FDA Releases Proposed Regulations

[problemsolverjc]

When I posted about this a month ago, there were a number of people who said that the FDA regulating cigars more closely was not going to happen and that I was just propagating rumors...

Well... here you go... USA Today.... WFMZ

Last night the FDA released their proposed rules on the strict regulation of e-cigs, cigars, pipe tobacco, nicotine gels, etc. This regulation requires:

1) The inclusion of additional health warnings
2) The required registration of all products and ingredients with the FDA.
3) Required approval by the FDA for all new products being brough to market, including "scientific evidence concerning the direct or implied risk reduction associated with their products."
4) Companies may no longer provide "free samples" of products - No more free cigars at manufacturers events!

If enacted, manufactures would have 24 months to submit an application to the FDA to ask for permission to keep their current products on the market.

If you are not a CRA member join, get involved in talking to your representatives in Washington DC. This IS REAL!!!

 

[ENV]

Well....this sucks. Time to stockpile

 

[Madcox]

This does suck...

 

[Whtwtrman79]

Yep no good

 

[mwlabel]

Last December, Mitch Zeller, head of the FDA’s Center for Tobacco Products, mentioned premium cigars and hinted that the category could be treated differently:

There’s one thing that I do want to add, especially about the so-called ‘premium cigar’ category. I have had a lot of meetings with a lot of parties from public health and consumer groups to various sectors of the tobacco industry including representatives of the premium cigar industry.
The message that the premium cigar interests have tried to deliver is that there are differences between products that sell for upwards of eight, nine, 10, 11 dollars a piece and are not sold in packages, kept in special climate-controlled facilities and that the consumer—and they say it’s only adult consumers—come and buy one, two, three at a time. So, we have gotten the messages that there maybe differences when it comes to premium cigars versus other cigars and the message is that FDA needs to take that into account into figuring out how they should be regulated

it is however not all good news. The FDA has stated it believe the outlines proposed in the deeming document would be the first step in regulating flavored tobacco. Part of that comes from extending its mandates into product categories like e-cigarettes and cigars, and other parts come from new disclosure and registration requirements.

- http://halfwheel.com/fda-announces-regulations-plans-premium-cigars-might-receive-exemption/54931


Is this info no longer good, and USA Today has updated stuff? Or is there still discrepancies in the reporting?

 

[MoJo]

no free samples??? There goes half the blogging community...

 

[FamousTLo]

Here's the full document from the FDA - https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf. Looks like we have a chance for premium cigars to escape regulation entirely. If they are regulated, it'll be more waiting game to see exactly what they want to do. It seems again like every regulation currently imposed on cigarettes will be on the table, but would most likely be some smaller subset of regulations on cigarettes. Regardless, we're all going to have the chance to make our voices heard and if we can be loud enough someone might actually listen!

 

[problemsolverjc]

Last December, Mitch Zeller, head of the FDA’s Center for Tobacco Products, mentioned premium cigars and hinted that the category could be treated differently:

There’s one thing that I do want to add, especially about the so-called ‘premium cigar’ category. I have had a lot of meetings with a lot of parties from public health and consumer groups to various sectors of the tobacco industry including representatives of the premium cigar industry.
The message that the premium cigar interests have tried to deliver is that there are differences between products that sell for upwards of eight, nine, 10, 11 dollars a piece and are not sold in packages, kept in special climate-controlled facilities and that the consumer—and they say it’s only adult consumers—come and buy one, two, three at a time. So, we have gotten the messages that there maybe differences when it comes to premium cigars versus other cigars and the message is that FDA needs to take that into account into figuring out how they should be regulated

it is however not all good news. The FDA has stated it believe the outlines proposed in the deeming document would be the first step in regulating flavored tobacco. Part of that comes from extending its mandates into product categories like e-cigarettes and cigars, and other parts come from new disclosure and registration requirements.

- http://halfwheel.com/fda-announces-regulations-plans-premium-cigars-might-receive-exemption/54931


Is this info no longer good, and USA Today has updated stuff? Or is there still discrepancies in the reporting?

A little bit of both. HalfWheel's report includes that quote, from back in December, and the USA today piece was written before the FDA released the actual text at 9am this morning.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf This is the regulations actual text as it was released at 9am this morning (after my original post). In it, the FDA gives two options... Option 1 extends their oversight to all products except accessories. Option 2 extends their oversight to everything except premium cigars and accessories.

They define a "premium" cigar as those meeting the following:
1) Is wrapped in whole tobacco leaf
2) contains 100% leaf tobacco
3) contains primarily long filler tobacco
4) is made by combining manually the wrapper, filler, binder
5) has no filter, tip or non-tabacco mouthpiece and is capped by hand
6) has a retail price (after discounts and coupons) of no less than $10 per cigar
7) does not have a characterizing flavor other than tobacco
8) weights more than 6 pounds per 1000 units

These regulations are open for a 75 day comment window, at which time the FDA will select option 1 or option 2. There are lots of questions on pages 33-forward considering these 8 points, and if they should be included in the definition.

At the end of the day, the FDA could choose to move forward with option 1 and not care about the exemption, or they could change the requirements above. "Although the Agency is proposing a definition with respect to Option 2, FDA remains
concerned that any attempts to create a subset of premium cigars that are excluded from regulatory authority might sweep other cigar products under its umbrella."

In either case, if we want to this to end in our favor we need to take action. Hoping that the federal government makes the right decisions is not productive at all!

 

[Craig Mac]

Thanks for the link to the proposal guys!

 

[W.B.]

no free samples??? There goes half the blogging community...

Bwahahaha!

 

[problemsolverjc]

The industry is using the hashtag #getfiredup. If you want to do something small, spread this hashtag on social media (Twitter, facebook, etc.).

 

[problemsolverjc]

At 3:00 pm EST today, April 24, the FDA will host a telebriefing to discuss "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act," the newly proposed rule. CRA urges you to participate by calling in to 866-844-9416 (international callers, dial 1-203-369-5026). The passcode for callers is "Industry." The line opens at 2:30 pm EST.

Essentially, this means you can call the number presented, and listen in on the conversation the FDA is having at 3pm regarding this proposed ban.

 

[FamousTLo]

UPDATE: According to our sources at the CRA:

At 3:00 pm EST today, April 24, the FDA will host a telebriefing to discuss "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act," the newly proposed rule. CRA urges you to participate by calling in to 866-844-9416 (international callers, dial 1-203-369-5026). The passcode for callers is "Industry." The line opens at 2:30 pm EST.

#getfiredup

 

[ar2381]

There could be an exemption for premium cigars on these regulations. There is a 75 day window for the FDA to hear the public's opinion regarding the premium cigar exemption. I am hopeful and positive this will work in our favor.

 

[SpartanFan]

Most of what they purpose is reasonable especially when you factor in that these steps are made towards the goal of complete ban and removal, which society will inevitably lean towards, as the trend shows.

Obviously these aren't the most convenient towards the cigar enthusiasts, though the FDA is never going to side towards encouraging cigars via lackluster regulation. I think the price mechanic needs rethinking and a bit of tweaking, but this is probably what the end result will look like.

Still, taking out the magazine cigarette discounts and coupons should have been a focus.

 

[mjohop]

We have a 75 day window to tell the FDA to stay out of the premium cigar business...that means don't wait around and hope for the best.

 

[problemsolverjc]

We have a 75 day window to tell the FDA to stay out of the premium cigar business...that means don't wait around and hope for the best.

+1...

 

[Nas]

why doesn't the FDA regulate the poison pills they let these billion $ companies produce and doctors prescribe only to find out the adverse effects later pay a small fine in comparison to their profits. smh

 

[FamousTLo]

why doesn't the FDA regulate the poison pills they let these billion $ companies produce and doctors prescribe only to find out the adverse effects later pay a small fine in comparison to their profits. smh

because smoking is baaaaaaaaad... mmmmkay? Or maybe it's that those companies provide billions and billions more dollars to political campaigns than the cigar industry ever could...... #getfiredup

 

[Nas]

why doesn't the FDA regulate the poison pills they let these billion $ companies produce and doctors prescribe only to find out the adverse effects later pay a small fine in comparison to their profits. smh

because smoking is baaaaaaaaad... mmmmkay? Or maybe it's that those companies provide billions and billions more dollars to political campaigns than the cigar industry ever could...... #getfiredup

I know I know it was more a vent, than a question seeking resolve. #getfiredup