Not Good...FDA ruling

[CVAC085]

I have a feeling this will get all of us worked up and hopefully will get shot down. Keyword there, hopefully. Brace ourselves for the worst and hope for the best.

This reminds me of how it was a few years back here in NY with firearm's and ammo when word got out about changes to the laws here. Nothing but empty ammo shelves and sold out firearms as every gun owner in NY stocked up and braced themselves for the worst.

 

[StogieNinja]

I'm curious about the "substantial equivalent" exception thing... can anyone explain that to me? It seems to me that everything I've read is "game over" for cigars introduced after 2007, but with this exception, shouldn't most newer cigars qualify since all premium cigars are all made from essentially the same materials?

 

[DogRockets]

I'm convinced if our Founding Fathers were alive today, they'd be planning on how to colonize the moon. The government is in every part of our life and it's reach is not getting any smaller any time soon.

 

[AlohaStyle]

I'm curious about the "substantial equivalent" exception thing... can anyone explain that to me? It seems to me that everything I've read is "game over" for cigars introduced after 2007, but with this exception, shouldn't most newer cigars qualify since all premium cigars are all made from essentially the same materials?

Any new blend does not fall under that category... only the same cigar, same name from year to year if there are minor differences in farm supply/crops from year to year. Has nothing to do with materials, but the blend and make-up of a specific cigar that is marketed. Fuente can't pump out a new cigar and claim it under substantial equivalent.

 

[vivalanation734]

hey this fda option 1 kinda helps out the Cuban cigar industry if the embargo is lifted eh?

They would have to go through the same process... would hinder them too.

 

[Mr. McSquirelly]

Does this mean the end of Crowned Heads?

 

[Mikenice81]

Does this mean the end of Crowned Heads?

It could very likely mean that all of our favorite boutique brands disappear over the next couple of years.

This also effects e-cigs and personal vaporizers. They are basically now on a slow two-year slide to extinction. Isn't it weird that the rest of the world as looking to the personal vaporizer as a cessation or harm reduction tool and our FDA chairman that received $85,000 from the makers of nicorette wants to ban them?

I need somebody to save me from the people trying to save me.

 

[Mr. McSquirelly]

It could very likely mean that all of our favorite boutique brands disappear over the next couple of years.

It's seems like it will happen much faster than that. Beginning of August this year.

 

[StogieNinja]

I wonder how much money Altadis and General spent to make the 2007 date stick and make life harder for the little guys...

 

[Mr. McSquirelly]

I wonder how much money Altadis and General spent to make the 2007 date stick and make life harder for the little guys...

Here's the CA article, http://www.cigaraficionado.com/webfeatures/show/id/fda-ruling-threatens-cigar-industry-18788. It discusses that very point. There was lobbying to get 2016 as the date, but FDA shot it down. I'll tell ya, man, we have the greediest government in the history of the world. This is no different than The Tea Act passed by British Parliament in 1773!

 

[StogieNinja]

It's seems like it will happen much faster than that. Beginning of August this year.

So I'm doing more reading and it seems like there are at least two years where the new products can be sold; after that they have to file for "substantial equivalent" and can continue to sell unless/until the FDA comes back and says no.

But the language for the "substantial equivalent" doesn't seem to require it to be an existing brand, only an existing type of product...

Report Preceding Introduction of Certain Substantially Equivalent Products Into Interstate Commerce

1. In General. Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)
   1. the basis for such person's determination that
      1. the tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that is in compliance with the requirements of this Act; or
      2. the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compliance with the requirements of this Act, and all of the modifications are covered by exemptions granted by the Secretary pursuant to paragraph (3); and

The definition is:

Substantially Equivalent Defined.

1. In General. In this section and section 905(j), the term 'substantially equivalent' or 'substantial equivalence' means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product
   1. has the same characteristics as the predicate tobacco product; or
   2. has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.
2. Characteristics. In subparagraph (A), the term 'characteristics' means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.
3. Limitation. A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated.

It doesn't say anything about brand, and most premium cigars share materials, ingredients, design, composition, and heating source, don't they?

 

[Mikenice81]

So I'm doing more reading and it seems like there are at least two years where the new products can be sold; after that they have to file for "substantial equivalent" and can continue to sell unless/until the FDA comes back and says no.

But the language for the "substantial equivalent" doesn't seem to require it to be an existing brand, only an existing type of product...



The definition is:


It doesn't say anything about brand, and most premium cigars share materials, ingredients, design, composition, and heating source, don't they?

The problem is the FDA has only made two approvals under the process for cigarettes and the backlog is several years. So, any company applying would have to have the money for the fees, the money to stay afloat while waiting years, and then almost certainly face being turned down.

 

[StogieJim]

what a fucking joke.

 

[Mr. McSquirelly]

Let's organize a million man HERF on the steps of the Capitol!

 

[TheReMixologist]

I feel bad for the Florida economy

 

[Mr. McSquirelly]

Here's @NicaNick statement: https://www.instagram.com/p/BFCXcktHX4V/

 

[Undercrown509]

All the FDA did was create a black/secondary market. The next two years folks with cash will buy up what they can. Some will keep what they buy, others will supply others. And lets nit forget that there are some good cigars that are pre 2007 we will be able to get. But the next two years are gonna suck.

 

[Dick Leighton]

Let's organize a million man HERF on the steps of the Capitol!

For real!

 

[Mr. McSquirelly]

All the FDA did was create a black/secondary market.

I was just thinking the same thing. What if smaller manufacturers just moved to online retail in Nicaragua and Dominican Republic. Customs would be the only barrier. And some of us know how well customs prevents cigars from getting into the country! It all makes sense now. Drew Estates sells. There's rumors that Oliva is in negotiations to sell to STG. The real winners here are Altadis and General. All the boutique guys will be forced to quit or sell brands to either STG or Altadis, because those companies have the bankroll and lawyers to bribe FDA for approval.

 

[stin187]

This is no different than The Tea Act passed by British Parliament in 1773!

Well the big difference is there will be no revolution, sadly. And I for one am not driving up to Boston to throw cigars in the harbor.