4 ms·
Whoa yikes, the main page says "What's your struggle?" and then includes "General Anxiety" and "Panic Attacks." o_O I am not your lawyer, and this is not lega
by chasb 12y ago
Whoa yikes, the main page says "What's your struggle?" and then includes "General Anxiety" and "Panic Attacks."
o_O
I am not your lawyer, and this is not legal advice, but I strongly suggest you talk to an attorney who is experienced with the FDA's regulatory approach right now.
Claims that a product helps treat anxiety are regulated. Claims that a product is based on CBT (or any therapy) are even stronger warning signs.
This does not look like a grey area to me at all.
- beermann 12y agoWe have taken that line out. When we put it up, I guess I saw it a bit differently. I think you're right though. We really are trying to do right by the FDA. We'll go through the process to get Class I clearance as soon as we have the resources to do so. Until then, we really are not trying to make claims about treating specific disorders. As for being based on CBT, I have not seen anything that specifically addresses that type of claim. Put another way, we're trying to help people understand the cycle between thoughts, behaviors, and feelings. To us, that's the core of CBT.