FDA CHOOSES OPTION 1, WILL REGULATE PREMIUM CIGARS

[Orion21]

I asked the same question on another forum about the "substantial equivalent" process.

In addition to the other responses, just take a look at the FDA's record on new cigarette approvals. How many new products have you seen hit the market?

Here's an article from 2013:

http://www.theatlantic.com/health/archive/2013/03/how-the-fda-is-keeping-new-cigarettes-off-the-market/273679/

In those four years (09-13) four years, the FDA approved ZERO substantial equivalents. I could be wrong, but I think since then (7 years) it's only ruled on three total submissions, and one of those was denied despite being exactly the same size, shape, and material as something already on the market.

You made an excellent observation. This isn't about the fees for product approval. It's about creating an insurmountable wall for tobacco products to make it to market. The FDA wants to KILL smoking of all kinds, tobacco consumption of all kinds and nicotine delivery of all kinds in the USA. Those of you taking this wait and see attitude are Fing naive. So naive you should just stop posting. It's becoming very apparent you can't see past your own nose to Fing defend your own freedom to buy new cigars. Your government in the USA put a law in place that give a government agency the POWER to regulate your beloved hobby out of existence if they want to do so. And believe me they have the desire - 110% have the desire.

What will they decide they need to protect us from next? How about our political beliefs? Or our views on global warming? It could literally be anything that someone with an agenda and power deems dangerous or unhealthy.

[semifan1]

... just picked up a new 80% lower this weekend! For those of you who don't know what I am talking about, it will just make you mad so you best not Google it! -LOL

-the Pig

That's why I started stocking up on mags now. I know the regulation or ban is coming back.

[Stogieninja]

You made an excellent observation. This isn't about the fees for product approval. It's about creating an insurmountable wall for tobacco products to make it to market. The FDA wants to KILL smoking of all kinds, tobacco consumption of all kinds and nicotine delivery of all kinds in the USA. Those of you taking this wait and see attitude are Fing naive. So naive you should just stop posting. It's becoming very apparent you can't see past your own nose to Fing defend your own freedom to buy new cigars. Your government in the USA put a law in place that give a government agency the POWER to regulate your beloved hobby out of existence if they want to do so. And believe me they have the desire - 110% have the desire.

What will they decide they need to protect us from next? How about our political beliefs? Or our views on global warming? It could literally be anything that someone with an agenda and power deems dangerous or unhealthy.

Correction: they FDA wants to kill all tobacco not run by big tobacco. They're totally in bed together. If I were big tobacco, eliminating the new brands and any potential CCs in one fell swoop would be the best news ever. Big tobacco deals with a much smaller market, but in exchange they get a monopoly on that market.

[Orion21]

Correction: they FDA wants to kill all tobacco not run by big tobacco. They're totally in bed together. If I were big tobacco, eliminating the new brands and any potential CCs in one fell swoop would be the best news ever. Big tobacco deals with a much smaller market, but in exchange they get a monopoly on that market.

I don't believe this for a second. The whole tobacco industry is their sworn enemy. I think it's more to do with political realities and having a tactical view of slowly eliminating the ability to smoke or use tobacco products by the FDA vs choosing big over small business. You do realize we are dealing with anti-tobacco zealots, right? Not some even handed thoughtful people who weight personal liberty and differentiate between cigarettes (with know cancer causing additives) vs cigars. To these people tobacco products = cancer, higher medical costs and a future social/financial liability to the system. They aren't buddy buddy with anyone in tobacco. They will someday outlaw it...mark my words.

[ElPuro]

Not to insert myself into this debate, but please note that regularly smoking cigars can cause cancer. It's not as risky as cigarettes, but certainly not the same as being a non smoker (unless perhaps you only smoke once a month).

[Orion21]

Not to insert myself into this debate, but please note that regularly smoking cigars can cause cancer. It's not as risky as cigarettes, but certainly not the same as being a non smoker (unless perhaps you only smoke once a month).

I don't think anyone would disagree with you on that point, but the only study I have seen on this is decades old and the lowest use rate was 1 per day and the result were astonishing. The risk was elevated, but it was very nominal. Compared to cigarettes it was basically like being a non-smoker. I can also look at it from a risk perspective. I work with insurance companies that DO differentiate between cigarettes and cigars. Their view is that one cigar a week is considered a non-smoker. More than 1 per week and we can still negotiate non-smoker rates if other measures of health are good. The way underwriters have explained it to me is that cigars are not that important to them. If smoking cigars is associated with an unhealthy lifestyle that leads to being overweight, having high blood pressure or other medical issues they look at it. Otherwise, cigars are not that big of a deal. However, other less progressive insurers still lump cigars in as "any tobacco use."

[NSXCIGAR]

Not to insert myself into this debate, but please note that regularly smoking cigars can cause cancer. It's not as risky as cigarettes, but certainly not the same as being a non smoker (unless perhaps you only smoke once a month).

I don't think anyone denies that cigars contain carcinogens, but in terms of quantifying actual harm done, Big Macs and high fructose corn syrup are almost certainly more harmful to more people. If you allow regulation on something, you really open the door to allow it for everything.

There are always unintended consequences of any regulation, be it from taxation or outright prohibition. There's almost no evidence that higher tobacco costs reduce cigarette smoking, so the result is simply that people have less disposable income, reducing their wealth and lowering their quality of life. It's simply a trade-off, as are most things in life.

Prohibitions tend to give rise to organized crime, which leads to physical harm via violence, harm via adulterated product, thefts, urban decay and mass incarceration.

[ElPuro]

There's almost no evidence that higher tobacco costs reduce cigarette smoking..

This is not true. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228562/

There are many studies showing higher taxes reduces useage.

[luv2fly]

All in all, I say F them.

Not contributing to the thread but just wanted to throw that out.

Sorry, but a piss of a day today.

[NSXCIGAR]

This is not true. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228562/

There are many studies showing higher taxes reduces useage.

And here is the most recent research that shows none or a very tiny correlation, and that conclude that increased taxes are not a cost-effective means of reducing consumption:

http://www.nber.org/papers/w18326

http://object.cato.org/sites/cato.org/files/serials/files/regulation/2014/12/regulation-v37n4-7.pdf

Again, the evidence is mixed at best with the most recent leaning towards little to no effect. And of course, as I mentioned, this neglects to take into account the impact of reduced wealth and disposable income of the taxpayer, which in the case of lower income families directly affects many children.

Sure, raise taxes high enough and you'll surely reduce use, but you'll create de facto prohibition, black markets, organized crime, etc.

At the end of the day, there's very little governments can do to reduce the use of anything, and most attempts either exacerbate the problem or lead to a whole host of unintended consequences.

[CanuckSARTech]

I'm not sure if it's been lost on anyone...

That initial hyperlink to Halfwheel: http://halfwheel.com/fda-chooses-option-1-will-regulate-premium-cigars/113855

Whenever I navigate to that page, the main ad, right at the top of the page and flashing dead-center up there, is a hypnotic advert for Illusione.

Now, being that the FDA put in it's own report that one of the main three reasons for them to go with the harsher Option 1 take, was that "premium cigars are used by youth and young adults".

Flavoured and infused cigars, by Illusione, Drew Estate, Acid, etc., etc., DO unfortunately target towards a "younger demographic". Which sucks. It is a sneakily similar way as to what cigarette companies did back in the day.

Frankly, if the cigar industry was serious, they would have self-policed this MUCH EARLIER, and dealt with these tactics better.

If you're a "premium cigar" industry, fine - do that. But the youth marketing GIVES the gov't the reason to put a giant target up there.

And, for what it's worth...

It's gov't hogwash and nanny-state at it's finest. Some historical figure back in the day said, "...there's statistics, other statistics, and damn lies", or something along that line. It's the same thing with this "protecting kids" thing. Yes, the flavour-infused brands gave the gov't the easy target. But saying they're protecting "kids" and "youth" and "children" and "young adults", etc., is all BS!!!!! MOST states, I believe, have an 18-year age-of-majority rule for purchase of tobacco. And rightly so. But guess what???? Once you're an 18-y-o, you're an ADULT!!!! Yes, technically, the years 18 and 19 still end with the word "teen". But these types use that "teen" to make you think they're a "teenager" and then change it out for a pseudo-synonym of "kids". They purposely tweak the words around, to make people think there's vendors and manufacturers out there ACTUALLY focused on selling purely to 13-year-old teeny boppers.

Do teens (13-17) potentially get their hands on cigarettes??? For sure. Do they perhaps do the same with flavour-infused cigarellos? Yeah, probably likely.

But I've yet to meet a 13-17 year old saying they just NEED to get a box of legit Cohibas or Montecristos or any other ACTUAL premium cigars.

[CanuckSARTech]

Also, for what it's worth, Hamlet and I chatted about this FDA thing when I met up with him last week.

Pretty funny how the manufacturers are already prepped and planning for this, how there's certain things they don't like, but how there's other things that have MASSIVE holes in them, and go-arounds.

[amart]

If this ends up being a de facto 'ban' on premium cigars (read: they do not approve any new products ever) then this is surely an overreach of the FDA's rulemaking authority.

[Steens]

Not to insert myself into this debate, but please note that regularly smoking cigars can cause cancer. It's not as risky as cigarettes, but certainly not the same as being a non smoker (unless perhaps you only smoke once a month).

Hi ELPuro, Could you clarify " regularly" and do you have scientific evidence for "can cause cancer"

Cheers

[Zigatoh]

Hi ELPuro, Could you clarify " regularly" and do you have scientific evidence for "can cause cancer"

Cheers

Plenty of studies available with a quick google -

http://jnci.oxfordjournals.org/content/92/4/333.full

http://www.ncbi.nlm.nih.gov/pubmed/10927783

This one has an amusing table for anyone who thinks banning advertising doesn't work -

http://cancercontrol.cancer.gov/brp/tcrb/monographs/9/m9_1.pdf

http://blogs.biomedcentral.com/bmcseriesblog/2015/05/29/mortality-cigar-smoking/

http://www.cigargroup.com/faq/health/

http://www.cigargroup.com/faq/health/ncifaq.htm

And on and on... It does seem for people who don't smoke multiple cigars >2 every day the risk of lung cancer for example 'may' not be increased (without inhaling) there is a significant increase in various other cancers.

[ElPuro]

Hi ELPuro, Could you clarify " regularly" and do you have scientific evidence for "can cause cancer"

Cheers

Don't want to hijack the thread, but there is ample evidence. Would encourage you to spend some time researching using Google or the like. Some will downplay the results, but regular cigar use can cause cancer.

EDIT: see above

[NSXCIGAR]

...But I've yet to meet a 13-17 year old saying they just NEED to get a box of legit Cohibas or Montecristos or any other ACTUAL premium cigars.

You obviously never met me as a teenager...

[ElLoboLoco]

Increased risks of getting a fairly lower risk cancer/disease. This is true.

So, if the risk factor is increased by 10% of a specific disease that is diagnosed in 10 of 100,000 people, that means you could be number 11 of 100,000 people by smoking more than 2 cigars per day for that specific disease type.

One additional case for the cigar smoker group.

This is an example and not actual data. Do your own work.

Bottom line, understand your risks and live life with no remorse.

[El Presidente]

I am getting a little feedback from industry (Cuban and non Cuban side) on the FDA ruling.

You can sum it up as "confusion".

Lawyers are having a field day seeking FDA clarification on the ruling as well as preparing for extensions.

[Blazer]

I am getting a little feedback from industry (Cuban and non Cuban side) on the FDA ruling.

You can sum it up as "confusion".

Lawyers are having a field day seeking FDA clarification on the ruling as well as preparing for extensions.

Good luck with that! FDA purposefully creates ambiguous regulations because it allows them continue to "decide" whether companies are or are not in compliance with their rulings. Requests for clarity by companies an lawyers will only be met with more ambiguity. Its sort of the "we can't tell you what porn is, but we know it when we see it" mantra.

[wabashcr]

Good luck with that! FDA purposefully creates ambiguous regulations because it allows them continue to "decide" whether companies are or are not in compliance with their rulings. Requests for clarity by companies an lawyers will only be met with more ambiguity. Its sort of the "we can't tell you what porn is, but we know it when we see it" mantra.

There's a lot of truth in this. I don't think it's quite that cynical, but due to their bureaucratic incompetence, the end result is essentially the same.

I sense there's an expectation among some in the industry that the FDA will provide some guidance and clarification on the "substantial equivalence" standard, but I wouldn't hold my breath. I don't think the FDA itself knows how it will handle this until they start seeing some applications. Clarification is more likely to come from manufacturers engaging the FDA's painfully slow, drawn out application process. I just don't see how anyone other than the few big corporate producers will be able to afford this, knowing that when it comes to tobacco, most new applications are ultimately likely to be rejected. Who has the resources to gamble on this?

[SCgarman]

I am getting a little feedback from industry (Cuban and non Cuban side) on the FDA ruling.

You can sum it up as "confusion".

Lawyers are having a field day seeking FDA clarification on the ruling as well as preparing for extensions.

As far as the Cuban side, as of now it is a moot point right?, as they are not legally sold in the US (and may never be now thanks to FDA). I feel really bad for somebody like Hamlet, who just launched his own brand of cigars which now may face extinction in the next couple of years!

[Zigatoh]

But Cuba could still sell anything released pre2007 in the US right? So the majority of current production?

[Zigatoh]

But Cuba could still sell anything released pre2007 in the US right? So the majority of current production?

[wabashcr]

But Cuba could still sell anything released pre2007 in the US right? So the majority of current production?

Not 100% certain, but my understanding, and the belief of most, is that since they weren't legally available on the US market, they will not be grandfathered in. Of course any of this is subject to change, but right now it doesn't look good for legal CCs, either.

Here is an article that explains this in more detail.