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Approved by the FDA or Not?

March 22, 2018

If you have seen the phrase “FDA Approved” on a company website or commercial where a treatment or product is being marketed, you may automatically trust the said product. The question here, though, is how can you be sure that the FDA has indeed given their stamp of approval?

The U.S. Food and Drug Administration (FDA) regulates everything from food and tobacco products to medical devices and animal drugs to ensure that what manufacturers put on the market is safe for the public.

What you need to be aware of, though, is that not every product is granted premarket approval, which means it may become available for sale before being approved by the FDA. In some cases, the FDA is forced to go after companies that release products prior to approval. The U.S. Congress has long since granted the FDA the authority to act when they see that a company has put out products or treatments that may be considered a health risk to the general public.

Let’s take a moment to look at the FDA regulation process, as well as finding out the things that they do not approve.

Companies Are Not Approved by the FDA

Manufacturers, laboratories, and healthcare facilities are not approved by the FDA. That said, the FDA is well within their right to inspect these types of facilities to ensure that they use acceptable manufacturing regulations.

Unless some sort of exemption is in place, domestic and foreign food and drug operators are required to register their facilities with the FDA. The same rules apply to blood and tissue facilities.

Mammography facilities are required to have FDA certification, and their certificate needs to be clearly on display for patients. The certificate lets patients know that the facility has met or exceeded the strict health regulations that the FDA have in place.

New Drugs and Biologics are Approved by the FDA

All new drugs, as well as certain biologics, need to receive FDA approval before a company can take them to market. The biologics that usually require FDA approval include vaccines, blood and blood products, cellular therapies, and therapeutic proteins. In order to be granted approval, manufacturers need to be able to show that their products can be produced in adherence to federal quality standards.

The FDA does not actually test or develop products prior to approval. What they do instead is look at lab, animal, and human testing results performed by the manufacturer. The FDA will grant approval to a product if they deem it to have more benefits than known risks when used as directed.

Compounded Drugs Are Not Approved by the FDA

Pharmacists or doctors will sometimes combine ingredients to create new medications that meet the specific needs of individual patients. This is referred to as compounding and is a practice that is also used to deliver meds to patients who may be allergic to certain FDA-approved drugs. The FDA does not approve compounded drugs, so patients need to be aware that the effectiveness, safety, and quality of those drugs cannot be verified.

 

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