Hi Folks,
This is a serious matter that needs attention and comment from all people. I encourage you to read the guidance proposal from the link below.
If the FDA has their way (and I cant believe that it will go through) this guidance could have an huge negative impact on the massage and alternative health industries.
An example of the absurdity of this guidance;
Massage therapy by itself is not regulated under this guidance. However, if I were to use an oil, lotion or a device while working on my clients then I would be practicing "medicine" and therefore working out of scope of practice.
I ask once again to please take the time to read the guidance and forward it to all you know who are associated with these industries.
There is also a link so you can leave a comment to the FDA.
The following is the Info I received from my Professional Association.
Thank You,
Ed Lark
Professional Therapeutic Bodywork
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The US Food and Drug Administration (FDA) is seeking comments on a draft guidance entitled “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.”
The FDA states clearly that they neither can nor should regulate massage therapy. In the draft guidance, however, they do state that oils, lotions, creams, and other products and massage devices that we use in our practice may be subject to FDA regulation.
On behalf of anyone who uses alternative practices in their life, I want to encourage to use this excellent opportunity to comment to the FDA on this issue.
Please note that Professional organizations have asked FDA for an extension to their deadline, but as of now the comment period will end April 30, 2007. So, there’s only a short time to express your views.
You can read the Federal Register notification about the call for comment here: https://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm
You can read the draft guidance here:
https://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
To comment on the draft guidance directly to FDA click here (Be sure to reference docket number 2006D-0480):
https://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&
Please take some time to voice your professional opinion about the FDA draft guidance.