It doesn't matter whether it's "Harmful" or not. It can still be ruled a drug/drug delivery combination device. FDA has very broad jurisdiction, or assumes it has jurisdiction, over many things by default, at this juncture. There are hundreds of thousands of things the FDA has to review, they just want to cover their butts and this is just one product of about 522,000 products and/or claims of products and/or complaints that are in cue to review (this year alone).
The bill to give FDA jurisdiction over tobacco was a REALLY bad idea. They are WAY too inundated with workload.....and now they are taking the T out of ATF..... It's like saying I want to trade in my used car to get the same used car from a different used car dealer....big waste of time and money. I know for fact that the FDA at this point is just taking all the ATF protocols and guidelines and laws on tobacco from the ATF site and applying the same stuff to their regulation rules etc. Seems stupid.