Wednesday, December 17, 2014 5:15:27 PM
If the full truth be known, rather than horribly self-serving and misleading statements, it goes something like this:
3 years ago FDA issued a standard form cease and desist letter, sends out hundreds each year.
BIEL had been doing nothing more than advance its business in the U.S., claiming high efficacy and no negative side-effects.
FDA was then honest and courageous enough to state, hold it, we are deficient in this PEMF/SWT device area, we need to hire more in-house experts who know this stuff, and it did.
Then, a Proposed Rule Feb 2014 stating in part, "FDA is proposing this based on new information", and, "on its own initiative", and, "requests public comments for 90 days". That happened.
Comments were all reviewed within a month and the Good Guys here have e-mails in hand stating FDA is fully aware of urgency; understands advantages; is working on the drafting and in -house approvals for a Final Rule to be published in the Federal Register reclassifying these devices to Class II. Not TENS, not heat patches, still highly efficacious, drug-free, non-addictive and no negative side-effects, unless you eat one or two ActiPatchs.
It's coming folks, so don't be misled by false and manipulative hyperbole. . ., everything else but the truth is nonsense; have I got this right?
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