FDA Steps Up

I promise that I understand the desire to get an easy fix to things that do not please us. I promise too, that I am not going to age gracefully as I already fret about sagging eyelids and wrinkles above my lip. I do not know what I will do about these things - and I only share my concern to let you know that I GET IT...



I do believe in the idea of controlling the things that you can, however and am not at all afraid to work very hard to maintain a fit and healthy body. I was once overweight with a BMI of 27.3 - three little points away from obesity - and now that my BMI is closer to 18 - I am so much more comfortable in my skin.



I am getting off topic I think - but I wanted you to know that I do not talk without experience and empathy. I am grateful really, that I had to work to lose weight and keep it off because I am now very physically active (agile) and confident. I do not think I would have gained any fitness points if I had just been able to take some pill to shed my pounds. But you know, I did try various things over the years - wanting to believe that the latest gimmick was going to change my life. ( In the 80s I took Dexatrim while taking dance classes at an arts school. During one of my classes I felt certain that my heart was going to burst, I was so unbelievably scared. I went back to the dorm and slept for 24 hours. Later, in my late 20s I took these pills I ordered from the TV. They had some fancy schmancy name, but they were fiber pills. Three a day, three times a day - craziness. When the pills ran out, the hunger returned!)

These days the big spin is on a fat dissolving injection. It is supposed to do what liposuction does, but without surgery. I can't even begin to wrap my mind around liposuction itself - so I won't.

The current trend is something that is occurring in spas around the world. In the US it is marketed with several different names. Liposissolve, mesotherapy, lipozap and lipotherpay. I did a search and found spas offering it just a few minutes from my home. The FDA has sent out warning letters to at least 7 businesses, unfortunately, the one I just noted is not on the list. (SO I of course, alerted them!)

The drug that the companies use is a combination of two FDA approved medicines. However, the medicines are approved for something different. A clinician can request that the drugs be compounded at a pharmacy and then the clinician is able to use them in practice, as they see fit. It is similar to using a medicine off label. Unfortunately, the FDA does not regulate compounding and that is another issue.

Remember from past blogs, a company cannot market a medicine to treat a condition for which it was not tested and is not FDA approved. That is exactly what these spas are doing. They are making false and undocumented claims. Before this lipodissolve can be advertised for use in fat reduction, the FDA must approve it, and that would require clinical testing for efficacy and safety.

The FDA has received complaints of side effects, including disfigurement, and lack of effect. You can read the letter to consumers here.