April 6th, 2016

Bluffer's guide to FDA regulation of tobacco and nicotine products

FDA puzzle

Updated 27 August 2016

If you aren’t American, or even if you are, the regulation of tobacco, nicotine, and vape products in the United States can seem bewildering but somehow important. So if you want to be on it, here’s my bluffer’s guide to the United States Food and Drug Administration (FDA) and its approach to tobacco and nicotine products.

Regulatory framework and process

  1. What law gives the FDA the power to regulate tobacco or nicotine? For tobacco, FDA operates under the Family Smoking Prevention and Tobacco Control Act of 2009 – usually shortened to ‘Tobacco Control Act’ (TCA)   This is primary legislation made by Congress and it governs the institutional framework and regulatory regime for tobacco products.   The TCA actually amends the Federal Food Drug and Cosmetic Act to create Chapter IX on tobacco products. For pharma nicotine, medical regulation under Chapter V applies.
  1. How is the FDA set up internally to deal with tobacco? The TCA set up the Center for Tobacco Products (CTP) as the main regulatory body within the FDA, and this is currently headed by Mitch Zeller. Mr Zeller has made encouraging public statements indicating that he recognises that different tobacco products have different risks and should be regulated accordingly. However, we cannot assume that the FDA-CTP will act consistently with that view – it will be confined by law, by its interpretation of science, and by how others in FDA want to approach the issue.
zeller

Mitch Zeller JD

  1. Why is the FDA regulating vaping nicotine products as if they are tobacco products? Like the UK and EU, the FDA originally tried to regulate e-cigarettes as medicines, which would have been a disaster.  Thankfully, FDA was defeated in the appeal courts in 2010 in the ‘Sottera case‘ in which the court found that unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act. This is because the TCA defines ‘tobacco product’ to mean ‘any product made or derived from tobacco that is intended for human consumption‘ – and the nicotine in e-liquids is derived from tobacco.
  1. What does “deeming” mean and how is the FDA getting control of vape products? The Tobacco Control Act did not initially cover e-cigarettes, so in April 2014 FDA announced it was initiating the process of ‘deeming’ e-cigarettes (as well as a several other tobacco products such as dissolvable tobacco, hookah, little and big cigars, and pipes) to be tobacco products under the definition used in the Act – and in May 2016 that process completed and FDA asserted it has powers over vape products.  Now it has deemed vape products to be tobacco products under the TCA, the FDA will apply concepts from the TCA to regulate e-cigs and liquids. Under the deeming rule, the FDA will require age restrictions, a warning label, and registration, as well as mandate a pre-market approval process for e-cigarettes (see 6 PMTA below) from the outset.  The FDA, companies and consumers all agree that the PMTA process is so burdensome that is will radically reshape the market, reducing the choice available and causing most firms to ‘exit’ – they differ by how much it will change, and how much this matters.
  1. What FDA is proposing sounds terrible, why can’t they do something sensible? Because it is operating under the Tobacco Control Act, FDA can only do what the TCA allows or requires, and no more or less. But the TCA was created when no-one had any idea about e-cigarettes. The TCA was designed with a couple of purposes in mind – to stop innovation in cigarette design on the basis that it might be harmful, and to create a very high bar for demonstrating ‘reduced risk’ claims for products in case these mislead smokers into a false sense of security. But these are objectives that if applied to products that are in reality likely to be at least 95% lower risk than smoking, amount to a stranglehold on the vastly improved alternative – the opposite of what a sensible regulator would want.
  1. What are the ways that vape or tobacco products can get on to the market?  The TCA allowed any product on the market on 15 February 2007 to remain on the market – this is called ‘grandfathering’, and amounts to a free pass for the most dangerous products.  The vast majority of cigarettes on sale now were waved through because they were on sale in 2007.  For new products or variations on old products made after 2007, the TCA (and hence FDA) provides four routes to market:

6.1 Substantial equivalence. This is a supposed to be a straightforward route to market for products with characteristics that are ‘substantially equivalent’ to a ‘predicate product’ that was on the market on 15 Feb 2007. It might mean some change in formulation, packaging, colour etc. but essentially has same characteristics and doesn’t raise new public health questions. Products announced before 22 March 2011 can stay on the market provided they have made a substantial equivalence application until FDA completes the evaluation.  Given many tobacco products have changed in some way since 2007, there have been over 3,600 applications and there is now a large backlog, casting doubt on whether it is a straightforward route or whether FDA has regulatory capacity to deal with new categories, like e-cigarettes.

6.2 Exemption from substantial equivalence. For minor changes to existing products.

6.3. Pre-Market Tobacco Application (PMTA). This is for products that are not substantially equivalent, and would apply to e-cigarettes. To issue an order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product on the population as a whole, including tobacco product users as well as non-users. Note that this has to be done before the product is allowed on the market – and requires an assessment of the positive or negative impact on cessation and initiation.

…the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account–

(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products

Just imagine what you would have to know to be able to answer this question. The test is virtually impossible to meet for a product that has never been on the market – so models are created to try to show what will happen.  A much better way in my view would be to allow products onto market based on their individual risk controlled by a cross-industry standard, and then monitor for adverse population effects – but that is not what the TCA says.

6.4. Modified Risk Tobacco Product (MRTP). This is the route used if the manufacturer wants to make a claim of reduced risk in some way. This is like the PMTA but with the added burden of showing that the health claim is true and will be positive for public health.  There is only one product that has attempted this – Swedish Match has submitted 130,000 pages of evidence to show that snus is less harmful than smoking – something everyone knows.  The main aim of SM is to get warnings removed for which there is no evidence and to change the generic warning:

Current label:
Warning: this product is not a safe alternative to smoking

Requested:
Warning: no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes

Amazingly, this change is totally opposed by the US public health establishment and FDA’s ‘independent’ Tobacco Products Scientific Advisory Committee (TPSAC) and there is a legal consortium that has vowed to challenge it.  In my view, the MRTP approach is nuts: it means consumers only get realistic risk information if a tobacco company finds it commercially worthwhile to go through this process, and then public health will always it. Nothing is done to check whether the existing warning is misleading or causing harm. It’s nuts!

  1. And the problem for vape products is…? The problem with this framework is that e-cigarettes barely existed in 2007 – so the substantial equivalence route is closed. That leaves them with PMTA.  Consumer advocates argue that this route is so onerous and costly in terms of its evidence and paperwork requirements and compliance costs that it will wipe out almost every product in the US market – see CASAA’s most recent statement  or for those with an iron will, Bill Godshall’s comprehensive case. They are also concerned about the FDA using these rules to create a de facto ban on flavours simply by requiring impossible burdens of proof (that, of course, do not apply to cigarettes).
  1. Does anyone have a game-plan? Advocates are trying various ideas – getting an amendment to the 15 Feb 2007 grandfathering date added to a Bill going through Congress (e.g. HR2058 – or an amendment to the Agricultural Appropriations Bill for 2017); suggesting easing off on enforcement (the proposed rule already included a 24-month delay in enforcement of the PMTA requirement). Some experts close to the FDA claim they have more flexibility and discretion than appears at first sight. Maybe this is right, but there is little sign of much flexibility in the deeming rule.
  1. Where are we in what seems like a never-ending process? The process of regulatory scrutiny is very demanding in the US – and the FDA treads very carefully because it expects legal challenges and needs watertight decisions (nothing like the EU!). Stage 9 is complete and the final rule was published on 10 May 2016, and came into effect on 8 August 2016 (see below).

FDA process

Central to the legal challenges that have now commenced is whether these regulations have correctly followed the requirements for making regulations and whether there has been adequate justification. In October 2015, the regulation was sent to the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) for review – these are the best thought of as the President’s ‘enforcers’ on good quality regulation and sensible spending.

  1. What does OIRA/OMB do? OIRA and OMB were supposed to apply the criteria in two presidential executive orders to decide if this is good regulation. These are:

Executive Order 12866, “Regulatory Planning and Review” 1993 establishes and governs the process under which OIRA reviews agency draft and proposed final regulatory actions. It requires an analysis of the costs and benefits of rules and, to the extent permitted by law, action only on the basis of a reasoned determination that the benefits justify the costs.

Executive Order 13563 “Improving Regulation and Regulatory Review” 2011 updates this, but does not fundamentally change the underlying principles: it points to the need for predictability and for certainty, and for use of the least burdensome tools for achieving regulatory ends. It indicates that agencies “must take into account benefits and costs, both quantitative and qualitative.” It asks agencies “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” It also authorizes agencies to consider, and discuss qualitatively, “values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.”

These requirements form an important basis to challenge the rule.

  1. When will this all actually affect the businesses and products?  The rule was published in May 2016 and came into effect on 8 August 2016. From this point, new products or variants will need a PMTA approval. Existing products can stay on the market as long as they file a PMTA within two years and as long as the FDA has granted an approval within a further year. Note that even improvements (including in safety, ease of use, toxicity, consistency) can not be introduced from 8 August 2016 without a PMTA.
  1. Is there a better way? Yes, there is.

12.1 Do nothing. Sticking with the status quo would be an enormous improvement on everything in the Final Rule. That is because there isn’t actually a serious problem for regulators to address and benefits of the products are large. How about simply never publishing the deeming rule? Into the long grass, something for the next president to ignore. This is superior to all other strategies

12.2 Move the predicate date.  At least do what was done for cigarettes and let everything already in the market continue.  There are no problems and all is working well for health. Whether this needs a Congressional action or can be done within the existing TCA is a source of dispute.

12.3. Consumer protection framework. A variation on ‘do nothing’ is to regulate vape products as consumer products, at least until Congress had provided FDA a legal framework fit for purpose, which the current TCA isn’t. This would have meant no deeming regulation and supervision by default by the Consumer Products Safety Commission, which has general product safety responsibilities – and could deal with electrical, mechanical, and thermal safety, child-resistant containers, warning labels etc – actually the more pressing issues.

CPSC is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency’s jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard.

12.4. Give FDA new law fit for purpose? In an ideal world, health advocates would have lobbied Congress for a purpose-built legislation that would have secured a framework for proportionate and non-discriminatory risk-based regulation that wouldn’t wipe the industry out as part of trying to make it safer – see my notes on regulating new and disruptive technologies. Instead, I think they actually like FDA regulation under the TCA precisely because it is so damaging. In that mindset, heavy regulatory burdens are a benefit, not a cost.

12.5. Same law but FDA is smarter with it. Optimists claim that FDA can do it all under the TCA, just by ‘being smarter’ and finding a legally watertight way to reduce the pre-market burdens to some acceptable proportional level.

In all scenarios, CDC and its state-level equivalents should stop deceiving the American public and start communicating relative risk honestly – something they could learn from England.

  1. Can you just summarise all that? The basic problem is that the Tobacco Control Act was set up to do something completely different – opposite in fact – to what consumers and public health need for e-cigarettes. The FDA has to apply it and can’t do that much with it – even if it wanted to, which is far from clear. This form of regulations creates really high barriers to entry (suits the cigarette trade); puts a brake on innovation (suits the cigarette trade); will dramatically reduce competition in the e-cigarette industry (suits the cigarette trade); and favours the e-cigarette business model favoured by the tobacco industry – bricks and mortar high volume simple products (suits… ).

Deeming regulation final rule announced

On 10 May 2016, FDA announced the long-awaited rule and related guidance, officially published 10 may 2016.

Commentary

My 2014 submission to FDA: Critical commentary on the public comments on the FDA deeming rule submitted by UCSF faculty and fellows – in which I focus on countering the multiple highly misleading submissions from Professor Glantz and his team at UCSF.

Reaction from the industry and legitimate public health advocates was swift and withering….

A good summary by Mike Siegel on the cases brought by various litigants as of June 2016.

1. Nicopure Labs 

2. Right to be Smoke-free Coalition

The Nicopure Labs and Right to be Smokefree Coalition cases have been joined in the District Court of Washington DC.

Plaintiffs’ case

Amicus Curiae briefs

These are briefs submitted by ‘friends of the court’ that add a further perspective for the benefit of the court. The following were filed support of the plaintiffs on 5 August 2016.

The following were filed in support of the FDA

FDA response

Plaintiffs’ response to FDA’s defence

3. Lost Art Liquids 

4. Larry W. Faircloth (State Representative West Virginia)

17 comments to Bluffer’s guide to FDA regulation of tobacco and nicotine products

  • […] as Clive Bates explains, this really ties their hands in terms of what they can do. The Tobacco Control Act didn’t have […]

  • […] A recent article in the New York Times (A Lobbyist Wrote the Bill. Will the Tobacco Industry Win Its E-Cigarette Fight?) falsely suggested that opposition to FDA’s deeming rule for e-cigarettes is all about tobacco industry interests. It quoted Mitch Zeller of the FDA on the e-cigarette industry. Zeller is the federal official responsible for regulation of vaping and tobacco products in the United States (see my Bluffer’s Guide)…. […]

  • […] a more in-depth breakdown of the FDA’s deeming regulation, check out the Counter-Factual as Clive Bates went into a great deal of detail, especially considering that the British Government […]

  • […] entre 1 500 et 5 000 heures de travail pour les nouveaux produits et coûtera environ 335 000 $, selon Clive Bates. On peut légitimement craindre un gel du marché de la […]

  • […] Bluffer’s guide to FDA regulation of tobacco and nicotine products – A month before final publication, but accurate enough. […]

  • Zanderzan

    I chain-smoked heavily since 1989 until 3-almost 4 years ago now, and it almost killed me. This caused serious problems in time, of course and I even almost lost my voice, and had my lungs collapse.. E-cigarettes saved my life, and have permitted me to keep lowering my dosage of nicotine until I am almost off entirely. They are virtually odorless and leave no residue, nothing is burned, only atomized like an ultrasonic humidifier. I have my singing voice back, my blood pressure and heart rate are back to normal, and the doctors can’t even tell that I Ever smoked as my lungs are clear. I feel wonderful, and most importantly of all.. The house, and me don’t stink, and the dust in the house is down by 90%. I can even use this in the car around my mother who is HORRIBLY allergic to tobacco. I can’t tell you how grateful I am. I would have used them years ago if I had been able to, and can appreciate some.. regulation, to keep certain dangerous products off of the market..

    E-juice should ONLY BE Vegetable Glycerin, Polypropylene Glycol, Pharmaceutical Grade Nicotine, and Food Grade Flavorings.. I also agree that they should prevent children from using the products, but this is Nicotine Replacement Therapy, and I would have definitely died well, well, well before my time without it. The Human Body Runs On Glycerin BTW.

    I am one of those people who began smoking because I have a very particular physical condition that affects about 3% of smokers concerning why we started.. Ever so slightly low blood pressure.. The doctors can’t give us anything for it, and all the other stimulants don’t work, or are hazardous, and/or both. I tried so many things to keep from nodding off in the middle of meetings, and in college classes, and the like.. then came tobacco.. I knew it was dangerous and contained over 500 toxins including cyanide and formaldehyde, and more, ( It is a relative of Belladonna after all and the only good thing in it IS.. the Nicotine ), but it worked for many years until my body broke down.. E-cigarettes are so very clean, and it was easy to get off of actual tobacco, something I though I would never be able to do.

    Batteries and mods should be limited to the safer, electronic models, with full digital control and self terminating features that are not guilty of exploding, or burning up.. I have had no problems with mine because I use quality products of this type.. Manual mods that can’t be turned off are dangerous.. again, a case for PROPER regulation. One again.. I can’t say thanks enough for this product… and ask the government to listen to all of us behind this debacle caused by foolish people who believe all the hype, and never research anything or listen, and behind greedy companies who want to cause prices to soar so they may gain a monopoly over every facet of people’s lives, especially their pocketbooks.

    Folks have been trying to get rid of tobacco for years now.. E-cigarettes are the way to do it.. Humanity has been smoking since the beginning.. The best way to eliminate the hazards and the STINK of it is to provide us with something that doesn’t’ smell, and isn’t toxic to the neighbors, so to speak, and won’t kill us to use it.. I ask people from time to time, does my house smell OK? They always reply. I can’t smell anything but fresh, and clean… your house smells nice. This is definitely a move in the right direction. I can also understand certain rules for the sake of propriety and politeness, since humanity is given to such excesses.

    We have to set ground rules, but they must not be excessive or absolutely ridiculous.. Right now? all this fiasco has cause people to even believe that e-cigarettes BURN.. the juice.. which is absolutely, and totally untrue. I know so many people who every day speak of stopping smoking and wanting to stop.. This.. is the way.. to do it.. We can remove all tobacco from the shelves and clean up the air and our lives in time with this method.. given time, and reasonable thinking and practice, and proper education. Imagine… just imagine.. one day nobody smokes that filthy stuff anymore.. and the industry still makes money.. Two birds with one stone. Here is one more factoid from my personal experience…

    This actually costs me.. more per month.. because I used to roll my own, and only spent a small amount each month on tobaccoand papers, but I don’t’ care! I have my life back!!! and it is better than ever.. and I feel and smell clean. I don’t care that it costs me more.. It’s worth it… to be able to stay off of that filthy stuff and one day see the time when I am free… totally free of it.

    Big Tobacco is in on the development of this product, and sees the writing on the wall at last… I know people who’s family members work for RJ Reynolds in the very departments that are making sure this is done properly, and they fought it at first.. Half of the medical community is mad because it is taking a bite out of their profits from our suffering that we force upon ourselves behind tobacco.. That’s just too darn bad.. They make trillions off of the ridiculous, HEATHEN prices they charge for their services anyway.. Enough is enough people!! They know it works and refuse to admit it to the extent of concocting stories and out right LIES… so this garbage make keep rolling around, and rolling around until stupid, and ignorant, insalubrious decisions come to pass.. While they get to fill their bank accounts on other’s sufferings.. That’s just WRONG~! The other half knows it works and is glad of it, as they actually CARE, about their patients. Please folks… stand your ground, and let’s plant this tree..

    Namaste…

  • Teri Malaski

    I’m no-one special or a member of any regulatory office but I do have a comment on why these products are important to us small people in the world… I have e MS, and I had smoked cigarettes since I was about 14 years old because it “was cool”, and because my dad and others did… I tried to stop smoking many, many times with no success… I did stop for about three weeks and found that I was in “more pain” than I was when I was smoking… I asked my neurologist about this, and she stated that a number of patients that were non-smokers with MS started smoking and found that they had less pain when they smoked… Shortly after is when e-cigarettes came out, and then e-vapes… I tried that instead of cigarettes and am still using these products to this day. I thank whoever came out with these products because they have helped me with my pain management and it’s sooooooo much better than smelling like an ashtray!! Thank you.

  • Anonymous

    Desperate stuff here:

    http://www.independent.co.uk/life-style/health-and-families/health-news/promoting-e-cigarettes-to-stop-adults-smoking-is-encouraging-young-people-to-vape-a6984671.html

    “Young people who recalled seeing e-cigarettes in small shops were more likely to have used the products in the past “

  • […] Clive Bates: Bluffer s guide to FDA regulation of tobacco and nicotine products (comprehensively describes the TCA and FDA s deeming ban, Godshall comments) http://www.clivebates.com/?p=3857 […]

  • Bill Godshall

    If/when a Final Rule for the Deeming Regulation is issued, lawsuits will be filed against the FDA.

    The federal courts could strike down the Deeming Regulation on many grounds, including:
    – FDA’s failure to consider the huge “black market” the rule would create (which the TCA requires for all newly proposed tobacco regulations),
    – FDA’s absurdly low estimate of the costs to submit a PMTA,
    – FDA’s absurdly low estimate of the number of products affected by the rule,
    – FDA’s failure to acknowledge the Deeming Regulation protects the leading cause of death (cigarettes), and threatens the lives of millions of vapers and tens of millions of cigarette smokers.

  • Bill Godshall

    Please note that the TCA was secretly negotiated and agreed to in 2003/04 by Philip Morris lawyers and executives, by Big Pharma financed Matt Myers at CTFK, and by GlaxoSmithKline lobbyist Mitch Zeller.

    The reason why the grandfather date (which was originally set at 2003 in the original 2004 TCA bills) was included in the legislation was to protect PM’s Marlboro cigarette monopoly and GSK’s nicotine gum/lozenge/patch from future market competition by newly introduced cigarette and/or smokeless tobacco products (by making it extremely expensive and probably impossible for any new cigarette or smokeless tobacco product to be introduced via a PMTA). CTFK (and its partners ACS, AHA, ALA) strongly supported (and still support) the grandfather date because they vehemently oppose the introduction of any new tobacco or nicotine product onto the market (even if the new product is 99% less harmful than cigarettes).

    Another provision of the TCA agreed to by PM, CTFK and GSK in 2003/04 was to require significantly larger false and misleading warning labels on all advertisements for smokeless tobacco products stating “This product is not a safe alternative to cigarettes”, “This product may cause mouth cancer”, and “This product may cause tooth loss and gum disease.”

    PM, CTFK and GSK also wanted the Modified Risk Tobacco Product provision included in the TCA to ban smokeless tobacco companies from truthfully marketing their products to smokers as less harmful alternatives to cigarettes (also to protect PM’s Marlboro monopoly and GSK’s nicotine gums, lozenges and patches from market competion by smokeless tobacco products).

    That’s also why Swedish Match and United States Smokeless Tobacco Company vehemently opposed the TCA until 2007 (when PM bought USSTC, and when Swedish Match agreed to support the TCA in exchange for Waxman altering the TCA to allow for the sampling of smokeless tobacco products in certain adult locations.

    In sum, a primary goal of CTFK’s Matt Myers and GSK’s Mitch Zeller (when negotiating the TCA with PM, and subsequently lobbying Congress to enact it into law) was to protect cigarettes and GSK’s NRT products from market competition by smokeless tobacco products.

    At the time of the negotiations, I repeatedly informed Myers and Zeller that the TCA they were negotiating (as I had all early drafts of the legislation) protected cigarettes and threatened the lives of 45 million smokers, while doing virtually nothing to reduce cigarette smoking.

    Their response was to stop communicating with me, to cut the legislative deal with PM, and to then aggressively lobby Congress to enact the TCA by falsely claiming it was necessary to protect children from Big Tobacco and to protect public health.

    In 2009, FDA banned all e-cigarette imports after lobbying by Sen. Lautenberg (the leading recipient of Big Pharma funding in US Congress), by Big Pharma financed CTFK, ACA, AHA, ALA, AAP, and by Legacy. Ironically, FDA and all of those groups insisted (in multiple filings with the Federal Court, and in multiple press releases) insisted that e-cigarettes were NOT tobacco products.

    When proposing the Deeming Regulation in 2014, the FDA exempted large premium cigars (but not less harmful e-cigarettes) from many of the disastrous provisions (including the PMTA and MRTP clauses) in Chapter IX of the TCA. The agency could/should have similarly exempted vapor products from those Chapter IX provisions (and can still do so in the Final Rule), but the agency’s goal under the leadership of Mitch Zeller was/is to BAN vapor products.

    In its proposed Deeming Regulation, the FDA estimated (reasonably in my view) that 25 PMTA’s would be submitted to the FDA for new e-cigarette products before the agency’s blanket ban on e-cigs goes into effect 24 months after issuance of the Final Rule.

    The FDA even estimated that the Deeming Regulation would ban >98.5% of e-cigarettes products on the market, but FDA inaccurately estimated that there were only 1,675 different e-cigs on the market. Had the FDA realized that several thousand vape shops have already manufactured more than 1,675 different e-cig products (according to the TCA’s definition of “tobacco product”), the agency would have correctly estimated that the Deeming Regulation would ban >99.99% of nicotine e-cigarette products.

    The FDA also inaccurately estimated that it would cost just $335,000 to submit each PMTA for a new vapor product. In reality, it will costs many millions of dollars, and probably tens of millions of dollars to submit a PMTA to the FDA (that the FDA formally accepts for consideration, something the agency didn’t do for 4 other PMTA’s that were already submitted for cigarettes or smokeless tobacco products).

    So while the FDA (and other DHHS agencies), hundreds of DHHS funding recipients, and dozens of Big Pharma funding recipients have (since 2011) repeatedly claimed the Deeming Regulation is necessary to protect children an public health, they’ve been fully aware that the deeming regulation protects cigarettes and NRT products, and threatens the lives of millions of vapers and tens of millions of cigarette smokers.

    The FDA Deeming Regulation is the worst case of scientific fraud and public health malpractice in US history.

    In 2013, I and 25,000+ vapers submitted Petition to the White House to
    “Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids” at
    https://petitions.whitehouse.gov/petition/prevent-fda-regulating-or-banning-sale-and-use-electronic-cigarettes-accessories-and-associated/RQLBYRsd

    On the day in April, 2014 when FDA proposed the Deeming Regulation, FDA’s Mitch Zeller responded to our White House petition by falsely claiming:
    “While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them.”

    So not only has Obama’s FDA knowingly and intentionally lied about e-cigarettes since 2009, the agency has also lied (since 2011) about the disastrous ramifications of the Deeming Regulation, which I first revealed back in December, 2011 at
    https://www.e-cigarette-forum.com/forum/threads/fda-may-soon-propose-regulation-that-could-ban-many-most-e-cigarette-products-eliminate-many-most-companies.244558/

  • John walker

    Clive
    Australia has a system: a office of ‘ regulatory best practice’ ,and a requirement for regulatory impact statements (RIS) ,which sounds similar to the U.S. Problem is that regulations can be exempted from RIS by PM and cabinet and departments can also (and at times do ) simply not meet the requirement re cost benefit and market distortion statements-studies, with no aparent adverse consequences for them.
    (In fact some of the worst, decisions, regulations of the past eight years have involved things that were either exempted from the RIS requirements or quite simply did not bother to comply .)

    What’s the situation in the US like?

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