Hey GBull - At the helpful suggestion by UK Sausage to do a little more research, I found the mission of the FDA. It is clear the goals are safety, efficacy and security of humans and us mutts. Nice mention of medical devices, FDA likes them too and it clearly acknowledges their endorsement of alternatives to drugs, it's where the world is and should be going.
QUOTE
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. UNQUOTE
So, both the FDA and Health Canada have safety and efficacy as the priorities - as they properly should. And they both cite devices.
To your post - I invested in BIEL because the ActiPatch worked a small miracle on a black & blue sprained ankle and I did not have to take the painkillers and anti-inlammatory drugs prescribed by my Doc. After 3 days of almost 24 hour ActiPatch, I went back to him, walking comfortably, most swelling gone. Tender? yes. Tentative? yes. But I was mobile and pretty comfortable. He couldn't believe it. It works!
Why did I go back to my Doc? To return the crutches - comments he made to me after the examination were were - "X-ray shows no break; you've got a very severe sprain, which is often more painful than a cracked or broken ankle; you'd better be prepared to be mostly off that ankle for 3 weeks to a month and here use these."
In my opinion, if BIEL does not get FDA approval ASAP, it is proof that the drug companies can influence decisions inappropriately, but I stress, I'm not a scientist. When BIEL does get its approval, it will be solid proof that the FDA is above the influences of the big drug companies and common sense prevailed. Pretty simple stuff.
