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FDA Approved & FDA Certified: Do They Mean the Same Thing?

FDA Clearance, FDA Approval, FDA Certification, and FDA Registration - you see and hear these terms used all the time. But what do they really mean? Some of these phrases are actually valid and important to be aware of, but others are nothing more than marketing mumbo-jumbo. Therefore, knowing the difference between all of these terms is pretty important. Let’s differentiate between all four of them.
  • FDA Registered

FDA Approved & FDA Certified FDA approved

When you see a website or business point out that it’s ‘FDA registered,’ it’s usually an empty claim. All this means is that a manufacturer registered their company with the FDA. However, this doesn’t mean that their devices or products have passed FDA approval or that they even applied for said approval.

Certain businesses, such as medical device manufacturers, are required by the FDA to register and renew their registration every year, but the FDA doesn’t review their facilities or oversee the manufacturing process when a business claims that it’s FDA registered.

When you see this claim on a product, it doesn’t mean that the product has been reviewed by the FDA at all.

  • FDA Certified

Similar to the previous claim, ‘FDA Certified’ is nothing but a shady and alarming marketing practice. The FDA doesn’t issue registration certificates to all companies under the sun. In fact, the term ‘FDA Certified’ isn’t even recognized by the FDA, so definitely treat this marketing trick as a red flag.

One of the few exceptions to that rule is mammography centers. The facilities require FDA certification and always display their certificates for customers.

  • FDA Cleared

FDA Approved & FDA Certified meds

When used in good faith, a drug or device that’s been said to be ‘FDA Cleared’ actually has more credibility to its name than the previous cases we mentioned. The FDA requires a number of medical devices to undergo premarket review. These are all devices that could have a moderate to high risk to the user or patient, so they require FDA clearance under something called the 510(k) process. Such products as enema kits, catheters, and wheelchairs are subject to this kind of clearance.

  • FDA Approved

‘FDA Approved’ sounds impressive, right? That’s because it kind of is… Only the most dangerous and highly controlled substances require FDA approval. These products include drugs, some medical devices, food additives, and the like. Pacemakers, medications, and vaccines all fall within this category. Since these products have a high risk of harming human health and can pose a serious threat to one’s life, the FDA requires a rigid approval process and clinical testing completed by the manufacturer before the product in question can appear on the market.

According to the FDA, a product is approved when the agency “has determined that the benefits of the product outweigh the known risks for the intended use.” So when the label ‘FDA approved’ appears on medication, it is a sign that the drug is considered safe and reviewed by the FDA. 

However, be mindful of the following trickery. Some companies that don’t ever require FDA approval, like food supplements or cosmetics, for example, may put the label ‘FDA approved’ on their products. Be critical of such packaging claims, as well as vague terms like “we are working towards FDA approval.” These misleading marketing claims don’t mean anything on products like these because neither cosmetics nor nutritional supplements require approval by the FDA in the first place.

As the FDA state themselves, “neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients”. The responsibility for the safety of such products lies completely on the manufacturer, so cosmetics labeled “FDA approved” are no more effective or better than similar products without such a label.

If you’d like to check if a product is FDA cleared or approved, the best way to do so is by visiting the FDA database here - The Official FDA Database. If a product or company that claims to be FDA Approved or Cleared isn’t on this list, they are lying and trying to trick the consumer.

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H/T: Mental Floss

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