Pete, loose application is exactly why it was written that way. This is the ninth time the FDA has attempted to grab a hold of premium cigars, and they are basically acting like a rabid dog looking to bite. They're relentless, and they want unimpeded access to make the next generation completely smoke-free.
The gist is this: the FDA wants to regulate cigars the same way they do beef or any other consumable. For the safety of the kids, of course. To the best of my knowledge, premium cigar tobacco, pipe tobacco, nasal snuff, chew, etc., would be lumped in with e-cigarettes, dry cured cigarillos, chemically-flavored gas station blunts, etc. Basically there would be cigarettes, and then everything else.
Let's say you want to market a cigar. Your farm would be inspected by an FDA agent (which you're paying for), and your crops would be inspected by an FDA agent (which you're paying for), and then you would harvest your crop and blend your cigar. Each individual leaf of your new blend - one wrapper, one/two binder(s), and let's say two or three filler tobaccos - would need to be submitted to the FDA with the finished product and a pre-market application, plus a check for $55,000 or more. Per size. Want to make a robusto, corona, belicoso, and churchill? You're submitting four applications. This is obviously immediately going to put smaller boutique brands out of business.
And that's just to get in the door. Concerning the last 40,000 applications sent to the FDA for tobacco-related products that they currently oversee, less than 40 have been reviewed and only one has been approved. Obviously they aren't in a hurry to allow new products to reach market. Oh, and this is retroactive also. Any cigar released to market after February 15, 2007 (check that date, I may be off a few days) will be pulled from the shelves to be submitted. This is obviously immediately going to put even more smaller and/or newer brands out of business.
On top of this, the most noticeable regulations are: promotional materials, giveaways, and samples of tobacco, would be illegal; the minimum price of a cigar would be $10, regardless of size, weight, or makeup; packaging would become restrictive (which I honestly am not worried about - but it's proposed to make these products less appealing to children which is an argument I can't stand behind); there could potentially be expensive permits needed to sell tobacco products; the minimum age to purchase tobacco could raise to 21; there could potentially be no more cigar bars and/or smoking lounges nationwide; it would be nearly impossible to release special edition, small batch, limited, seasonal, etc. cigars; and, obviously, a gigantic list of further restrictions.
Needless to say, a lot cigar manufacturers would close shop, a lot of small business tobacconists would close shop, and tens of thousands of people both here in the US and in South American countries would be jobless overnight.
The FDA had already announced that we're basically down to outcomes. Option one, which is our worst nightmare, is where they gain oversight over premium tobacco products. Option two is to exempt cigars from oversight. The OMB right now is basically the last step in this process. From what I've been able to understand, Congress can't necessarily stop the OMB from making whatever decision they're going to make, and there are no easy avenues for a legal hold on temporarily stopping any immediate changes due to new regulations, so their decision is final. We could see regulations take effect as soon as 30 days after the announcement of their decision.
Now, I have no idea where pipe tobacco falls in this. I haven't heard any concrete answers regarding that, and my biggest issue with this whole debacle has been the cigar industry leaving other forms of premium tobacco in the dust. But, I don't think it's a stretch to say that if cigars fall, everything else will too. As far as I'm concerned, the entire premium tobacco industry should have banded together to fight this. Any time that I've written to, spoken on the phone with, or confronted in person, an elected official regarding this - whether on the local or national level - I have made it very clear that I wanted ALL premium tobacco to be exempt. It's left a bad taste in my mouth, honestly, because I can't draw a line between these products.