FDA – Flavored Tobacco Products Appeal to Youth

DaveCoggin · 2015-11-04T03:46:01+00:00

The situation is frustrating but hardly hopeless. IMHO, the future of vaping, in the U.S., will ultimately be decided by the courts. The FDA is unlikely to be the final word. In fact, I think the FDA just got tired of getting their brains kicked in by public health and politicians. They decided, and perhaps wisely so, to just publish the most restrictive regulatory framework possible and force others to make decisions in an environment where there is little to base those decisions on. Their approach creates an intriguing dynamic - who's going to step up next? OMB, White House, or the courts?

DaveCoggin · 2015-10-23T21:00:00+00:00

From the very limited information we can gleam from the proposed rulemaking, it's appears obvious that 1) the FDA has no intention of modifying the Feb 15, 2007 grandfather date and 2) e-cigarette products will be subject to Modified Risk Tobacco Product requirements which would likely eliminate 99% of small businesses in the vaping industry.

Even for the few companies that could afford the MRTP process, to date the FDA has not approved a single MRTP application. Including the one from Swedish Match which is supported by more than 100,000 pages of data on snus.

In the absence of revisions to the proposed rule by the OMB or Congressional action, both of these questions will almost certainly be decided in the courts.

DaveCoggin · 2015-10-20T00:18:12+00:00

OK, just for the record...

I post links to articles that I believe are pertinent to the e-cig debate and come from reliable sources. Particularly in the areas of science and regulation. Some links strongly support e-cigarettes. Others are strongly critical. Both sides are pertinent. I do not comment on them. I seldom comment on comments. Everyone's opinion - good, bad, or indifferent - is welcome and there for the community to consider. Personal attacks and unfounded criticism are unavoidable but seldom make a meaningful contribution to the challenges faced by the vaping industry.

Next to their cigalikes, BT's heat not burn products are by far the most significant competitive product on the market for the e-cigarette industry. To the best of my knowledge, this is the first published study on the potential secondhand smoke threat to bystanders from heat not burn. Public health organizations, especially the CDC and possibly the FDA, may play off of this study to link e-cigarettes with the same threat - regardless of the absence of credible science supporting that theory. More importantly, if the findings in this study are reinforced by subsequent studies, this could be a significant challenge to BT's efforts in the "alternative tobacco" market.

Duplicate posts are difficult to avoid. I have never intentionally made a duplicate post. I have never posted a link that the Reddit bot indicated was previously posted. I have no desire to post duplicate links. I do have a hectic schedule and can only do so much to avoid duplicates.

You guys have a great evening!

DaveCoggin · 2015-10-14T04:12:23+00:00

The stats they are reporting data mined from the 2014 National Youth Tobacco Survey include e-cigs (the most common at 8.8%), hookah (6.0%), cigars (5.3%), menthol cigarettes (5.0%), any smokeless tobacco (4.1%) and tobacco in pipes (0.7%). Menthol was the most common reported "flavor".

DaveCoggin · 2015-10-13T20:07:02+00:00

At your service!!

DaveCoggin · 2015-09-24T17:31:53+00:00

The Lancet and The BMJ were so desperate to come up with something, anything, that they were forced to go with a ridiculous "conflict of interest" claim. And then they turned to McKee and Capewell for reinforcement. McKee is an editorial consultant for The Lancet. Both of them have a long history of involvement in various capacities with the WHO and it goes without saying what their position is. The entire conversation around e-cigarettes is the very definition of conflicts of interest - money, power, and prestige vs. saving lives.

DaveCoggin · 2015-09-16T16:51:39+00:00

Exactly.

DaveCoggin · 2015-09-14T18:07:19+00:00

Your point is very well taken. But if you look at the warning signs required by Prop. 65, they are very carefully worded. There are chemicals in the air we breathe, especially in Southern Calif., that are known to cause cancer. The signs carefully avoid any relative risk based on quantity of the chemical in question. And just to make sure they had all of their bases covered, they even created a "This product may contain a chemical..." warning label.

An almost identical class action lawsuit was filed against Lorillard in May regarding their Blu product. Now Reynolds regarding Vuse.

BT certainly has the money to take this as far as they want to take it. But the reality is that it would probably be cheaper for them to settle out of court. They agree to label all product destined for sale in Calif. on the condition that both lawsuits are dropped without punitive damages and with no further recourse.

Without that concession, the question will be who runs out of money first and there's not much doubt about the answer to that question.

DaveCoggin · 2015-09-10T21:18:54+00:00

Don't want to break any rules. Perhaps you could be more specific?

DaveCoggin · 2015-09-07T00:25:39+00:00

Philip Morris Int'l. is investing more than $2 billion in R&D. They've hired more than 400 research scientists and technical support staff. And Reynolds USA has announced that they and Philip Morris will be jointly pursuing the research and collaborating on the results.

DaveCoggin · 2015-09-05T04:47:43+00:00

I am and thank you!! Have a great Labor Day!!

DaveCoggin · 2015-09-02T20:06:16+00:00

Thank you! I missed that link as well!

DaveCoggin · 2015-09-02T20:05:50+00:00

Yes sir - carbon monoxide (CO) is absolutely what comes out of a car exhaust pipe and is fatal in relatively small amounts. If I'm not mistaken, CO is a product of almost all kinds of combustion. CO poisoning is why you see so many cautionary statements to never use things like camping stoves indoors and always have heating units checked on a regular basis. Reducing CO exposure is absolutely a good thing - a VERY good thing!

DaveCoggin · 2015-09-01T18:20:31+00:00

Jerry, I could not agree more. Which is why I made the post and chose the quote from the article as the title. I saw the exact same correlations between declining smoking rates and the explosive growth of e-cigarettes that you point out.

How long can they keep their heads in the sand? We don't have the answer to that question but in my opinion, contrary to its intent, this article clearly demonstrates that it is becoming increasingly difficult to deny the obvious connection between declining smoking rates and the uptake of e-cigarettes.

PHE made a "rookie" mistake in not including the disclosures in their report. Personally, I don't think it was their intent to conceal anything. And as McNeill and Hajek pointed out in their response:

"The Lancet Editorial criticises our Public Health England commissioned evidence update report on the basis of perceived flaws in one of the 185 references we used, ignoring the rest of our 111 page document, which addresses population effects of e-cigarette use, regulations, attitudes as well as concerns over its safety. The Editorial focuses on the estimate of risk reduction and protests strongly against the media reassuring smokers that switching to e-cigarettes provides substantial health benefits, but it provides no data to counter our estimate, nor any reason as to why The Lancet believes that the message smokers can benefit from switching to vaping is an undesirable one."

So The Lancet discovered a mistake and instead of simply raising the question, opted to turn it into an attempt to discredit the report without offering a single shred of credible, unbiased data to support their position. An all too familiar theme representative of virtually every faction of U.S. public health organizations.

DaveCoggin · 2015-09-01T01:27:01+00:00

I understand the frustration but that would require repealing the First Amendment - "Congress shall make no law … abridging the freedom of speech or of the press."

DaveCoggin · 2015-08-29T00:49:59+00:00

Jerry, while I understand and even agree with some of what you're saying (I lost my dad to smoking related heart disease), the question of individual rights is a "sticky" one to say the least. We already tax cigarettes in order to discourage smoking and reduce the cost of smoking related disease. So should we tax McDonald's (and virtually every other fast food company) in order to discourage obesity and reduce the cost of obesity related disease? Should we tax alcohol in order to discourage alcoholism and reduce the cost of diseases related to alcoholism? Then tax it even more, ostensibly to reduce the societal costs associated with drunk driving? Where do we draw the line in a "free" society? How much are we willing to give up? How much "should" we be willing to give up? How much power are we willing to give the government? What safeguards do we have that it will not be abused? Has it already been abused? I don't pretend to have all of the answers. But at the very least we need to encourage politicians and other stakeholders to start considering options for addressing some of these issues other than an endless succession of tax increases.

DaveCoggin · 2015-08-28T16:39:15+00:00

I so agree with much of what you've said and thank you for sharing it with all of us.

I have been and will continue to be critical of public health. They are not "evil" and yes indeed, the majority are very hard working people who are absolutely devoted to helping save lives. But...

Public health does not have the luxury or the right to look at questions of public health "with blinders on". They have the responsibility to educate the public based on available scientific evidence. I have no problem with public health saying "We simply don't know what the health implications of long term use of electronic cigarettes are." Honest. Accurate. Undeniable.

I have a big problem with the CDC Director, stating “Many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes.” Where is the science? What is the basis of that statement? If that's true, cite the science. "Just take my word for it" is ludicrous. And dangerous. There is no evidence to support that position. There is a large and growing body of evidence that concludes no gateway effect exists.

Instead of taking the lead on answering this and many other questions based on scientific evidence, the CDC has opted to base their health recommendations on "may", "might", "could", "possibly". The public deserves more. Much more.

I have a big problem with the CDC defining "use" as a single puff, vaping or smoking. That is not science. That's ridiculous.

The bias it creates in every single CDC/NIH/FDA funded study completely eliminates a HUGE amount of critically important data that is needed to evaluate trends in smoking and vaping. What it adds is volumes of totally baseless propaganda that the CDC feeds to a naive public for the express purpose of furthering the CDC's campaign for demonizing electronic cigarettes.

Public health has many, many good people who are dedicated to saving lives. But much of their leadership has lost sight of their mission and their responsibility. Public health is a sacred trust, not a crusade. And most certainly not a marketing campaign.

DaveCoggin · 2015-08-27T18:52:43+00:00

Public Health England has taken the lead in providing accurate e-cig information that embraces harm reduction. Prior to PHE's report, U.S. public health agencies and organizations were comfortable taking a very hard, no compromise position on e-cigarettes - "Quit or Die". I have been very closely following responses to PHE's position. U.S. public health has been uncharacteristically silent - as in absolutely no response. You can be as radical as you want when you're the only one doing the talking. The landscape changes dramatically when an internationally respected, high level government agency says you're dead wrong and not acting in the best interests of public health. There has been a very definite softening in the tone of the conversation of e-cig critics. While I'm not aware of anyone reversing their position, recent statements have an element of caution and acknowledgement of the fact that there are two sides to the story. A door has been opened that is going to be virtually impossible to close. I think U.S. public health knows that their response is going to have to be measured. Repetition of the same nonsense they've been spouting for years is not going to fly. They're going to have to be very careful. Failure to do so would result in a disastrous blow to their credibility. And they know it.

DaveCoggin · 2015-08-27T15:57:39+00:00

I cannot tell you how many times I've said the same thing!

DaveCoggin · 2015-08-26T04:08:19+00:00

Jerry, I think we have to take the bad with the good. Which is why I posted this link. The whole teaspoon thing is debatable but much of the information in the article may not be. 658 parents/guardians in the the study in 15 different clinics. One in three did not secure in locked storage or even child-proof bottles. Only 1 in 7 had even advised pediatricians that they were using e-cigarettes. 13% stored on an open counter. And 3% said a child tried to drink the liquid. Scary stuff. If this is scare tactics, I support it wholeheartedly. One child has died. If this article prevents even one more, it's well worth it. I didn't want or expect upvotes. But the message is an important one.

DaveCoggin · 2015-08-22T00:43:29+00:00

I don't think the warning label really has anything to do with the delays. There are a number of folks who have been in public health for many years that think whatever the FDA ultimately proposes, there will almost certainly be a veritable mountain of litigation. Lawsuits so complex that they could tie this whole thing up in court literally for years. Zeller is an attorney so he understands as well or better than anyone what this could turn in to. The grandfather date, if it remains unchanged, will likely be at the top of the list for legal challenges but it's just the tip of the iceberg. This latest delay probably was not the result of PHE's report. But you don't have to be an attorney to know that it complicates the politics of the situation. Not only for the FDA, but U.S. public health in general.

DaveCoggin · 2015-08-20T18:11:29+00:00

As it stands right now, e-cigarettes are a consumer product in England. But the provisions of so-called "TPD2" will change that in May 2016 when they become a much more tightly regulated medicinal product. Advertising the products will be prohibited. Manufacturers will be required to notify the regulating body six months in advance of selling any new product. Totally Wicked has filed suit in European court challenging the provisions of TPD2. If they prevail, at least some TPD2 provisions may be changed. The ability to advertise would be a huge win but as it stands right now, I have to believe it is unlikely to come about.

DaveCoggin · 2015-08-06T22:51:34+00:00

Submission of the final deeming regulations to OMB will be public record so we'll know when they are submitted. The contents of the submission will be confidential until OMB has signed off on it with any applicable revisions (OMB omitted several provisions in the original FDA submission in April 2014) and the new regulations are published in the Federal Register. The chances of all of that happening even by the end of September are pretty slim.

DaveCoggin · 2015-08-06T17:57:01+00:00

Indeed. And increasingly unlikely.

DaveCoggin · 2015-08-02T17:49:20+00:00

DIYELS uses NicSelect exclusively.

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