Court Rules FDA Acted Improperly in Regulation of Premium Cigars

[Cigar Surgeon]

https://halfwheel.com/fdas-regulations-of-premium-cigars-struck-down-by-court/410505/

This is great news for the NC cigar industry in the US, and likely for other countries since there's been a global movement to copy tobacco legislation (see Canada and Australia).

It seems likely either regulating cigars in the industry will go away, or they will lean towards Option 2 which means a cigar meeting the definition of 'premium' will be exempt. 

Edit:

I will add there has been a lot of divisiveness over this issue, specifically blaming one political party or another. The judge who ruled in this case, Judge Mehta, was appointed by President Obama. 

[HarveyBoulevard]

The US Supreme Court had a great ruling in an EPA case that found these agencies are promulgating legislation and not just interpreting the laws on the books.  It also found that what interpreting has been done to be overreaching with regards to their authority to do so .  This is going to affect how the EPA, FDA, DOJ, ATF, etc all 'interpret' the laws enacted by the legislature.

Taking that ruling and applying it to the aforementioned case is a big win for cigar smokers.

Note:  I am not taking a political position on the issue, just indicating that the Court has affirmed the powers of the legislature and not to these agencies who cannot be held to answer for their actions.

[rcarlson]

45 minutes ago, HarveyBoulevard said:

The US Supreme Court had a great ruling in an EPA case that found these agencies are promulgating legislation and not just interpreting the laws on the books.  It also found that what interpreting has been done to be overreaching with regards to their authority to do so .  This is going to affect how the EPA, FDA, DOJ, ATF, etc all 'interpret' the laws enacted by the legislature.

Taking that ruling and applying it to the aforementioned case is a big win for cigar smokers.

Note:  I am not taking a political position on the issue, just indicating that the Court has affirmed the powers of the legislature and not to these agencies who cannot be held to answer for their actions.

I'm fascinated that some label the curtailing of unchecked authority by an ever-expanding agency state as anti-democratic.              

[Cigar Surgeon]

3 minutes ago, BoliDan said:

I figured premium cigars got lumped in for no other reason than it would create a loophole that they didn't want. So, they will probably come out with something outlandish to meet the requirements as the premium definition. I bet acids and other infused cigars will not meet it. Still, good news. FDA has been overreaching for too long.

The "premium" definition does not include flavored / infused cigars.

The definition Judge Mehta previously referred to was:

1. is wrapped in whole tobacco leaf;
2. contains a 100 percent leaf tobacco binder;
3. contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
4. is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
5. has no filter, nontobacco tip, or nontobacco mouthpiece;
6. does not have a characterizing flavor other than tobacco;
7. contains only tobacco, water, and vegetable gum with no other ingredients or additives;
8. and weighs more than 6 pounds per 1,000 units.

[ha_banos]

6. No infused cigars lol

[NSXCIGAR]

3 hours ago, HarveyBoulevard said:

Taking that ruling and applying it to the aforementioned case is a big win for cigar smokers.

If only it was that nuanced--the FDA straight up lied to the court in this case and claimed there wasn't any evidence on premium cigars when there clearly was. They also misinterpreted data so obviously and egregiously that it can't be anything other than intentional. You know it had to be outrageous for an Obama judge to call it out.  And our tax dollars went to a bunch of lawyers to fight this ridiculous case. The FDA should have settled it and relented years ago. No consequences for the individuals in these agencies and bags of cash for the trial lawyers. 

When these agencies resort to lying and obfuscation they are clearly political machines and money generators for lawyers. End them. 

[JustDave]

Maybe I'm missing something, why would someone claim that premium cigars should be regulated differently than other cigars?  Is the claim that they are used differently and as such they should be regulated differently or is there something else going on?

Is the only ramification of this and the other ruling the removal of the user fees and ban on free for donations/samples?  removing that particular tax on them is nice I guess and letting them be given away at events or to a charity is good, but does that really move the needle?  anyone know how much of the cost of an NC is the user fee, is this quibbling over a few cents or is it a significant burden?

[MrBirdman]

4 hours ago, HarveyBoulevard said:

The US Supreme Court had a great ruling in an EPA case that found these agencies are promulgating legislation and not just interpreting the laws on the books.  It also found that what interpreting has been done to be overreaching with regards to their authority to do so .  This is going to affect how the EPA, FDA, DOJ, ATF, etc all 'interpret' the laws enacted by the legislature.

Taking that ruling and applying it to the aforementioned case is a big win for cigar smokers.

Note:  I am not taking a political position on the issue, just indicating that the Court has affirmed the powers of the legislature and not to these agencies who cannot be held to answer for their actions.

This has nothing to do with the FDA’s legislative authority. It’s an administrative law question about whether the FDA followed the policies and procedures required of federal rule making.

[rcarlson]

9 minutes ago, MrBirdman said:

This has nothing to do with the FDA’s legislative authority. It’s an administrative law question about whether the FDA followed the policies and procedures required of federal rule making.

It's regulatory authority that it doesn't get to resolve for itself.  

[MrBirdman]

2 minutes ago, rcarlson said:

It's regulatory authority that it doesn't get to resolve for itself.  

Well, yes, in the sense that the FDA can’t do whatever it wants. But that’s true of every agency (or legislature, for that matter). 

The FDA has the authority to regulate tobacco. But they need to demonstrate good cause to do so and cannot act capriciously - which is what the judge determined they did. 

[rcarlson]

2 minutes ago, MrBirdman said:

Well, yes, in the sense that the FDA can’t do whatever it wants. But that’s true of every agency (or legislature, for that matter). 

The FDA has the authority to regulate tobacco. But they need to demonstrate good cause to do so and cannot act capriciously - which is what the judge determined they did. 

Capricious is always a challenge to overreaching regulatory authority, and it rarely succeeds in controversial social arenas, particularly in the DC Circuit.  The greenhouse gas (endangerment finding) is a primo example and depending on your vantage point, these federal agencies quite often do what they want.     

[JustDave]

I get the overreach and why it was ruled and what it is indicative of in american agency vs legislation and all the rest, I was more just curious what the impact was.  Are we talking 20 cents per stick or are we talking about 50% of the cost?  when industry people say things like 'Our small artisan cottage industry has been under attack for over a decade with unscrupulous taxes' it makes me think it's 20 cents a stick that just turns into more profit for them.  

[MrBirdman]

41 minutes ago, rcarlson said:

depending on your vantage point, these federal agencies quite often do what they want.     

I’m sure. 

 

26 minutes ago, JustDave said:

I get the overreach and why it was ruled and what it is indicative of in american agency vs legislation and all the rest, I was more just curious what the impact was.  Are we talking 20 cents per stick or are we talking about 50% of the cost?  when industry people say things like 'Our small artisan cottage industry has been under attack for over a decade with unscrupulous taxes' it makes me think it's 20 cents a stick that just turns into more profit for them.  

This isn’t “overreach” like some here are describing it. The FDA has the authority to regulate tobacco products. This is beyond dispute. But they still have the follow the rules of evidence and procedure when it comes to doing so. The question here is whether they were justified in treating premium cigars the same as all others - and the finding is that the capriciously disregarded the only evidence on offer (that they are not the same) in making their decision. 

[JustDave]

2 minutes ago, MrBirdman said:

This isn’t “overreach” like some here are describing it. The FDA has the authority to regulate tobacco. This is beyond dispute. But they still have the follow the rules of evidence and procedure when it comes to doing so. The question here is whether they were justified in treating premium cigars the same as all others - and the finding is that the capriciously disregarded the only evidence on offer (that they are not the same) in making their decision. 

but why would they even make that distinction?  premium vs non premium, why treat them separately? purely user behavior?

[MrBirdman]

2 minutes ago, JustDave said:

but why would they even make that distinction?  premium vs non premium, why treat them separately? purely user behavior?

In large part. If you read the article they go into it - basically there are usage patterns that make the health risk from premium cigars distinct and thus worthy of being treated differently from other cigars. 

To be clear, by premium cigars they don’t mean just top end stuff - they mean all hand rolled, non-flavored cigars that we here enjoy. 

[Fuzz AI]

1 hour ago, BoliDan said:

I don't know, hopefully we will see the prices. This statement by Rocky Patel makes it seem as if it was significant.

“Our small artisan cottage industry has been under attack for over a decade with unscrupulous taxes and overreaching regulations. I am overwhelmed with tears of joy with the court’s ruling. Happy that we can go back to work and save thousands of jobs that were in jeopardy worldwide,” says Rocky Patel.

Cigar manufacturing is a small cottage industry?

[MrBirdman]

7 minutes ago, Fuzz said:

Cigar manufacturing is a small cottage industry?

Yeah listening to them General Cigar is a veteran who sells cigars off the back of his pickup.

[El Presidente]

8 minutes ago, Fuzz said:

Cigar manufacturing is a small cottage industry?

 

Fuzz, come on man! .......

RP submitted this as a photo of his operations. 

 

[NSXCIGAR]

4 hours ago, rcarlson said:

Capricious is always a challenge to overreaching regulatory authority, and it rarely succeeds in controversial social arenas, particularly in the DC Circuit. 

Agreed, and that should be an indication of how obnoxiously the FDA behaved in this case. A high standard and an Obama judge tossed it. The fact that the FDA lawyers went forward fighting this should result in sanctions. They had no case and it was a money grab. 

 

3 hours ago, Fuzz said:

Cigar manufacturing is a small cottage industry?

Yeah, the small players Rocky Patel wants to obliterate! 

I suppose in comparison to cigarettes and machine made cigars yes, premiums are infinitely smaller, although "cottage industry" is a bit of a stretch.

[Cigar Surgeon]

15 hours ago, JustDave said:

Maybe I'm missing something, why would someone claim that premium cigars should be regulated differently than other cigars?  Is the claim that they are used differently and as such they should be regulated differently or is there something else going on?

Is the only ramification of this and the other ruling the removal of the user fees and ban on free for donations/samples?  removing that particular tax on them is nice I guess and letting them be given away at events or to a charity is good, but does that really move the needle?  anyone know how much of the cost of an NC is the user fee, is this quibbling over a few cents or is it a significant burden?

I'll try and be as succinct as possible here, because the answer could be 6 pages long. 

The short version is:

• The majority (90%+) of cigar smokers do not smoke cigars daily, only casually.
• The majority of cigar smokers don't inhale.
• The Monograph #9 studies showed an almost insignificant health risk from cigar smoking
• Frequency of usage and inhalation determine health risks
• There's almost zero premium cigar usage among kids (less than 1%)

The ramifications are:

• Potential removal of pre-market approval
• Which would open the door to new products not requiring grandfather or pre-market status
• Removal of user fees for approval

I can't remember the costs involved but it was enough that quite a number of smaller boutique brands sold their brand and packed it in.

[Puros Y Vino]

5 minutes ago, Cigar Surgeon said:

I'll try and be as succinct as possible here, because the answer could be 6 pages long. 

The short version is:

• The majority (90%+) of cigar smokers do not smoke cigars daily, only casually.
• The majority of cigar smokers don't inhale.
• The Monograph #9 studies showed an almost insignificant health risk from cigar smoking
• Frequency of usage and inhalation determine health risks
• There's almost zero premium cigar usage among kids (less than 1%)

The ramifications are:

• Potential removal of pre-market approval
• Which would open the door to new products not requiring grandfather or pre-market status
• Removal of user fees for approval

I can't remember the costs involved but it was enough that quite a number of smaller boutique brands sold their brand and packed it in.

Nicely done John. I knew you'd comb through the ruling.

[Cigar Surgeon]

3 minutes ago, Puros Y Vino said:

Nicely done John. I knew you'd comb through the ruling.

Charlie's the expert, I've only been following along on the sidelines. 

[JustDave]

5 hours ago, Cigar Surgeon said:

I'll try and be as succinct as possible here, because the answer could be 6 pages long. 

The short version is:

• The majority (90%+) of cigar smokers do not smoke cigars daily, only casually.
• The majority of cigar smokers don't inhale.
• The Monograph #9 studies showed an almost insignificant health risk from cigar smoking
• Frequency of usage and inhalation determine health risks
• There's almost zero premium cigar usage among kids (less than 1%)

The ramifications are:

• Potential removal of pre-market approval
• Which would open the door to new products not requiring grandfather or pre-market status
• Removal of user fees for approval

I can't remember the costs involved but it was enough that quite a number of smaller boutique brands sold their brand and packed it in.

• The majority of super heavily peated 20+ year old scotch drinkers do not drink scotch daily, only on special occasions.
• The majority of super heavily peated 20+ year old scotch drinkers do not drink scotch to the point of intoxication.
• Studies show that mild to moderate alcohol ingestion showed an almost insignificant health risk.
• There's almost zero drinking of super heavily peated 20+ year old scotch among kids.

 

So can we remove regulation from "super heavily peated 20+ year old scotch" or anything else like this?  and where do we draw the line?

 

[HarveyBoulevard]

23 hours ago, MrBirdman said:

This has nothing to do with the FDA’s legislative authority. It’s an administrative law question about whether the FDA followed the policies and procedures required of federal rule making.

Perhaps my wording was unclear.  I will see if I can elaborate on my point.

These agencies were created to regulate the laws drafted and voted on by the legislature.  These agencies were not given the authority to CREATE legislation or to regulate their particular areas outside the scope of the authority.

No one will argue the EPA wasn't created to regulate in the area of Environmental Protection. No one will argue that the FDA wasn't created to regulate in the area of Food and Drugs (including cigarettes and cigars), and no one will argue the ATF wasn't created to regulate Alcohol, Tobacco (the enforcement side), and Firearms.  The list goes on.

The problem with these agencies over the decades has been their growth and the expansion of the regulations.  They have given themselves, with assistance from the executive branch, carte blanch with regards to promulgating new regulations absent authority to do and to define the legislation that exceeds their legal abilities to do so.

The EPA case was certainly about the EPA administratively regulating regarding the environment.  That is their function.  The problem was the EPA had just run amuck and was handed it's proverbial legal ass.  Similarly, the FDA was administratively regulating nicotine products (as is within it's purview), however, it too has run amuck and was also handed it's ass (legally speaking of course).

So, no one says these agencies don't have the legal authority, as granted by Congress, to regulate these areas.  What is being said is that the overreaching of these agencies and their attempting to exceed their scope has now been addressed.  When these agencies create/change/alter definitions to broaden their administrative powers and create new rules that exceed their ability to do so, the courts step in.  That is what I was attempting to point out with my earlier comment.

This was hard to do on my phone so my apologies for any grammar or spelling errors.

 

[NSXCIGAR]

16 hours ago, Cigar Surgeon said:

There's almost zero premium cigar usage among kids (less than 1%)

I want to know who these kids are. Even I didn't start smoking cigars until 13 and it wasn't easy or cheap to get premiums. I had to suffer through with Swisher Sweets and Tiparillos many times...yes, it was the dark ages. 

11 hours ago, JustDave said:

So can we remove regulation from "super heavily peated 20+ year old scotch" or anything else like this?  and where do we draw the line?

All alcoholic beverages are consumed the same way. Not so with tobacco products. In fact I know of few products that are consumed as differently as tobacco.

Cheap cigars are consumed in a fundamentally different fashion than premium cigars. Both are consumed in a fundamentally different fashion than cigarettes. And all of those are consumed in a fundamentally different fashion than chewing tobacco. 100 years ago they were even sniffing the stuff.

They can't even be considered the same product and the data show that and the court agreed.