As another sidenote: Was everyone aware that Biel was (illegally) selling their devices w/o a prescription and proper labeling in the US before the FDA issued a warning letter on 1/31/12? Sales spiked after the Dr. Oz showed aired. Did everyone already know that NSE letters were sent prior to the FDA warning? Was I the only one who didn't know? Or were we led to believe that the FDA is still evaluating the applications?
Biel (and Andy) may have put all shareholders as well as consumers at risk with these actions, whether you side with the FDA or Andy. IMO, Biel was aware of the law, but tried to find a back-channel to sell their products OTC in the US. Lucky for all of us, they got a warning.
If Andy told investors about this stuff prior to the letter, then I will have to admit I missed it. Otherwise (like I said), desperation but also red flags.
The Office of Compliance, in the Center for Devices and Radiological Health (CDRH), reviewed your firm’s websites at www.actipatchstore.com, www.allaystore.com, www.actipatch.ca, and www.bielcorp.com. Under section 201(h) of the Act, 21 U.S.C. § 321(h), the products noted above, which are sold on these sites, are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Your firm currently has an FDA-cleared premarket notification (510(k)) for the ActiBand device, K022404, which was cleared on August 8, 2002. The indication for use (IFU) statement for your ActiBand device is, “for the treatment of edema following Blepharoplasty.”
Your websites and device labeling for the ActiPatch, RecoveryRx, and Allay products include the following claims that FDA considers to be outside of the IFU for your 510(k)-cleared ActiBand device. These claims represent major changes or modifications in the cleared intended use of the ActiBand device, under 21 CFR 807.81(a)(3)(ii).
A review of our records reveals that you have not obtained marketing authorization before you began offering the above-noted devices for sale. You submitted premarket notifications for the Allay device on April 30, 2010, for the ActiPatch device on July 22, 2010, and for the RecoveryRx device on April 6, 2011. CDRH determined that the ActiPatch, (b)(4) are “not substantially equivalent” (NSE) to any legally-marketed devices. In (b)(4) CDRH’s NSE decision letters, CDRH stated that, “Any commercial distribution of this device prior to approval of a PMA, or the effective date of any order by the Food and Drug Administration re-classifying this device into class I or II, would be a violation of the Act.”
Furthermore, the ActiPatch and Allay devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for these devices fails to bear adequate directions for use for the purpose for which they are intended. Your cleared ActiBand device, K022404, is a prescription device, as described in 21 CFR 801.109. As a prescription device, the ActiBand “is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.” 21 CFR 801.109(a)(2). In addition, as a prescription device, the label of the ActiBand must bear the statement: "Caution: Federal law restricts this device to sale by or on the order of a ____" – the blank to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the state in which he practices to use or order the use of the device. 21 CFR 801.109(b)(1). The ActiPatch and Allay devices, were they cleared, would likewise be required to be sold as prescription devices with required cautionary statements. However, these products are being sold on your firm’s websites, www.actipatchstore.com and www.allaystore.com, without requiring a prescription or other order of a practitioner. CDRH was able to order the ActiPatch BACK PAIN THERAPY device from www.actipatchstore.com and the Allay device from www.allaystore.com, without your firm requiring a prescription or other order from a licensed practitioner. Moreover, the labels of these devices fail to bear the above-quoted cautionary statement.
My posts are solely my opinion unless presented with (or directed to) factual information. All investors are strongly encouraged by myself to do their own due diligence before making an investment decision.
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