FDA rules announced

prairiedruid · May 5, 2016

NBC News on FDA regs
Just announced; 90 day "comment" period before becoming official. Bans e-cigs for anyone under 18 and brings cigars and pipe tobacco under the deeming process. I feel safer already.... :roll:
Also looks like we get to look forward to those lovely warning labels we see on European products.

cosmicfolklore · May 5, 2016

Just 90 days before new blends have to be approved... quick someone start blending a rustica, perique rope!!! Give us one blend to Rule Them All!!!

prairiedruid · May 5, 2016

Reading through various articles looks like deeming process will take some time to get running; maybe a 1-2 year window that allows sales while current blends goes through process. This may effect any blend that has come to market since 2009. Also applies to our cigar smoking brethren.
New note: FDA release says any product that wasn't on the market as of Feb. 15, 2007.

newbroom · May 5, 2016

One blend to rule them all, for me could be something as simple as Carter Hall, or something a bit more adventurous and wonderful in its own right, Billy Budd.

zitotczito · May 5, 2016

Not worried, I am cellared deep.

cosmicfolklore · May 5, 2016

I was thinking stratospherically strong. When I read about blenders being hesitant to mix burleys and perique because of strength, I have to wonder why. Wouldn't that be a positive selling point for those of us who like to end the day with the strongest possible smoke we can find? Flavor, phhht, nicotine flavored is all I want sometimes before bed.

jmatt · May 5, 2016

This is why I have 40 pounds now, and will have 120 pounds within 24 months. Imagine blends like SixPence, which is about 18 months old now, being gone because it's too much of a pain in the @$$ to get through the regs. Repeat that for any and all blends that didn't exist pre 2007.

pappymac · May 5, 2016

So much for Congress passing something a bill to reign the FDA in.

cosmicfolklore · May 5, 2016

Shhhh, damn you jmatt. Watch what you say. I put odds on now not being able to find a few of those blends for a few years now.

I've seen this happen. :::cough cough::: Yep, better get all that Lane Ready Rubbed you can find... :::cough cough:::

papipeguy · May 5, 2016

From the FDA.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm

gtrhtr · May 5, 2016

Very interesting. I'm optimistic, although I have no reason for that. Thanks for the update and link.

admin · May 5, 2016

Here's the full 499 page document. Happy reading.

https://www.scribd.com/doc/311598778/FDA-Regulations

admin · May 5, 2016

Let the hoarding begin!

admin · May 5, 2016

Page 282 on pipe tobacco.

markus · May 5, 2016

Looks like they are going to enforce the blurry line between pipe tobacco and RYO tobacco. I wondered how long it would take before the Nazi's got around to closing this loophole.

dmcmtk · May 5, 2016

All entities that meet the definition of "tobacco product manufacturer" in section 900(20) of the FD&C Act, including retail establishments that blend pipe tobacco, are subject to and must comply with all applicable statutory and regulatory requirements for tobacco product manufacturers.

From Title X in the above from Kevin's link. The section that includes Pipe Tobacco, on page 284.

jefff · May 5, 2016

Once again, tobacco will never be cheaper then it is today.

macaroon · May 5, 2016

Thank you Kevin, for highlighting the section on pipe tobacco for us!

FDA indicated that pipe tobacco smokers have a risk of tobacco-related disease similar to the risk of those who inhale cigar smoke or smoke cigarettes (Ref. 221).

Reference 221 happens to be the report that I have linked to multiple times on this forum, and I'm fairly familiar with it. It was the study I primarily looked to when deciding whether or not take up the pipe in the first place. I'd really like to know what they consider "similar" in this context, and what pipe usage patterns (degree of inhalation and frequency of use) they were referencing for comparison to cigarette smoking. Preventing underage tobacco use is a worthwhile goal, but they ought to at least be clear about the connections that are being drawn. The extreme vagueness of their language almost borders on misrepresentation in my mind. Not quite, but close enough to annoy me. OR maybe I'm just reading the numbers from the study incorrectly. I don't think I am, but I suppose I've been wrong before.

dmcmtk · May 5, 2016

Once again, tobacco will never be cheaper then it is today.

You've got that right!!!

admin · May 5, 2016

Here's one piece of good news within the bad for pipe tobacco manufacturers. The irony is that the FDA is saying that there really isn't anything new in pipe tobacco, and they don't expect there to be anything new - it's all the same old stuff in a new package - that's how I interpret this... SE = Substantial Equivalent.

Comment 299) Several comments disagreed with FDA's proposed premarket review burdens for pipe tobacco manufacturers. At least one comment indicated that FDA's proposed estimate that it will receive only one new product application for pipe tobacco products grossly underestimates the number of brands of pipe tobacco that have entered the market since 2007 or indicates that the Agency expects all but one manufacturer to voluntarily stop production of new pipe tobacco products without submitting an SE report or PTMA application.
In addition, the comments stated that pipe tobacco manufacturers will incur cost and time burdens if they are required to submit PMTAs for each new blend of pipe tobacco that they manufacture, including millions of dollars per year in research to prepare the PMTAs. (Response) At this time, FDA finds there is insufficient evidence to increase the burden estimates. FDA believes that pipe tobacco manufacturers will utilize the SE and SE exemption pathways. We believe they are manufactured similarly with few, if any, modifications and many of the ingredients and suppliers are the same as those utilized in previous years.

FDA rules announced

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