Sure... but we have stated it a 100 times over and no one wants to listen.
It all goes back to the form letter that gets tossed around here like a monkey with poo.The FDA does, in fact, have jurisdiction to stop "quit smoking devices" and "lung apparatus" from entering this country. It all goes to marketing and claims.
The WHO gave us our first warning in September of 2008. Don't market these as quit smoking devices because we cannot prove they are such. Noted. The FDA has had Christopher Kelly state that they are looking at these on a case by case basis. What does that mean? That means that they are looking at everything in the shipment. If your manual says "quit smoking", then yes, you do in fact have a "new drug".
No matter what anyone wants to think, the FDA has a right to step in on those who are marketing these as NRT's and I think they should. If you are going to make health claims and quit smoking claims, then you should be held to the rules of the FDA.
Is it possible this all changes if the Senate gives the FDA control? Sure. We have never said that the road will not be bumpy. And many of us have said that we are not against regulations because it does promote safety for our users. Many of us are taking our own steps to ensure better packaging, etc. to show that we are in fact, attempting to do this properly.
Either way, the suppliers are privy to information from our lawyers, the FDA, Health Canada, that isn't out there yet. Before we lay our cards out on the table for all of the forum to abuse, we are going to get together and determine the best hand. We made an announcement regarding the Association last week and to our surprise, it was poo'd on more then it was praised. Frankly, I was kind of shocked that more members weren't happy the suppliers were coming together to be proactive.
Lacy--Many of us are happy to see the Suppliers getting united and on the same page. But --and correct me if I am wrong--Does the FDA not have much broader power then just how a product is marketed and claims--Are they not charged with the the safety of products as well. I can understand you concern about not showing your hand for " Forum Abuse". I would just like to know if the saftey argument is being addressed because I see the attack from the FDA looking like this:
FDA ADVISORY--From Rita Chappelle
For Immediate Release
"The FDA announced today that, after review, and upon advise of their medical consultants, it is ordering that the importation, sale, and marketing of all, so called electroinc cigarettes are halted today and banned until such time as their saftey can be evaluated."
So Lacy I do hope that your group and Counsel are addressing it from a saftey issue as well---Thanks for all you efforts and wish I could help more---Sun
