A recent editorial in the journal Tobacco Control discusses what’s wrong with the FDA. In fact, the editorial is more telling about what’s wrong with tobacco control.
Update: my e-letter in Tobacco Control – Missing the point
The President of the Campaign for Tobacco-Free Kids, Matthew L. Myers – arguably the de facto world leader in tobacco control advocacy – appears to believe that the main problem with the FDA is that it is not doing enough to prevent new niche cigarette products reaching the market. See this Tobacco Control editorial by Myers: Towards more effective FDA premarket review of new tobacco products.
This singular focus of concern is absurd, given several thousand cigarette products are readily available and largely untroubled by any intrusive FDA intervention. I’ve no great desire to see new cigarette products coming on the market, but is this really the most pressing agenda?
Myers’ approach was nicely satirised by Mike Siegel writing in 2015 in his blog Campaign for Tobacco-Free Kids Touts Major Victory: Camel Crush Bold Taken Off the Market. Siegel points out that FDA blocking one Camel variant left only 24 Camel variants for smokers still to choose from. Also, this approach implicitly promotes the idea that there are good cigarettes (approved by FDA) and bad cigarettes (banned by FDA), which has the obvious potential to backfire.
But far worse is what Myers just ignores. No word in his editorial on any of the following, which really are important issues for FDA/Congress to address…
- FDA’s governing framework for tobacco, the Tobacco Control Act, is unfit for the purpose of managing reduced risk products. It is designed to raise a high regulatory barrier to entry to the recreational nicotine market and to suppress innovation in the tobacco and nicotine field. At the same time, it protected the existing cigarette trade by grandfathering the thousands of products that were on the market at 15 Feb 2007 and offering them an easy ride for subsequent modifications. A new Nicotine Act is needed in which the silly pretence that e-liquids are tobacco products can be abandoned, and meaningful, consumer-orientated, proportionate and non-discriminatory regulation introduced, recognising a spectrum of risks and the significant risk discontinuity between combustible and non-combustible products. I’m not even sure that FDA is culturally the appropriate agency to take this on.
- FDA is unlikely to offer a sensible route to market for vapour products and will cause chaos. Despite the widespread beneficial effects these products are having, there are no scenarios in which FDA’s involvement improves matters and many in which it creates more harmful unintended consequences [see my Bluffer’s guide to FDA regulation]. The vapour category would be largely wiped out and confined to the tobacco industry’s high volume commodity products if FDA proceeds on its present course, with CTFK’s backing. That would provide further protection for the cigarette trade and stimulate a black market. I suspect the anticipated carnage is a feature rather than a flaw for most tobacco control activists. For example, CTFK vehemently opposes a shift of the ‘predicate date’ of 15 Feb 2007 that would postpone and partially ameliorate the forthcoming chaos FDA is likely to cause in the e-cigarette industry. The real priority is to find a reasonable workaround, or simply leave the deeming regulation on a shelf because there isn’t actually a problem that FDA is capable of solving under the existing legislation. “Do nothing” is actually the least-worst strategy available to FDA now – it would be good if CTFK could get behind “do nothing”.
- FDA’s approach does little that supports and a lot that suppresses innovation, regardless of whether particular innovations are desirable for consumers. For example, under the proposed framework for vapour products to access the market, a third generation e-cig manufacturer would likely need to go through a new and massively burdensome authorisation (PMTA) to introduce new safety features like temperature control or to improve nicotine delivery through better aerosol science. Who benefits from barriers to them doing that? A better approach would be notification regime, with FDA having a right to intervene if it has evidence-based grounds for concern. This would be much better than an authorisation regime deliberately designed to be cumbersome.
- FDA applies a completely ridiculous approach to communicating the far lower risk of products like snus to consumers. We can be pretty sure that snus is about 98-100% less risky than smoking, and one might expect that knowledge to be relevant to consumers. The approach to communicating this (MRTP) starts from a default FDA-imposed highly misleading and harmful warning (“this product is not a safe alternative to smoking“), and then requires tobacco companies to calculate if they are rich enough, the data expansive enough and whether it is sufficiently in their commercial interest to go through an arduous process to convince the FDA to allow them to change the warning to something more truthful (“No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes“). They have to do this facing hostile opposition all the way from CTFK and its allies, a legal consortium and FDA’s own scientific advisers, who display appalling bias and group-think. Why not have risk communication driven by consumer interests rather than tobacco company interests – and put the onus on the FDA to accurately gauge relative risk and ensure messaging from itself and CDC align public risk perceptions with reality?
- FDA suffers from mission creep – a regulator should not get involved in campaigning. This week, FDA launched a highly misleading campaign on smokeless tobacco to add to its anti-scientific Real Cost campaign for adolescents – see Brad Rodu’s devastating critique. FDA should function, and be seen to function, as a neutral technocratic regulatory agency, leaving the hype to public health bodies like the CDC (at least there would then be only one of them). In this case, there is a further problem – the scientific foundations of the smokeless campaign are feeble and undermine FDA’s credibility more generally. The @FDAtobacco twitter feed is habitually misleading and should be closed down or repurposed to focus on regulatory science.
I really despair: CTFK and Matt Myers could embrace the science, open their minds, show real leadership and get to work on this agenda. They could make a real difference. Instead, they are wasting their people’s time, their funders’ money and their organisation’s credibility on things that barely matter to anyone but an insular circle of activists.
Further reading
Counterfactual: Bluffer’s guide to the FDA regulation of tobacco and nicotine products – my crib sheet on how it all works, and why it doesn’t.
Counterfactual: 10 ways to improve Matt Myers’ letter to the New York Times – on Matt Myers’ difficulties with the evidence and science of tobacco harm reduction.
Joel Nitzkin: What drives tobacco control policy? – a concise account of the strange belief system that appears to underpin the FDA’s approach to tobacco and nicotine.
Your last paragraph Clive. Actually they are drawing out their jobs. (Like a building contractors do)
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Since 1997, Matt Myers (and Mitch Zeller) have done far more to protect cigarette markets (and threaten the lives of smokers) than have cigarette company executives, lobbyists, lawyers and advertisements ALL combined.
What’s amazing is Myers has continued to dupe and deceive large health and medical organizations, most of the public health community, left wing Democrats, and the news media to believe that he and CTFK are public health advocates who want to reduce cigarette smoking.
In 1997/98, Myers lied about and lobbied Congress to enact the Global Tobacco Bailout that would immunize cigarette companies from pending and future lawsuits. Had Myers prevailed then, hundreds of injured smokers’s would have been denied their right to seek legal redress against cigarette companies.
In 2001, Myers and GSK protected cigarettes by petitioning the FDA to ban very low risk tobacco lozenges made by Star Scientific, as well as other very low risk smokefree nicotine product alternatives.
Then, Matt Myers, Mitch Zeller and Philip Morris negotiated, agreed to, and lobbied US Congress to enact the TCA (from 2003-2009) because it imposed the grandfather date (banning all new low risk tobacco products) and the MRTP provision (banning smokeless tobacco companies from truthfully informing smokers that smokeless is less harmful than cigarettes).
Myers and Zeller (and Waxman/Kennedy) ensured that the TCA also protected cigarettes by prohibiting FDA from banning the sale of cigarettes to 18 year old 12th grade high school students, whom Myers and Zeller feign concern about, and by expanding false and misleading warnings on smokeless tobacco products to discourage smokers from switching.
From 2009-2011, Myers protected cigarettes by urging FDA to unlawfully ban all e-cigarettes, and then filed multiple briefs with the appeals court defending FDA’s unlawful e-cig ban.
Since 2011, Myers and Zeller have been lying to and lobbying the White House, Congress and the American news media to impose the deeming regulation because it protects cigarettes by banning all nicotine vapor products (and most hookah, pipe tobacco and cigars).
In sum, during the past fifteen years, Matt Myers (and Mitch Zeller) have done far more than cigarette companies to protect cigarettes and threaten the lives of smokers.
Such a shame, especially since I’ve informed Myers weekly since 1997 how his anti THR policies and claims protect cigarettes. I’ve similarly informed Mitch Zeller hundreds of times since 2003 that his TCA protects cigarettes, and since 2011 that his Deeming Ban protect cigarettes.
Clive a bit off topic, but relevant
have you read this ?
https://www.newscientist.com/article/mg23030690-500-why-so-much-science-research-is-flawed-and-what-to-do-about-it/
CTFK is a front lobby group for the Robert Wood Johnson Foundation (RWJF) who founded them and RWJF are a front lobby group for Johnson & Johnson Pharmaceutical Company. So don’t expect CTFK to change its stance any time soon.
Other funders and coalition lobby groups of CTFK are ACS, AHA, AMA and ALA, amongst many others and pharma has a foot in the door of all of them. They have advocated for regulation of tobacco products by the FDA and they all promote pharma’s products. As do people like Stan Glantz who is funded by the FDA and RWJF.
Pharma’s influence: Health Canada blocked quit-smoking aid after Pfizer complaint http://www.theglobeandmail.com/news/national/court-rules-health-canada-unfairly-blocked-quit-smoking-aid-after-pfizer-complaint/article29707496/
Below is a comment I read by FXR on Michael Siegel’s blog: A Lie A Day: Campaign for Tobacco-Free Kids Wrongly Accuses Tobacco Companies of Marketing Gummy Bear E-Cigarettes http://tobaccoanalysis.blogspot.co.uk/2016/04/a-lie-day-campaign-for-tobacco-free.html
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FYI “anti nicotine groups” described herein, are criminal in nature and past deeds. Defective and dangerous, by design.
“Intellectual and artistic creativeness can be imperiled by the quality of sameness imposed on us when standards of thought and form are delivered into the hands of a few businessmen.”
http://www.duhaime.org/LegalDi…
“Antitrust laws apply to virtually all industries and to every level of business, including manufacturing, transportation, distribution, and marketing. They prohibit a variety of practices that restrain trade, such as price-fixing conspiracies, corporate mergers likely to reduce the competitive vigor of particular markets, and predatory acts designed to achieve or maintain monopoly power.”
“The Sherman Antitrust Act
… outlaws all contracts, combinations and conspiracies that
unreasonably restrain interstate and foreign trade. This includes agreements among competitors to fix prices, rig bids and allocate customers.
“The Sherman Act also makes it a crime to monopolize any
part of interstate commerce. An unlawful monopoly exists when only one firm controls the market for a product or service, and it has obtained that market power, not because its product or service is superior to others, but by suppressing competition with anti-competitive conduct.
“The Act is not violated simply when one firm’s vigorous competition and lower prices take sales from its less efficient competitors—that is competition working properly.”
https://en.wikipedia.org/wiki/…
“The Racketeer Influenced and Corrupt Organizations Act, commonly referred to as the RICO Act or simply RICO, is a United States federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization. The RICO Act focuses specifically on racketeering, and it allows the leaders of a syndicate to be tried for the crimes which they ordered others to do or assisted them in doing, closing a perceived loophole that allowed a person who instructed someone else to, for example, murder, to be exempt from the trial because he did not actually commit the crime personally”
The FDA know how safe nicotine is. Regarding a change of labelling for OTC NRT, they gave approval for long term and concomitant use of nicotine replacement therapies, with other nicotine containing products, including cigarettes, with no concerns for safety or abuse (addiction).
https://www.federalregister.gov/articles/2013/04/02/2013-07528/modifications-to-labeling-of-nicotine-replacement-therapy-products-for-over-the-counter-human-use
One group were given access to gum for up to five years, with no problems and this was accepted by the FDA as evidence and I believe in the 1980s patches were only studied for five years before being placed on the market. Obviously, there’s a difference in that vaping is inhaling, but it’s been on the market for over 10 years with no known harms, studied for several years and clearly it must be compared with smoking, where particles are solid, whereas vaping is droplets.
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Former Commissioner, Dr. Margaret Hamburg, Charged In Federal Racketeering Lawsuit
http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/
Maybe this will give the FDA pause for thought about destroying the independent vapouriser market, which will protect the smoking economy and tobacco and pharma’s profits and share prices.
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This article is also related to the topic of how well FDA is regulating vapor products: http://dailysignal.com/2016/07/05/5-myths-about-fdas-regulation-of-vapor-products/