Thank you for your question!
You’re asking if it’s against the FDA to inject Botox™ anywhere below the eyes
and you described in detail that you would like to address the bunny lines, the dimples
in your chin as well as the tip of your nose drooping with Botox™ but a practitioner
you went to stated that she could treat the crow’s feet line but would be endangering
her license by performing the Botox™ anywhere else. Well, I can certainly give you some
guidance on this question.
I have been a practicing cosmetic surgeon for over 20 years in Manhattan and Long Island.
I’m board certified by the American Board of Surgery and fellowship trained through
the American Society of Oculoplastic Reconstructive Surgery. I have been using Botox™ for patients
since 1993 and I have extensive experience with the use of Botox™ in multiple areas
of the body.
For clarification, the FDA does not legislate how physicians practice medicine. It’s that
straightforward. The practice of medicine is basically guided by state and the FDA is
intended for the determination of safety of medical devices and drugs. Now, what does
that mean? Well, when a company like Allergan went to the FDA for approval for the term
Botox™ cosmetic and although I’m not a lawyer, I can just give you my interpretation
as what is communicated to me, they got FDA approval for cosmetic purpose for only one
area and that is on the frown lines so the glabella, the number 11s. Now, with that approval,
they can market Botox™ cosmetic but prior to that approval, Botox™ was already being
used by physicians appropriately trained in multiple areas in the face for cosmetic purposes
including bunny lines, chin dimples as well as smile lines and for all the things you
want including the tip of the nose drooping which is to relax a muscle called the depressor
septi muscle.
That being said, I think there may be a question about whether or not your practitioner is
a physician or a non-physician offering this but I still don’t think that there’s any
issue at the federal level which the FDA is but rather at the state level. I think that
if you look for physicians who perform Botox™ in your area, you’ll find that most doctors
are willing to do Botox™ in areas that they’re comfortable doing. So in our practice, we
use it for forehead lines, crow’s feet lines, frown lines, for chin dimples and for a variety
of things even for underarm sweating.
Botox™ is a remarkable drug and it has a lot of remarkable uses so I don’t think
you have to worry about violating any type of legal grounds or law by having the treatment
done. It’s really having to do with the way companies are able to market their products
in terms of safety and regulation of that end but the FDA is actually prohibited from
preventing a physician from using a drug Botox™ in an off-label use whether it’s a drug
or a device. Physicians practice medicine and there to serve their patients. So, off-label
in no way and I think it’s overly misinterpreted, off-label doesn’t mean illegal. Off-label
has to do with the safety and the process that a company went through to get an approval
but certainly it is common practice for physicians, in this example, in using Botox™ off-label
when you think of the one area that is approved which is the glabella. So the practitioner
that you went to who was comfortable with doing the crow’s feet lines was already
working off-label.
So, from that respect, with due respect, I think you may find someone who’s a little
more experience or is a little more established and comfortable certainly because you one
to get the dosage and delivery process right. You know, Botox™, is not a general procedure
no matter how much people try to commoditize it. There is an art to doing injectables so
that’s a side note for you to consider when you find the right physician to help you with
what you want.
So I hope that was helpful, I wish you the best of luck and thank you for your question