FDA product approval

Started by sweatsock, 01/20/2020 06:17 PM

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sweatsock

When this was announced it was viewed as a ticking time bomb. I can't find what the grandfather date was but remember it was back quite a few years.  The question was what the manufacturers would do with non grandfathered inventory. Would it get blown out and approved non grandfathered inventory would be expensive. I don't spend a lot of time thinking about things I can't control and quit payinq attention to the issue. The deadline was pushed out to 2021 and may never happen.  

https://halfwheel.com/fda-delays-submission-deadline-product-approval-2021/171990/

CW Piperman

" The statute establishes a "substantial equivalence" (SE) pathway for a new tobacco product to enter the market if it is substantially equivalent to a "predicate product," meaning a product commercially marketed in the United States as of February 15, 2007. FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products."

It's my understanding after reading the regs that any product introduced into the market after the 2007 date above must be submitted to the FDA for substantial equivalence testing, and taken off the market until testing is complete. If a tobacco product introduced after this date is not submitted for testing, the product must be removed from the market. Bad news for smaller tobacco houses who cannot afford the hundreds of thousands of dollars for testing of each product. This would include any new tobacco blends, new cigar blends, etc....

CW
"It's a dangerous business, Frodo, going out your door. You step onto the road, and if you don't keep your feet, there's no knowing where you might be swept off to" --J.R.R. Tolkein, #Bilbo #LOTR #TFOTR

Humidor: http://www.cigargeeks.com/index.php?action=humidors;area=public;member=CW+Piperman

sweatsock

Thanks for your reply. The date was pushed from 2018 to 2021. I can't imagine how many new cigars were created between 2007 and 2018. I expect before 2021 premium cigars will get exempted.

CW Piperman

Very possible. We must, however, do what we can to influence the definition of "premium" cigars. The initial offering of "$12 and up" ignores a ton of $6-10 very excellent cigars.
"It's a dangerous business, Frodo, going out your door. You step onto the road, and if you don't keep your feet, there's no knowing where you might be swept off to" --J.R.R. Tolkein, #Bilbo #LOTR #TFOTR

Humidor: http://www.cigargeeks.com/index.php?action=humidors;area=public;member=CW+Piperman

tuck0411

QuoteCW Piperman - 1/22/2020  8:56 PM

Very possible. We must, however, do what we can to influence the definition of "premium" cigars. The initial offering of "$12 and up" ignores a ton of $6-10 very excellent cigars.

Here's hoping they don't put the cut-off at $6.  The vast majority of sticks I smoke and enjoy cost quite a bit less than $6, so reducing it from $12 to $6 would not help very much at all.
Todd

"Those sticks won't smoke themselves..." -- OZZ

sweatsock

MSRP isn't relevant to me. A premium cigar to me is hand made and long filler regardless of MSRP.

ninfiction

Quotesweatsock - 1/23/2020  9:27 AM

MSRP isn't relevant to me. A premium cigar to me is hand made and long filler regardless of MSRP.

This is where most of the disagreement within the industry lies. All of the larger companies produce cigars that are machine made, or short filler, or infused/flavored, or a combination. The large companies don't want to distinguish between cigars. While the "boutique" companies only produce hand made long filler cigars and would probably be fine with it.

This is part of the issues with the Vegas trade show this year. Along with the pissing match over B&M vs Online retailers.

 The industry is divided and that is not helping the cause. The reason the FDA has delayed anything is because they don't have the ability to implement the requirements...and changing leadership...and confusion...and....
This is not the admin you're looking for...

sweatsock

I believe that the FDA should play a role in what people consume, but the criteria should be very restrictive. Price is a bad criteria. Additives is a good criteria.
I remember that something was added or talked about adding to cigarettes to make them less of a fire hazard. The main issue with 100% tobacco cigars would be organic/non organic and pesticides. There would be no grandfathering with this criteria. With global warming, botany and technological improvements, China could start producing cigars and I remember the issues with Chinese drywall. It is only a matter of time when Cannabis is added to cigars. I don't use and don't inhale anyhting and assume that a high could still be obtained my non inhaling cigar smokers. New cigar blends are about flavor and nicotine content. Cigars that would be grandfathered can have a high nicotine content so I don't see a difference regarding blending grandfathered and non grandfathered cigars. As written, the proposed regulations don't make a lot of sense to the consumer.

nathanw13

Quotesweatsock - It is only a matter of time when Cannabis is added to cigars.

 

Hate to tell you but... 

 https://uncrate.com/jas-sum-kral-cbd-cigar/

 

 

Our country has plenty of five-cent cigars, but the trouble is they charge fifteen cents for them.

Will Rogers

Cfickter

Quotesweatsock - 1/23/2020  1:28 PM  I believe that the FDA should play a role in what people consume, but the criteria should be very restrictive. Price is a bad criteria. Additives is a good criteria. I remember that something was added or talked about adding to cigarettes to make them less of a fire hazard. The main issue with 100% tobacco cigars would be organic/non organic and pesticides. There would be no grandfathering with this criteria. With global warming, botany and technological improvements, China could start producing cigars and I remember the issues with Chinese drywall. It is only a matter of time when Cannabis is added to cigars. I don't use and don't inhale anyhting and assume that a high could still be obtained my non inhaling cigar smokers. New cigar blends are about flavor and nicotine content. Cigars that would be grandfathered can have a high nicotine content so I don't see a difference regarding blending grandfathered and non grandfathered cigars. As written, the proposed regulations don't make a lot of sense to the consumer.

 Wow, this goes all over the place

If you look at it the $12 marker to ID premium cigars is actually a win. Never before had anyone from the other side been willing to put any stake in the ground to identify what a premium cigars is.  Now hopefully that is just the starting point.  Yes, I agree that price is not a good marker and we all would like to see "hand rolled" used to designate what a premium cigar is.

The FDA will not in the near future make a ruling on cigars (IMHO), at least what might be considered premium cigars.  I follow this issue very closely.  Each Congress, for the past number of years, has introduced bills to try and regulate cigars, lumping it in with cigarettes, snuff, and chewing tobacco, now vaping.  All based on a flawed survey of adolescents  No bill has made it out of committee.  Some not even out of subcommittee. The same for bills that supported the cigar industry like S.9 and HR.1854.  There are some very powerful Congressional leaders, like Marco Rubio, along with Senators Toomey, Menendez, Graham and others who support the industry.   This also has bipartisan support.

If it is 100% tobacco there should be no non-organic components.  If you are worried about pesticides in cigars do you worry also about similar pesticides on your fruits and vegetables?  

Yes, like mentioned above Cannabis (the umbrella term for marijuana or hemp) has made it way into cigars in the form of CBD.  I can't see THC being introduced into cigars (as a marketable product) but hell, who knows.

China has been producing cigars since 1918, Great Wall Cigars produces over 2 million per year.  But if you have not tried a Chinese cigar or cigarette, don't put it on your bucket list.  Beside when in China you can get Cubans   

I don't believe blenders are creating new blends focused on nicotine as a component,  Flavors, complexity, strength.  Yes a cigar's strength can be directly related to the amount of nicotine.  But blenders are creating stronger cigars based on the tobacco leaf, the type, where it is taken from the plant (priming), sun vs shade, and how it is aged.  I believe that if you are smoking a cigar just for the nicotine you are missing the best parts.

Guru Master of the Minions

Alcohol, Tobacco, & Firearms should be a convenience store, not a department of our government!

Gunga galunga ... gunga, gunga-lagunga." - Carl Spackler

Education is important, cigars are importanter!

I like long walks, especially when they're taken by people who annoy me





sweatsock

Quotenathanw13 - 1/23/2020  1:13 PM

Quotesweatsock - It is only a matter of time when Cannabis is added to cigars.

 

Hate to tell you but... 

 https://uncrate.com/jas-sum-kral-cbd-cigar/

 

 


They put cbd in cornflakes. I was talking about tch.

sweatsock

QuoteCfickter - 1/23/2020  3:25 PM

Quotesweatsock - 1/23/2020  1:28 PM  I believe that the FDA should play a role in what people consume, but the criteria should be very restrictive. Price is a bad criteria. Additives is a good criteria. I remember that something was added or talked about adding to cigarettes to make them less of a fire hazard. The main issue with 100% tobacco cigars would be organic/non organic and pesticides. There would be no grandfathering with this criteria. With global warming, botany and technological improvements, China could start producing cigars and I remember the issues with Chinese drywall. It is only a matter of time when Cannabis is added to cigars. I don't use and don't inhale anyhting and assume that a high could still be obtained my non inhaling cigar smokers. New cigar blends are about flavor and nicotine content. Cigars that would be grandfathered can have a high nicotine content so I don't see a difference regarding blending grandfathered and non grandfathered cigars. As written, the proposed regulations don't make a lot of sense to the consumer.

 Wow, this goes all over the place

If you look at it the $12 marker to ID premium cigars is actually a win. Never before had anyone from the other side been willing to put any stake in the ground to identify what a premium cigars is.  Now hopefully that is just the starting point.  Yes, I agree that price is not a good marker and we all would like to see "hand rolled" used to designate what a premium cigar is.

The FDA will not in the near future make a ruling on cigars (IMHO), at least what might be considered premium cigars.  I follow this issue very closely.  Each Congress, for the past number of years, has introduced bills to try and regulate cigars, lumping it in with cigarettes, snuff, and chewing tobacco, now vaping.  All based on a flawed survey of adolescents  No bill has made it out of committee.  Some not even out of subcommittee. The same for bills that supported the cigar industry like S.9 and HR.1854.  There are some very powerful Congressional leaders, like Marco Rubio, along with Senators Toomey, Menendez, Graham and others who support the industry.   This also has bipartisan support.

If it is 100% tobacco there should be no non-organic components.  If you are worried about pesticides in cigars do you worry also about similar pesticides on your fruits and vegetables?  

Yes, like mentioned above Cannabis (the umbrella term for marijuana or hemp) has made it way into cigars in the form of CBD.  I can't see THC being introduced into cigars (as a marketable product) but hell, who knows.

China has been producing cigars since 1918, Great Wall Cigars produces over 2 million per year.  But if you have not tried a Chinese cigar or cigarette, don't put it on your bucket list.  Beside when in China you can get Cubans   

I don't believe blenders are creating new blends focused on nicotine as a component,  Flavors, complexity, strength.  Yes a cigar's strength can be directly related to the amount of nicotine.  But blenders are creating stronger cigars based on the tobacco leaf, the type, where it is taken from the plant (priming), sun vs shade, and how it is aged.  I believe that if you are smoking a cigar just for the nicotine you are missing the best parts.


We basically agree. I could have made my points clearer. The current direction is bull and best to leave things as they are. I don't see a $12 marker a win for the consumer. It may be a win for the manufacturers. A $12 cigar at a California B&M is $20. I buy about 1,000 cigars a year at an average cost of $2.25 a cigar. I smoke good cigars.
Average price paid for a Montecristo is $3 which is marketed as an over $10 cigar. I regularly spend more for than my average for some more expensive cigars to compare against what I smoke; markdowns and seconds.

Cfickter

[/QUOTE]  We basically agree. I could have made my points clearer. The current direction is bull and best to leave things as they are. I don't see a $12 marker a win for the consumer. It may be a win for the manufacturers. A $12 cigar at a California B&M is $20. I buy about 1,000 cigars a year at an average cost of $2.25 a cigar. I smoke good cigars. Average price paid for a Montecristo is $3 which is marketed as an over $10 cigar. I regularly spend more for than my average for some more expensive cigars to compare against what I smoke; markdowns and seconds.[/QUOTE]

 I think you found the solution.  If you look at your Monte example and then look at cigars like Gurkha, Villager, Rocky's you see "$10, $12" cigars selling for half or less of the keystone price.  So if the FDA uses MSRP and set it at $12, I'm putting all my cigars at $12 and deeply discounting to shops.  But it isn't going to happen.  I feel this is still a long way off from being a settled issue, especially if Trump get reelected. 

Guru Master of the Minions

Alcohol, Tobacco, & Firearms should be a convenience store, not a department of our government!

Gunga galunga ... gunga, gunga-lagunga." - Carl Spackler

Education is important, cigars are importanter!

I like long walks, especially when they're taken by people who annoy me





bstessl

#13
Quotesweatsock - 1/23/2020  3:26 PM  
Quotenathanw13 - 1/23/2020  1:13 PM  

Quotesweatsock - It is only a matter of time when Cannabis is added to cigars.

 

Hate to tell you but... 

 https://uncrate.com/jas-sum-kral-cbd-cigar/

 

 

They put cbd in cornflakes. I was talking about tch.

 

Hate to tell you, but, he's already working on a THC version.

 

 https://halfwheel.com/jas-sum-kral-adds-nuggs-kune-puro-selection-thc-infused-cigar/361580/

Smoking cigarettes is a habit, smoking a cigar is an event. - Brad Paisley


   
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