I am absolutely NOT encouraging others to disregard the FDA regulations, and neither do I do it myself. I am also not insinuating that because others do it and get away with it that it is right. If I wasn't clear, then at least let me clarify that point.This.
Of course there are a lot of people that do it, and a lot of people get away with it. That doesn't make it right, and it doesn't make it legal. I'm sorry, but it isn't a "grey area" IMO. The FDA is very clear about what constitutes a drug and how they have to be handled and labeled if selling to the public. The "real world information" that someone is getting away with it is anecdotal at best. What you (the OP and PP) or anyone else chooses to risk is your business, but encouraging others to disregard the regulations is IMO irresponsible.
My "grey area" comment is regarding making an herbal product and selling it WITHOUT MAKING ANY MEDICAL CLAIMS either on the label or in marketing. Just making and selling a Calendula Salve and selling it as Calendula Salve - is that considered a drug? Calendula Salve can certainly be used for cosmetic purposes (to moisturize dry skin on heels, for example), but it can certainly be used as an "herbal medicine" also (as a treatment for eczema)...so where does it fall in the FDA categories? Is it only a drug if marketed or labeled that way? If there are no claims made on it's use, either in label or marketing, but it's labeled with the INCI ingredients, is it now a cosmetic? That's the grey area for me. I linked the FDA's stance on labeling/marketing and intended use so that any question about using brochures/flyers to give "medical" information about a product while not labeling your product it as a drug would still be against regulation.
As for the herbalist I contacted - I have no idea of her circumstances, and would not just assume she's not complying with FDA regulations, or that she is. I was only stating that she is an educated and successful business woman in this particular arena, and can possibly share her knowledge or information regarding this topic. It's certainly possible that she's flying in the face of danger, using medical claims, and could care less what the FDA says. I don't know, which is why I contacted her instead of making assumptions. I'm hoping that she has dealt with the FDA regarding her products and can shed a little light. And while she may not be an FDA official, she may have dealt with this exact circumstance and can speak from her experience.
If you had read my previous posts, you would see that I am simply "questioning out loud", stating my opinion and my experience. I am not irresponsible with my labeling or marketing (feel free to check out my Etsy store, FB page, or website), nor encouraging others to be - though I may be encouraging others to think for themselves and ask questions, not just take something found on the internet or forum as fact. Saying that someone finds a loophole and gets away with some illegal activity and wondering how is NOT encouraging others to do so, nor is it stating it's morally or ethically right. It's more a matter of questioning why something hasn't been done about it - if I have to follow strict guidelines, they should, too.