The problem here is that the majority of companies that support our industry don't have enough people working for them to produce 100,000 pages of dribble let alone real content in the time currently allotted. Assuming a single worker qualified to produce such a document exists in each company they have 20,800 hours in the coming 2 years to produce 100,000 pages on a single product. That's 4.8 pages per day or 1h 40m per page. Maybe that's somewhat within reason but a company with 100 products would certainly need 100 qualified people on staff just to draft this document.
The question of cost then really comes down to who is qualified to draft an effective MRTP application, and what do these people command as an hourly rate? Are there enough people qualified to draft the MRTP applications for each and every product in existence? My guess is that there are not enough qualified people in the first place, thus the demand for this service will become even more costly because the supply of skill is smaller than the need for the skill.
Assuming applications are made for every product currently in existence it becomes certain that none will be fairly reviewed for at least this; there is not enough time to read the documents let alone understand the content, not in a year, not in an eternity, not likely if the entire USA reading population were tasked with using their spare time to read MRTP application pages could they all be finished in a years time.
Maurice
It's pretty obvious that the regulations are a ban without saying that they are banning them. One of the conditions in the original act was that a tobacco category could NOT be outright banned (which I think should be another reason for a lawsuit, but I'm not a lawyer nor do I know how practical that is). BT / cigalike companies thought they had deals in place that would allow their products on the market and they have deep enough pockets + experience with the FDA that completing a good share of this paperwork is copy and paste for them. The actual cost of a price of cigarettes is about $1 including labor. Within an hour of deemng being "officially" published, BT was on record announcing how pleased they were. I'm still not sure what their intention was by pre-publishing the draft regulations but I doubt it was an accidedent (another cause for a lawsuit?).
In the Economic Impact report, there were statements about how regulations would reduce consumer choice over every regulation ("exiting" is the word they used) and then stated that even though the number of products would be limited, that the "volume" purchased (or spent) wouldn't necessarly change. Right. They think we'll buy cigalikes instead.
However, the real world is showing that sales of cigalikes have stalled. People are jumping directly to 2nd and 3rd generation devices (tanks and pv's/mods), skipping the cigalikes. Some of this I think is due to a wider acceptance of vaping vs. people feeling self-conscious when sucking on a pipe or a hot pink/purple device. So despite the media, I think there are strong signs vaping is accepted even among a lot of non-smokers. So this means that a number of cigalike makers are going to venture into tank systems that are refillable. I think it's safe to assume they are not so confident about FDA regulations with that.
On the FDA website there was a linked discussion about the changes in the warning labels for NRT products; they are now approved for dual use (including other NRT's and those who are still smoking, using them for extended periods of time i.e. > 6 months and advice to use NRT's to help with cravings (rather than abstenence). The FDA claimed no signs of harm from nicotine used this way and NOT A SINGLE NEW CLINICAL STUDY was referenced. Nope. The reason? The length of time the products had been on the market with low adverse events and COMPLAINTS THAT WAS REQUIRED DUE TO ECIGS. Yes, BP manufacturers were complaining their sales had taken a nose dive and basically, "that wasn't fair" (awww...). The FDA approved. This is why I started moaning that MRTP's were being held to a HIGHER standard than pharmaceticals were.
I guess the difference between medical use vs. recreational tobacco use is that the "public, greater good" standard does not apply to medications. They can consider the benifit to an individual for treatment of a specific illness without looking at the total cost to society (kill 'em with Chantix).
This "greater public good" is significant and it won't go away which is why individual stories about success have no value with the FDA / CDC (but do with Congress). I don't think there is a clear definition of what exactly that standard is so it feels like aiming at a target that moves and fades. I get the jist of it, but I think it needs to be spelled out in the regulations very specifically - or it's another reason to go to court to get clarification. Right now it means whatever they want it to that's convienent.
One aspect is that they say ecig use is substituting one addiction for another - and that's true if our ecigs were removed and smoking rates climbed again. The point is that vaping is a safer alternative and that concept is not really considered viable arguement do to the "light" cigarette fiasco. MRTP was basically written so that wouldn't happen again and IMO is directed at BT which is why it carries such enourmous costs and complexities/catch 22's.
Cigarette manufacturers have admitted to using additional ingredients to make cigarettes more addictive without increasing the nicotine level. The Surgeon General's Report on smoking stated that more people were dying from smoking now than in the 70's even though fewer people were smoking. That smoking had become more lethal - and this included the time period under the FDA's watch. It makes sense to me that vaping, without those added chemicals, would also make quitting nicotine for good much easier. DOH.
The FDA is claiming that by substituting vaping for smoking, people are not attempting to abstain and therefore, aren't quitting when they could. I think that's laughable since they've approved NRT's for long term use, dual use, etc. but I guess those are for individual treatment, not society as q whole. I'm kinda lost at this one. All I know is that it's estimated that 70% of smokers want to quit (documented) and currently less than 10% are able to do so. That's a pathetic rate of "success" and not much to "loose" to give an alternative method a chance. There is no other medical treatment that would be approved by the FDA / reimbursed by insurance with such a low rate of success (Obamacare will cover cessation NRT's but I don't know the details). The FDA wouldn't approve a heart, diabetic, obesity medication with under 10% success at 6 months.
So what are they really "loosing"? Less than 10% abstanence at 6 months - and even that figure is still substituting nicotine containing NRT products so based on the FDA's definition the actual abstence from all nicotine for 6 months is probably closer to 3% (or less). And this is what the FDA is saying the "greater good is". I'm not sure whether to laugh, cry or scream. But I guess that's all our lives are worth.
No study has shown non-smokers attracted to vaping, including children. They need to prove that statement. Every single "getting ready to quit" advice, hotline, counseling, hand-out has always said to "change the brand of cigarettes" before your quit date "so that you aren't addicted to the flavor too". It's well known that the further away a person can get from their cigarette brand tobacco flavor the less attracted they will be to light up again. This is why NRT's are sold in cherry, mint, citrus flavors and not tobacco flavored. Let's not forget the alcohol aisle contains the same flavorings, as well as intimate 'personal' products (condoms, lubricants). Are they really attempting to say those are being marketed to children?
You would think the FDA / CDC had some experience with the psycology of addction, but it doesn't appear so.
Personally I wouldn't mind seeing an independent review of the current marketing for vaping since the only one I'm aware of is the same BAD report done by Durbin's staff that only looked at cigalikes. I'd never heard of most of those brands and the rest of their report was seriously flawed, short sighted and myopic. It did not look at, consider or acknowledge the vaping industry even existed.
The facts available in 2012 only had figures from cigalikes and it appears that's the only data Congress still has = and the FDA / CDC. B&M's didn't exist as a category and they still don't have a way to guage oversea sales / non-traditional sales. They should have more updated figures now, but those are also woefully behind the times. Without a trade organization compiling these figures, it will be difficult to prove how widespread vaping is or the economic impact. The best shot we have is by getting CASAA numbers up IMO. Right now I think were marginalized like a fringe group.
The reality is that BT bought into vaping as placeholders. They contributed nothing to the research and development of the industry. Vaping was pioneered by small and medium sized business by ex-smokers to help other smokers to quit and that's a very important difference in the way cigarette manufacturers have treated smoking in the past. Yet it's these businesses that the FDA is comfortable regulating out of business and turn over to an industry that has done nothing to deserve it, has a history of lying, manipulating and decieving Congress, the FDA and the public for profit to the extent that extreme measures like the Master Settlement and the Tobacco Act were required in the first place. That's asking for trouble.
I think banning (without a ban, but regulations) all businesses under a certain size, reducing the number of brands from thousands to a handful and the number of products from over 100k to about 25 could also be called market manipulation or something. I know that strikes a bad vibe in almost everyone; smoker, non-smoker, small business owner, even some large owners. It's just bad. It's like emminent domain and property rights. You don't take something away and give it to someone else who just feels entittled to the profits and doesn't do a thing to earn them. Cashing dividend checks is not "hard work".
But the FDA has no idea how many businesses are involved, how many products, or how many should put in applications if their process were fair and they wanted vaping to survive or they were sincerly interested in public health. Which they don't. The FDA is designed to work with a handful of mega-corporations and that's why there is no "customer service: or "help desk" at the FDA with meaningful guidence, no guarentees and no accountability that what's said is accurate. The FDA isn't concerned with economic fallout, consumer trends, desires, or dealing with > 100,000+ applications. The idea of "personalized" or "customizable" per individual needs sends a chill down their spine as "faulty and poorly designed equipment". The FDA demands standarization and measured doses, the very things that make NRT's and cigalikes so pathetically unsuccessful and worthless.
Basically, as long as the FDA has control of smoking cessation only a tiny percentage will stop smoking. Successful addiction programs just can't be designed by never-addicts. When AA started, the never-alcoholics didn't think it would be successful either. I'd like to hear Zeller explain how < 3% quitting out of 70% that want to is so precious to preseve and in the best interest of the public.
I wrote a $#%? book again. I think this is practice for my final submission (without references and editing). Oh well, it's late.
