What Does It Mean When a Cosmetic Treatment Is Used "Off Label?"

Read Transcript

In the United States, many of the treatment we use are regulated by the FDA. The FDA approves any given medication or treatment for a specific use. For example when aspirin was first approved it was approved for headaches. Now for many years after that people were using aspirin for heart attacks.

However, that was considered an off-label use until studies were presented to the FDA and they approved it for heart attacks. Now some uses for some medications and procedures never get approved as arm label, that's often because it costs so much money to send any of these studies to the FDA.

So with fillers and botulinum toxins in many of our lasers most of the way we use them is off label. A doctor can use anything that is allowed in the United States as approved by the FDA for an On Label use in another reasonable way that he or she considers appropriate. For example, filling agents are approved in the United States for the nasal labial folds and the marionette lines, recently one was also approved for the lips.

However I spent most of my time filling areas like the temples, the chicks and the jawlines to give them more natural appearance. That's called Off Label and it's safe in the right hands.