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Don’t Be Fooled: Here’s What ‘FDA Approved’ Really Means

Posted 19 February 2024

From The Conversation

If you’ve ever reached for a bottle of moisturizer labeled “patented” or “FDA approved,” you might want to think twice. In a recent study of hundreds of advertisements, I found that supplements and beauty products often misleadingly use these terms to suggest safety or efficacy.

As a law professor, I suspect this is confusing for consumers, maybe even dangerous. Having a patent means only that you can stop others from making, using, selling or importing your invention. It doesn’t mean the invention works or that it won’t blow up in your face.

“FDA approved,” meanwhile, means a product’s benefits have been found to outweigh its risks for a specific purpose – not that it’s of high quality or low risk in general.

Led astray by the label

I wanted to know whether companies exploit these sorts of misunderstandings, so I analyzed hundreds … Read the rest

Companies warned about misleading “FDA registration certificates.”

Posted 07 July 2021

The FDA has ordered 25 companies to stop issuing documents that state that a medical device has been registered with the FDA. The certificates often look like official government documents, and many display the FDA logo. The agency believes that the certificates falsely imply that a device has been evaluated, cleared, or approved as effective for its intended purposes. The FDA does not issue any type of device registration certificate, and registration does not denote approval or clearance of a manufacturer or its devices. It merely means that certain information has been provided to the FDA.
Reference: Barrett S. FDA orders 25 companies to stop issuing misleading “FDA registration certificates.” Device Watch, July 4, 2021

The marketers of Healy bioresonance devices are using a certificate which states that their device has been cleared. Although the recent FDA action concerned registration certificates, the same principles … Read the rest