August 9th, 2016

FDA shoots itself in the foot, cigarette trade celebrates, public health loses - a summary in two quotes

A typical day at the FDA Center For Tobacco Products

The FDA’s deeming rule went live yesterday, 8th August 2016. You will see a blizzard of expert comment about what it all means (feel the pain of Phil Bursado – see 8/8).  In essence, FDA requires an enormously burdensome Pre-Market Tobacco Application (PMTA) to be filed and accepted by FDA for any new product from now on. So that’s the end of innovation, including pro-health and pro-safety innovation. For all products currently on the market, a PMTA has to be filed within two years, with a further year for FDA to review – that will wipe out most products and most smaller firms and open the way to the black market. (For the official view, see FDA overview and Q&A)

When thinking about this regulation from a public health point of view, there are two quotes I think everyone should have in mind:

Quote 1: The Royal College of Physicians

The first is a proper public health perspective on e-cigarette regulation.  In my opinion, this is the best quote in the April 2016 Royal College of Physicians report Nicotine Without Smoke: Tobacco Harm Reduction and it is what matters, above all, with the FDA’s regulation.

A risk-averse, precautionary approach to e-cigarette regulation can be proposed as a means of minimising the risk of avoidable harm, eg exposure to toxins in e-cigarette vapour, renormalisation, gateway progression to smoking, or other real or potential risks. However, if this approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking.  Getting this balance right is difficult. (Section 12.10 page 187)

Quote 2: Wells Fargo Securities

The second is a take on how well FDA is dealing with the difficult challenge of “getting the balance right”.  This is the Wall Street view yesterday from Bonnie Herzog, the senior tobacco analyst at Wells Fargo Securities (my emphasis added):

Further Implications of Deeming Regs: (1) We expect to see a continued shift in consumption of e-cigs/vapor back to combustible cigs as e-cig choices become more limited — a net ‘win’ for big tobacco. This has continued to baffle us given the FDA’s public health priorities. (2) We expect further e-cig/vapor consolidation and, as a result, manufacturers’ pricing power and retail leverage to increase with MO and RAI best positioned given their scale and capabilities. (3) We expect increased, but manageable, timing risk for MO to be able to commercialize iQOS by late FY17/early FY18 assuming its premarket tobacco application (PMTA) is approved given PM & MO’s active dialogue with the FDA.

As Is, Deeming Regs Are A Clear ‘Win’ For Big Tobacco, Not Necessarily Public Health – Our main concern remains that the final deeming e-cig regs will realistically stifle innovation, which could dramatically slow industry growth by dis-incentivizing consumer conversion from combustible cigs to e-cigs. This ultimately has a net negative impact on public health, which is clearly in direct opposition to the FDA’s goal. However, we have reason to be more optimistic given actions being taken by both MO & RAI to soften the current limitations of the deeming regs on innovation.

Oh dear…

The problem with the FDA’s regulation is that the claimed benefits are nugatory and don’t actually address any real-world problems. However, the risks of unintended consequences leading to more smoking are clear and foreseen (by the Royal College of Physicians among many others) but are unacknowledged by FDA.  When monetized, these risks and health detriments would completely dominate and destroy the cost-benefit analysis justification for the rule.

This is the theme of the amici curiae brief sixteen of us have just filed in the Nicopure Labs et al versus FDA legal case (see especially part C)

I’m prepared to believe they aren’t doing it deliberately, but I just have this feeling that the big players behind the FDA’s intervention, such as Mitch Zeller and Matt Myers, do not have the faintest idea what they are actually doing.

48 comments to FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two quotes

  • john Walker

    Clive
    They know what they do, they are evil.

  • Steven R

    Never ascribe to evil what can be ascribed to stupidity (and hubris)

    “it’s for the kids!” they cry, as they burn down the childrens home, as it’s a well known fact that kids are abused in childrens homes, so they must be destroyed.

    That’s the sort of blind, rampantly idiotic logic we’re looking at here – where they don’t care about the actual causes of problems, they just want to be seen to be doing something.

    Steven R

  • Chris Erickson

    You are far kinder than I. I believe they know what they are doing but it is a great financial gain, in some way or another, for those pushing this bizarre and nonsensical ruling. Apparently, it matters not whether the result is a billion deaths.

    • Sean

      Death sold to the highest bidder.

    • “Deeming” vaping products to be tobacco is clearly a setup for future taxation. As always, just follow the money.

      • John Walker

        Actually there is a plant , native to australia that has much higher levels of nicotine than any of the tobacco genus: Duboisia hopwoodii which is a species of the Duboisia genus of the solanaceae family. The leaves of this plant were consumed in great quantities by the Aborigines , who would travel hundreds of kilometers to obtain it.

        The Australian Taxation office sensibly States that “While both the Duboisia and Nicotiana are of the solanaceae family, and the leaves of some of the species of each genus have been used for chewing or smoking, the ordinary usage of the term ‘tobacco’ is a reference to a species of the Nicotiana genus. Generally, but not be limited to, the N. tabacum and N. rusticum species of the plants.
        Therefore Duboisia hopwoodii plant is not a ‘tobacco plant’ for the purposes the Excise Act.”

  • […] this counterfactual article: FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in … PB had a rant on his website. Wish he'd made it as a video […]

  • Roger Hall

    A very sad day for our US vaping friends, but let no one be under any illusion that the impact won’t be felt in the UK over time. With the world’s largest vaping market normal global economic supply and demand will affect us all. I’m not clear how anyone can give the “big US players” any benefit of the doubt considering the overwhelming scientific evidence in favour of vaping. It’s a pure economic decision and they know exactly what they are doing – protecting the tobacco economy! The legal US ecig industry has now been gifted to Big T via the FDA so the illusionary war against Big T can continue. When there is a strong political motivation to safeguard smoking and the MSA payments the little issue of Public Health concerns are simply a distraction to be ignored and bypassed.

  • dodderer

    This suggests he accepts that there exists a continuum of risk but doesn’t agree with PHE,RCP et al the level of risk from non-smoked products – presumably at the population rather than the individual level

    http://tobaccocontrol.bmj.com/content/22/suppl_1/i40.full

  • Don’t lose sight of the contribution of a constantly underlying fact in this area: There most certainly exists a subset, and I believe a very significant subset, of the antivaping crowd that is simply not that interested in the health aspects of e-cigs. Part of that subset is driven by greed based upon their grants and comfort in continuing their fight in the arena of their expertise; part of it is driven by morality concerning “drugs” such as nicotine; part of it is driven by the neuroticism of those convinced that those “clouds” MUST be poisonous and MUST result in allergic/asthmatic/potentially-harmful or deadly effects upon an unspecified number of people; and part of it is driven by simple irrational negativity toward anything that LOOKS like smoking.

    See http://www.sott.net/article/128768-Recognising+Anti-Smoking+Types and http://wispofsmoke.net/recovery.html to get a better feeling for that element of vaping’s opposition. I believe you need to give it more attention in your planning.

    How powerful is that subset? From what I’ve seen in my years of fighting the Antismokers (who make up virtually 100% of your antivaping opposition), I believe they’re quite powerful AND both highly skilled and well-funded.

    – MJM

  • Peg

    They know exactly what they are doing. By strangulating the industry, forcing it to consolidate down to land under the umbrella of the tobacco giants, they get e-cigs exactly where they want them.

    In the hands of tobacco, where they can now safely fall under the MSA – propping up tobacco’s sales, thus propping up the MSA bonds taken out by a lot of the states.

    It’s all about the money.

  • Not Marco

    I think that if Marco Rubio were here commenting, he would say:

    “Let’s dispel with the myth that Mitch Zeller doesn’t know what he’s doing. HE KNOWS EXACTLY WHAT HE IS DOING”.

  • JackZ

    Money talks! Tobacco and big Pharm have oodles of it. In fact, their money doesn’t talk, it screams! And, there is that fact that non-vapers mostly do not give a darned about what our issues are. We are turning in to a mean country.

  • Unfortunately for science, ethics, humanity and public health, Mitch Zeller and Matt Myers known exactly what they’re doing.

    In fact, they’ve been conspiring and lobbying to ban the manufacture and sale of all NEW low risk smokefree alternatives (but not deadly cigarettes) since 2001/2002 when GlaxoSmithKline, CTFK, Legacy, ACS, AHA, ALA, AAP, AMA, ACPM, APHA, ASAM, ASCO, ATS, LCAT, NALBOH, NEA, ONS, OHA, NSTEP, PfP, and 41 State Attorneys General all petitioned the FDA to ban Star’s Ariva lozenges and several other smokefree nicotine alternatives.

    After leaving FDA in 2000, Mitch Zeller worked for Legacy in 2001, and then became GSK’s lobbyist (via Pinney Associates) from 2002 to 2013.

    In 2003, FDA banned several of the nicotine alternatives, but stated the agency did NOT have the legal authority to regulate tobacco products (citing the 2000 SCOTUS ruling), and as such could not ban Star’s Ariva.

    Matt Myers and Mitch Zeller also helped draft and lobby for the first TCA bills (after the 2000 SCOTUS ruling) in 2001 and 2003 that banned the manufacturing and sale of all new tobacco products (while exempting all deadly cigarettes) by establishing grandfather dates the year prior to the bills’ introduction.

    In response, Philip Morris introduced its own TCA bills in Congress (in 2002 and again in 2003) that contained 90%-95% of the clauses and text of the already introduced TCA bills lobbied for by CTFK, ACS, AHA, ALA, AMA, etc (including banning new tobacco products by establishing a grandfather date).

    Since CTFK’s legislative strategy was to partner their TCA bill with a tobacco grower quota buyout bill (to gain the votes of tobacco state Senators), RJ Reynolds responded by lobbying Congress to enact a stand alone tobacco quota buyout bill.

    To preserve the votes for the TCA by tobacco state Senators, CTFK’s Myers (in collaboration with GSK’s Zeller) began to negotiate with Philip Morris on the precise wording of the TCA legislation in 2003/04 that each could support and join forces to lobby Congress to enact into law (because Myers’ priority was to quickly cut a deal with Philip Morris to prevent Reynolds’ stand alone tobacco quota buyout bill, which was gaining traction in Congress, from being enacted.

    Since GSK and PM both knew smokeless tobacco products were cutting into their sales and profits, in addition to banning all new tobacco products, the different TCA bills in 2003 also included Section 911 (although with slightly different wording) that banned smokeless tobacco companies from truthfully claiming their products are less harmful than cigarettes, and both bills required the same (and even larger) false and misleading fear mongering warnings on smokeless tobacco products (i.e. “not a safe alternative to cigarettes, may cause mouth cancer, may cause gum disease and tooth loss).

    After negotiation in 2003/04, PM, CTFK, Waxman and Kennedy issued press releases on the same hour in the spring of 2004 praising and introducing their negotiated and agreed-to TCA legislation.

    That same day (and until 2009), I denounced (and urged public health advocates and Congress to reject) the TCA legislation because it protected PM’s Marlboro monopoly and Big Pharma’s NRT monopoly from future market competition by low risk smokeless tobacco products.

    From 2004 until 2009, Philip Morris (which changed its name to Altria), GSK, CTFK, ACS, AHA, ALA, AAP, etc, hundreds of DHHS funding recipients, dozens of duped State AGs, and most left wing Democrats in Congress aggressively lobbied to enact the TCA into law.

    During that same time, GSK lobbyist Mitch Zeller spoke at dozens of tobacco control conferences praising the TCA, while demonizing smokeless tobacco products, falsely claiming they were about 50% as harmful as cigarettes while NRT was 99% less harmful, and falsely accusing smokeless tobacco companies of target marketing to teens (by showing lots of slides of smokeless tobacco ads claiming they appealed to youth) even though UST signed a smokeless tobacco MSA with State AGs similar to the cigarette MSA.

    At virtually all of those conferences, Mitch was touted and introduced by the conference organizers as “former FDA Deputy Commissioner” or as a “tobacco regulation expert” instead of a “GSK lobbyist”. Meanwhile, virtually all of the 20+ abstracts I submitted to many of those conferences (to expose how the TCA protected cigarettes by banning THR products) were rejected by those same conference organizers (which primarily included employees and funding recipients of DHHS and state health agencies, CTFK, ACS, AHA, ALA, Legacy, etc.)

    The grandfather date (to ban new tobacco products) was originally set for 2003 in the 2004 TCA bills, while the 2005 TCA bills set it for 2/15/05, and the 2007 bills set it for 2/15/07. But in 2009, CTFK urged Waxman and Kennedy to not move to grandfather date to 2/15/09 because doing so would exempt newly introduced smokefree alternatives (Camel Snus, Orbs, Strips, Sticks).

    In 2009, Sen. Frank Lautenberg (the leading recipient of Big Pharma funding in the history of US Congress) urged FDA to ban all e-cigs, and CTFK, ACS, AHA, ALA did the same one week later. Within weeks, US Customs agents began seizing shipments of e-cigarettes at US Ports, which is what prompted SE and NJOY to sue the FDA.

    In 2011, GSK (under Mitch Zeller’s leadership) formally urged FDA to ban all dissolvable tobacco products (i.e. Star Ariva and Stonewall, Camel Orbs, Strips and Sticks).

    When Mitch went back to FDA in 2013, the first thing he did was send a report to Congress on new low risk tobacco products and smoking cessation products that praised and proposed deregulating Big Pharma NRT, but never mentioned vapor products (even though a dozen THR advocates and vapers testified at the FDA’s hearing and even though vapers submitted >95% of the 5,000 FDA docket comments submitted to the agency pointing out how vaping helped them quit smoking after they relapsed and had psychotic experiences using FDA approved drugs).

    By proposing and now finalizing the Deeming Regulaiton, Mitch Zeller (and Matt Myers) have now achieved their 15+ year legislative and regulatory goal of banning the manufacturing and sale of all new smokefree alternatives to cigarettes.

    In order to achieve their legislative and regulatory goal, Myers, Zeller and other THR prohibitionists have knowingly and intentionally misrepresented the scientific evidence on the comparable risks and benefits of different tobacco/nicotine products (for the past 15 years).

    This conspiracy (to protect cigarettes and Big Pharma drugs from future market competition by very low risk alternative products) has been unethical, inhumane, crony capitalist public health malpractice of the worst kind.

    Since FDA’s Deeming Ban could cause the easily preventable deaths of millions of vapers (and tens of millions of smokers), the 15 year long conspiracy by Zeller, Myers et al (to deny smokers and vapers legal access to lifesaving vapor products) is a crime against humanity.

  • Reverend Jeffrey Town-Campbell

    I will continue to vape as long as i want too. The FDA cant tell me what i can and cannot put in my body. I am an American a voter and a vaper. I smoked 1 1/2 packs everyday for 30 years and tried EVERYTHING on the market until i was introduced to vaping I smoked and vaped for two weeks before finally throwing the expensive cigarettes away and I havent looked back since. As a matter of fact I think their should be more regulation on when and where people can smoke cigaretes. I HATE walking into a grocery store and all you see and smell is cigarettes when entering them.I have been cigarette free since 08/10/2015 at 10am So almost 11 months and I am saving a tone of money Sorry but not sorry big tabacco #Vapingsavedmylive #ScrewtheFDA #Vapatarian #Vaping #Vapers #Ilovevaping

  • Anonymous

    These new laws are a crock of shit thought up by some over paid asswhole

  • Nate

    FDA is going to get laughed out of the courtroom when the deeming regs are subjected to judicial review, just like they did in 2010 after they tried to unilaterally ban all e-cigs because they felt like it. And they know perfectly well they’re going to get laughed out of the courtroom, but they have no compunction about flushing tens of millions of taxpayer dollars down the proverbial toilet mounting a legal defense on behalf of something that is legally indefensible.

    So let’s not overreact here. The militant tobacco control lunatics who run the FDA can’t just do whatever they want for any reason they like. Our system of government has checks and balances built into it that prevent such things. In six months’ time, the deeming regs will sit in the dustbin of history where they belong.

  • […] The FDA’s deeming rule went live yesterday, 8th August 2016. You will see a blizzard of expert comment about what it all means (feel the pain of Phil Bursado – see 8/8). In essence, FD…  […]

  • Sarah

    In other news: Tobacco Control abandons the Scream Test amid confusion as evidence emerges that Big Tobacco has manipulated the test using a clever technique known as ‘The Bluff’

    One senior Tobacco Controller who did not want to be named put down his pie long enough to say:

    “They’ve been lying for decades in an attempt to undermine our efforts and they’re doing it again. We are now working on a new test which will be know as ‘The Reverse Scream Test’. We will not be releasing the details of the new test in order to ensure that Big Tobacco do not counter with new techniques such as ‘The Double Bluff’. We’re ready for them”.

    Watch this space for further developments.

  • ListlessSpectre

    Don’t you get it? The FDA can approve pharmaceuticals that can cause heart attack, respiratory failure, seizures, dizziness, nausea, etc.,etc.,etc….but they won’t approve smoking cessation products that, at it’s worst, can give a person a sore throat?

    They’re just another corrupt American agency that’s too involved in sucking the dicks of giant cash cows like tobacco and pharmaceutical for their financial contributions to just about every known governmental agency for industrial protection and immunity.

    I hate the fucking system in this country and they need to be uprooted, desecrated and made an example of for the next bunch of dimwits that take office so they won’t make the same mistake. Total political annihilation…the time for anarchy has passed, and it’s only going to get worse.

  • Sean

    Unfortunately, rule of law and checks and balances aren’t the rule anymore…who you know, how much power they have and how much you pay them is.

  • William

    Yep, the FDA started out as a good idea which, if I recall correctly, was the side effects of the drug thalidomide.

    Pretty much since then, it has all be about protecting the major drug industry players. Most, but not all, new drugs are no better than previous versions and in many cases are worse – sometimes far worse.

    • Bob

      I recently heard a news report about thalidomide being an asymmetrical molecule and only one version (left handed?) caused the birth defects while the other (right handed?) did not. The FDAs response was to just ban all future research. For a scientific agency they don’t seem very scientific.

  • Terry Bell

    Can’t you mount a hostile take-over bid on Campaign for Tobacco Free Kids? If a company was as rubbish as them, its CEO would have been booted out by now and it would be under new management. I wish non-profits had the same sort of results pressure.

  • jose costa

    Aparently from what a shop told me they are no longer allowed to teach people anything and cant help with setups or builds so i called the fda for help on it and they didnt know what to say and also called them out of child safety for cigarette boxs since juice has to have them also why shouldnt cigarettes and once again they didnt know what to say

    • john Walker

      God only knows what the status of all those utube tutorials on ecigs would be. For example- If a UK citizen publishes a video on how to do’ X ‘, and it’s viewed by a US citizen , has the bloke in the UK breached US law, could they be extradited??

    • Bob

      As I understand the new rules it is only a violation for “employees of the vaping industry” from the local shopkeeper to a CEO to offer help, advice or truthful information. If I had the time I’d spend all day at the local vape shop saying what the employees are no longer allowed to say.

  • Chad Conway

    There’s one major player nobody seems to mention or be talking about, and that’s the Chinese corporations manufacturing the vast majority of e-cigs. Maybe vapors (myself included) should be rallying behind Shenzhen corporate giants. As un-american as it sounds, we’ve been supporting them for years by buying their products while the American tobacco companies would have us choking on toxic combustible cigarettes. Do these Chinese manufacturers have the lobbyists and political sway to save the day?

    • john Walker

      Would the FDA have any authority over Alibaba , doubt it.
      Policing importation of tens of thousands of small parcels for personal use will be very expensive.

  • […] FDA shoots itself in the foot, cigarette trade celebrates, public health loses Clive Bates highlights the failure of the FDA regulations on Vaping in America […]

  • Chris W

    Vaping helped me quit smoking in under a week. 15 years of smoking a pack a day I thought I would never be able to quit the disgusting habbit. When my sisters who had been vaping for a few months gave me a vaping starter kit(some of their old vaping tanks and mods) and I was hesitant at first but started liking it very quickly. And within a week had switched completely to vaping. Its the best way for anyone to quit smoking cigarettes. The people in charge of the FDA should be fired they are all about money and not about what’s best for public health and safety. America stand up and fight for the freedom of vaping even if you don’t vape you will be giving them the right to take more of our freedom away. America the land of scare tactics and lies for greedy selfish people. I’m so disappointed in America. I hate being a part of the nation that’s going to exterminate all humans for a paycheck.

  • […] opportunities. Recently Clive Bates penned a rather damning post on the FDA’s deeming “FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in …” wherein he ends with the […]

  • Ah, such an interesting idea… My response to you, and Carl, would not fit in a comment so it is available here: http://wp.me/p6ecKh-3P

  • Anonymous

    I have yet to quit smoking! I’m a Father of 3 and my son is just like me. He is now 19 and has been Vaping for years now. My other 2 never smoked anything ,which i’m very proud of.I started smoking 40 years ago when smokes were 35 cents a pack. I have tried to switch to Vaping,but have not made this transition yet.I’m not so worried what happens with me, But for my son. He deserves the option of a safer way to enjoy smoking. It is just not right that he will have to switch to smoking. What has happened to this Country!What a sick time we live in!

  • […] FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two … […]

  • […] Clive Bates: FDA shoots itself in foot, cigarette trade celebrates, public health loses – a summary in two quotes http://www.clivebates.com/?p=4278 […]

  • […] FDA shoots itself in the foot, cigarette trade celebrates, public health loses Clive Bates highlights the failure of the FDA regulations on Vaping in America […]

  • Carson

    It’s funny how right after August 8th the big tobacco companies aired the Eqos (fancy tobacco baking device) after attempting to drop “ENDS.”

    With all respect aside, as I have no form of respect for the food and drug administration, they know what they’re doing and they’re happy watching this industry burn like their cigarettes.

    Clive, I welcome you into the shop I work at, to speak to my customers and listen to their story.

    Thank you.

  • […] opportunities. Recently Clive Bates penned a rather damning post on the FDA’s deeming “FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two …” wherein he ends with the […]

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