDA, and even products that are approved are not always guaranteed to be safe and effective.
So, how do you know whether something has been approved by the FDA?
Step One: Determine What the FDA Is Responsible for Approving
Say you’re interested in a dietary supplement, and you saw a commercial that advertised the product is “FDA approved,” “registered with the FDA” or something similar, but you’re not sure whether this phrase has any merit. First, you must determine whether the FDA approves, clears or even evaluates dietary supplements in general.
So, What Does the FDA Approve?
The FDA does approve:
The FDA does not approve:
Color additives in FDA-regulated products
Companies* including healthcare facilities, laboratories and manufacturers.
Certain medical devices
Compounded drugs, which are created when pharmacists combine or alter ingredients in pharmaceuticals to create unique medications to meet specific needs of individual patients.
Drugs and additives in food for animals
Cosmetics (unless they contain color additives).
New additives in food for people, or those which are not Generally Recognized As Safe (GRAS) (ingredients that haven’t appeared in the public food supply before 1958), as well as additives that can leach from food packaging.
New biologics, which include vaccines, blood and blood components, allergenics, and cellular and gene therapies, among others.
Food labels, including nutrition facts.
Medical foods, which are used under the supervision of a physician for the dietary management of a disease or health condition that requires specific nutrient needs.
Structure-function claims (e.g., “Calcium builds strong bones”).
This table was adapted from the FDA’s article “Is It Really FDA Approved?”
Are you surprised to find that products, including dietary supplements and infant formula, as well as structure-function claims, are on the right side of this table? It’s a bit bizarre, but it’s true. More often than not, the FDA “passes the buck” when it comes to evaluating and approving products, facilities and product claims.
It’s true that there are some minor exceptions. For instance, certain products and facilities marked with asterisks (*) above have to register with the FDA before they can be marketed to the public; however, registering with the FDA is not the same as receiving the agency’s approval.
Getting back to that dietary supplement you’re interested in, the table shows that the agency is not responsible for approving these products. So, companies that manufacture dietary supplements are not required to submit any clinical studies to the FDA proving that they are safe or effective. Furthermore, the FDA doesn’t monitor the structure-function claims on any products, and dietary supplements can essentially be advertised with any type of claim as long as there is a disclaimer somewhere on the product’s packaging telling consumers that the claim hasn’t been approved by the FDA.
Therefore, it’s likely that the supplement’s manufacturer is using this purported approval to convince consumers that the product is safe and effective – even though it may be neither of these things.
Step Two: Understand How the FDA’s Approval Processes Work
So you’ve figured out that the FDA is responsible for approving a product you’re interested in, but what type of evaluation does the agency perform?
There are several different methods for approving products. When a company wants to market a new food additive, for instance, the manufacturer must submit an application to the FDA with test results that show the ingredient is safe, which the FDA will review and evaluate to make its decision. If the FDA “approves” the application, the agency had determined that the new food additive is Generally Recognized As Safe (GRAS).
In the case of new drugs and biologics, manufacturers must submit more extensive applications with results from laboratory, animal or human clinical studies proving their product is safe and effective. FDA experts then review these studies to determine whether the new drug or biologic’s benefits outweigh its risks. If so, the agency will approve the application and the new product can be marketed and sold to the public.
Products – such as medical devices, which may vary in terms of importance and risk – fall somewhere in the middle of the FDA’s approval spectrum. Depending on their placement in the FDA’s three-tier rating system, medical devices undergo different approval processes.
Class I medical devices, or low-risk devices, include bandages, arm slings and enema kits, among other things. According to the FDA, 95 percent of Class I devices are exempt from any type of regulatory processes, so manufacturers can often market their devices without having to receive any type of FDA approval and without submitting applications with results of clinical studies proving their safety and effectiveness.
Class II medical devices, or moderate-risk devices, include dialysis equipment, catheters and power wheelchairs.
Class III medical devices, or high-risk devices, include mechanical heart valves, implantable infusion pumps and other devices that sustain life.
Only a small number of Class II and III devices must undergo Premarket Approval (PMA), the FDA’s most stringent approval process. The PMA application is similar to the type of approval process that new drugs and biologics undergo: manufacturers must submit clinical studies to the FDA, which will then use this information to determine whether the device is reasonably safe.
The majority of Class II and III devices, however, are approved for sale through the FDA’s expedited 510(k) approval process. Under this process, items that are “substantially equivalent” to others that are already on the market (i.e., those that are proven to function identically to devices already available) are approved without much scrutiny.
What’s the Bottom Line?
When considering products with an “FDA approved” label, remember that there isn’t a concrete definition for the term or a specific set of criteria that companies must meet to use the label. In fact, many times “FDA approved” labels should be red flags for consumers, because products that the FDA does evaluate (e.g., food, drugs, etc.) typically have implied approval. Manufacturers who explicitly use “FDA approved” labels may be doing so just to deceive you about the quality of their products.
Furthermore, the FDA never guarantees that a product is safe or effective – even if it is responsible for approving the product in the first place. For example, medical devices, including metal-on-metal hip replacements and transvaginal mesh, were approved through the FDA’s 501(k) process; however, many of these devices were recalled and some of the devices’ manufacturers faced extensive litigation that alleged the products were defective and put patients at risk for serious injuries.
Finally, the FDA bases its approvals on tests performed by manufacturers themselves. So, the studies that manufacturers perform may be biased or purposely isolated from other studies to meet a specific agenda, namely that their product is safe and effective and should be approved by the FDA.
Therefore, the phrase “FDA approved” – whether expressly stated or implied – may not carry as much weight as many believe, and must always be taken with a grain of salt.
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