FDA rules announced

[lordofthepiperings]

Just saw on Cigar Afficianado that the House has amended the deeming regulations from a 2007 date to 2016, meaning they're approving that anything made before 2016 when the regulations were made public would be grandfathered in. Anything new after the date the deeming regulations were announced would be subject to the sku fee and approval process. Still has to be approved by the Senate and President.

 

[jmatt]

Peck - that's why I was saying 180 days to act. It doesn't look like Substantial Equivalence is going to be a viable strategy for most things. Think Lane Dark Red, GL Pease Sixpence or C&D Bijou. How do any of those rely on SE?

 

[peckinpahhombre]

jmatt, if they can't rely on SE then the 180 days is essentially meaningless if the reported costs of using the pre-marketing authorization pathway is right - I can't believe any of the blenders is going to spend several hundred thousand dollars per blend (or more) to try to get a post 2007 blend approved (especially if such efforts may ultimately be unsuccessful). The pipe tobacco market is just way too small. Moreover, it seems that even under the PM pathway the FDA effectively can extend out the 180 days at whim by requesting more data or otherwise indicating that the application is incomplete, which is what they have done in the cigarette context. I think if the SE pathway doesn't get blenders to the finish line then we are going to see a whole lot of blends fall off the table.

 

[jmatt]

I think if the SE pathway doesn't get blenders to the finish line then we are going to see a whole lot of blends fall off the table.

Could not agree more.

 

[lincolnsbark]

Even going down the SE path will require an application by the blender and an exemption by the FDA, is that correct? Or can a substantially equivalent tobacco be introduced without first obtaining the waiver.
I had high hopes most tobaccos would fall under the SE definition, which I had hoped the FDA would lump most pipe tobaccos under and turn a blind eye to all of us.

 

[peckinpahhombre]

lincoln, you need to apply and demonstrate SE to the FDA and they have to agree with it.

 

[lincolnsbark]

That is what I was afraid of, would have been so easy for the FDA to just ignore us with a statutory interpretation loop hole.
Relying on the FDA to say yes rather than just bury their heads in the sand are two very different things.

 

[tinsel]

Just saw on Cigar Afficianado that the House has amended the deeming regulations from a 2007 date to 2016, meaning they're approving that anything made before 2016 when the regulations were made public would be grandfathered in. Anything new after the date the deeming regulations were announced would be subject to the sku fee and approval process. Still has to be approved by the Senate and President

Yeah this happened a while ago. It would change the Feb 2007 cutoff date to the date the rules take effect. In other words, every product on the market when the new rule goes into effect would be exempt from having to go through the application process ... If the amendment holds up that is.
http://thehill.com/regulation/legislation/276883-house-committee-changes-fda-tobacco-rules-in-ag-budget-bill

 

[smokeyweb]

The pipe and cigar community will be crippled by this. Pipe, cigar, and vape enthusiasts need to unite, pool resources, and fight this, before the industry is crushed. At least Nightcap will be safe...

 

[smokeyweb]

We all need to go the CRA (cigar rights of America) and petition congress to try to save our beloved blends before it is too late!!! All brick and mortar shops should require this at the time of purchase. I am truly sickened by this.

 

[skraps]

We all need to go the CRA (cigar rights of America) and petition congress to try to save our beloved blends before it is too late!!! All brick and mortar shops should require this at the time of purchase. I am truly sickened by this.

Hate to break to it everyone, but the IPCPR has been lobbying for years, especially since the SCHIP act passed changing the federal taxes on cigars and pipe tobacco. http://www.ipcpr.org/. I have been signing petitions and writing my reps since that happened, but I recall even then many pipe consumers saying "nah, it will never happen to us."
Unfortunately, the cigar guys seemed to have taken this much more seriously than the pipe guys at least on a consumer level. Although it's pretty obvious at this point, it wouldn't have made much of a difference. The FDA did what they wanted, and the only ones making out in this are big tobacco.

 

[northernneil]

Here are some questions...
How will this affect blenders outside of the USA? Will companies like MacBaren, Germain, Gawith and Orlic be forced to adhere to these new regulations in order to sell inside the USA? Will they be exempt?
Also, what makes the FDA believe if the blend was made before 2007 that it is "safer" that post 2007 blends? I have to assume that is their logic. I mean, this is being carried out in the name of health is it not?
Finally, if blenders stop using topping's and casing's (I know, I know, it is impossible), would that allow them to be exempt from the new regulations because tobacco pre-dates 2007?

 

[lordofthepiperings]

Congress is all about the dollars. My hope is they see the lost tax dollars because of this FDA death sentence and shut it down. I'm not holding my breath though for the government to do the logical intelligent thing.

 

[peckinpahhombre]

How will this affect blenders outside of the USA? Will companies like MacBaren, Germain, Gawith and Orlic be forced to adhere to these new regulations in order to sell inside the USA? Will they be exempt?

They will be forced to adhere if they want to sell into the US market.

Also, what makes the FDA believe if the blend was made before 2007 that it is "safer" that post 2007 blends? I have to assume that is there logic. I mean, this is being carried out in the name of health is it not?

Because that was the date set by the Tobacco Control Act. According to this commentary from the vaping lobby:

Although the FDA has promoted its proposed deeming rule as a reasonable regulation to protect children, the agency’s proposal would ban the sale of most nicotine vapor products on the market because the Tobacco Control Act established February 15, 2007 as the “grandfather date,” which is the date for any tobacco product regulated by Chapter IX (including newly deemed products) to be sold on the U.S. market, and avoids having companies submit (and FDA approve) a PreMarket Tobacco Application (PMTA). Virtually no vapor products were on the market at that time, so the time-consuming and expensive PMTA is the only legal pathway for all other vapor products”. This is why moving the “grandfather date” is so important. Complicating the issue, the FDA has also claimed, “We do not believe that we have the authority to alter or amend this grandfather date.”
In the originally introduced Tobacco Control Act legislation in 2004 (negotiated and agreed to by Phillip Morris, the Center for Tobacco Free Kids’ Matt Myers and then Glaxo Smith Klein lobbyist Mitch Zeller), the grandfather date was set at June 30, 2003. When the legislation was reintroduced in 2005, the grandfather date was then changed to February 15, 2005, and later to February 15, 2007 when it was reintroduced in 2007, which remained when the legislation was reintroduced, again, in 2009; probably in an attempt to ban several recently introduced smokeless tobacco products by Reynolds.

Finally, if blenders stop using topping's and casing's (I know, I know, it is impossible), would that allow them to be exempt from the new regulations because tobacco pre-dates 2007?

They would not be exempt unless that particular blend in that particular form was sold on February 15, 2007. Even changing the name or a word on the packaging requires approval. They may be able to apply through the SE pathway. It would be a question of the SE pathway and how substantial equivalence will be determined. There is still a great deal of uncertainty (at least to me) on this.

 

[jmatt]

Even changing the name or a word on the packaging requires approval.

Yes - this was in the FDA's Q&A section about what constituted Substantial Equivalence. Among other things, they suggested changing a font to italics was SE, but other wording changes would not qualify. If changing the word on a tin kicks you out of the SE pool, I'd think certainly changing the percentage of any one tobacco leaf component in a blend would make the SE path unavailable. And think about the proof required for every different topping, topping amount, and topping process that would be required. Plug, flake, and ready-rubbed versions are three distinct products now needing three distinct approvals. Sutliffe Molte Dolce - a very highly-reviewed aromatic: My bet is gone. Lane Dark Red - another brand new aromatic: My bet is gone. C&D's Small Batch project: I'm guessing is gone. And all of the small blenders out there like Boswells? I'm guessing gone.
I'm not sure what happens to bulk tobacco, which is sold without packaging at all. Perhaps it all goes into a ziplock bag with the appropriate warnings slapped on a sticker?
And I wonder about McClelland's Christmas Cheer. On one hand it's the same every year: A single year of exceptional Virginia tobacco. But each year the label changes with a new year on it and a new description of the specific tobacco used. Does that mean it's different each year? I sure hope not.

 

[jacks6]

Bulk is going to be interesting. The 5 or 2lb bags from the manufacturer will now need a warning label but I can't see how retailers are going to split that out anymore. Dividing that bag into ziplock bags or whatnot will now be a "new product" because the packaging and amount that's being sold is changing. I think bulk can only continue to be sold in the large bags is my guess.

 

[cosmicfolklore]

If you've ever gotten a few oz of bulk from a European retailer, they come in printed bags that has the warning on them. I have a few somewhere at home.

 

[andrew]

Bulk is going to be interesting. The 5 or 2lb bags from the manufacturer will now need a warning label but I can't see how retailers are going to split that out anymore. Dividing that bag into ziplock bags or whatnot will now be a "new product" because the packaging and amount that's being sold is changing. I think bulk can only continue to be sold in the large bags is my guess.

That aspect won't be a problem, in Canada if you buy bulk they simply put it into a ziplock and slap a warning label sticker on it. You can still buy small amounts.

 

[deathmetal]

I'm not holding my breath though for the government to do the logical intelligent thing.

I chuckled at this one. The government that governs best, governs least, in my view.

 

[woodsroad]

Congress is all about the dollars. My hope is they see the lost tax dollars because of this FDA death sentence and shut it down. I'm not holding my breath though for the government to do the logical intelligent thing.

Congress doesn't give a rat's ass about the money. It's such a small amount, and besides, when was the last time they were concerned about balancing the budget?
Bulk: As the regs now read, no more repackaging will be allowed. So no more bulk jars at the B&M, no ordering 4oz from your favorite e-tailer.
And to be clear: If it wasn't sold on 2-15-07, kiss it goodbye. Manufacturers have until 8-8-16 to introduce "new" blends, but those blends have to be exactly the same as a blend sold on 2-15-07. And all of those blends will still have to go through the FDA's SE approval process, which will most likely be quite costly. Many, many blends will not make the journey to the Brave New World.
The door closes on 8-8-18. So you still have 2 years to stock up. Well, maybe 1 year. Nobody wants to get stuck with pipe tobacco that they are forbidden to sell.